AMO Catalys OptiMedica, Руководство оператора

Страница: 30 / 314

Chapter 2 System Overview
Page 30 of 314 Part Number: 0160-6411, Rev A, 02/2019
Software Release: cOS 5.00
2.3 Bench Testing
Bench testing of the CATALYS® System was conducted to demonstrate the OCT sub-system's
ability to measure depth, surface profiles and iris diameters with accuracy and precision. Various
test article substrates of known dimensions were measured multiple times by the system's OCT
sub-system. All OCT-measured values met the test protocol acceptance criteria of ±40µm for all
thicknesses and diameters, and ±1% for all surface radii. This testing verifies that the OCT
subsystem of the
CATALYS® System can measure depth, surface profiles and diameters
accurately and precisely.
Bench testing of the CATALYS® System was also conducted to demonstrate the system's ability
to deliver a variety of laser patterns intended for capsulotomy or phacofragmentation with
corresponding accuracy and precision. In this test, all laser parameters, such as spot spacing,
depth spacing and pulse energy, were bracketed to assess the full capability of the system.
Additionally, the system's entire suite of capsulotomy and phacofragmentation patterns was
similarly bracketed to test the full spectrum of physician-selectable pattern variations. Multiple
samples for a given test pattern were created in a test substrate that was subsequently cross-
sectioned and measured using a NIST-traceable reticule, under magnified digital image analysis.
All measured values met the test protocol acceptance criteria of ±100µm relative to the
intended cut dimensions. The spectrum of pattern testing validated the system capability to cut
a variety of capsulotomy and phacofragmentation patterns within specified limits for accuracy
and precision.
Bench testing of the CATALYS® System was conducted to demonstrate the system's ability to
deliver a variety of laser patterns intended for corneal incisions with corresponding accuracy and
precision. In this test, the system's entire suite of corneal incision patterns was bracketed to test
the full spectrum of physician-selectable pattern variations. Multiple samples for a given test
pattern were created in a test substrate that was subsequently cross-sectioned and measured
using a NIST-traceable reticule, under magnified digital image analysis. All measured values met
the test protocol acceptance criteria of ±75µm relative to the intended cut dimensions. The
spectrum of pattern testing validated the system capability to cut a variety of single plane and
multi-plane arc cuts/incisions patterns within specified limits for accuracy and precision.
2.4 Animal and Cadaver Testing
Animal testing was performed to demonstrate retinal and corneal safety. The irradiance levels
on the corneal endothelium and retina ranged between 16x-64x greater than the levels allowed
in clinical use. Histology samples were collected and analyzed for possible damage
retrospectively. The results showed that no damage occurred. Additional animal testing was also
conducted to establish the strength of the lens post-capsulotomy. The results demonstrate that
the
CATALYS® System-created capsulotomies are stronger than the capsulorrhexis created by
standard continuous curvilinear capsulorrhexis (CCC) surgical technique.
Animal testing was also performed to demonstrate corneal safety. In this test, laser-created
corneal incisions and standard manual surgical incisions histology was compared. The laser
parameters selected for this performance testing represent a worst case type evaluation, using