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I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance as requested in the prompt. The document describes toxicology tests, eye irritation tests, and cytotoxicity tests for a contact lens material, along with design specifications and a comparison to a predicate device. However, it does not provide details like a table of acceptance criteria vs. reported performance, sample sizes for test sets, expert qualifications for ground truth, adjudication methods, details of MRMC or standalone studies, or ground truth establishment for training and test sets.
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Image /page/0/Picture/0 description: The image shows a logo for Rand Scientific Corporation on the left side of the image. The date "MAY 16 1996" is printed in the center of the image. On the right side of the image, the text "K955777" is circled, and the word "TRANS/AIRE" is printed below it.
4135 Northgare Blvd , Suite 9 . Sacramento, CA 95834 . 800/RPG Phone: 916/921-5535 · Fax: 916/921-5927 · 800/747-8439
SUMMARY OF SAFETY AND EFFECTIVENESS A.
1. TOXICOLOGY
USP SYSTEMIC INJECTION TEST
Clinical Observations: No toxic signs were observed during the 72 hour observation period.
Weights: All animals gained weight during the test.
Conclusion: This test material met the requirements of the USP Systemic Injection Test, using the extracting medial.
2. USP PRIMARY EYE IRRITATION TEST
EYE IRRITATION STUDY: No irritation was observed during the study period. Clinical Observations: All animals remained healthy throughout the study period.
Conclusion: The test material produced no irritation response in the eyes of the New Zealand rabbits.
B. CYTOTOXICITY - AGAR DIFFUSION
Results: There was no reactivity with the tinted or clear PMMA contact lens buttons.
Conclusion: These samples meet the requirements of USP 23 and ISO 10993-5 for this Cytotoxicity Test.
- C. The spherical contact lens design will have a sphencal front and back surface. The base curve (back surface) will contain one or more spherical curves on the periphery of the lens which will have a longer radius of curvature than the central section (optic zone)
- D. The low eccentricity aspheric contact lens will have a spherical front surface and an aspherical back surface (base curve). The eccentricity of the base curve will provide design more closely matching the curvature of the cornea. The design may or may not contain peripheral curves.
- E. Contact lenses were manufactured with a variety of prescriptions to demonstrate they could be manufactured. Rand uses ANSI Z80.2 as a standard for all contact lens tolerances.
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STATEMENT OF SIMILARITIES AND DIFFERENCES ド.
CLASSIC PMMA
PREDICATE DEVICE
Polymethyl methacrylate Lathe cut Not gas permeable Less than 2% water content Index of refraction 1.49 Hardness 95 (Shore D)
Polymethy methacrylate and silicone Lathe cut Not gas permeable Less than 2% water content Index of refraction 1.49 Hardness 95 (Shore D)
- G. THE RESULTS OF THE TOXICOLOGY TESTS AND THE FACT THAT PMMA CONTACT LENSES HAVE BEEN MARKETED FOR OVER THIRTY YEARS SHOWS THAT THE PMMA CLASSIC CONTACT LENSES ARE SAFE AND EFFECTIVE FOR THEIR INTENDED USE.
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