(148 days)
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No
The summary only describes toxicology and irritation testing, which are standard biocompatibility tests for medical devices, particularly those in contact with the body like contact lenses. There is no mention of any computational or analytical functions that would suggest the use of AI/ML.
No
The provided text only contains toxicology and irritation test results for a material intended for contact lenses, which are corrective or cosmetic devices, not therapeutic ones. There is no information indicating any therapeutic claims or intended use.
No
The provided text describes toxicology and irritation tests for a contact lens material (PMMA) intended for use in the eyes. These tests determine the safety and biocompatibility of the material, not its ability to diagnose medical conditions.
No
The summary describes toxicology and irritation tests on physical materials (PMMA contact lens buttons), indicating the device includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Lack of IVD characteristics: The description focuses on toxicology and irritation testing related to contact lenses (implied by "PMMA contact lens buttons" and "eyes"). These tests are evaluating the biocompatibility and safety of a material or device that comes into contact with the body, not a diagnostic test performed in vitro on biological samples to diagnose a condition.
- No mention of diagnostic purpose: There is no indication that this device is used to analyze biological samples (like blood, urine, tissue) to provide information about a patient's health status or disease.
- Performance studies are not diagnostic: The performance studies described (Systemic Injection Test, Primary Eye Irritation Test, Cytotoxicity) are all related to the safety and biocompatibility of a material, not the diagnostic accuracy of a test.
Therefore, based on the available text, this device appears to be a medical device intended for contact with the eyes (likely a contact lens or related material), and the testing described is for its safety and biocompatibility, not for in vitro diagnostic purposes.
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Intended Use / Indications for Use
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Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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0
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.
1
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.