(83 days)
The Preference® standard, CooperHTM, CooperHTM, CV 43™, Vantage® and Vantage® Accents (tetrafilcon A) Hydrophilic Contact Lenses are indicated for the correction of visual accity by nowabnake persons with non-diseased eyes that are myopic or hyperopic. The lenses can be worn by persons who exhibit astigmatism of 2.50 diopters or less that does not interfere with visual acuity.
The Preference Toric ™ and Cooper Toric™ hydrophilic contact lenses are indicated for daily wear use by not anhake persons with non-diseased eyes that are myopic or hyperopic, who exhibit astigmatism up to 9.00 diopters and can obtain satisfactory visual acuity, in a spherical range of -20.00 to +12.00.
All tetrafilcon A Soft (hydrophilic) Contact Lenses are hemispherical shells and are available as a spherical or astigmatic lens. When placed on the cornea, the hydrated lens acts as a refracting medium to focus light rays on the retina.
The lens material is a hydrophilic random terpolymer of 2-hydroxyethyl methacrylate, N-vinylpyrrolidone and methylmethacrylate joined in a three dimensional network of terpolymer chains by divinylbenzene cross links.
When produced with a handling or enhancement tint, the lens is coupled with one or more of three dye moieties through the use of varying combinations and concentrations of C.I. Reactive Blue 163, Yellow 86, and Red 22. Lenses with a handling tint are tinted blue on the surface of the lens. The handling tint increases the visibility of the lens when not worn on the eye. Lenses tinted wit an enhancement tint are tinted on the anterior surface in the shape of an iris. The enhancement tint colors available are Sky Blue, Turquoise, Violet Blue, Spring Green, Auburn and Misty Brown.
The provided text is a 510(k) summary for CooperVision contact lenses. It does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as typically understood in the context of device performance metrics like sensitivity, specificity, accuracy, etc.
Instead, the document details a submission for substantial equivalence based on manufacturing changes. The "Summary of Non-Clinical Tests" section mentions physical and chemical properties testing, but it does not provide specific acceptance criteria or performance results in a way that allows for the construction of the requested table.
Therefore, I cannot fulfill your request for the specific acceptance criteria and study details. The document focuses on showing that the newly manufactured lenses are equivalent to existing ones, rather than establishing initial performance metrics against clinical acceptance criteria.
Here's what I can extract based on the provided text, highlighting the lack of relevant information for most of your points:
1. A table of acceptance criteria and the reported device performance
Cannot be provided. The document does not define specific acceptance criteria (e.g., specific thresholds for water content, light transmittance, etc.) nor does it report the values for these properties that were measured in a performance study against such criteria. It merely states that "Physical and chemical properties testing was performed" and implicitly, that the results were deemed acceptable for substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only mentions "lenses made by Aspect using the alternate manufacturing method."
- Data Provenance: The "lenses made by Aspect" implies a manufacturing site, but no country of origin is explicitly stated for the data itself. The study appears to be for manufacturing equivalence rather than clinical performance from patient data.
- Retrospective or Prospective: Not stated, but likely prospective given it's about newly manufactured lenses.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This document describes non-clinical testing of physical and chemical properties and toxicity. There is no mention of human experts establishing ground truth for a clinical test set.
4. Adjudication method for the test set
- Not applicable. As above, no clinical test set with human adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This document is about contact lenses, not an AI device. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This document is about contact lenses, not an algorithm.
7. The type of ground truth used
- For the non-clinical tests mentioned (water content, light transmittance, refractive index, mechanical properties, toxicity), the "ground truth" would be established by standard scientific measurement methods and predefined material specifications. These are not "expert consensus," "pathology," or "outcomes data."
8. The sample size for the training set
- Not applicable. As this is not an AI device, there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable. As this is not an AI device, there is no concept of a "training set" or its ground truth.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.