(175 days)
The TYRO™-97 (hofocon A) and ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.
The lenses may be disinfected only by using chemical disinfection
The TYRO™ 97 (hofocon A) Rigid Gas Permeable lens material, hofocon A, is a polymer of trifluoroethyl methacrylate and silicone methacrylate, with no methyl methacrylate. The blue tinted lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and Cl Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, [ 2-(2'-hydroxy-5'-methacryloxyethylphenyl)-2H-benzotriazole. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.
The ONSI™-56 (onsifocon A) Rigid Gas Permeable lens material, onsifocon A,is a polymer of trifluoroethyl methacrylate polymer with tris (trimethylsiloxy) methacryloxypropylsilane 3trimethoxysilylpropylmethacrylate methacrylic acid 1,3-bis(3methacryloxypropyl)tetrakis(trimethylsiloxane ethylene glycol dimethacrylate 2-hydroxyethyl methacrylate N-vinylpyrrolidone.
The blue tinted onsifocon A lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and Cl Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, { 2-(2'-hydroxy-5'methacryloxyethylphenyl)-2H-benzotriazole. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.
Here's a breakdown of the acceptance criteria and the study information for the TYRO™-97 and ONSI™-56 Rigid Gas Permeable Contact Lenses, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for these devices are based on demonstrating substantial equivalence to existing legally marketed predicate devices. This is achieved by comparing several key physical properties of the new contact lens materials (hofocon A and onsifocon A) to those of the predicate devices (BOSTON ES, BOSTON EO, and BOSTON XO).
Table of Acceptance Criteria and Reported Device Performance:
| Property | Acceptance Criteria (Predicate Devices: BOSTON ES, BOSTON EO, BOSTON XO) | TYRO™-97 (hofocon A) Performance | ONSI™-56 (onsifocon A) Performance |
|---|---|---|---|
| Water Content | 85% to >92% (ranges of predicates) | Clear >95%T, Blue >70% T, Green >70% T | Clear >95% T, Blue >70% T, Green >70% T, Grey >70% T, Blue-violet >70% T, Blue-UV >70%T(400-780nm) |
Study Information:
The document describes a 510(k) Premarket Notification process, which relies on demonstrating substantial equivalence to predicate devices rather than independent clinical trials for new materials per se.
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Sample size used for the test set and the data provenance:
- The document does not explicitly mention a "test set" in the traditional sense of a clinical trial for evaluating the performance of the new devices against specific acceptance criteria. Instead, it relies on bench testing of the material properties to justify substantial equivalence.
- Therefore, the sample sizes for the material property tests (e.g., number of lenses tested for oxygen permeability, hardness) are not specified in the provided text.
- The data provenance for the reported performance values (e.g., Oxygen Permeability of 97 ANSI units for hofocon A) is from laboratory testing of the new materials (hofocon A and onsifocon A). The location or context of these labs is not given, nor is it specified if this was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in this context. The "ground truth" for the material properties is established through standardized physical and chemical testing methods (e.g., Fatt Method for oxygen permeability, sessile drop method for wetting angle, Shore Hardness for hardness). These are objective measurements, not subjective expert assessments.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. There is no "adjudication" in the sense of resolving discrepancies between expert opinions, as the evaluation is based on objective material property measurements.
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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:
- This is not applicable. This submission is for rigid gas permeable contact lenses, which are physical medical devices, not AI-powered diagnostic tools. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This refers to a medical device's algorithm performance, which is not relevant for contact lenses.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- As mentioned above, the "ground truth" for the performance claims (which are material properties) is established through standardized physical and chemical laboratory testing measurements. The document explicitly lists methods like "Fatt Method" for oxygen permeability and "sessile drop method" for wetting angle.
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The sample size for the training set:
- This is not applicable. This submission is for physical medical devices (contact lenses), not a machine learning algorithm that requires a training set.
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How the ground truth for the training set was established:
- This is not applicable for the same reason as point 7.
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.