(79 days)
Frequency 55 UV and Frequency 55 UV Aspheric lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Frequency 55 UV Toric lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with nondiseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less.
FREQUENCY 55 LENSES WITH UV ABSORBING MONOMER HELPS PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND THE EYE.
Note: Only chemical (not heat) and hydrogen peroxide disinfection systems may be used with Frequency 55 UV lenses.
Frequent/Planned Replacement Wear
When prescribed for Frequent/Planned Replacement Wear, the Frequency 55 UV and Frequency 55 UV Toric lenses are to be cleaned, rinsed and disinfected each time they are removed from the eye and discarded after the recommended wearing period prescribed by the eye care practitioner.
Disposable Wear
When prescribed for Disposable Wear, the wearing time prescribed by the eye care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at each removal.
Frequency 55 UV and Frequency 55 UV Aspheric (methafilcon A) soft (hydrophilic) contact lenses are available as spherical lenses. Frequency 55 UV Toric (methafilcon A) soft (hydrophilic) contact lenses are available as astigmatic (toric) lenses. The lens material, methafilcon A, is a random copolymer of hydroxyethylmethacrylate and methacrylic acid. A benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315 nm and less than 40% in the UVA range of 315 to 380 nm. The lenses are tinted aqua from edge to edge for visibility purposes with the color additives, C.I. Reactive Blue No. 4 and C.I. Reactive Yellow 86.
Frequency 55 UV. Frequency 55 UV Aspheric and Frequency 55 UV Toric contact lenses are hemispherical shells with the following dimensions:
Diameter: 14.0mm to 15.0mm
Base Curve: 8.0mm to 9.5mm
Center Thickness: 0.03mm to 0.60mm (varies with power)
Spherical Powers: -20.00 to +20.00D
Cylindrical Powers: plano to -12.00
Axis: 1° to 180°
The physical/optical properties of the Frequency 55 UV and Frequency 55 UV Aspheric and Frequency 55 UV Toric contact lenses are:
Refractive Index: 1.40
% Transmittance @ 590nm: >90%
% Transmittance @ 280-315nm:
The provided text is a 510(k) Premarket Notification for contact lenses. It describes the device, its indications for use, and a comparison to predicate devices to establish substantial equivalence.
Based on the nature of this document (a 510(k) for contact lenses), it focuses on demonstrating equivalence to existing legally marketed devices, rather than a clinical study evaluating the performance of an AI-powered diagnostic device against specific acceptance criteria in the way you've outlined. Therefore, many of the requested data points (sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or not present in this type of submission.
However, I can extract information related to the device's technical specifications and how they compare to the predicate devices, which serves as the "acceptance criteria" in this context for demonstrating substantial equivalence.
Here's the closest interpretation of your request based on the provided document:
Acceptance Criteria and Device Performance (for Substantial Equivalence)
For a 510(k) submission, "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as a legally marketed "predicate device," without raising new questions of safety or effectiveness. This is done by comparing various attributes. The table below outlines key comparative data presented to establish substantial equivalence rather than explicit "acceptance criteria" in the context of a clinical study.
| Acceptance Criteria (Predicate Device Value) | Reported Device Performance (Frequency 55 UV) | Interpretation / Conclusion |
|---|---|---|
| Lens Material: Methafilcon A (Equivalent) | Methafilcon A | Equivalent |
| Material Classification: Group 4 >50% ionic polymer (Equivalent) | Group 4 >50% ionic polymer | Equivalent |
| Indication: Myopia, hyperopia, and astigmatism (for Frequency 55 UVAM predicate) | Myopia, hyperopia, and astigmatism | Equivalent |
| Water Content: 55% (Equivalent) | 55% | Equivalent |
| Light Transmittance (%) @ 590nm: 94.61% (for Sauflon 55 UV) / 93.58% (for Frequency 55 UVAM) | 94.61% | Within range of predicates |
| UVA region (316-380nm): 36.00% (for Sauflon 55 UV) / 4.09% (for Frequency 55 UVAM) | 36.00% | Matches Sauflon 55 UV, higher than Frequency 55 UVAM, but within acceptable range for UV blocking.* |
| UVB region (280-315nm): 9.41% (for Sauflon 55 UV) / 6.00% (for Frequency 55 UVAM) | 9.41% | Matches Sauflon 55 UV, higher than Frequency 55 UVAM, but within acceptable range for UV blocking.* |
| Dk (35° C): 15.8 x 10-11 (for Sauflon 55 UV) / 14.0 x 10-11 (for Frequency 55 UVAM) | 15.8 x 10-11 | Matches Sauflon 55 UV, higher than Frequency 55 UVAM |
| Powers: +20.00 to -20.00 D (Equivalent) | +20.00 to -20.00 D | Equivalent |
| Tint: Aquamarine (for Sauflon 55 UV) / Clear or Aquamarine (for Frequency 55 UVAM) | Clear or Aquamarine | Consistent with predicates |
| Manufacturing Method: Fully Molded (Equivalent) | Fully Molded | Equivalent |
| Lens Design: Spherical, Aspheric, Back Surface Toric (consistent with predicates) | Spherical, Aspheric, Back Surface Toric | Consistent with predicates |
| Packaging: Blister Pack (Equivalent) | Blister Pack | Equivalent |
*Note on UV Transmittance: The document states "The average transmittance characteristics are less than 10% in the UVB range of 280 to 315 nm and less than 40% in the UVA range of 315 to 380 nm." The reported values are 9.41% for UVB and 36.00% for UVA, which meet these internal specifications. The comparison table shows the Frequency 55 UV matching the Sauflon 55 UV for these characteristics.
Study Information (as applicable for a 510(k) for contact lenses)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable in the context of an "AI test set." The "test" for this device is primarily a comparison of its physical, chemical, and optical properties, and safety (toxicology), rather than a clinical performance study with a patient population and ground truth.
- Data Provenance: The data primarily comes from laboratory testing (e.g., transmittance measurements, Dk, toxicological assays) and engineering specifications. Country of origin not specified, but the submitter is in Scottsville, NY, USA. The data is prospective as it pertains to the newly developed device and its characteristics.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. "Ground truth" in the clinical sense is not established by experts for this type of device comparison. The "truth" is based on objective scientific measurements and established safety standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no adjudication in the sense of expert consensus on diagnostic outcomes.
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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:
- Not applicable. This is not an AI-powered diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm. The device's standalone performance is its physical and chemical properties and safety.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device comparison is based on objective laboratory measurements (e.g., refractive index, % transmittance, water content, oxygen permeability, cytotoxicity, ocular irritation, systemic toxicity, leachability, extractables) and adherence to established material and design specifications that have been previously deemed safe and effective for predicate devices.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.