(87 days)
The Specialty 42 and the Specialty T-42 Toric (hefilcon A) Hydrophilic Contact Lenses (clear and visibility tinted) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes.
Eye care practitioners may prescribe the lenses for daily wear in a Frequent Replacement program with scheduled replacement. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.
Soft contact lenses are hemispherical shells manufactured of a copolymer of 2hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolldone (NVP), which yield the appearance of lenses, which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power, which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6 mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.
This document is a 510(k) Summary for a contact lens device, not a study report describing acceptance criteria and performance data. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not present.
However, I can extract the information provided about the device's technical specifications and how its "substantial equivalence" to a predicate device serves as the basis for its market acceptance.
This document does not contain information about:
- Acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, specificity, etc.) for a study.
- A study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number/qualifications of experts used for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used (pathology, outcomes data, etc.) for a study.
- How ground truth for a training set was established.
Information Extractable from the Provided Document:
1. A table of acceptance criteria and the reported device performance:
The acceptance for this device is based on "substantial equivalence" to a legally marketed predicate device. The document does not describe performance metrics in the way one would for an AI/algorithm-based device (e.g., accuracy, sensitivity, specificity). Instead, it compares the physical, optical, and chemical properties, material, indications for use, and method of manufacture to the predicate device. The "acceptance criteria" here are effectively that these characteristics are sufficiently similar to the predicate to establish substantial equivalence.
| Parameter | Acceptance Criteria (Predicate Device: Flexlens Hydrophilic Contact Lens for Daily Wear) | Reported Device Performance (Specialty 42 Hydrophilic Contact Lens for Daily Wear) |
|---|---|---|
| Material | hefilcon A | hefilcon A |
| Indication for Use | myopia, hyperopia and astigmatism | myopia and hyperopia (Note: Toric version also covers astigmatism) |
| Water Content | 42% | 42% |
| Light Transmittance | >95% | >95% |
| Dk (35° C) | 13.13 X 10-11 | 13.25 X 10-11 |
| Powers | +20.00 to -20.00 Diopters | +20.00 to -20.00 Diopters |
| Color | clear | clear and blue visibility |
| Specific Gravity | 1.044 | 1.031 |
| Refractive Index | 1.413 | 1.417 |
| Method of Manufacture | Lathe cut | Lathe cut |
| FDA Material Grouping | Group 1 (low water, non-ionic polymers) | Group 1 (low water, non-ionic polymers) |
| Disinfection Systems | (Implicitly similar for Group 1 material) | Heat, chemical or hydrogen peroxide disinfection systems |
| Wear Modality | Daily Wear | Daily Wear |
| Replacement Program | (Implicitly similar for Daily Wear) | Frequent Replacement program with scheduled replacement |
2. Sample sized used for the test set and the data provenance:
Not applicable. This is a contact lens submission based on substantial equivalence, not an AI/algorithm study with test sets and data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for a test set is not mentioned as this is a device clearance based on substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this type of device (contact lens), the "ground truth" for "acceptance" is its physical, chemical, and optical properties and its intended use, which are verified against a predicate device and established material classifications (e.g., FDA Group 1 for materials). There isn't a "ground truth" in the diagnostic or prognostic sense.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device requiring a training set.
9. 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.