(103 days)
The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, and hyperopia) in aphakic or not-aphakic persons with non-diseased eves that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The lenses may be disinfected using a chemical or hydrogen peroxide disinfection system. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.
The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera. The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is available as a single vision lens. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is tinted using D & C Green #6 in an in-monomer tinting process.
The provided text describes a 510(k) submission for a soft contact lens and does not contain information about a device that uses AI or requires a study with expert review, ground truth establishment, or MRMC studies. The text focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of physicochemical properties and safety.
Therefore, I cannot fulfill the request to describe acceptance criteria, test set details, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not relevant to the provided content.
Here's a breakdown of what is available in the document regarding "acceptance criteria" (more accurately, comparative criteria) and the "study" (non-clinical testing for substantial equivalence):
1. A table of acceptance criteria and the reported device performance:
The document presents a comparison between the new device and its predicate device to demonstrate substantial equivalence. The "acceptance criteria" here are essentially that the new device's parameters are comparable to those of the predicate device.
| PARAMETER | Acceptance Criteria (Predicate Device) | Reported Device Performance (New Device) |
|---|---|---|
| Material | methafilcon A | methafilcon A |
| Material Classification | Hydrophilic Lens Group 4 | Hydrophilic Lens Group 4 |
| Indication for Use | myopia, hyperopia | myopia, hyperopia |
| Water Content | 55% | 55% |
| Light Transmittance | Approximately 98% | Approximately 98% |
| Dk (35° C) | 18.8 x 10 -11 | 18.8 x 10 -11 |
| Powers | +20.00 to -20.00 Diopters | +20.00 to -20.00 Diopters |
| Color | blue visibility | blue visibility |
| Refractive Index | 1.42 | 1.42 |
| Specific Gravity | 1.06 | 1.06 |
| Method of Manufacture | Molded | Molded |
| Tint | D&C Green #6 (Note: Predicate lists "D&C Green #6" while the new device description lists "D & C Green #6" and the comparison table lists "Vat Blue #6" for the predicate. This seems like a discrepancy in the provided text. For consistency with the summary, D&C Green #6 is used for the new device and assume consistency with predicate for this table based on the summary statement) | D&C Green #6 |
| Tint Process | Entrapment process during polymerization | Entrapment process during polymerization |
| Cytotoxicity | Non-cytotoxic (implied by predicate's safety) | Non-cytotoxic (reported for new device) |
| Leachability | No detectable tint level (implied by predicate's safety) | No detectable level of tint in test extracts (reported for new device) |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical testing rather than a typical "test set" for an algorithm.
- Sample Size: Not explicitly stated for specific tests (e.g., how many lenses were tested for Dk, water content, etc.). The statement "Results of cytotoxicity testing show the lens material to be non-cytotoxic. the physicochemical properties of the lens to be comparable to the predicate device, and the leachability testing demonstrates no detectable level of tint in the test extracts." implies that sufficient samples were tested to assert these properties.
- Data Provenance: The testing was "conducted in accordance to the Premarket Notification 510(k) Guidance Document for Class II Contact Lenses issued by FDA in May, 1994." This implies controlled laboratory testing, not patient data from specific countries or retrospective/prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable to this type of device submission. There is no "ground truth" to be established by experts as it's a physical medical device (contact lens) assessed through material and performance testing against established standards and comparisons to a predicate device, not through interpretation of data by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as there is no "test set" in the context of expert review or image interpretation. The evaluation is based on laboratory test results.
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:
This is not applicable. This is a contact lens, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This is a contact lens, not an algorithm.
7. The type of ground truth used:
The "ground truth" for affirming the device's properties is based on physicochemical testing standards and results, and cytotoxicity/leachability assays, compared directly to a legally marketed predicate device as per FDA guidelines for Class II contact lenses.
8. The sample size for the training set:
This is not applicable. There is no "training set" for a physical medical device like a contact lens.
9. How the ground truth for the training set was established:
This is 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.