(209 days)
The METRO FOCAL 38 ASPHERIC (polymacon) soft (hydrophilic) contact lenses for daily wear are available in clear and with a blue visibility tint. The lenses are indicated for visual acuity in non-aphakic patients with with non-diseased eves. The lenses are available in powers of -20.00 up to +10.00 Diopters of and up to 2.50 Diopters of add. These lenses will mask 2.00 Diopters of astigmatism where it does not interfere with visual aculty.
The METRO FOCAT 38 ASPHERIC (polymacon) soft (hydrophilic) contact lenses are lathe cut into an aspherical contact lens geometry which becomes a hemispherical shell. The polymer. polymacon was the first soft (hydrophilic) material and is one of the most frequently used polymers of HEMA at this time. Tt consists of 62% polymacon and 38% water by weight when fully hydrated in normal saline solution buffered with sodium bicarbonate.
The METRO FOCAT ASPHERTC (polymacon) soft (hydrophilic) contact lenses when hydrated and placed on the cornea acts as a refracting medium to focus light rays on the retina.
The provided text describes a 510(k) submission for a contact lens, the METRO FOCAL 38 ASPHERIC (polymacon) soft contact lens. This submission claims substantial equivalence to previously marketed devices. Therefore, the "study" conducted for this device is not a traditional clinical trial demonstrating de novo performance against acceptance criteria, but rather a demonstration of equivalence to existing, legally marketed devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This section is not directly applicable in the traditional sense for this 510(k) submission. The document explicitly states: "This lens should be the equivalent of any other lens of aspheric configuration." and "Potential Safety and Effectiveness as well as Adverse Effects of the Device would be about the same as that of any other aspheric polymacon lens."
Instead of specific acceptance criteria for a new clinical study, the "acceptance criteria" are implied to be meeting the performance and safety profiles of existing, substantially equivalent aspheric polymacon contact lenses. The reported "device performance" is essentially a claim of equivalence.
| Acceptance Criteria (Implied for Equivalence) | Reported Device Performance (Claimed for Equivalence) |
|---|---|
| Toxicology results within normal limits (for polymacon) | "Results were within normal limits." (Referencing prior submission) |
| Microbiology results within normal limits (for polymacon) | "Results were within normal limits." (Referencing prior submission) |
| Compatibility results within normal limits (for polymacon) | "Results were within normal limits." (Referencing prior submission) |
| Stability validating expiration date (for polymacon) | "Results were within normal limits." (Referencing prior submission, and on-going studies for 4 years for clear lens) |
| Preservative uptake tests within normal limits (for polymacon) | "Results were within normal limits." (Referencing prior submission) |
| Manufacturing materials, methods, and quality control comparable to existing predicate devices. | "The manufacturing materials, manufacturing methods, and quality control methods employed by most companies are equivalent. The results are all approximately the same." |
| Safety and Effectiveness comparable to other aspheric polymacon lenses. | "Potential Safety and Effectiveness as well as Adverse Effects of the Device would be about the same as that of any other aspheric polymacon lens." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable as a separate "test set" in a traditional clinical trial sense. The submission relies on existing data for the polymacon polymer and the general performance of equivalent aspheric contact lenses.
- Data Provenance: The data provenance for the pre-clinical tests (toxicology, microbiology, compatibility, stability, preservative uptake) is stated as "another submission" or "in 1990" for the polymacon polymer. This indicates retrospective data analysis, likely from previous regulatory submissions for similar devices using the same polymer, rather than prospective data specifically generated for this new device. The clinical "data" is based on the general understanding and performance of 18 existing aspheric contact lens companies, 13 of which use polymacon.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Given that this is a 510(k) submission relying on equivalence, direct expert establishment of "ground truth" for a novel test set, as might occur in a diagnostic accuracy study, is not described. The "ground truth" is effectively the established safety and efficacy profile of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. There was no specific "test set" and no "ground truth" established by experts in the context of a new clinical study requiring adjudication.
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 device is a contact lens, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a contact lens, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is the established safety and effectiveness profile of legally marketed predicate devices, specifically other aspheric polymacon contact lenses. This is implicitly supported by:
- Pre-clinical safety data on the polymacon polymer gathered in prior submissions.
- The general understanding and performance of 18 existing companies producing aspheric contact lenses, 13 of which use the same polymacon polymer.
- The sponsor's claim that the new lens should be "equivalent" to these existing devices.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning model, so there is no "training set" in that context. The "training" in a broader sense would be the cumulative data and experience with contact lens manufacturing and the polymacon polymer over time, but not a specific dataset for algorithm training.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth establishment process for it.
§ 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.