(49 days)
SynergEyes"16 A and M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive crror including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D and +4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.
SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact lenses for keratoconus are indicated for use in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 10,00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.
SynergEyes 106 PS (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism, and irregular astigmatism in aphakic and not aphakic, nondiseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20,00 D eves with irregular astigmatism up to 6.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.
SynergEyes TM - A, M, KC, and PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens
This FDA 510(k) clearance letter for the SynergEyes Hybrid Contact Lenses does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and a study proving device performance. This document is a clearance letter, indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, not a scientific study report.
Here's a breakdown of what can be extracted and what is missing:
The core of the request is to describe the acceptance criteria and a detailed study proving the device meets those criteria, specifically for an AI/ML context. This document is for a medical device (contact lenses) and does not involve AI/ML. Therefore, most of the requested fields related to AI/ML study design (test sets, ground truth, experts, MRMC, standalone performance, training sets) are not applicable or cannot be found in this document.
Information Extracted from the Provided Text:
- Device Name: SynergEyes (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for Daily Wear
Table of Acceptance Criteria and Reported Device Performance:
Based on the document, there are no explicit acceptance criteria or reported device performance metrics in the format usually provided for AI/ML or efficacy studies. The "acceptance" here is the FDA's determination of substantial equivalence, which is based on demonstrating the device is as safe and effective as a predicate device, not necessarily on meeting specific numerical performance targets outlined in this letter.
The "Indications for Use" section defines what the lenses are for, which can be seen as the intended performance scope, but not numerical acceptance criteria.
| Acceptance Criteria (Not explicitly stated in numerical terms for performance in this document) | Reported Device Performance (Not quantitative performance data for this device in this document) |
|---|---|
| Safe and effective as predicate device (implicit for 510(k) clearance) | Not explicitly reported in this document beyond being substantially equivalent to a predicate. |
| Correction of hyperopic, myopic, and astigmatic refractive error (including presbyopia) | Device is indicated for these uses. |
| Daily wear | Device is indicated for daily wear. |
| Correction up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D (for A and M models) | Device is indicated for this range. |
| Add powers between +1.00 D and +4.00 D (for presbyopia) | Device is indicated for this range. |
| Correction of irregular astigmatism up to 10.00 D (for KC model) | Device is indicated for this range. |
| Correction of irregular astigmatism up to 6.00 D (for PS model) | Device is indicated for this range. |
| Disinfection using chemical disinfecting system compatible with both hydrogel and RGP lenses | Lenses require this type of disinfection. |
Missing Information (Not present in this 510(k) clearance letter):
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not described. The 510(k) process relies on equivalence to predicate devices, and while testing would have been done by the manufacturer, the details of those studies are not in this clearance letter.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not described as this is not an AI/ML study.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not described.
- 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, as this is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as this is not an AI/ML study. Performance for contact lenses would typically involve clinical trials assessing visual acuity, comfort, fit, and physiological response, but these details are not in this clearance letter.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
§ 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.