(133 days)
SynergEyes® A and M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the concession of inyporopic myspice eyes. The lenses are indicated for daily presuyopla, in aphakic and not aprilike, nor alocused byest with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00D. The lenses may be disinfected using only a presoyopia, add powers between · 1.00 and · 1.00 and · 1.00 lense · Provinsible lenses.
The SynergEyes™ A and M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens is a The Syreigeyes ... A and M (palificon B non ibernison) , hydrion surrounded by a soft hydrophilic skirt that straddles the limbus of the eye :
- in the power range of -20.00 to +20.00 diopters for sphere, ●
- with center thickness from 0.12mm to 0.30mm .
- with base curves of 7.10mm to 9.00mm .
- with diameter of 14.50mm .
- .
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The SynergEyes™ A and M Hybrid Daily Wear Contact Lens is a rigid gas permeable material of The soft skirt is comprised of HEMA (paflulofon-D) rigid gas permeable polymer. (hydroxyethylmethacrylate) of 27% water and 73% polymer.
The junction between the rigid material and soft material is bound by a proprietary chemical bonding method.
The provided text describes the 510(k) summary for the SynergEyes™ A and M Hybrid Daily Wear Contact Lens. It outlines the device description, intended use, predicate devices, characteristics, and non-clinical and clinical studies conducted to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for the clinical study in a quantifiable manner (e.g., "comfort must be >X%"). Instead, it describes the outcomes and compares them to predicate devices, focusing on demonstrating safety and efficacy.
| Category | Acceptance Criteria (Implied / Comparison) | Reported Device Performance (SynergEyes™ Hybrid Contact Lens) |
|---|---|---|
| Safety | No significant adverse events, minimal complaints, stable keratometric readings. Comparative to predicate devices' historical experience. | - No adverse events reported. |
- Complaints were minimal, with comfort being the most prevalent.
- One complication, "Poor outcome with lenses," reported; subject treated and discontinued.
- No other significant safety findings, though the comfort complaint was "lost during the course of the study" (possibly meaning resolved or no longer primary). |
| Efficacy | No negative changes in refractive correction or visual acuity. Comparative to predicate devices' historical experience. | - No negative changes in efficacy upon evaluation of the data (no details on specific metrics provided beyond "changes in refractive correction, lens visual acuity"). |
| Material Properties| Substantial equivalence to predicate materials (Paragon HDS 100, Synergicon A). | - Material property data for SynergEyes™ and Paragon HDS 100 were "substantially equivalent." - Listed Dk permeability for RGP Center (FATT: 145, ISO: 100) and Soft Skirt (9.1) compared favorably to SoftPerm® (FATT: 14, Soft Skirt: 5.5).
- Dk/L transmissibility (FATT: 66-77, ISO: 46-53) compared to SoftPerm® (ISO: 17.5).
- Light transmittance (>90%) compared to SoftPerm® (88-92%). |
| Toxicology | Meet ISO 10993 standards (no cytotoxicity, no systemic toxicity, no ocular irritation). | - Cytotoxicity Test (ISO 10993-5): Test articles were not cytotoxic. - Acute Systemic Injection Test in mouse (ISO 10993-11): Each test article met the test requirements (no systemic toxicity).
- Ocular Eye Irritation Test in rabbit (ISO 10993-10): No evidence of ocular irritation; extracts are not considered irritants to ocular tissue. |
| Sterilization | Maintain sterility and stability. | - Sterilized using e-Beam sterilization. - Established 1-year sterility and stability with an approved protocol. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size (Clinical Study Subjects): 107 subjects (214 eyes)
- Data Provenance: The document does not explicitly state the country of origin. Given the context of a 510(k) summary for the FDA in the US, it is highly probable the study was conducted in the United States, or at least under US regulatory standards. The study was prospective, as indicated by "A Clinical Study was performed to establish the safety and efficacy..." and "The clinical investigation...was conducted on 107 subjects for a period of 3 months."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided. The clinical study assessed safety and efficacy in human subjects, relying on clinical observations and measurements rather than expert consensus on a test set of pre-existing data. For regulatory applications like this, the "ground truth" for clinical performance is derived from the direct observation of patient outcomes and measurements during the study.
4. Adjudication Method for the Test Set:
- This information is not explicitly stated. For clinical studies, "adjudication" typically refers to independent review of adverse events or specific endpoints by experts to ensure consistency and objectivity. While adverse events were reported and assessed, the specific adjudication method is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed to evaluate the impact of an AI system on human reader performance, usually in image interpretation tasks. This document pertains to a physical medical device (contact lens) and its clinical performance, not an AI software.
6. Standalone (Algorithm Only) Performance Study:
- No, a standalone performance study was not done. This concept is relevant for AI algorithms that operate without human intervention. The device in question is a contact lens, which is physically worn and interacts with the human eye.
7. Type of Ground Truth Used:
- The ground truth for the clinical study was derived from direct clinical observation, measurements from human subjects, and patient self-reported symptoms/satisfaction (e.g., adverse events, slit lamp findings, refractive correction changes, visual acuity, comfort complaints). For material properties, the ground truth was laboratory testing results.
8. Sample Size for the Training Set:
- This is not applicable as the document describes a physical medical device. There is no "training set" in the context of an AI algorithm learning from data. The clinical study results are used to demonstrate the device's performance, not to train an algorithm.
9. How Ground Truth for the Training Set Was Established:
- Not applicable (see point 8).
§ 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.