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510(k) Data Aggregation
(140 days)
SynergEyes® SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error 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 and +4.00D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.
The SynergEyes™ SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens is a combination of high Dk rigid gas permeable contact lens corneal option surrounded by a soft hydrophilic silicone-hydrogel skirt (periphery) that straddles the limbus of the eye :
- in the power range of -20.00 to +20.00 diopters for sphere,
- . cylinder powers up to 6.00 diopters for astigmatism
- with center thickness from 0.12mm to 0.30mm .
- with base curves of 7.10mm to 9.00mm
- with diameter of 14.50mm
- Add Powers 1.00 to 4.00 (multifocal)
This lens material for the rigid portion is petrafocon A, an upgrade high Dk silicone base RGP material, lathe cut, surrounded by soft hydrophilis silicone-hydrogel copolymer (hem-larafilizon A), sterilized by means of e-beam sterilization. When placed on the human cornea, the SynergEyes™ SiH Hybrid Contact Lens acts as a refracting medium to focus light rays onto the The device is available in the following indications: spherical, toric, and multifocal, with retina. spherical or aspheric surfaces in violet visibility tim the RGP center, and multing, will may device is substantially equivalent to the SyneryEyes™ A and M (paflufocon D hem-iberfilion A) Hybrid Daily Wear Contact Lens predicate devices manufactured by the sponsor, Synerglyes, Inc.
The SynergEyes™ Sill Hybrid Daily Wear Contact Lens center is a highly oxygen permeable (Dk 130) rigid gas material of (petrafocon A). The soft skirt is comprised of silicone-hydrogel copolymer (hem-larafilcon A) of 33% water and 73% polymer.
The junction between the rigid material is bound by a proprietary chemical bonding method.
Acceptance Criteria and Study for SynergEyes™ SiH Hybrid Contact Lens
This document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the SynergEyes™ SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lens to its predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating "no worse than" performance compared to the predicate device across various safety and effectiveness measures. The study aimed to show substantial equivalence, meaning the new device performs at least as well as the existing one.
| Acceptance Criteria (Implicit: No Worse Than Predicate) | Reported Device Performance (vs. Control Lens) |
|---|---|
| Primary Safety Variables: | |
| Adverse Event Rate | Test Cohort: 4 AEs (2 SAEs, 1 abrasion, 1 microbial keratitis) |
| Control Cohort: 1 AE (1 SAE, liver failure - unrelated to lens) | |
| Slit Lamp Findings (e.g., staining, other signs) | Test cohort eyes presented with more staining overall. |
| All other slit lamp findings were similar rates and severities. | |
| Effectiveness Variables: | |
| Discontinuation Rate | Test Cohort: 15 (73.2% completed) |
| Control Cohort: 4 (87.1% completed) | |
| Visual Acuity Stability (Snellen) | Stable for both cohorts throughout the study. |
| Only 2 Test cohort eyes and 2 Control cohort eyes reported 2 or more line drops at final visit. | |
| Average Daily Wearing Time | Similar (Test: 11.6-13.0 hrs/day; Control: 12.1-12.8 hrs/day) |
| Lens Deposit Evaluations | Similar results between cohorts. |
| Fitting Evaluations | Similar results between cohorts. |
| Lens Replacements | Test lenses replaced more for parameter change. |
| Control lenses replaced more for discomfort. | |
| Symptoms/Complaints (e.g., discomfort, dryness, halos) | Test cohort reported proportionately greater symptoms (e.g., 8.6% for halos, 16.1% for dryness). |
| Differences were generally small (3.7% or less), except for halos and dryness. |
Note: The submission frames the "acceptance criteria" as demonstrating that "the test lens performed no worse than the control lens on a daily basis," thereby establishing substantial equivalence. Specific quantitative thresholds for "no worse than" are not explicitly stated in the provided text for each outcome.
2. Sample Size and Data Provenance for Test Set
- Sample Size:
- Total Subjects Randomized and Dispensed: 87
- Test Cohort (dispensed): 56 subjects (eyes implicitly, given contact lens context)
- Control Cohort (dispensed): 31 subjects (eyes implicitly)
- Completed 90-day study: 41 Test cohort subjects (73.2%), 27 Control cohort subjects (87.1%)
- Data Provenance: The study was conducted at 8 investigational sites. The country of origin is not explicitly stated, but the submission is to the FDA (United States), suggesting the study likely took place in the USA. The study was prospective and unmasked, open-label.
3. Number of Experts and Qualifications for Ground Truth
This type of study (clinical trial for contact lenses) does not typically involve external experts establishing a "ground truth" for the test set in the way an imaging AI study would. Instead, the ground truth is clinical data collected by investigators/clinicians at the 8 investigational sites.
Their qualifications are not explicitly stated but would be assumed to be licensed ophthalmologists or optometrists experienced in fitting and evaluating contact lenses and ocular health, as is standard for clinical trials. They performed slit-lamp examinations, visual acuity assessments, and recorded adverse events and patient complaints.
4. Adjudication Method for Test Set
There is no mention of an independent adjudication method (like 2+1 or 3+1 consensus) for the collected clinical data. The data interpretation and reporting appear to be based on the findings of the individual investigators at the 8 sites, compiled and analyzed statistically.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is a clinical trial comparing a new device (contact lens) to a predicate device in human subjects, not an assessment of AI's assistance to human readers. Therefore, an effect size of human readers improving with/without AI assistance is not applicable.
6. Standalone (Algorithm Only) Performance
No, a standalone (algorithm only) performance assessment was not done. This device is a physical contact lens, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context refers to the clinical observations and outcomes data collected directly from the study subjects. This includes:
- Adverse events (e.g., abrasions, microbial keratitis)
- Slit lamp findings (e.g., staining, other ocular signs)
- Visual acuity measurements
- Patient-reported symptoms and complaints (e.g., discomfort, dryness, itching/burning, halos)
- Wearing times
- Lens deposit and fitting evaluations
- Reasons for discontinuation
These are directly observed or reported clinical realities in the study population.
8. Sample Size for the Training Set
This submission describes a clinical trial for a physical medical device (contact lens). There is no "training set" or "algorithm" involved in the development or evaluation of this contact lens, as it is not an AI/ML device. Therefore, this question is not applicable.
9. How Ground Truth for Training Set Was Established
As there is no training set for an algorithm, this question is not applicable.
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