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510(k) Data Aggregation
(205 days)
The Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia is indicated for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may have 1.00D or less of astigmatism.
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism is indicated for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may have 4.00D or less of astigmatism
The Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking lenses are to be prescribed for single-use disposable wear, and are to be discarded after each removal.
The Deseyne (vifilcon C) Daily Disposable Soft (hydrophililic) Contact Lenses with UV Blocking are manufactured in spherical or toric configurations. The lens material, vifilcon C is a hydrophilic polymer of 2-hydroxyethyl methacrylate, methacrylic acid and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA) and using azobisisobutyronitrile (AIBN) as the initiator. A UV absorbing monomer, 2-[3-(2H- Benzotriazol-2v1)-4-hydroxyphenyl] ethyl methacrylate, is incorporated into the lens polymer and used to block UV radiation. The lens contains 60% water by weight in a saline solution containing hyaluronic acid and TSP (Tamarind Seed Polysaccharide) polymers. The lens is visibility tinted using Pigment Blue 15 (Copper phthalocvanine) to make the lens more visible for handling.
The provided text describes the acceptance criteria and the study that proves the device meets them for the "Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism."
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a table of acceptance criteria with corresponding performance for all aspects. Instead, it lists various evaluations and states that the device "meets or exceeds all properties and tolerances associated with each test conducted" or that endpoints were "met in accordance with the definitions of the protocol."
However, we can infer some key criteria and performance from the "Material Properties" section and the study results:
| Feature/Criterion | Acceptance Criterion (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Optical Characteristics (Myopia & Hyperopia Lens) | ||
| Powers | From -20.00D to +20.00D | From -20.00D to +20.00D |
| Cylinder | none | none |
| Axis | none | none |
| Base Curve | 8.60 | 8.60 |
| Diameter | 14.10 | 14.10 |
| Center Thickness | 0.05 | 0.05 |
| Optic Zone | 10.00 | 10.00 |
| Optical Characteristics (Astigmatism Lens) | ||
| Powers | From -20.00D to +20.00D | From -20.00D to +20.00D |
| Cylinder | From -1.00D to -3.50D | From -1.00D to -3.50D |
| Axis | From 5° to 180° with 5° step | From 5° to 180° with 5° step |
| Base Curve | 8.50 | 8.50 |
| Diameter | 14.40 | 14.40 |
| Center Thickness | 0.08 | 0.08 |
| Optic Zone | 8.00 | 8.00 |
| Tolerances | ||
| Powers | 0.00 D ~ ± 10 D, ± 0.25 D; ± 10.12 D ~ ± 20 D, ± 0.50 D | Device is designed to meet these, "meet or exceed all properties and tolerances" |
| Base Curve | ± 0.20 mm | Device is designed to meet this, "meet or exceed all properties and tolerances" |
| Diameter | ± 0.20 mm | Device is designed to meet this, "meet or exceed all properties and tolerances" |
| Center Thickness | ± 0.010 mm + 10% | Device is designed to meet this, "meet or exceed all properties and tolerances" |
| Surface Appearance | No Surface Defect, No Edge Defect, No Bubble | Device is designed to meet this, "meet or exceed all properties and tolerances" |
| Physical Properties | ||
| Refractive Index | Implicitly similar to predicate (1.40) or within acceptable range | 1.403 |
| Light Transmittance | >90% | >90% |
| UV Transmittance | τUVB <0.05τV; τUVA <0.50τV | τUVB <0.05τV; τUVA <0.50τV |
| Oxygen Permeability | Implicitly similar to predicate (28.0 x 10^-11) or within acceptable range for Group IV lenses (27.5×10^-11 (cm2/s) [mL O2 / (mL mmHg)]) | 27.5×10^-11 (cm2/s) [mL O2 / (mL mmHg)] |
| Water Content | Implicitly similar to predicate (58%) or within Group IV range | 60% |
| Biocompatibility | No evidence of irritation, non-cytotoxic, no evidence of systemic toxicity, not sensitizing. | Ocular Irritation: No evidence of ocular irritation.In Vitro Cytotoxicity: Not cytotoxic.Systemic Injection: No evidence of systemic toxicity.Sensitization: Not sensitizing. (All for device and storage solution) |
| Clinical Effectiveness | ||
| Primary Effectiveness Endpoints | Change from baseline to each post-baseline visit in distance logMAR VA by eye; Number and percentage of subjects with ≤ -5logMAR letters read loss. | "The Primary Effectiveness Endpoints were met in accordance with the parameters outlined in the protocol." (No specific numbers given, but states criteria were met) |
| Clinical Safety | No loss of vision, acceptable adverse reaction rates, successful completion of protocol. | No loss of vision of 2 or more lines. Three adverse reactions (control lenses), none for test lenses. All subjects completed with VA within one line of initial. |
| Primary Safety Endpoints | Proportion of eyes with any slit lamp findings. | "The Primary Safety Endpoints were met in accordance with the definitions of the protocol." (No specific numbers given, but states criteria were met) |
2. Sample size used for the test set and the data provenance
- Sample Size: 81 subjects were enrolled. 78 subjects completed the clinical trial (53 in the investigational device arm, 25 in the control arm).
- Data Provenance: The study was conducted at five (5) clinical sites, all in the United States. It was a prospective, 3-month multi-arm (2), randomized, un-masked, active control study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts used to establish ground truth for the test set or their qualifications. The clinical study involved ophthalmologists/optometrists at clinical sites for evaluations (e.g., slit lamp findings, visual acuity measurements), but it does not detail a separate "ground truth" establishment process by a panel of experts.
4. Adjudication method for the test set
The document does not describe any explicit adjudication method (e.g., 2+1, 3+1) for the test set's clinical evaluations. The clinical data appears to have been collected and assessed by the clinical investigators at each site based on the study protocol.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for contact lenses, which are medical devices for vision correction, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the device described. The device is a physical contact lens, not an algorithm or AI system. Its performance is inherent to the lens itself when worn by a human, not a standalone algorithmic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical study, the "ground truth" for effectiveness and safety was established by clinical assessments and measurements performed by ophthalmic professionals (e.g., distance logMAR VA measurements, slit lamp examinations, adverse event reporting) during the course of the 3-month study, compared against a control lens. For non-clinical testing, ground truth was based on adherence to ISO standards and specified physical/chemical property criteria.
8. The sample size for the training set
The document does not mention a "training set" in the context of device development or evaluation. This is because the device is a contact lens, not a machine learning model that requires a training set. The clinical study was an efficacy and safety study.
9. How the ground truth for the training set was established
As there was no training set mentioned or implied in the context of this device, this question is not applicable.
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