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510(k) Data Aggregation
(213 days)
The SportSight GP (paflufocon C) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The SportSight GP (paflufocon C) rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes who are nearsighted (myopic), farsighted (hyperopic) and who may exhibit corneal astigmatism up to 4.00 diopters or less that does not interfere with visual acuity. SportSight GP (paflufocon C) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. SportSight GP bifocal lenses are indicated for presbyopic persons (far or near sighted) including astigmatic corrections up to +4.00 D requiring add power of up to + 4.00 D. SportSight GP (paflufocon C) contact lenses are indicated for the attenuation of bright light and the reduction of glare. SportSight TM GP (paflufocon C) contact lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The SportSight GP (paflufocon C) intensely tinted, rigid gas permeable contact lenses are available in SportSight Gray. The Gray tinted lens contains D&C Red # 17, D & C Green No. 6, and Perox Yellow No. 9. The lenses have the following dimensions: Refractive Index 1.466(Nd at 25°C), Luminous Transmittance (driving allowed) 8% - 26%, Luminous Transmittance (driving prohibited) 1% - 8%, Wetting Angle (Receding Angle) 12.81 1.14, Specific Gravity, Hardness (Shore D) 84, <1% Water Content, Oxygen Permeability 30 x 1 0-1 1 Dk* at 35°C *(cm³/sec)(mL 02/mL x mm Hg) Revised method of Irving Fatt, Ph.D. ** harmonic mean transmission over 4mm. Lens Parameters: Chord Diameter 7.0 to 14.5 mm, Center Thickness (driving allowed) 0.09 - 0.275 mm, Center Thickness (driving prohibited) 0.275- 0.475 mm, Base Curve 6.50 to 9.00 mm, Powers -20.00 to +12.00 Diopters, Bifocal Add Powers +0.25 to + 4.00 Diopters, Concentric Bifocal Add Diameter 2.0 to 4.0 mm, Monocentric Bifocal Add Diameter 4.0 to 9.0 mm, Monocentric Bifocal Prism 1.0 to 2.5 Diopters.
The provided text describes the technical specifications and testing of "SportSight™ GP (paflufocon C)" rigid gas permeable contact lenses, but it does not contain information about a device that uses artificial intelligence (AI) or a study that evaluates its performance against acceptance criteria in the context of AI/ML.
Instead, the document is a 510(k) submission for a traditional medical device (contact lenses) and focuses on demonstrating substantial equivalence to a predicate device and compliance with physical and safety standards. The "acceptance criteria" discussed are product specifications (e.g., light transmittance, UV blocking, material properties) and the "study" is primarily physical testing and biocompatibility assessments, not performance evaluations of an AI algorithm.
Therefore, I cannot provide the requested information about AI acceptance criteria, device performance, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided text.
The information that is available about the device's properties and testing is presented below, aligning with the format requested where applicable for such a device:
Acceptance Criteria and Device Performance (SportSight™ GP Contact Lenses)
The acceptance criteria for the SportSight™ GP contact lenses are primarily based on optical properties and material characteristics, benchmarked against standards like ANSI Z80.3-1996 for Nonprescription Sunglasses and Fashion Eyewear. The study demonstrates that the device meets these criteria through laboratory measurements.
1. Table of Acceptance Criteria and Reported Device Performance
The following table summarizes key performance characteristics based on various lens powers and associated center thicknesses ("Lower", "Recom" - recommended, "Upper", and "Special*"). The acceptance criteria are implicit in the reported values meeting the specified ranges and standards.
| Characteristic | Acceptance Criteria (e.g., ANSI Z80.3-1996) | Reported Device Performance (Range across power/thickness variations) |
|---|---|---|
| Luminous Transmittance (%) | Driving Allowed: 8% - 26% (based on specific thickness, lower transmittance for thicker lenses) | For driving allowed lenses: 8% - 26% |
| Driving Prohibited: 1% - 8% (for special prescription lenses with thickness beyond safe driving limit) | For driving prohibited lenses: 1% | |
| UV Mean Transmittance UVB (290-315 nm) | Minimum 99% reduction of UVA and UVB entering the eye (implies <1% transmittance). ANSI Z80.3-1996 compliance. | 0.0% - 0.2% (demonstrates greater than 99% reduction) |
| UV Mean Transmittance UVA (315-380 nm) | Minimum 99% reduction of UVA and UVB entering the eye (implies <1% transmittance). ANSI Z80.3-1996 compliance. | 0.0% - 0.2% (demonstrates greater than 99% reduction) |
| Solar Blue Transmittance (380-500 nm) | Minimum 77% attenuation (implies <= 23% transmittance). Recommended design: 85% attenuation (implies <= 15% transmittance). | 1% - 26% (varies significantly with lens power and thickness; generally meets or exceeds attenuation requirements, with lower percentages for thicker/higher power lenses) |
| Traffic Signal Transmittance (Red) | Meet ANSI Z80.3-1996 Standard for minimal transmission of red, green, and yellow light to assure traffic light recognition unless labeled to the contrary. (Implied: sufficient transmittance for recognition). | 6% - 23% |
| Traffic Signal Transmittance (Yellow) | Meet ANSI Z80.3-1996 Standard for minimal transmission of red, green, and yellow light to assure traffic light recognition unless labeled to the contrary. (Implied: sufficient transmittance for recognition). | 8% - 25% |
| Traffic Signal Transmittance (Green) | Meet ANSI Z80.3-1996 Standard for minimal transmission of red, green, and yellow light to assure traffic light recognition unless labeled to the contrary. (Implied: sufficient transmittance for recognition). | 6% - 21% |
| Chromaticity Coordinates (Yellow Signal) | Meets ANSI Z80.3-1996 for traffic signal recognition. | x 0.58, y 0.42 |
| Chromaticity Coordinates (Green Signal) | Meets ANSI Z80.3-1996 for traffic signal recognition. | x 0.23 - x 0.26, y 0.41 - y 0.42 |
| Chromaticity Coordinates (Average Daylight D65) | Meets ANSI Z80.3-1996 for general color recognition. | x 0.35 - x 0.38, y 0.35 - y 0.37 |
| Biocompatibility | No signs of toxicity or incompatibility for Cytotoxicity, Ocular Irritation, Systemic Toxicity, and Sensitization. | All tests showed no signs of toxicity or incompatibility for a maximized tint formulation, as well as final validation batches. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "preliminary analysis of batches of each of the colors" and "final validation batches for each of the products" for toxicity and biocompatibility testing. For the optical properties, the data is presented across various lens powers and associated center thicknesses, indicating multiple physical samples were measured for each configuration.
- Sample Size: Not explicitly stated as a numerical count for each test, but implied to be sufficient for batch testing and across the range of product specifications.
- Data Provenance: The tests and measurements were conducted by Paragon Vision Sciences, presumably in the USA given the company address and FDA submission. The data is prospective, generated specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a contact lens, and its performance (e.g., light transmission, biocompatibility) is objectively measured by laboratory instruments and standardized biological tests, not interpreted by human experts to establish ground truth in the way an AI diagnostic device would require.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described above, the "tests" are physical and biological measurements, not requiring human adjudication of results.
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 is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For optical properties (e.g., Luminous Transmittance, UV Transmittance, Solar Blue Transmittance, Traffic Signal Transmittance, Chromaticity Coordinates), the ground truth is established by physical measurements using calibrated spectrophotometers and other optical testing equipment as described in the ANSI Z80.3-1996 standard.
For biocompatibility and toxicity, the ground truth is established by standardized biological and chemical assays (Cytotoxicity, Ocular Irritation, Systemic Toxicity, and Sensitization) based on predefined observable outcomes and established safety criteria for medical devices.
8. The sample size for the training set
Not applicable. This is a traditional medical device, not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML device, there is no training set or ground truth in that context.
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