(78 days)
The S-38™ (polymacon) Soft (hydrophilic) Contact Lens with blue tint is indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who may exhibit astigmatism of 1.50 diopters or less that does not interfere with visual acuity.
The Esstech® PS (polymacon) Soft (hydrophilic) Contact Lens, with blue tint is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic The lens may be worn by persons who may presbyopes. exhibit astigmatism of not more than 2.00 diopters that does not interfere with visual acuity.
The Esstech® SV (polymacon) Soft (hydrophilic) Contact Lens, with blue tint is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic and/or marqinally presbyopic requiring up to +1.00 D of The lens may be worn by persons who exhibit add. astiqmatism of 1.50 diopters or less but may not be suitable for higher degrees of astigmatism.
The lenses are identical to the already approved and cleared products S-38™ (polymacon) Soft (hydrophilic) Contact Lens, the Esstech® PS (polymacon) Soft (hydrophilic) Contact Lens and the Esstech® SV (polymacon) Soft (hydrophilic) Contact Lens, except for the addition of the listed color additive Procion Blue MX-R (Reactive Dye Blue #4).
The provided text describes a 510(k) submission for tinted contact lenses and focuses on establishing substantial equivalence to previously cleared devices. It does not contain information about the acceptance criteria or a study proving that the device meets those acceptance criteria in the way typically associated with a medical device performance study (e.g., measuring sensitivity, specificity, or reader agreement for an AI/algorithm-based device). Instead, the submission relies on demonstrating that the new tinted lenses have the "same" performance characteristics as the predicate untinted lenses, which were previously approved.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this particular document. I will fill in what is available and indicate where information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly defined by demonstrating that the blue-tinted lenses maintain the same characteristics or remain within acceptable ranges compared to their untinted predicate devices. The "reported device performance" are the physical and chemical properties of the tinted lenses.
| Characteristic | Acceptance Criteria (based on predicate untinted lenses) | Reported Device Performance (Blue Tinted Lenses) |
|---|---|---|
| S-38™ (polymacon) | ||
| Water Content | 38% | Same (38%) |
| Refractive Index (hydrated) | 1.43 | Same (1.43) |
| Light Transmittance (visible) | >97% | >95% |
| Oxygen Permeability (Dk) | 8.5 (cm/sec)(ml O2/ml x mm Hg) @ 35°C | Same (8.5 Dk) |
| Chord Diameter | 12.5 to 15.0 mm | Same (12.5 to 15.0 mm) |
| Center Thickness | 0.07 to 0.97 mm | Same (0.07 to 0.97 mm) |
| Base Curve | 7.40 to 9.60 mm | Same (7.40 to 9.60 mm) |
| Powers | -20.00 to +20.00 D | Same (-20.00 to +20.00 D) |
| ESSTECH® PS (polymacon) | ||
| Water Content | 38% | Same (38%) |
| Refractive Index (hydrated) | 1.43 | Same (1.43) |
| Light Transmittance (visible) | >97% | >95% |
| Oxygen Permeability (Dk) | 8.5 (cm/sec)(ml O2/ml x mm Hg) @ 35°C | Same (8.5 Dk) |
| Chord Diameter | 14.00 ± 0.20 mm | Same (14.00 ± 0.20 mm) |
| Center Thickness | 0.17 ± 0.02 mm | Same (0.17 ± 0.02 mm) |
| Base Curve | 8.30, 8.70, and 9.10 ± 0.10 mm | Same (8.30, 8.70, and 9.10 ± 0.10 mm) |
| Powers | +10.00 to -10.00 D in 0.25 steps | Same (+10.00 to -10.00 D in 0.25 steps) |
| ESSTECH® SV (polymacon) | ||
| Water Content | 38% | Same (38%) |
| Refractive Index (hydrated) | 1.43 | Same (1.43) |
| Light Transmittance (visible) | >97% | >95% |
| Oxygen Permeability (Dk) | 8.5 (cm/sec)(ml O2/ml x mm Hg) @ 35°C | Same (8.5 Dk) |
| Chord Diameter | 14.00 ± 0.20 mm | Same (14.00 ± 0.20 mm) |
| Center Thickness (Minus) | 0.07 to 0.14 ± 0.02 mm | Same (0.07 to 0.14 ± 0.02 mm) |
| Center Thickness (Plus) | 0.15 to 0.30 ± 0.02 mm | Same (0.15 to 0.30 ± 0.02 mm) |
| Base Curve | 8.30, 8.70, and 9.10 ± 0.10 mm | Same (8.30, 8.70, and 9.10 ± 0.10 mm) |
| Powers | +10.00 to -10.00 D in 0.25 steps | Same (+10.00 to -10.00 D in 0.25 steps) |
Additionally, the lenses passed toxicology (cytotoxicity, systemic toxicity, ocular irritation testing) for the blue tint. Microbiology and manufacturing were stated to be identical to the predicate devices or with standard tinting processes.
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a "test set" in the context of clinical performance comparison for an AI device. The new tinted devices themselves are the "test" in comparison to the predicate devices. The data provenance related to the properties listed above would be from manufacturing and laboratory testing of the tinted lenses.
- Data provenance: Laboratory measurements and toxicology testing. No country of origin is specified. The data is likely prospective (generated for this submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The data is based on physical and chemical measurements and toxicology tests, not expert interpretation of diagnostic images or clinical scenarios for which ground truth would be established by experts.
4. Adjudication method for the test set:
Not applicable.
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/algorithm device; it is a contact lens.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/algorithm device.
7. The type of ground truth used:
The "ground truth" for the assessment of these contact lenses is based on established physical and chemical measurement standards (e.g., for water content, refractive index, oxygen permeability, dimensions) and recognized toxicology testing protocols. For the tinted lenses, the ground truth is that they perform "the same" as the untinted predicate lenses for these parameters, with a slight adjustment noted for light transmittance.
8. The sample size for the training set:
Not applicable. This is not an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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.