(244 days)
Spherical and Aspherical - Biomedics 55 (ocufilcon D) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from - 20.00D to +20.00D diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.
Toric - Biomedics 55 (ocufilcon D) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.00 diopters.
Multifocal - Biomedics 55 (ocufilcon D) MULTIFOCAL lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +10.00 diopters and with add powers from +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity.
The Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for single use daily disposable wear or for planned replacement. As prescribed for single use daily disposable wear, patients are instructed to dispose of the lens at each removal. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting system.
The lenses, Biomedics® 55 (ocufilcon D) soft (hydrophilic) contact lenses, are a hemispherical shell available in a spheric, toric or multifocal design, intended for daily wear for frequent/planned replacement wear or for single use daily disposable wear. The lens material is equivalent to other ocufilcon D daily wear soft (hydrophilic) contact lenses cleared under several predicate device 510(k) Premarket notifications.
The lenses are in-monomer tinted from edge to edge for visibility purposes with Vat Blue 6.
The Biomedics® 55 (ocufilcon D) soft (hydrophilic) contact lenses are available as sphere, asphere, toric or multifocal lenses with the following dimension ranges:
- Chord Diameter: 12.5 to 18.0 mm
- Center Thickness: 0.025 to 0.40 mm (varies with power)
- Base Curve: 6.50 mm to 10.8 mm
- Spherical Powers: -20.00 D to +20.00 D
- Add Powers: +0.25 D to +3.00
- Cylinder Powers: -0.25 to -10.00 D
- Axis: 1° to 180°
The physical properties of the lenses are:
- Refractive Index at 25°C: 1.41
- Oxygen Permeability (Dk): 19.6 x 10⁻¹¹ (cm²/sec) ml O₂/ml x mm Hg at 35°C (Fatt method)
- Light Transmittance: >95%
- Water Content: 55 %
This submission is for a contact lens, not an AI/ML device, and thus the requested information regarding acceptance criteria and studies that prove a device meets acceptance criteria, is not applicable in the typical sense for AI/ML.
Here's an analysis based on the provided document, addressing what information is available and what is not in the context of a contact lens submission:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present acceptance criteria in a formal table with specific numerical targets like for an AI model's performance metrics (e.g., sensitivity, specificity). Instead, it establishes substantial equivalence by comparing the modified device's characteristics to those of legally marketed predicate devices.
The "acceptance criteria" for this device are implicitly that its physical, chemical, and biological properties are equivalent to or within established specifications for the predicate devices, and that it is safe and effective for its indicated use.
| Characteristic | Modified Device (Biomedics® 55, ocufilcon D) | Unmodified Predicate Device (K972303) |
|---|---|---|
| Material (USAN Name) | ocufilcon D | ocufilcon D |
| FDA Category (Group) | Group II Non-Ionic High Water | Group II Non-Ionic High Water |
| Indication for Use | Daily Wear for Frequent/Planned Replacement Wear or for Daily Disposable Wear | Daily Wear for Frequent/Planned Replacement Wear or for Daily Disposable Wear |
| Water Content | 55% | 55% |
| Dk (Oxygen Permeability) | 19.6 x 10⁻¹¹ (cm²/sec) ml O₂/ml x mm Hg at 35°C (Fatt method) | 19.6 x 10⁻¹¹ (cm²/sec) ml O₂/ml x mm Hg at 35°C (Fatt method) |
| Light Transmittance | >95% | >95% |
| Refractive Index | 1.41 | 1.41 |
| Manufacturing Method | Cast-Molded | Cast-Molded |
| Sterilization | Steam | Steam |
| Packaging | Blister Pack | Blister Pack |
| Blue Handling Tint | Yes (Entrapment Dye) | Yes (Entrapment Dye) |
| Surfactant in Final Saline | Yes | None |
Study that proves the device meets the acceptance criteria:
The primary "study" proving the device meets the criteria is a substantial equivalence comparison and non-clinical testing.
- Physicochemical Tests: The document states, "The physical, optical and chemical properties of this lens remain unchanged from the unmodified device, and are within established specifications for the lenses." This confirms that the critical parameters (water content, Dk, refractive index, light transmittance) are identical to the predicate.
- Toxicological Tests: "Results from in-vivo and in-vitro studies were conducted and verify that the lenses remain non-toxic and are biocompatible with the ocular environment." This demonstrates safety.
- Clinical Studies: The submission states that "no clinical data is required" because "The technical characteristics, formulation, manufacturing, and sterilization processes of this lens are equivalent to ocufilcon D soft contact lenses currently marketed by CooperVision." This indicates that the equivalence of the technical properties is deemed sufficient by the FDA for the device to perform as safely and effectively as the predicate without requiring new human clinical trials.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable in the context of this contact lens submission. There is no "test set" in the sense of a dataset for validating an algorithm. The testing involves physicochemical and toxicological evaluations of the lens material and design, not data analysis on a clinical dataset.
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. There is no diagnostic "ground truth" establishment by experts for this type of medical device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no test set or adjudication for diagnostic performance.
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.
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):
Not applicable as there is no diagnostic ground truth. The "ground truth" for a contact lens would be its objectively measured physical and chemical properties, and its biological compatibility, established through laboratory methods.
8. The sample size for the training set:
Not applicable. There is no training set for a contact lens.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for a contact lens.
§ 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.