(141 days)
Spherical:
Biomedics® 60 (ocufilcon F) UV Blocking Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
Toric:
Biomedics® 60 (ocufilcon F) UV Blocking Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 10.00 diopters.
The lenses may be prescribed for Daily Wear in not-aphakic persons. The eye care practitioner may prescribe the contact lens for either single use disposable wear or for frequent replacement wear, with cleaning, disinfection, and scheduled replacement (SEE WEARING SCHEDULE). When prescribing for frequent replacement wear, the contact lens may be disinfected using a chemical (not heat) disinfecting system.
Biomedics 60 (ocufilcon F) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and other monomeric ingredients including a proprietary ultraviolet absorber, crosslinked with EDGMA and other components which vield the appearance of lenses which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.
Here's a breakdown of the acceptance criteria and study information for the Biomedics 60 (ocufilcon "F") UV Blocking Daily Wear soft (Hydrophilic) Contact Lens, based on the provided 510(k) summary:
The entire submission is focused on demonstrating substantial equivalence to a previously cleared device, not on meeting specific acceptance criteria through a de novo clinical study for this specific device.
Because this is a 510(k) submission based on substantial equivalence, there isn't a traditional "acceptance criteria" table with numerical performance targets and reported device performance from a new clinical study for this specific device. Instead, the acceptance criteria are implicitly that the new device's physical, optical, and chemical properties, as well as its indications for use, are substantially equivalent to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Biomedics 60) |
|---|---|
| Material Properties: | |
| - Water content | 60% |
| - Oxygen Permeability | 25.3 x 10⁻¹¹ (cm³/sec)(mL x mm Hg) |
| - Refractive Index | 1.4041 |
| - Light Transmittance | 97.7% |
| - UV-A Transmittance (thinnest lenses) | 23.4% |
| - UV-B Transmittance (thinnest lenses) | 5.8% |
| - Material Composition | HEMA and other monomeric ingredients (ocufilcon "F"), proprietary UV absorber, crosslinked with EDGMA |
| - Chemical Residuals (Monomers, UV Additive) | Extremely low levels for product monomers, undetectable for UV additive |
| - Category (FDA Guidance for Daily Wear Contact Lenses) | Category IV (high water, ionic) |
| Device Characteristics: | |
| - Geometry (Base Curves, Diameters, Powers, Center Thickness) | Equivalent to predicate devices |
| - Tint | Blue Visibility Tint |
| - Compatibility with cleaning/disinfecting solutions | Compatible with all soft contact lens solutions |
| Safety: | |
| - Toxicological analyses (Ocular Irritation, Cytotoxicity, Systemic Toxicity) | Non-toxic in animal tests |
| Indications for Use: | |
| - Correction of Myopia/Hyperopia with Astigmatism | Spherical: up to 2.00 diopters astigmatism; Toric: up to 10.00 diopters astigmatism |
| - Daily Wear use in not-aphakic persons | Yes |
| - UV Blocking claims | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. No dedicated clinical "test set" was used for this device. The submission relies on preclinical data and the established safety and efficacy of predicate devices.
- Data Provenance: Preclinical data (toxicology) was likely generated internally or through contract labs. The "proof" of substantial equivalence comes from comparing the physical and chemical properties of the Biomedics 60 to already cleared devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts & Qualifications: Not applicable. There was no clinical trial for this specific device, and thus no "ground truth" established by experts for a test set. The FDA review process involves their own internal experts (e.g., A. Ralph Rosenthal, M.D., Director, Division of Ophthalmic Devices).
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set requiring expert adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission specifically states: "There was no clinical investigation of this lens as the characteristics of the device are substantially equivalent to the device from which the lens was modified."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a contact lens, not an AI algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the preclinical evaluations mentioned (toxicology), the "ground truth" would be the observed biological responses in the animal models, interpreted by scientists/toxicologists. For the substantial equivalence argument, the "ground truth" refers to the established safety and effectiveness of the predicate devices based on their prior clinical evaluations and market history.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/machine learning device. The "training" in this context refers to the accumulated knowledge and clinical data from the predicate devices that form the basis for the substantial equivalence claim.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable in the AI sense. However, the basis for the claim of safety and efficacy (analogous to "ground truth") for the predicate devices was established through:
- Prior clinical evaluations (clinical trials) conducted for those specific predicate devices (e.g., P890023/S26, K984046, K972303, K942214).
- Regulatory clearance processes for those predicate devices, which would have involved FDA review of clinical data, preclinical data, and manufacturing information.
- "Performance data available on the predicate device(s) through product testing, literature review, and/or clinical experience." (implied by the substantial equivalence argument).
§ 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.