(161 days)
The BIOMEDICS 55 (ocufilcon D) UV Blocking soft (hydrophilic) contact lens is indicated for daily wear in not-aphakic, normal eyes which manifest myopia, hyperopia, or astigmatism in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Spherical lenses may mask astigmatism in patients with up to 2.00 diopters that does not interfere with visual acuity. The lens may be dispensed in a daily disposable or scheduled replacement program. The lenses may be prescribed for daily wear for disposal after removal in the Disposable Lens Program or for cleaning and disinfection in the Scheduled Replacement Program, as recommended by the eyecare practitioner. The lens may be disinfected only with a chemical disinfection regimen.
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and other monomeric ingredients including UVAM, an ultraviolet absorber. crosslinked with EGDMA and other components which yield 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 an analysis of the provided text regarding the acceptance criteria and study for the BIOMEDICS® 55 (ocufilcon D) UV Blocking Daily Wear soft (Hydrophilic) Contact Lens.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results in the same way a Premarket Approval (PMA) application would. Therefore, some of the information you requested, especially regarding human reader studies or detailed efficacy trials, is not typically found in this type of submission.
Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating that the BIOMEDICS 55 (ocufilcon D) UV Blocking contact lens is substantially equivalent to already approved predicate devices. The acceptance criteria, therefore, revolve around matching the characteristics and performance of these predicates, particularly in terms of physical, optical, and chemical properties, and UV blocking capabilities.
| Acceptance Criteria Category | Specific Criteria (Implied from Substantial Equivalence) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Material Composition | Equivalent to ocufilcon D material, including HEMA, UVAM (ultraviolet absorber), and crosslinking with EGDMA, as established in predicate devices (K942214, P890023/S26, K972303). | The device is manufactured from HEMA and other monomeric ingredients including UVAM, crosslinked with EGDMA. It is described as having "the same characteristics and properties as the clear BIOMEDICS 55 (ocufilcon D) cast molded contact lens, cleared under K942214, and P890023/S26," and "substantially equivalent to both the clear and tinted versions of the BIOMEDICS 55 (ocufilcon D) ocufilcon D cast molded contact lenses." The material is ocufilcon D. |
| Classification (FDA Group) | Must fall into the Lens Group IV high water ionic group as established by the FDA. | The lens is stated to be "in the Lens Group IV high water ionic group as established by the FDA." |
| Physical Parameters | Equivalent range of Base Curves, Diameters, Powers, Cylinder Power, and Center Thickness to predicate devices. | Base Curves: 6.50 mm to 10.8 mm |
| Diameters: 12.5 mm to 18.0 mm | ||
| Powers: -20.00 to +20.00 Diopters sphere | ||
| Cylinder Power: -00.25 to -10.00 Diopters (Note: This device is for spherical correction but spherical lenses may mask astigmatism up to 2.00 Diopters) | ||
| Center Thickness: 0.025 mm to 0.27 mm depending on power | ||
| Tint: Blue Visibility tint. These parameters are consistent with the description of a standard soft contact lens and are implied to be equivalent to the predicate devices. | ||
| Optical Properties (UV Blocking) | Demonstrate effective UV blocking in the UVA and UVB range, comparable to or exceeding human corneal and crystalline lens protective capabilities at relevant wavelengths, as achieved by the UVAM ingredient in the predicate. (Criteria for UV blocking for contact lenses generally involve specific % transmittance limits at certain wavelengths). | A graph titled "Typical Transmittance Profile of Ocufilcon D Hydrophilic Contact Lens with UVAM versus a Human Cornea and a Human Lens" is provided. This graph shows: |
- Ocufilcon D contact lens with UVAM significantly blocks UV light across the UVB (200-320 nm) and UVA (320-400 nm) spectrum, with transmission near 0% in parts of the UV range.
- Its UV blocking capabilities appear to be notably better than a 24-year-old human cornea and comparable to or better than a 25-year-old human crystalline lens in the UV region.
- In the visible spectrum (approx. 400-700 nm), the lens has high transmission, similar to the human eye structures, as expected for a clear vision lens. This explicitly demonstrates the UV blocking performance. |
| Indications for Use | The indications for use match those of the predicate devices. | "Indicated for daily wear in not-aphakic, normal eyes which manifest myopia, hyperopia, or astigmatism in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Spherical lenses may mask astigmatism in patients with up to 2.00 diopters that does not interfere with visual acuity. The lens may be dispensed in a daily disposable or scheduled replacement program...disinfected only with a chemical disinfection regimen." This is stated to be substantially equivalent to the predicate device K972303's indications. |
| Wear Modality & Care | Daily wear, compatible with daily disposable or scheduled replacement programs, and chemical disinfection. | As above, "daily wear," "daily disposable or scheduled replacement program," and "disinfected only with a chemical disinfection regimen." |
Study Details (as inferable from a 510(k) Summary)
Given this is a 510(k) submission, the "study" for acceptance criteria is primarily a comparison to predicate devices and verification of compliance with established standards (like FDA Lens Group classification and UV transmittance testing). There isn't a traditional clinical trial described with independent test and training sets in the AI sense.
-
Sample sizes used for the test set and data provenance:
- Test Set: No explicit "test set" in the context of an AI model is mentioned. The UV transmittance data is presented as "Typical Transmittance Profile," implying measurements taken on samples of the device. The exact number of lenses measured is not specified, but it would typically be a statistically representative sample from a manufacturing batch, tested under laboratory conditions.
- Data Provenance: The UV transmittance data is laboratory-generated, likely from a manufacturing or R&D facility of Ocular Sciences, Inc., the submitter, or a contracted testing facility. No country of origin for patient data is relevant as clinical patient data is not the primary basis for this type of substantial equivalence.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the AI sense. The "ground truth" for the UV blocking criteria is derived from established scientific principles of UV absorption and transmission, measured by calibrated laboratory equipment, and compared against known human eye absorption profiles. The "experts" would be the scientists and engineers who designed the test, performed the measurements, and interpreted the results, upholding standard scientific and regulatory practices.
-
Adjudication method for the test set:
- Not applicable. The data is objective measurement from laboratory instruments for UV transmittance.
-
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:
- No. This is a contact lens, not an AI diagnostic device. Therefore, no MRMC study or AI assistance is relevant.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device (contact lens), not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for demonstrating equivalence largely relies on:
- Standardized material specifications: Conforming to the chemical composition of ocufilcon D as previously approved.
- Laboratory measurements: Objective physical, optical (including UV transmittance), and chemical property measurements using calibrated instruments.
- Regulatory classification: Adherence to FDA's established Lens Group IV criteria.
- Comparison to predicate device claims: Verifying that the proposed indications for use align with those of the legally marketed predicate devices.
- The "ground truth" for demonstrating equivalence largely relies on:
-
The sample size for the training set:
- Not applicable. There is no AI training set for this device submission. The design and validation of the contact lens material (ocufilcon D with UVAM) would have involved extensive R&D and material science studies, which effectively form the "training data" for the physical and chemical properties of the lens, but this is not an AI training set.
-
How the ground truth for the training set was established:
- Not applicable due to the absence of an AI training set. The "ground truth" for the lens's design and manufacturing processes would have been established through years of material science research, clinical experience with the base material (ocufilcon D), and adherence to ophthalmic device manufacturing standards.
§ 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.