(133 days)
The Specialty T (ocufilicon A) Soft (hydrophilic) Toric Contact Lons is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2,50 diopters,
Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide disinfection system.
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and other monomeric ingredients 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 conter 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 eve 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 7mm. 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. The lens is manufactured by spin casting and has a front toric surface which is determined by the shape of the mold to provide consistent optics. Orientation marks are molded into the front surface as part ofd the spin casting process. The lens is a prism ballasted, non-truncated toric, with an inferior slab off to help maintain patient comfort, Axis stabilization is achieved by the action of the differential thickness profile (prism) of the lens squeezing the thicker portion of the lens to the bottom.
The provided 510(k) summary for the Specialty T (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear does not contain information about acceptance criteria and a study proving the device meets those criteria in the typical sense of a new medical device study with performance metrics like sensitivity, specificity, or accuracy.
Instead, this submission focuses on demonstrating substantial equivalence to a predicate device, the Hydron Ultra T (ocufilcon A) Toric Soft (Hydrophilic) Contact Lens for Daily Wear. The "study" here is a side-by-side comparison of physical, optical, and chemical properties between the new device and the predicate device, aiming to show they are functionally the same.
Here's an analysis based on your requested categories, interpreting the provided text within the context of an equivalence submission:
1. A table of acceptance criteria and the reported device performance
For a substantial equivalence submission, the "acceptance criteria" are implied to be that the physical/mechanical properties of the new device (Specialty T) are statistically comparable or within an acceptable range of the predicate device (Ultra T). The reported device performance is the measurements for both devices.
| Parameter | Acceptance Criteria (Implied: Comparable to Predicate) | Specialty T (ocufilcon A) Toric Performance (mean ± st. dev.) | Predicate (Ultra T ocufilcon A) Toric Performance (mean ± st. dev.) |
|---|---|---|---|
| Refractive Index | Comparable to 1.427 ± 0.002 | 1.427 ± 0.001 | 1.427 ± 0.002 |
| Specific Gravity | Comparable to 1.16* | 1.16* | 1.16* |
| Water Content (%) | Comparable to 43.7 ± 0.45 | 44.1 ± 0.37 | 43.7 ± 0.45 |
| Oxygen Permeability Dk (@35°C) | Comparable to 10.2 ± 1.41 | 11.3 ± 1.43 | 10.2 ± 1.41 |
| Light Transmittance (@590 Nm) % | Comparable to 98.31 ± 1.27 | 98.51 ± 0.82 | 98.31 ± 1.27 |
| Modulus (N/mm²) | Comparable to 0.37 ± 0.048 | 0.36 ± 0.051 | 0.37 ± 0.048 |
| Tensile Strength (N/mm²) | Comparable to 0.37 ± 0.048 | 0.34 ± 0.136 | 0.37 ± 0.048 |
| Elongation @ break (%) | Comparable to 148 ± 53 | 165 ± 69 | 148 ± 53 |
Note: The specific gravity was reported as a single measurement for each with a range, not a mean and standard deviation from multiple samples.
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Sizes:
- Refractive Index: 30 lenses for each device
- Water Content: 29 lenses for predicate, 30 for Specialty T
- Oxygen Permeability: 20 lenses for each device
- Light Transmittance: 10 lenses for each device
- Modulus: 21 lenses for predicate, 18 for Specialty T
- Tensile Strength: 21 lenses for predicate, 18 for Specialty T
- Elongation @ break: 21 lenses for predicate, 18 for Specialty T
- Specific Gravity: 10 lenses for a single measurement (for the range indication).
- Data Provenance: Not specified, but generally, such physical and mechanical property testing would be conducted in a laboratory setting, likely by the manufacturer or a contract lab. There is no mention of country of origin or whether it was retrospective or prospective in the sense of clinical trials. This is laboratory testing of manufactured products.
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)
This type of submission does not involve "experts" establishing ground truth in the traditional medical sense. The "ground truth" here is the measured physical and mechanical properties of the contact lenses. These measurements would be performed by lab technicians or engineers using calibrated equipment according to established test methodologies for contact lenses (e.g., ISO or ASTM standards). No clinical expert involvement in data generation is indicated.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving human readers or interpretation requiring adjudication. It's direct measurement of physical properties.
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 a contact lens and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the measured physical and mechanical properties of the contact lenses, determined via laboratory testing using standardized procedures.
8. The sample size for the training set
Not applicable. There is no algorithm or 'training set' in the context of this contact lens submission. The comparison is between two manufactured products.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set mentioned or implied.
§ 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.