(315 days)
The Benz-G 4X 54% (hioxifilcon D) soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10.00 Diopters. Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.
Benz-G 4X 54% (hioxifilcon D) lathed soft contact lenses are hemispherical shells and are available as spherical or toric lens designs. The Benz-G 4X 54% (hioxifilcon D) lathed soft contact lens is fabricated from hioxifilcon D, which is a non-ionic, copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 46% hioxifileon D and 54% water by weight when immersed in normal buffered saline solution buffered. The lens is available with a blue visibility handling tint, phthalocyanato (2) - (copper). In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped. However, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The provided text describes a 510(k) premarket notification for a soft contact lens, the Benz-G 4X (hioxifilcon D) Lathed Sphere and Toric Lenses. The submission asserts substantial equivalence to a predicate device, Extreme H2O® 54% (hioxifilcon D) molded soft contact lens (K051430).
Based on the document, here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in a typical quantitative clinical trial sense (e.g., a specific sensitivity or specificity threshold). Instead, the substantial equivalence is based on a comparison of material properties, intended use, and non-clinical performance to a predicate device. The performance characteristics are compared as follows:
| Characteristic | Acceptance Criteria (Predicate: Extreme H2O® 54% Molded Lens) | Reported Device Performance (Benz-G 4X Lathed Lens) |
|---|---|---|
| Intended Use | Same as new device | Same as predicate device |
| Lens Material | Hioxifilcon D | Hioxifilcon D |
| Material Classification | FDA Group 2 (> 50% H₂O, non-ionic polymer) | FDA Group 2 (> 50% H₂O, non-ionic polymer) |
| Production Method | Cast-Molded | Lathe-Cut |
| Water content | 54% +/- 2 | 54% +/- 2 |
| Refractive Index (hydrated) | 1.414 | 1.408 |
| Light Transmission | Greater than 95% T | Greater than 95% T |
| Tint | Blue Phthalocyanato (2) - (copper) | Blue Phthalocyanato (2) - (copper) |
| Oxygen Permeability (Fatt Dk) | 21 | 18 |
| Cytotoxicity (Agar Diffusion) | Considered non-cytotoxic | Considered non-cytotoxic |
| Systemic Reaction (Systemic Injection) | Did not induce significantly greater biological reaction than controls | Did not induce significantly greater biological reaction than controls |
| Ocular Irritation (Primary Ocular Irritation) | Non-irritant | Non-irritant |
2. Sample size used for the test set and the data provenance
The document states, "It was determined that clinical studies were not necessary to establish the safety and effectiveness of the Benz-G 4X (hioxifilcon D) lathed lens." Therefore, there is no "test set" in the context of a clinical trial with human subjects. The data provenance is from non-clinical testing (e.g., Agar Diffusion Test, Systemic Injection Test, Primary Ocular Irritation Test) performed in accordance with 21 CFR, Part 58. The specific number of samples for these tests is not provided, nor is the country of origin, though it's implied to be from the manufacturer's testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As clinical studies were not deemed necessary, there was no "ground truth" derived from human experts in a clinical setting. The non-clinical tests rely on standardized methodologies and interpretation by qualified laboratory personnel, rather than expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no "test set" requiring adjudication by multiple readers or experts. The non-clinical tests have objective endpoints.
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 device is a soft contact lens, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical device (contact lens), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is derived from the objective results of the standardized biological and chemical tests. For example, in the Agar Diffusion Test, the absence of a zone of inhibition would be considered "non-cytotoxic," which is an objective observation rather than an interpretive "ground truth" from an expert. Similarly, for the systemic injection test, the "ground truth" comes from comparing biological reactions to control articles, and for ocular irritation, the "ground truth" is the observation of non-irritancy based on established criteria.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a "training set." The manufacture of the contact lens relies on established materials and processes, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.
§ 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.