(95 days)
METRO-G 3X Spherical (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or a blue visibility tint are indicated in daily wear for the correction of visual acuity in aphapic and/or non-aphakic persons with with non-diseased eyes. The Spherical lenses are available from +20.00 to - 20.00 Diopters for persons with up to1.50 Diopters of astigmatism where the astigmatism does not interfere with visual acuity.
METRO-G 3X Toric (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZETRO-G 3X (hioxifilcon B) optical blanks in clear or blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and nonaphakic persons with with non-diseased eyes. The toric lenses are available from +20.00 to -20.00 Diopters and up to 4.50 Diopters of astigmatic correction.
The material. BENZ-G 3X (hioxifilcon B), is a non-ionic polymer that may be disinfected using either the heat (thermal) or the chemical (not heat) disinfection system.
METRO-G 3X (hioxifilcon B) Spherical or Toric is lathed into a soft (hydrophilic) contact lens which is a hemispherical The Toric has a Toric Base Curve. The non-ionic shell . material, hioxifilcon B is a copolymer of 2-hydroxyethyl methrylate (2-HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol Methacrylate, GMA).
The copolymer consists of 52% METRO-G 3X (hioxifileon B) and 48% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.
The lens METRO-G 3X (hioxifilcon B) is made from BENZ-G 3X (hioxifilcon B) optical buttons. When the lens is hydrated and placed on the cornea it acts as a refracting medium to focus light rays on the retina.
Due to the nature of the provided text, which appears to be regulatory submissions for a contact lens, the concept of "device performance" and "acceptance criteria" is not in terms of AI model metrics like sensitivity or specificity. Instead, it refers to the physical properties, safety, and compatibility of the contact lens. Therefore, the response will be tailored to this context, interpreting "acceptance criteria" as various tests and standards the contact lens had to meet for approval.
Here's an analysis based on the provided text:
Based on the provided text, the device is the METRO-G 3X (hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses for Daily Wear. The "acceptance criteria" and "device performance" are established through various pre-clinical studies to demonstrate the safety and effectiveness of the contact lenses.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance / Assessment |
|---|---|---|
| Toxicology | Safety profile for daily wear contact lenses | Results were within normal limits. |
| Microbiology | Sterilization and biocompatibility | Relevant studies were run and included; autoclave validation performed. |
| Lens Compatibility | Compatibility with manufacturing materials/processes | Studies run by the polymer's developer and referenced; Conclusion: Within Normal Limits. |
| Lens Stability (Shelf Life) | Assure sterility to a one-year duration | Studies started and to be completed early 1997 (late January 1997) based on FDA guidance. Product not distributed until tests complete and FDA approved. |
| Preservative Uptake | Interaction with preservatives | Tests run by ATCON and referenced by the polymer's developer; Results were within normal limits. |
| Tint Leeching | No identifiable leeching of tint pigment | Extraction studies showed no identifiable evidence of tint pigment leeching for visibility tint. |
| Disinfection Method (Heat/Chemical) | No injurious effect from disinfection methods | In-house tests showed heat has no injurious effect on the lenses. |
| Material Properties (Water Content) | Material composition (e.g., water content) | Copolymer consists of 52% hioxifilcon B and 48% water by weight. Considered close to METRO-G 55 (5X) (hioxifilcon A) which has 58% water and was previously approved as safe and effective. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for the studies (e.g., toxicology, microbiology, lens stability, preservative uptake, extraction studies). It refers to "relevant studies," "in-house tests," and studies conducted by "Toxikon" and "ATCON."
- Data Provenance: The studies were conducted by specialized labs (Toxikon, ATCON) and by the developer of the polymer, as well as by Metro Optics of Austin, Inc. The location is implied by "Metro Optics of Austin, INC." in Pflugerville, TX, USA. The studies appear to be prospective in nature, as they were conducted specifically for the purpose of this 510(k) submission.
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)
The document does not specify the number or qualifications of experts involved in establishing the "ground truth" for the test sets. The "ground truth" here is less about expert consensus on interpretations and more about objective lab measurements and scientific assessments of material properties and biological responses. The studies were carried out by specialized testing facilities (Toxikon for toxicology, ATCON for preservative uptake) and the polymer developer, implying expertise in those fields.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method in the context of expert review or consensus for the test results. The studies appear to rely on standard laboratory procedures and established scientific methods, with results interpreted against "normal limits" or industry standards.
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
No such MRMC comparative effectiveness study was described. This is expected as the device is a contact lens, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This 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.)
The "ground truth" for these studies is based on:
- Laboratory measurements and scientific standards: For toxicology, microbiology, lens stability, preservative uptake, and extraction studies. "Within normal limits" implies comparison against established safety and performance benchmarks.
- Material science characterization: For water content and chemical composition of the polymer.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI model.
§ 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.