(149 days)
Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity. The contact lenses are intended for daily wear, single use and are to be discarded at the end of the day.
The Aveo (omafilcon A) 1-DaY Aspheric Soft (Hydrophilic) Contact Lenses are single use daily disposable soft contact lens produced from the HEMA-MPC copolymer material. MPC is similar to phospholipids (e.g., phosphatidylcholine) where molecules are found naturally in human cell membranes that improves the lens biocompatibility. The contact lenses contain 58% water by weight and is sold in the blister package immersed in phosphate buffered packaging saline. RB 246 pigment conforms to 21 CFR Part 73.3106 is used to provide the handling blue tint for the lens. The device is a corneal contact lens having a total diameter more than the visible iris diameter and is designed to be worn in its entirety on the cornea. The device has an aspheric front curve (external curve) which is tri-curve and spherical base curve (internal curve). The contact lenses are hydrophilic, soft and it is supplied in sterile state.
This document describes a 510(k) premarket notification for the "Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses." The submission claims substantial equivalence to two predicate devices: "Proclear Asphere (omafilcon A) Soft Contact Lenses" (K112302) and "Proclear XC (omafilcon A) and Proclear 1 day (omafilcon A) Hydrophilic Contact Lenses for Daily Wear" (K061948), both from CooperVision, Inc.
The document indicates that no clinical studies were required to demonstrate the safety or effectiveness of the subject device. Instead, the submission relies on the technological characteristics, formulation, manufacturing, and sterilization processes being the same as the predicate devices, along with physiochemical and toxicology studies. Therefore, a complete description of acceptance criteria for a clinical study and the study proving it cannot be provided from this document.
However, based on the provided "Toxicology Studies" section, we can infer some acceptance criteria for the pre-clinical performance data:
- A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria (Inferred from "Result") | Reported Device Performance (as "Performance of Subject Device") | Result |
|---|---|---|---|
| Cytotoxicity Test (ISO 10993-5: 2009(E)) | Non-cytotoxic | Non-cytotoxic. | Pass |
| Ocular Irritation Study in New Zealand White Rabbit (ISO 10993-10: 2010(E)) | Non-irritant to eyes of rabbits | Non-irritant to eyes of rabbits. | Pass |
| Skin Sensitization Study in Guinea Pigs (ISO 10993-10: 2010(E)) | Non-sensitizer | Non-sensitizer | Pass |
| Acute Systemic Toxicity Study in Swiss Albino Mice (ISO 10993-11: 2006(E)) | No systemic toxicity | Animals treated with the extract of the subject device did not show any systemic toxicity. | Pass |
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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 specify the sample sizes for the toxicology studies directly. It mentions "rabbits," "guinea pigs," and "Swiss Albino Mice." Specific numbers are not provided.
- The provenance is not explicitly stated as country of origin, nor is it classified as retrospective or prospective. These are lab-based pre-clinical studies.
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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 information is not applicable and not provided. Toxicology studies typically rely on established protocols and observations by trained laboratory personnel or toxicologists, rather than a consensus of experts in the way clinical diagnostic image interpretation might.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable and not provided. Laboratory toxicology studies follow standard operating procedures for assessment and reporting of results, rather than an adjudication process by multiple readers.
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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 MRMC comparative effectiveness study was done. This device is a contact lens, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a contact lens and not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the toxicology studies, the "ground truth" is based on established biological responses observed in the animal models according to the specified ISO standards (e.g., absence of cell death, absence of irritation, absence of sensitization, absence of systemic toxic effects). This is determined by macroscopic and microscopic observations and established toxicological endpoints.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of these pre-clinical toxicology studies for a contact lens.
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How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of evaluation.
§ 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.