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Aveo (omafilcon A) 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.

Aveo ( omafilcon A) Toric Soft ( Hydrophilic) Contact Lenses are indicated the 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 between 0.50D and 2.50D or less that does not interfere with visual acuity.

Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients.

Frequent Planned Replacement Wear
When prescribed for frequent planned replacement wear the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients' eve and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system.

Disposable Wear
When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.

The Aveo (Omafilcon A) Soft (Hydrophilic) Contact Lenses are daily wear soft contact lenses 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 are 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. Reactive ultraviolet absorber RUVA-93 is used to block UV radiation.

The device is a corneal contact lens having a total diameter less than the visible iris diameter and is designed to be worn in its entirety on the cornea.

Aveo (Omafilcon A) Aspheric Soft (Hydrophilic) Contact Lenses have an aspheric front curve (external curve) which is tri-curve and spherical base curve (internal curve).

Aveo (Omafilcon A) Toric Soft (Hydrophilic) Contact Lenses have an aspheric front curve (external curve) which is tri-curve for the sphere power and multi-radius base curve for the cylinder power (internal curve).

The contact lenses are hydrophilic, soft and it is supplied in sterile state.

The provided document is a 510(k) summary for a medical device, specifically contact lenses. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity (as would be typical for an AI/ML medical device submission).

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of performance metrics (like those for an AI/ML diagnostic) is not directly applicable to this document. This submission primarily relies on showing the new device is fundamentally similar to an already approved one.

However, I can extract the information relevant to the substantial equivalence claim, which acts as the "proof" for this type of device.

Here's an interpretation based on the document's content:

1. Table of "Acceptance Criteria" (for Substantial Equivalence) and Reported Device Performance:

For a 510(k) of a contact lens, the "acceptance criteria" are essentially demonstrating similarity to a predicate device across various characteristics, and the "performance" is the subject device exhibiting these similar characteristics.

Note: The "acceptance criteria" for a 510(k) submission are not rigid pass/fail thresholds like for a performance study, but rather demonstrating that the new device is as safe and effective as a legally marketed predicate device. Differences are acceptable if they do not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set (Non-Clinical Performance Data): The document refers to "Physiochemical Studies" and "Toxicology Studies."
  • Physiochemical Studies: Conducted according to ISO 18369-4:2006 and ISO 18369-3:2006. The sample sizes are not explicitly stated but would adhere to the standards' requirements (e.g., number of lenses tested for Dk, water content, etc.).
  • Toxicology Studies:
    • Cytotoxicity Test: Sample size not specified, typically in-vitro (cell cultures).
    • Ocular Irritation Study: "New Zealand White Rabbit" - not specified, but typically a small number of animals (e.g., 3-6).
    • Skin Sensitization Study: "Guinea Pigs" - not specified, typically a small number of animals (e.g., 10-20).
    • Acute Systemic Toxicity Study: "Swiss Albino Mice" - not specified, typically a small number of animals (e.g., 5-10 per group).
• Data Provenance: Not explicitly stated (e.g., country of origin for the non-clinical tests). These are prospective tests conducted specifically for the device submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable in the context of this 510(k) submission. Ground truth for an AI/ML device (e.g., presence/absence of disease based on expert consensus) is not relevant here. The "ground truth" for contact lens substantial equivalence relies on established international standards (ISO) for physical and chemical properties, and standard toxicology testing protocols.

4. Adjudication Method for the Test Set:

• Not applicable. This isn't a human-reader or AI performance study requiring adjudication. The results of the physiochemical and toxicology tests are directly measured/observed by the testing facility.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study (comparing human readers with and without AI assistance) is not conducted for contact lens submissions. The submission states, "no clinical studies were required to demonstrate the safety or effectiveness of the subject device" due to its substantial equivalence to the predicate.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This submission is for a physical medical device (contact lenses), not an algorithm or AI.

7. Type of Ground Truth Used:

• Standardized Test Results and Predicate Device Characteristics. The "ground truth" for this 510(k) relies on:
  • Results from physiochemical tests (e.g., water content, Dk, refractive index) measured according to ISO standards.
  • Results from toxicology tests (cytotoxicity, irritation, sensitization, systemic toxicity) measured according to ISO 10993 standards.
  • The established characteristics and safety profile of the legally marketed predicate device (Proclear, K112302, and also Aveo K162223 as another similar device).

8. Sample Size for the Training Set:

• Not applicable. Contact lenses are physical medical devices, not AI/ML algorithms that require training sets. Their manufacturing process is well-defined, and their properties are measured after production.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As there's no training set for an AI/ML algorithm, this question doesn't apply.

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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:

1. A table of acceptance criteria and the reported device performance:

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 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.

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 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.

4. 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.

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 MRMC comparative effectiveness study was done. This device is a contact lens, not an AI-assisted diagnostic tool.

6. 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.

7. 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.

8. 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.

9. How the ground truth for the training set was established:

   • Not applicable. There is no training set for this type of evaluation.

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