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The CONTAFLEX 54 (hioxifilcon D) Spherical Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive ametropia (nyperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system.

The CONTAFLEX 49 (hioxifilcon B) Spherical Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The CONTAFLEX 54 Spherical Soft (hydrophilic) Contact Lenses are fabricated from hioxifilcon D, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (hioxifilcon D) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and 2.3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 46% hioxifilcon D and 54% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility-handling tint, [phthalocyaninato (2-)] copper. The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN).

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 (hioxifilcon D) soft hydrophilic contact lens has a spherical back 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 hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 54% water by weight. The physical properties of the lens are:

Refractive Index 1.5193 (hydrated)
Light Transmission (clear) greater than 96%
Light Transmission (tinted) greater than 96%
Water Content 54 % ± 2%
Specific Gravity (wet) 1.120
Oxygen Permeability 20.96 X 10-11 (cm /sec) (ml O./ml x mm Hg @ 35℃), (revised Fatt method).

The CONTAFLEX 49 Spherical Soft (hydrophilic)Contact Lenses are fabricated from hioxifilcon B, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (hioxifilcon B) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 51% hioxifilcon B and 49% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility-handling tint. [phthalocvaninato (2-)] copper. The hioxifilcon B name has been adopted by the United States Adopted Names Council (USAN).

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 (hioxifilcon B) soft hydrophilic contact lens has a spherical back 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 hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 49% water by weight. The physical properties of the lens are:

Refractive Index 1.5164 (hydrated)
Light Transmission (clear) greater than 96%
Light Transmission (tinted) greater than 96%
Water Content 49% ± 2%
Specific Gravity (wet) 1.140
Oxygen Permeability 16.09 X 10-11 (cm /sec) (ml O./ml x mm Hg @ 35℃), (revised Fatt method).

This prompt is asking for a structured summary of acceptance criteria and device performance based on the provided FDA 510(k) submission document for Contaflex contact lenses. However, the document provided is a 510(k) Summary and Determination Letter, not a study report. As such, it does not contain the detailed information required to answer all parts of your request, particularly regarding specific study designs, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case (MRMC) studies.

The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of physical properties and toxicology, rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way you've outlined for an AI/diagnostic device.

Here's an attempt to extract the information that is available and explain what is missing:

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

For medical devices, especially contact lenses in a 510(k) submission, "acceptance criteria" are often tied to demonstrating that the device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use, technological characteristics, and raises no new questions of safety or effectiveness. The performance is demonstrated by comparing the new device's characteristics to those of the predicate.

Below is a table constructed from the "Substantial Equivalence Matrix" (Page 8), showing the comparison of the subject devices (Contaflex 54 and 49) with their respective predicate devices (BENZ-G 4X and BENZ-G 3X). The acceptance criteria, implicitly, are that the subject devices' properties are comparable to or fall within an acceptable range of the predicate devices.

Note: The "acceptance criteria" here are based on the comparative values of the predicate devices. The study demonstrates that the subject devices' properties are either identical or very similar (e.g., oxygen permeability) to their respective predicates, supporting substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in this 510(k) summary. The document mentions "a series of preclinical testing were performed" (Page 6) but does not provide details on the number of lenses or test subjects used for each specific test (e.g., cytotoxicity, systemic toxicity, ocular irritation).
• Data Provenance: Not explicitly stated. The applicant is based in England (Contamac Ltd., Saffron Walden, Essex, England, CB11 4JX - Page 3), which might suggest where the testing was conducted or data originated, but it's not confirmed for the studies themselves. The document describes pre-clinical testing, which are typically laboratory-based rather than patient-based cohort 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 type of information is not applicable or available in this submission. This document describes a medical device (contact lenses) for which ground truth is established through laboratory material characterization and toxicology testing, not through expert clinical interpretation of images or patient data in the way an AI diagnostic device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/available. Adjudication methods are typically used in clinical studies where multiple human readers assess cases, especially when establishing ground truth for AI algorithms. For contact lens material testing, laboratory standards and protocols are followed, not expert adjudication panels.

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. An MRMC comparative effectiveness study is not applicable here. This is a 510(k) submission for conventional contact lenses, not an AI-powered diagnostic device. The document does not describe any human reader studies or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not applicable as the device is a physical medical device (contact lens), not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device, the "ground truth" is established by:

• Physical material properties: Measured values (e.g., water content, oxygen permeability, refractive index, specific gravity) obtained through standardized laboratory testing methods.
• Chemical composition analysis: To confirm the copolymer (hioxifilcon D/B).
• Preclinical toxicology testing: In-vitro cytotoxicity, systemic toxicity, and acute ocular irritation tests are performed according to recognized standards (e.g., ISO 10993-5 mentioned for cytotoxicity), with results establishing the safety profile.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm, so there is no concept of a "training set" in the context you're asking. The data presented are for device characterization and safety validation for the final product, not for training a model.

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

Not applicable. As there is no training set for an AI algorithm, this question is not relevant to the provided document. The "ground truth" for the device's material properties and safety is established through the methods mentioned in point 7.

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