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Menicon Z™ (tisilfocon A) spherical, aspheric, prism ballast toric and prism ballast multifocal lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes.

Menicon Z™ (tisilfocon A) spherical, aspheric, non-prism ballast toric and non-prism ballast multifocal corneal lenses are indicated for extended wear (from 1 to 30 days between removals for cleaning and disinfection of the lenses, as recommended by the eyecare professional) for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in non-aphakic persons with non-diseased eyes.

The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.

The lens may be prescribed in spherical and aspheric powers ranging from -25.00 D to +25.00 D for daily wear and -25.00 D to +8.00 D for up to 30 days extended wear. Toric lenses are designed to correct up to 5.00 D of astigmatism and multifocal lenses to provide up to +3.00 D of reading add power for up to 30 days extended wear.

The lens may be disinfected using a chemical disinfection system only.

The Menicon Z™ lens material, tisilfocon A is a thermoset copolymer derived from fluoromethacrylate and siloxanylstyrene, bound by crosslinking agents.

The lens is tinted light blue with color additive D&C Green No. 6 (21 CFR 74.3206). Also, UV absorber (benzotriazol) is added.

This 510(k) summary describes a rigid gas permeable contact lens, not an AI/ML powered device. Therefore, a study proving the device meets acceptance criteria, as well as several other elements of the prompt (such as number of experts, adjudication method, AI improvement, training set size, etc.), are not applicable to this document. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices.

However, based on the information provided, here's an attempt to answer the relevant aspects of your request regarding acceptance criteria and the "study" that proves the device meets them, interpreting "acceptance criteria" as meeting the chemical and physical properties of similar, already-approved devices, and "study" as the comparison of these properties:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by the properties of the predicate devices. The Menicon Z™ rigid gas permeable contact lens is considered to meet these criteria if its material properties are comparable to those of the predicate devices.

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The Menicon Z™ Rigid Gas Permeable Contact Lens for Daily Wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased eyes who are myopic or hyperopic and have an astigmatism of up to 3.00 Diopters (D) that does not interfere with visual acuity. The lens may be disinfected using a chemical disinfection only.

The Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens is a lathe-cut nonpolished firm contact lens with spherical front and back surfaces. The posterior curve is selected so as to properly fit an individual eye and the anterior curve selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The lens material, tisilfocon A, is a thermoset copolymer derived form fluoro-methacrylate and siloxanylstyrene, bound by crosslinking agents. The lens colors are light blue or clear. The lens is tinted light blue with color additive D & C Green No. 6. A UV absorber 2-(5-Chloro-2H- benzotriazol-2-y1)-6-(1,1dimethylethyl)-4-methylphenol is also added.

This 510(k) summary describes a premarket notification for a medical device and doesn't contain the typical acceptance criteria and detailed study data (like sensitivity, specificity, AUC) that would be expected for an AI/ML device. It focuses on demonstrating substantial equivalence to a predicate device for regulatory approval.

However, I can extract the relevant information within the context of a medical device submission striving for "substantial equivalence."

Acceptance Criteria and Reported Device Performance

Since this is a submission for "substantial equivalence" for a non-AI/ML device, the concept of specific numerical acceptance criteria (e.g., "sensitivity must be > X%") isn't directly applicable in the same way it would be for an AI diagnostic device. Instead, the "acceptance criteria" here are implied by showing the new device is "as safe and effective" and "does not raise different types of safety and effectiveness questions" compared to the predicate device.

The reported device performance is largely a qualitative statement of comparability.

Detailed Study Information (Based on the Provided Text):

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: 118 eyes.
   • Data Provenance: Not explicitly stated (e.g., country of origin), but it was a prospective randomized, controlled clinical trial.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the 510(k) summary. For a contact lens study, "ground truth" would generally be established by ophthalmologists or optometrists assessing clinical parameters, but the number and qualifications are not detailed.

3. Adjudication method for the test set:

   • This information is not provided.

4. 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 study was NOT done. This device is a contact lens, not an AI diagnostic tool, so this type of study is not applicable. The comparison was between two lenses worn by patients.

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

   • No, this is NOT an AI device. Standalone algorithm performance is not applicable.

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

   • The "ground truth" was established by clinical observation and measurement by clinicians (likely ophthalmologists/optometrists) over the 3-month study, assessing parameters like visual acuity, adverse reactions, slit lamp findings, patient symptoms, lens replacements, etc. This aligns with outcomes data from a clinical trial.

7. The sample size for the training set:

   • This concept is not applicable as this is not an AI/ML device. The "training set" for the device itself would be the manufacturing process and material development.

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

   • Not applicable as this is not an AI/ML device.

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