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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 (tisilfocon A) Rigid Gas Permeable Contact Lenses are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic or not-aphakic persons with non-diseased eyes.

The lenses may be prescribed 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 lenses 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.

Lens designs for the management of irregular corneas include: 1) progressively flattening peripheral curves, 2) a reverse curve or series of reverse curves in the peripheral design, or 3) decentered optic zone and resulting peripheral curves, or 4) a combination of the first three systems.

The provided 510(k) summary for the Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses does not contain specific acceptance criteria, nor does it describe a study designed to prove the device meets such criteria in the way typically expected for novel devices demonstrating performance metrics.

Instead, the submission relies on the concept of substantial equivalence to predicate devices and previously cleared or approved applications for the same material.

Therefore, the following information is not present in the provided text:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, or standalone study details related to the performance of the device against specific criteria.
• The type of ground truth used for such a study.
• Sample size for a training set or how ground truth for a training set was established.

Here's an analysis based on the available information:

1. Acceptance Criteria and Reported Device Performance

The submission does not define specific performance acceptance criteria for the Menicon Z lenses in terms of efficacy or safety metrics. Instead, "acceptance" is based on substantial equivalence to predicate devices and previously cleared/approved applications for the material (tisilfocon A).

The reported device performance is summarized qualitatively:

"Results of a retrospective case study using the Menicon Z lenses for the management of keratoconus and other irregular corneal conditions demonstrated that the lenses effectively maintained corneal physiology and visual acuity."

This statement acts as the performance claim, but it's not tied to specific, quantifiable acceptance criteria.

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

The document mentions a "retrospective case study," but it does not provide any details regarding:

• The sample size of this study.
• The country of origin of the data.
• Whether the study was retrospective or prospective (though it explicitly states "retrospective").

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided. The "retrospective case study" is mentioned, but the methodology for establishing "ground truth" (e.g., what constitutes "maintained corneal physiology" or "effectively maintained visual acuity") and who assessed it is not detailed.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided.

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

An MRMC study is not mentioned in this 510(k) summary. This type of study is typically relevant for AI/CADe devices, which this contact lens is not.

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

This is not applicable as the device is a physical contact lens, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the retrospective case study would likely have been clinical assessments by ophthalmologists or optometrists, focusing on:

• Corneal physiology: Assessed through slit lamp examination, fluorescein staining, etc., to check for signs of hypoxia, edema, infiltrates, or other adverse events.
• Visual acuity: Measured using standard Snellen charts or equivalent.

However, the specific methods or whether this was expert consensus, pathology, or outcomes data is not explicitly stated.

8. The Sample Size for the Training Set

A "training set" isn't applicable in the context of this submission. The device is a physical product based on a known material, not an AI algorithm. The material itself has been previously studied and cleared/approved.

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

This is not applicable as there is no "training set" in the context of this device.

Summary of the Study and its Role in Acceptance:

The core of the submission for Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses relies on:

• Substantial Equivalence: The primary basis for clearance is that the Menicon Z material (tisilfocon A) has been previously cleared/approved in multiple 510(k)s (K962006, K970019) and PMAs (P990018, P990018/S002) for various wear durations and designs. This implies its safety and basic efficacy (biocompatibility, oxygen permeability, etc.) are already established.
• Predicate Devices: The device is considered substantially equivalent to other legally marketed RGP lenses for the correction of refractive ametropia and for the management of irregular corneal conditions (e.g., Rose K Post Graft, Dyna Intra-Limbal, Boston XO/EO/ES). This means the FDA found that the Menicon Z lens is as safe and effective as these existing devices, and does not raise new questions of safety or effectiveness.
• Retrospective Case Study (for Irregular Corneas Indication):
  • Purpose: To support the additional indication for the management of irregular corneal conditions (e.g., keratoconus, post-surgical).
  • Finding: The study "demonstrated that the lenses effectively maintained corneal physiology and visual acuity."
  • Details Missing: Specific details about the study (sample size, exact metrics, and ground truth establishment) are not provided in this summary. However, the FDA's acceptance of this statement implies they found it sufficiently supportive for the expanded indication, likely in conjunction with the established safety profile of the material.
  • Clinical Study Necessity: The document explicitly states: "Clinical study for the Menicon Z (tisilfocon A) material has been deemed as not necessary in support of this clearance, as no new or additional questions of safety or effectiveness have been raised." This indicates that the retrospective case study was likely a supportive piece of evidence rather than a primary, meticulously designed clinical trial to establish new safety/efficacy metrics from scratch.

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