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510(k) Data Aggregation
(59 days)
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.
| Property | Acceptance Criteria (Based on Predicate Devices) | Menicon Z (TISILFOCON A) |
|---|---|---|
| Specific Gravity | Range of 1.19 - 1.27 (from Boston XO2, XO, Equalens II) | 1.20 |
| Refractive Index | Range of 1.423 - 1.425 (from Boston XO2, XO, Equalens II) | 1.436 |
| Visible Light Transmittance | ≥70% (from Boston Equalens II), 83-92% (from Boston XO2, XO) | >95% |
| Water Content | <1% (from Boston XO2, XO, Equalens II) | <0.5% |
| Oxygen Permeability (Dk) | Range of 85-141 (polarographic) & 100-140 (gas-to-gas) (from Boston XO2, XO, Equalens II) | 189 (gas-to-gas method)*163 (polarographic method)** |
*Note: The Menicon Z™ Dk values are higher than the predicate examples, which is generally considered an advantage for contact lenses.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. This submission relies on material property comparisons and prior clearances, not a clinical test set in the traditional sense for an AI/ML device.
- Data Provenance: The data provided (material properties) are intrinsic to the device material and are likely derived from laboratory testing conducted by Menicon Co., Ltd. The document does not specify the country of origin of this specific material data or if it's retrospective/prospective outside of the general timeframe of the predicate device clearances.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of an AI/ML device, is not established for this type of submission. The "ground truth" for material properties would be the measured values determined by standardized laboratory methods.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" requiring expert adjudication.
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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for this submission are the measured physical and optical properties of the Menicon Z™ material, which are compared against those of already cleared predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, and thus there is no training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set.
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