(140 days)
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.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety: Adverse reactions, positive slit lamp findings, patient symptoms, problems, and complaints should be within expected limits for daily wear contact lenses. | "Adverse reactions, positive slit lamp findings, patient symptoms, problems, and complaints...were within expected limits for daily wear contact lens wearers." |
| Effectiveness: Visual acuity, lens replacements, discontinued patients, lens wearing time, and keratometry changes should be comparable to the predicate lens. | "Visual acuity results demonstrated that the Menicon Z™ Rigid Gas Permeable Contact Lens was comparable to the predicate lens." (Other factors like lens replacements, discontinued patients, lens wearing time, and keratometry changes were part of the clinical findings analyzed, which led to the overall conclusion of safety and effectiveness within expected limits, implicitly meaning they were comparable or acceptable for a RGP lens). |
Detailed Study Information (Based on the Provided Text):
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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.
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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.
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Adjudication method for the test set:
- This information is not provided.
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device.
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.