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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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The Menicon SF-P (melafocon A) Contact Lens is 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. The lens may be disinfected using a chemical disinfection system only.

The Menicon Z (tisilfocon A) Contact Lens is 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. The lens may be disinfected using a chemical disinfection system only.

The Menicon SF-P (melafocon A) RGP lens is a thermoset copolymer derived from fluoro-methacrylate, siloxanylmethacrylate and methacrylic acid with water absorbance of less than 0.5% by weight. The lens is available in blue tint. The blue tinted lens contains D&C Green No. 6 as the color additive.

The Menicon Z (tisilfocon A) RGP lens is a thermoset copolymer derived from fluoro-methacrylate and siloxanylstyrene, bound by crosslinking agents. Lens colors available are light blue and violet. The blue lens is tinted with color additive D & C Green No. 6 and the violet lens contains the color additives D & C Green No. 6 and D & C Violet No. 2. Also, UV absorber is added.

Solution used for packaging the Menicon RGP lenses:

BARNES-HIND® ComfortCare® GP WETTING & SOAKING SOLUTION, which contains edetate disodium and chlorhexidine gluconate as preservatives.

The provided document is a 510(k) summary for Menicon Rigid Gas Permeable Contact Lenses and discusses their substantial equivalence to predicate devices. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.

This document describes a process change for contact lenses (wet storage vs. dry storage) and focuses on non-clinical stability, microbiology, and toxicology testing to support substantial equivalence. It does not involve a study with a test set, ground truth established by experts, or any performance evaluation against numerical acceptance criteria for a diagnostic or AI-driven device.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details on sample size, expert ground truth, adjudication methods, MRMC studies, or standalone performance, as this information is not present in the provided text.

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The alternate designs of the Menicon Z (tisilfocon A) contact lens are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic and which may exhibit astigmatism of 3.00 Diopters (D) or less that does not interfere with visual acuity. The lens may be disinfected using a chemical disinfection only.

The alternate designs of the Menicon Z (tisilfocon A) contact lens are bifocal and trifocal design contact lenses. Conventional bifocal / trifocal designs are employed in the alternate designs of Menicon Z (tisilfocon A) rigid gas permeable contact lenses. The lens material, tisilfocon A, is a thermoset copolymer derived from fluoromethacrylate and siloxanylstyrene, bound by crosslinking agents. The lens is classified fluoro-silicone acrylate, group III, page 16, FDA's premarket notification (510(k)) guidance document for daily wear contact lenses. May 12. 1994. The lens is tinted light blue with color additive D&C Green No. 6 (21 CFR 74.3206). Also, UV absorber (2-(5-Chloro-2Hbenzotriazol-2-yl)-6-(1,1-dimethylethyl)-4-methylphenol)) is added.

The provided text describes a 510(k) summary for alternate designs (bifocal and trifocal) of the Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens. The submission aims to demonstrate substantial equivalence to the previously cleared spherical design of the same lens.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the alternate designs or report specific numerical performance metrics for these new designs. Instead, it relies on demonstrating substantial equivalence to the spherical design, which had already undergone testing.

The acceptance criteria for the spherical design were implicitly met by showing that "the clinical findings i.e., adverse reactions, positive slit lamp findings, patient symptoms, problems and complaints, visual acuity, lens replacements, discontinued patients, lens wearing time and keratometry changes were within the expected limits for daily wear lens wearers."

For the alternate designs (bifocal/trifocal), the acceptance criteria for substantial equivalence appears to be that their characteristics are comparable to the predicate (spherical) device, and they are as safe and effective, not raising different types of safety and effectiveness questions. The document does not provide specific comparative performance data for the alternate designs against these criteria.

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

• Test Set (for Spherical Design): The text mentions a "randomized, controlled clinical trial" for the spherical design where "subjects were randomly assigned in a two-to-one ratio to the spherical design of the Menicon Z™ Rigid Gas Permeable Contact Lens and to that of the Menicon SF-PTM Rigid Gas Permeable Contact Lens." However, the exact sample size of subjects is not provided.
• Data Provenance: Not explicitly stated, but the applicant's address is Nagoya, Japan, and the contact person is from Menicon U.S.A. Inc. It's common for clinical trials supporting 510(k)s to be conducted in the country of the applicant or in multiple countries. Given the 1997 date, detailed provenance might not have been as routinely reported in 510(k) summaries as today. The study was prospective as it was a "randomized, controlled clinical trial."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The clinical trial focused on general clinical findings and adverse events, which are typically assessed by treating practitioners (e.g., ophthalmologists, optometrists), but details on expert panels for ground truth determination are absent.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not explicitly mentioned. The clinical trial was focused on comparing the Menicon Z spherical design against another Menicon lens (SF-P) through direct patient outcomes, not on assessing human reader performance with or without an AI device. The device itself (contact lens) is not an AI diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable. The device is a contact lens, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used (for Spherical Design Clinical Trial)

The ground truth was based on clinical findings and patient outcomes observed during the randomized controlled trial. This includes:

• Adverse reactions
• Positive slit lamp findings (clinical examination)
• Patient symptoms, problems, and complaints (patient-reported)
• Visual acuity (objective measurement)
• Lens replacements (clinical event data)
• Discontinued patients (clinical event data)
• Lens wearing time (patient-reported or clinical record)
• Keratometry changes (objective measurement)

8. Sample Size for the Training Set

• Not applicable. This is a medical device (contact lens), not an AI/ML algorithm that requires a training set. The "training" for the lens itself would be its manufacturing process.

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

• Not applicable. As above, there is no AI/ML training set.

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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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