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Menicon Unique pH Multi-Purpose Solution is indicated for the cleaning, rinsing, disinfection and conditioning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses.

Menicon Unique pH Multi-Purpose Solution is a sterile, buffered aqueous solution. It contains hydroxypropyl guar, polyethylene glycol, poloxamine, boric acid, propylene glycol, and is preserve with polyquaternium-1 0.0011%, and edetate disodium 0.01%.

The provided text describes the 510(k) submission for the "Menicon Unique pH Multi-Purpose Solution for Rigid Gas Permeable Contact Lenses." However, it is not a study of a device that uses AI or machine learning. This submission relies on demonstrating substantial equivalence to a predicate device (Alcon RGP Multi-Purpose Solution ID 100136, K000148) by confirming that the new device has:

• The same formulation, ingredients, and intended use.
• Equivalence in chemical composition to the predicate device.
• Satisfactory biocompatibility and shelf-life stability.

Therefore, most of the requested information regarding AI/ML studies, such as sample sizes for test/training sets, expert consensus, MRMC studies, or standalone performance, are not applicable to this document. The "Performance Data" section explicitly states that "there were no additional clinical studies required to establish the safety and efficacy of the new device" due to its equivalence to the previously cleared predicate.

However, I can extract the acceptance criteria and performance data as presented for the non-clinical aspects and the general claim of equivalence.

Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are that the new device must be substantially equivalent to the predicate device across key characteristics. The "reported device performance" is the evidence presented to show this equivalence.

Non-Applicable Information for this type of Submission:

The following information is not present in the provided document because the submission relies on demonstrating substantial equivalence to an existing device rather than presenting a novel AI/ML device study:

1. Sample size used for the test set and the data provenance: Not applicable as no new clinical study was conducted for this device. The non-clinical testing was comparative/confirmatory.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
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: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: Not applicable in the context of an AI/ML study. The "ground truth" for this submission is the established safety and efficacy of the predicate device.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is the mixture of two sterile solutions, Progent A (active ingredient, sodium hypochlorite) and Progent B (active ingredient, potassium bromide). Progent A and B are mixed in a Menicon SP Vial. Allow lenses to soak in the Progent solution mixture for 30 minutes. Soaking for longer than 30 minutes is not recommended. The Progent treatment is recommended every two weeks. The frequency may vary according to the condition of your lens. Follow your eye care professional's directions (to a maximum of every 5 days).

The provided 510(k) summary for K122273 describes the Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses. This submission focuses on the equivalence of an alternative rinsing solution (sterile normal saline) to a previously cleared one (sterile purified water) and an alternative manufacturing site. Therefore, the study described is a non-clinical equivalence study rather than a study typically seen for novel diagnostic devices.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the numerical sample size (e.g., number of lenses or test runs) used for the "Residual Progent Testing." It only mentions that the test was "repeated with sterile normal saline."
• Data Provenance: The study was conducted by Menicon Co., Ltd. (Japan) as part of their 510(k) application. It is a non-clinical, bench-top study rather than a study involving human subjects or real-world data.

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

This type of study does not involve human experts establishing ground truth in the traditional sense of medical image analysis or diagnostic studies. The "ground truth" here is objective chemical measurement in vitro.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical, objective measurement study, not one requiring adjudication by human observers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This was a non-clinical bench study comparing rinsing efficacy of two solutions, not a study involving human readers or comparative effectiveness in a clinical setting.

6. If a Standalone Performance Study Was Done

Yes, in a sense. The "Residual Progent Testing" was done to evaluate the performance of the rinsing solutions in a controlled environment, independently measuring residual active chlorine concentration and pH. However, it's not a "standalone algorithm performance" in the context of AI/diagnostic devices, but rather a standalone test of a specific device function. The purpose was to show equivalence to a previously cleared product, so the performance was evaluated relative to the predicate.

7. The Type of Ground Truth Used

The ground truth was established by objective chemical measurements of active chlorine concentration and pH values in the rinsing solutions. This is an in vitro measurement, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is a non-clinical, bench-top study comparing two rinsing solutions. There is no machine learning component and therefore no "training set."

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

Not applicable, as there is no training set mentioned or implied.

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The One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism. The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens.

The One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The One Day Flat Pack Daily Disposable Contact Lens packaging system is designed to reduce lens handling by always presenting the lens anterior side up upon opening, which ensures correct lens orientation for proper eye insertion. The approximately 1mm flat packaging system is easily opened and reinforces the single-use factor. The non-ionic lens material, (hioxifilcon A) is a random copolymer of 2- hydroxyethyl methacylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycero) Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate. It consists of 42% hioxifileon A and 58% water by weight when immersed in a buffered saline solution. The lens is available with a blue visibility-handling tint, color additive 'Reactive Blue # 19', 21 CFR part 73.3121. The United States Adopted Names Council (USAN) has adopted the (hioxifilcon A) name. In the hydrated state, the lens conforms to the eve covering the corner and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

Here's an analysis of the provided information, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in a quantitative or pass/fail format beyond demonstrating substantial equivalence to the predicate device. Instead, it focuses on showing that the new packaging system does not negatively impact the established properties and safety of the contact lens. The "reported device performance" is essentially a comparison of the key physical and material properties of the lens in the new Flat Pack packaging versus the predicate device (Clear 1-Day - blister pkg.).

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (i.e., substantial equivalence) involved a series of non-clinical studies.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" (which in this context refers to the samples used in the non-clinical studies). It refers to "a series of in vivo preclinical toxicology and biocompatibility tests," "packaging integrity tests, stress tests, and simulations tests."
• Data Provenance: The document does not explicitly state the country of origin for the non-clinical study data. It can be assumed it was conducted as part of the manufacturer's (Menicon Co., Ltd., Japan) R&D processes. The studies are described as retrospective in the sense that they are presented as completed tests rather than ongoing trials.

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

This information is not provided in the document. Given that the studies are non-clinical (toxicology, biocompatibility, packaging integrity, physical/material properties), the "ground truth" would be established by the results of validated laboratory tests and analyses, not by expert consensus on observational data.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where human interpretation of medical images or patient outcomes requires a standardized method to resolve discrepancies between readers. This submission relies on objective laboratory measurements and tests for its non-clinical studies.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) might use AI assistance. The device in question is a contact lens and its packaging, which does not involve AI or human readers in a diagnostic context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This is also not applicable to a contact lens and its packaging.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical studies is based on:

• Objective laboratory measurements: for physical and material properties (e.g., refractive index, light transmission, water content, oxygen permeability, lens diameter, base curve, power, specific gravity).
• Validated toxicology and biocompatibility test results: to ensure the materials and extracts are not toxic or irritating.
• Packaging integrity, stress, and simulation test results: to confirm the robustness and integrity of the packaging system.
• Sterility testing: to confirm the lenses are sterile.

8. The Sample Size for the Training Set

Not Applicable. This submission details the substantial equivalence of a medical device (contact lens packaging) and does not involve AI/machine learning, therefore there is no "training set."

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

Not Applicable. As there is no training set, there is no ground truth to establish for it.

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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.

*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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Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is the mixture of two sterile solutions, Progent A (sodium hypochlorite, sodium carbonate, sodium hydroxide, purified water) and Progent B (potassium bromide, sodium carbonate, purified water). Progent A and B are mixed in a Menicon SP Vial. Allow lenses to soak in the Progent solution mixture for 30 minute. Soaking for longer than 30 minutes is not recommended. P Progent Rinsing Solution (sterile purified water) is provided for rinsing the lenses and SP vial. The Progent treatment is recommended every two weeks. The frequency may vary according to the condition of your lens. Follow your eve care professional's directions (to a maximum of every 5 days.

The provided 510(k) summary for Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses focuses on establishing substantial equivalence to a previously cleared device (K002140) and to Boston® Cleaner. It describes the product, its indications for use, and a high-level overview of testing performed.

However, the document does not include detailed information regarding specific acceptance criteria, comprehensive study results, sample sizes for test or training sets, expert qualifications for ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies. This type of information is typically found in the full submission, not always in the public-facing summary.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for protein removal efficiency, irritation levels, or equivalence metrics). The primary "acceptance" described is the claim of substantial equivalence to predicate devices.

Reported Device Performance:
The document states that "The applicant performed toxicological testing and clinical testing of the instructions for use to support the claim of substantial equivalence." No specific performance metrics (e.g., protein removal percentage, irritation scores, or other quantitative results) are provided in this summary.

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

The document states "clinical testing of the instructions for use" was performed, but does not specify the sample size for this clinical testing or any "test set."
It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature).

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

The concept of "ground truth" and "experts" as typically understood in AI/ML performance evaluation (e.g., for image interpretation) is not applicable in this context. This device is a contact lens care product, and its performance evaluation would likely involve objective laboratory tests (e.g., measuring protein removal) and clinical trials assessing safety and efficacy (e.g., lens comfort, ocular health, user compliance with instructions). These types of studies might involve clinicians, but not in the role of establishing "ground truth" for a machine learning algorithm.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (e.g., 2+1, 3+1) is not applicable in this context, as it relates to expert disagreement resolution in diagnostic studies, not to the evaluation of a contact lens cleaning solution.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI in radiology) where multiple human readers interpret cases with and without AI assistance. This device is a physical product for lens care.

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

No, a standalone algorithm performance study was not done. This concept is relevant for AI/ML algorithms. This device is a chemical solution.

7. The Type of Ground Truth Used

As mentioned, "ground truth" in the context of AI/ML evaluation is not applicable here. The "truth" for this device's performance would be established through:

• Laboratory testing: Objective measurements of protein removal effectiveness using standardized methods.
• Toxicological testing: Evaluation of the chemical's safety and potential for irritation.
• Clinical testing: Assessment of patient comfort, ocular health, and compliance when using the product as directed.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here, as this device is a chemical solution and not an AI/ML algorithm.

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

The concept of "ground truth for a training set" is not applicable here, as this device is not an AI/ML algorithm.

Summary of what is present and what is missing based only on the provided text:

The document clearly states the intent to establish substantial equivalence for a protein remover for RGP contact lenses. It mentions that toxicological testing and clinical testing of the instructions for use were performed to support this claim. However, it does not provide any details about the methodologies, specific results, sample sizes, or quantitative acceptance criteria for these tests. The bulk of the information requested (related to AI/ML performance evaluation) is not relevant to this type of device.

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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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Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans, disinfects and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses. This product is for professional in-office use only.

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses consists of two solutions, Progent A and Progent B, which are mixed together when used. They are packaged separately in natural low density polyethylene (USP classification :VI) ampoules, type "Bottle Pack", containing 5.5 ml of solution, (5 ml being usable). Each package consists of 7 pairs of ampoules. Progent A contains sodium hypochlorite and sodium carbonate; Progent B contains potassium bromide and sodium carbonate. Rigid Gas Permeable Contact Lenses are placed into the lens holder cap of the cleaning vial (SP Vial). Progent A, then Progent B are poured into the case receptacle, then the lenses are soaked in the Progent mixture for 30 minutes.

The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device.

The document describes a 510(k) premarket notification for a contact lens cleaning solution (Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses). The claim of substantial equivalence for this device is based on it being the same formulation as a previously marketed predicate device (K002140), with only the indications and directions for use being modified. The applicant performed non-clinical stability, toxicology, and microbiology testing to support this claim.

Therefore, the requested information regarding acceptance criteria for an AI/ML device, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, type of ground truth, training set size, and training set ground truth establishment is not applicable to this submission. This is a traditional medical device submission for a chemical product, not an AI/ML device.

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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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