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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 Progent Vial. Menicon Rinse solution is used once the lens soaking cycle is complete. 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 text describes a 510(k) premarket notification for the "Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses." However, it explicitly states that no new clinical or non-clinical studies were performed for this particular submission (K173136).

The device's clearance is based on its prior approvals and the fact that there are no product formulation changes. Therefore, the device's acceptance criteria and the study that proves it meets those criteria are established through substantial equivalence to predicate devices (Boston Cleaner and Boston Advance Cleaner) based on historical data, not new studies presented within this document.

As such, I cannot provide a table of acceptance criteria and reported device performance from a new study conducted for this 510(k) submission, nor can I detail sample sizes, expert qualifications, or adjudication methods for studies not conducted as part of this submission. The document explicitly states:

• "Non-clinical studies were unnecessary for this application. Menicon Progent Protein Remover has been cleared in prior applications. There are no product formulation changes made in this application therefor no non-clinical studies were required." (Page 4)
• "Clinical studies were unnecessary for this application. Menicon Progent Protein Remover has been cleared in prior applications. There are no product formulation changes made in this application therefor no clinical studies were required." (Page 4)

The "Conclusion" section on page 4 further reinforces this by stating: "Based upon the product history and data presented, the Menicon Progent Protein Remover can be used as safely and as effectively as the Boston Cleaner and the Boston Advance Cleaner."

Therefore, the requested information points regarding new studies (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to the immediate content of this 510(k) summary as no such new studies were performed. The acceptance criteria essentially stem from the historical performance and regulatory compliance of the predicate devices and the Menicon Progent Protein Remover's prior clearances.

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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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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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