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For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered 3% hydrogen peroxide contact lens solution.

The device is a specialized lens case consisting of a transparent cup with a connected unit of screw cap, lens holders (baskets) and platinum-coated neutralization disc. The platinum catalyst coating and shape of the plastic disc are designed to effectively neutralize hydrogen peroxide in the lens care system to harmless water and oxygen gas.

This looks like a 510(k) summary for a medical device with a minor modification (change in silicone material of a gasket). Generally, devices with such minor changes do not contain extensive studies as they are not typically required for demonstrating substantial equivalence. The document confirms this in Section VII, "Performance Data," stating that the device was evaluated in "biocompatibility, physicochemical and design functionality tests."

Given the information provided in the 510(k) summary:

• No extensive clinical study was conducted or is reported for the device. The primary purpose of this 510(k) (K191795) is to demonstrate substantial equivalence to a legally marketed predicate device after a change in a gasket material.
• The "performance data" mentioned refers to nonclinical testing, which is generally not a clinical trial involving human subjects or AI algorithm performance as you might expect in more complex device submissions.
• The information you are asking for (e.g., sample size for training set, MRMC study, number of experts for ground truth) is typical for AI/ML-driven devices or devices requiring extensive clinical validation. This device (AOCup Lens Case with AODisc) is a contact lens case, which falls under a different regulatory pathway and testing requirements.

Therefore, I cannot provide the detailed information you requested about acceptance criteria and study particulars in the format you specified, as those types of studies and criteria are not described in this 510(k) submission for this specific device. The provided text outlines a regulatory submission for a contact lens case after a material change, not an AI or imaging-based diagnostic device.

However, I can interpret the "Performance Data" section to infer general acceptance criteria and the "study" (nonclinical testing) that proves the device meets them:

General Acceptance Criteria and "Study" (Nonclinical Testing) for AOCup Lens Case with AODisc (K191795)

The primary acceptance criterion for this 510(k) submission is to demonstrate that the modified device (with the new silicone gasket material) maintains the same safety and effectiveness as the predicate device. This is achieved through nonclinical testing to ensure the material change does not negatively impact the device's intended function or biocompatibility.

1. A table of acceptance criteria and the reported device performance

Regarding the other points in your request:

• 2. Sample sized used for the test set and the data provenance: Not applicable. These were nonclinical (bench) tests, not involving a "test set" in the context of clinical data or AI algorithms.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for nonclinical tests is based on established testing standards and specifications, not expert interpretation of data.
• 4. Adjudication method: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an imaging or diagnostic device that would require such a study.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This device does not involve an algorithm.
• 7. The type of ground truth used: For biocompatibility, physicochemical, and design functionality tests, the "ground truth" would be defined by the established industry standards, test methods (e.g., ISO standards for biocompatibility), and internal product specifications for the performance of the gasket and the lens case.
• 8. The sample size for the training set: Not applicable. There is no training set for this type of device.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a regulatory submission for a physical medical device (contact lens case) with a minor material change. The "study" refers to nonclinical laboratory and bench testing rather than clinical trials or AI performance evaluations, therefore, most of your requested information is not relevant to this specific type of device and submission.

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Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) contact lenses as recommended by your eye care practitioner.

Clear Care Cleaning and Disinfecting Solution is an aqueous solution contains hydrogen peroxide 3% (stabilized with phosphoric acid), sodium chloride, a phosphate buffer system and a non-ionic surfactant.

Here's a breakdown of the provided information regarding the acceptance criteria and supporting studies for the Clear Care Cleaning and Disinfecting Solution.

Acceptance Criteria and Device Performance

The provided document describes studies aimed at demonstrating improved patient comfort and substantial equivalence to existing products, rather than defining explicit quantitative "acceptance criteria" in terms of specific performance metrics (e.g., minimum percent reduction in bacterial count). Instead, the acceptance is based on demonstrating statistically significant improvements in comfort symptoms and substantial equivalence in wearing time compared to control products.

The primary focus of this 510(k) submission is to add specific statements to the package insert regarding improved comfort. Therefore, the "acceptance criteria" are implicitly met by demonstrating these improvements through clinical trials.

Interpretation of Acceptance Criteria and Reported Performance

Study Information

Due to the nature of this submission (a 510(k) for revised labeling based on clinical comfort data), the typical structure of an AI/ML device study isn't directly applicable. However, I will describe the provided clinical studies in the requested format, interpreting "test set" as the enrolled patient population in the clinical trials, and "ground truth" as the patient-reported outcomes.

Clinical Study 1: A multicenter comparison of AOSept Clear Care and multipurpose contact lens care systems

1. Sample size used for the test set and the data provenance:

   • Sample Size: 148 patients were enrolled.
   • Data Provenance: Prospective, multicenter study conducted at 18 eyecare offices throughout the United States.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This study relies on patient-reported outcomes for comfort and dryness symptoms. Therefore, there were no external "experts" establishing a "ground truth" in the traditional sense of medical image interpretation. The patients themselves provided the subjective data based on their experience. The "experts" involved would be the eyecare practitioners (ophthalmologists, optometrists) at the 18 centers who conducted the evaluations, but their role was data collection rather than ground truth establishment of the primary endpoints.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable as the primary endpoints are patient-reported symptoms (subjective data directly from the participant). There's no external adjudication process for a patient's feeling of dryness or comfort.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, this was not an MRMC study. It was a comparative effectiveness study comparing patient-reported outcomes with different contact lens care systems.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. This is a contact lens solution, not an algorithm or AI device.

6. The type of ground truth used:

   • Patient-reported outcomes (subjective measures of dryness frequency, dryness intensity, comfort during the day, and end-of-day comfort).

7. The sample size for the training set:

   • Not applicable. This is a clinical trial, not an AI/ML development process with a distinct training set. The entire enrolled patient population serves as the "test set" for the study's conclusions.

8. How the ground truth for the training set was established:

   • Not applicable.

Clinical Study 2: AOSept Improved UKClinical Trial R-162-C-002

1. Sample size used for the test set and the data provenance:

   • Sample Size: 182 subjects.
   • Data Provenance: Prospective, randomized, masked, contra-lateral with crossover clinical trial conducted in the UK.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Similar to Study 1, the primary endpoints (wearing time, comfortable wearing time) would likely be patient-reported or measured, not subject to expert "ground truth" establishment in a diagnostic sense. The eyecare professionals conducting the trial would be responsible for data collection.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable as endpoints are objective measures (wearing time) or patient-reported (comfortable wearing time).

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, this was not an MRMC study.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a contact lens solution.

6. The type of ground truth used:

   • Measured (for lens wearing time) and patient-reported outcomes (for comfortable wearing time).

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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AOSept Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner.

The AOSEPT Clear Care Cleaning and Disinfecting Solution is an aqueous solution contains hydrogen peroxide 3% (stabilized with phosphonic acid), sodium chloride, a phosphate buffer system and a non-ionic surfactant. The solution is indicated for use in simultaneous cleaning and disinfecting, daily protein removal, and storing of soft (hvdrophilic) contact lenses as recommended by your eve care practitioner.

The provided text does not contain detailed acceptance criteria or a comprehensive study report in the format typically used for medical device performance. Instead, it is a 510(k) summary for a contact lens care solution, which refers to previously submitted studies and guidelines for demonstrating substantial equivalence.

However, based on the information provided, I can infer some aspects related to acceptance criteria and the nature of the studies.

1. Table of Acceptance Criteria and Reported Device Performance

The document implicitly refers to FDA guidance documents as the source of acceptance criteria. The specific performance metrics are mentioned in relation to meeting these guidelines.

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

The document does not specify the sample sizes used for the test sets in any of the mentioned studies (silicone hydrogel compatibility, cleaning efficacy, cytotoxicity, microbiology, clinical studies).

The data provenance is implied to be from studies conducted to support FDA submissions in the US, given the sender is a US company and referring to FDA guidance. Whether the data is retrospective or prospective is not explicitly stated, but clinical and compatibility studies are typically prospective.

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. The studies mentioned are primarily laboratory (in vitro) or clinical performance studies, not studies relying on expert consensus for "ground truth" in the way an AI diagnostic device would. For clinical studies, the "ground truth" would be established by clinical outcomes and observations, potentially by eye care practitioners, but their specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in studies where multiple human readers are interpreting data (e.g., medical images) and their discrepancies need to be resolved to establish an agreed-upon ground truth. The studies cited are for a contact lens cleaning solution and do not involve such a process.

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

This information is not applicable/provided. The product is a contact lens care solution, not an AI-powered diagnostic device. Therefore, MRMC studies evaluating human readers with and without AI assistance are not relevant to this device.

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

A form of standalone testing was done for the microbiological efficacy. The summary states: "These studies demonstrate that AOSEPT Clear Care meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry: Premarket Notification 510(k) Guidance Document for Contact Lens Care Products." This "stand-alone criteria" implies an in vitro test of the solution's ability to kill microorganisms without human intervention.

For other tests (cleaning, cytotoxicity, compatibility), these are inherently "standalone" in the sense that they evaluate the properties and effects of the solution directly, not in conjunction with human interpretation in a diagnostic loop.

7. The Type of Ground Truth Used

• Silicone Hydrogel Lens Compatibility: Measured properties of the lenses (optical, physical changes) against a control (saline).
• In Vitro Cleaning Efficacy: Quantitative measurement of protein removal, compared to a predicate device.
• Cytotoxicity: In vitro assays to determine toxicity and irritant potential.
• Microbiology: Quantitative reduction of specific microorganisms in a controlled laboratory setting as per FDA guidance.
• Clinical Testing: Clinical observations and outcomes related to contact lens wear, comfort, and ocular health. The ground truth would be based on clinical assessments rather than a single "expert consensus" pathology or outcome data in the context of an AI device.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of a chemical solution. "Training set" is a term used for machine learning models, which this product is not. The studies conducted are traditional laboratory and clinical studies.

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

This information is not applicable as there is no "training set" for this type of device.

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AOSept Clear Care Cleaning and Disinfecting Solution is indicated for use in cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) or rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.

AOSept Clear Care Cleaning and Disinfecting Solution is an aqueous solution contains hydrogen peroxide 3% (stabilized with phosphonic acid), sodium chloride, a phosphate buffer system and a non-ionic surfactant.

Here's a breakdown of the acceptance criteria and study information for the AOSEPT Clear Care Cleaning and Disinfecting Solution, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set (Clinical Study for RGP Lenses): The text states, "Two thirds of subjects used the AOSept Clear Care, while and one-third used the control solution." The total number of subjects is not specified, only the ratio.
• Data Provenance: The RGP lens clinical study was a "one-month prospective randomized trial." The country of origin of the data is not explicitly stated, but the submission is from CIBA Vision Corporation in Duluth, Georgia, USA, suggesting the study was likely conducted in the USA.
• Other Studies (Compatibility, Microbiology, Biocompatibility): Sample sizes for these preclinical studies are not provided in this summary. The summary mentions these were "previously conducted" and "reviewed by FDA under two 510(k), K013512 and K003345."

3. Number of Experts and Qualifications for Ground Truth

This submission does not detail the use of experts to establish ground truth in the typical sense of a diagnostic medical device's performance claims.

• For the clinical study, a "one-month prospective randomized, trial" was conducted. The "ground truth" for clinical effectiveness (e.g., lens cleanliness, comfort) would be based on subject reporting and potentially investigator observations. The qualifications of the clinical investigators are not specified.
• For pre-clinical tests (Microbiology, Compatibility, Biocompatibility), the "ground truth" is defined by standardized test methods (e.g., ISO 14729) and regulatory guidelines (e.g., FDA guidance documents, GLP regulations). Performance against these standards serves as the benchmark, rather than expert consensus on individual cases.

4. Adjudication Method

• No specific adjudication method (like 2+1 or 3+1) is mentioned or appears applicable given the nature of the device (contact lens solution) and the types of studies performed (compatibility, microbiology, clinical trial for lens care). Clinical endpoints like "lens cleanliness" and "comfort" are typically assessed by the subject or clinical investigator, not through a multi-expert adjudication of a diagnostic finding.

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

• No MRMC study was done. This type of study is relevant for diagnostic imaging AI devices where human readers interpret medical images with and without AI assistance. This device is a contact lens care solution, and its evaluation methodologies do not involve MRMC studies.

6. Standalone (Algorithm Only) Performance Study

• Not applicable/done in the context of an algorithm. This product is a chemical solution. The "standalone performance" is demonstrated by the various in vitro and in vivo tests, such as the ISO 14729 Stand Alone Test and Regimen Test for antimicrobial activity, which evaluate the solution's properties independent of human interaction during the test itself, but these tests are not for an AI algorithm.

7. Type of Ground Truth Used

• Compatibility: Ground truth is established by objective measurements against pre-defined specifications (e.g., optical power, diameter, visual appearance, % transmittance) and compliance with regulatory guidelines.
• Microbiology: Ground truth is established by adherence to in vitro antimicrobial efficacy standards as defined by ISO 14729 and FDA 510(k) performance criteria for contact lens disinfecting solutions, measured by reductions in microbial populations.
• Biocompatibility: Ground truth is established by meeting the guidelines set forth in FDA guidance documents and demonstrating non-toxicity and biocompatibility through standard tests.
• Clinical: Ground truth for effectiveness with RGP lenses is based on observed clinical outcomes and subject-reported data (e.g., lens cleanliness scores, comfort ratings, need for rewetting drops).

8. Sample Size for the Training Set

• Not applicable. This product is a chemical solution, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As there is no AI/ML algorithm, there is no training set or associated ground truth establishment process.

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AOSEPT Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses as recommonded by your eye care practitioner.

The AOSept Clear Care Cleaning and Disinfecting Solution is an aqueous solution contains hydrogen peroxide 3% (stabilized with phosphonic acid), sodium chloride, a phosphate buffer system and a non-ionic surfactant.

The provided text is a 510(k) summary for a contact lens care product, not a medical device that utilizes AI or algorithmic performance for diagnostics or treatment. Therefore, the information requested in your prompt regarding acceptance criteria, study design, expert involvement, and AI-specific metrics (like MRMC studies or standalone algorithm performance) is not applicable to this document.

The document discusses the substantial equivalence of AOSEPT Clear Care Cleaning and Disinfecting Solution to a predicate device based on pre-clinical and clinical studies submitted previously (K003345 and K013512). It confirms its intended use for cleaning, disinfecting, daily protein removal, and storing soft contact lenses.

Without details from the referenced prior submissions (K003345 and K013512), it's impossible to extract specific acceptance criteria, reported performance, or study methodologies that traditionally apply to AI-driven medical devices.

Summary of inapplicable questions:

• 1. A table of acceptance criteria and the reported device performance: Not provided. This document describes a chemical solution, not a performance-based diagnostic device.
• 2. Sample sized used for the test set and the data provenance: Not provided. The studies mentioned (K003345, K013512) are for the chemical solution's safety and effectiveness.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would relate to microbiological efficacy or clinical outcomes, not expert image interpretation.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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-assisted device.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated, but would likely involve microbiological challenge tests and clinical trial outcomes for safety/efficacy in contact lens care.
• 8. The sample size for the training set: Not applicable. There is no "training set" for this type of product.
• 9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

AOSEPT Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

The AOSept Clear Care Cleanir, and Disinfecting Solution is an aqueous solution contains hydrogen peroxide 3% (stabilized with phosphonic acid), sodium chloride, a phosphate buffer system and a non-ionic surfactant. The solution is indicated for use in simultaneous cleaning and disinfecting, daily protein removal, and storing of soft (hydrophilic) contact lenses as recommended by your eve care practitioner.

Here's an analysis of the provided text regarding the AOSEPT Clear Care Cleaning and Disinfecting Solution, focusing on acceptance criteria and supporting studies:

This document primarily describes the substantial equivalence of a contact lens cleaning solution to existing products, rather than a medical device employing AI or complex algorithms. Therefore, many of the standard questions regarding AI device evaluation (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets) are not directly applicable.

However, I can extract the relevant information from the provided text in the requested format where possible, and indicate when information is not applicable or not provided for this type of product.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size (Clinical Evaluation): Not explicitly stated as a number of participants. It mentions "Study participants were all randomized."
• Data Provenance: Prospective, randomized, single masked, contralateral trial. No country of origin is explicitly stated, but the submitter information is from Duluth, Georgia, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable in the context of this device (contact lens solution). The "ground truth" for clinical efficacy and safety was established through participant feedback, investigator observations, and objective measurements (dark-field image analysis). "Investigators" observed front surface wetting and appraised lens deposits, but their number and specific qualifications (e.g., ophthalmologist, optometrist) are not detailed.

4. Adjudication method for the test set:

• Not applicable as this is not an image-based or diagnostic device requiring expert adjudication. The study used a "single masked" design, where participants were masked to which eye received the test vs. control product.

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-assisted diagnostic device. The study compared two contact lens care solutions.

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

• Not applicable. This is not an algorithmic device. The "standalone" term is used in the context of microbiology testing, referring to the solution's ability to disinfect by itself, without a separate cleaning step. The text notes: "These studies demonstrate that AOSEPT Clear Care meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products."

7. The type of ground truth used:

• Performance (Microbiology): Compliance with FDA guidance for disinfection efficacy.
• Performance (Cleaning): Objectively measured protein removal, and dark-field image analysis of lenses for cleanliness.
• Clinical Efficacy/Safety: Subjective feedback (insertion comfort, dryness, cleanliness, overall preference) from study participants and objective observations/appraisals by investigators.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable.

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