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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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The device is an imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT). The device produces attenuation and nonattenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as x-ray transmission images of these areas. The PET and CT images are registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. The device can provide CT data suitable for use in attenuation correction.

The device is a combination Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) scanner that can be utilized in both conventional, fixed installations or mobile environments. The system integrates the two system operator consoles into a single workstation to allow straightforward planning and system operation. The individual PET and the CT gantries remain intact as major subsystem located within a common integrated housing. It can be used in clinical protocols and procedures, which have been clinically conducted in a separate CT system and/or a PET system. The system is intended for use primarily as a clinical whole body oncology scanner with high-end multislice CT capability and high-end GSO based PET performance. It mechanically separates to allow for the greater flexibility for above three operation modes.

Here's an analysis of the provided text regarding the Gemini 16 device's acceptance criteria and study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for the Gemini 16 does not specify quantitative acceptance criteria for its performance. Instead, it refers to compliance with established standards. The reported "device performance" is primarily articulated as meeting these technical and safety standards, and being "substantially equivalent" to predicate devices.

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

The document does not report any specific sample size for a test set or the provenance of any data. The evaluation relies on compliance with technical standards and a comparison to predicate devices, rather than a clinical study with a distinct test set of patient data.

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

This information is not applicable as there is no reported clinical study with a test set requiring expert-established ground truth. The evaluation focuses on technical performance and safety standards.

4. Adjudication Method for the Test Set

This information is not applicable as there is no reported clinical study with a test set requiring adjudication.

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

No, a MRMC comparative effectiveness study is not mentioned in the provided text. The document focuses on technical safety and performance, and substantial equivalence to predicate devices, not on the improvement of human readers with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

This information is not applicable in the context of this device. The Gemini 16 is a medical imaging system (a PET/CT scanner), not an AI algorithm. Its performance is inherent to its hardware and software functioning, which is evaluated against established physical and safety standards (NEMA NU-2, IEC, CFR). The "algorithm only" concept typically applies to software-based diagnostic aids.

7. The Type of Ground Truth Used

The "ground truth" for the Gemini 16's evaluation is primarily based on:

• Compliance with published technical standards: NEMA NU-2 for imaging performance, 21 CFR 1020.30 & 1020.33 for radiation safety, and IEC 60601-1 series for electrical and mechanical safety.
• Comparison to predicate devices: Establishing "substantial equivalence" based on intended use, technological comparison, and system performance as defined by the aforementioned standards.

8. The Sample Size for the Training Set

This information is not applicable. The Gemini 16 is a physical imaging device, not a machine learning model that requires a "training set."

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

This information is not applicable for the same reason as above.

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