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The forceps valve is intended to facilitate passage of an endotherapy device, to prevent leak or back flow of air and/or fluids, and to enable the suction function of a FUJIFILM or Olympus gastrointestinal endoscope.

The FROG forceps valve forms a tight seal with the biopsy port to prevent leakage of biomaterial, provide easy passage of endotherapy devices, and support the suction function.

The provided document is a 510(k) premarket notification letter and a 510(k) summary for the FROG Forceps Valve (VAL1-F1-100). This device is an endoscope accessory and its clearance is based on substantial equivalence to a predicate device (JAZZ Forceps Valve (part of JAZZ Disposable Valve Kit) K210625).

The document does not describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study. Instead, it focuses on bench testing, biocompatibility testing, and a comparison of technological characteristics to a predicate device.

Therefore, the requested information regarding acceptance criteria, performance data, sample sizes, expert involvement, ground truth establishment, and MRMC studies related to an AI device cannot be extracted from this document, as it pertains to a different type of medical device clearance (forceps valve, not AI/ML).

The information that can be extracted regarding the FROG Forceps Valve is as follows:

FROG Forceps Valve (VAL1-F1-100) Analysis:

This device is a physical accessory for endoscopes, not an AI/ML diagnostic or assistive tool. The performance evaluation is based on bench testing and biocompatibility, not on AI model performance metrics or human reader studies.

1. Table of acceptance criteria and the reported device performance:

The document states: "Additional performance specifications were evaluated against pre-defined acceptance criteria to demonstrate the effectiveness of the device over its stated 2-year shelf life." However, the specific acceptance criteria and the detailed reported performance values are NOT provided in this summary.

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

• Bench Testing: The document states "Bench testing was conducted to confirm the compatibility of the subject device with Olympus scopes." and "Additional performance specifications were evaluated...". The specific sample sizes for these bench tests are not mentioned.
• Biocompatibility Testing: The document refers to consensus standards (ISO 10993-1, -5, -7, -10) and FDA guidance for biocompatibility. Specific sample sizes for these tests are not provided.
• Data Provenance: The tests are likely laboratory-based bench tests and biocompatibility assessments, not clinical data from patients. The manufacturer is FUJIFILM medwork GmbH, located in Höchstadt, Germany, implying the testing would likely be performed in a controlled laboratory environment. Retrospective or prospective classification is not applicable here as it's not a clinical data study.

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

• This is not applicable as the device is a physical medical device (forceps valve), not an AI/ML diagnostic. Ground truth (e.g., for diagnostic accuracy) is not established by human experts in the context of this device's performance evaluation for FDA clearance. Performance is assessed via engineering and biocompatibility testing.

4. Adjudication method for the test set:

• Not applicable for this type of device and performance testing.

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

• No, an MRMC study was NOT done. This type of study is relevant for diagnostic AI tools where human readers' performance with and without AI assistance is evaluated. This document concerns a physical endoscope accessory.

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

• Not applicable. This is not an algorithm.

7. The type of ground truth used:

• For biocompatibility: Adherence to ISO standards and FDA guidance for biological evaluation.
• For performance: Engineering specifications and functional requirements (e.g., tight seal, easy passage of devices, support suction function). The "ground truth" is based on the device's ability to meet these pre-defined engineering performance criteria.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

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