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This device is a disposable device to be used to inflate, deflate and monitor pressure for gastrointestinal dilation balloons.

The Wilson-Cook Balloon Inflation Device is a hand-held mechanical device consisting of a 20cc capacity syringe, a 300 psi/20atm pressure gauge, a plunger mechanism, lever, extension line, and stopcock. This device is to be used to inflate, deflate and monitor pressure for gastrointestinal dilation balloons.

The provided text describes a medical device, the Wilson-Cook Balloon Inflation Device, and its premarket notification. However, it does not include detailed information regarding specific acceptance criteria for device performance or a comprehensive study report proving the device meets those criteria in the way typically expected for AI/ML-based medical devices (e.g., sensitivity, specificity, AUC).

Instead, the document focuses on regulatory compliance, description of the device, its intended use, and comparison to predicate devices, along with basic functional testing.

Therefore, for the given input, most of the requested information cannot be extracted. I will fill in what can be inferred and explicitly state what is not available.

Acceptance Criteria and Device Performance Study for the Wilson-Cook Balloon Inflation Device

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states "All samples tested" for in-house functional testing. A specific number of samples is not provided.
• Data Provenance: The testing was "in-house functional testing." This indicates the testing was conducted by Wilson-Cook Medical Inc. The data is retrospective in the sense that it was performed on manufactured samples. Country of origin of data is not specified but assumed to be the USA where Wilson-Cook Medical Inc. is located.

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

• This information is not applicable and not provided. The device is a mechanical balloon inflation device, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth for its performance assessment. Ground truth here would be based on engineering specifications and physical measurements.

4. Adjudication Method for the Test Set

• This information is not applicable and not provided. As it's a mechanical device, performance is typically assessed against engineering specifications, not through expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance

• This information is not applicable and not provided. The device is a mechanical instrument, not an AI system that assists human readers.

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

• This information is not applicable and not provided. The device is a mechanical instrument, not an algorithm. Its standalone performance is inherently what was tested through "in-house functional testing."

7. The type of ground truth used

• The ground truth for the "functional testing" would be based on engineering specifications and metrological standards for pressure accuracy, syringe capacity, inflation/deflation capabilities, and sterility. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• This information is not applicable and not provided. The device is a mechanical device, not an AI/ML model that requires a "training set."

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

• This information is not applicable and not provided for the same reason as point 8.

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