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The Boa Endoscopic Valve™ is used with endoscopes and endoscopic devices with a maximum outer diameter up to 0.167 in. Endoscopic devices are inserted through the Boa Endoscopic Valve™ and through the endoscope. The Boa Endoscopic Valve™ forms a seal around endoscopic devices, supports the endoscopic device, and maintains the position relative to the endoscope biopsy channel port. It is compatible with biopsy port valves and is positioned against the biopsy valve of the endoscope. The Boa Endoscopic Valve™ is non-sterile and is designed for single patient use.

AI/ML Overview

The provided document is a 510(k) summary for the Boa Endoscopic Valve™. It states that the device is substantially equivalent to a predicate device (EndoChoice Seal Biopsy Valve, K111821).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text, using the structure you requested:

The document does not specify "acceptance criteria" in terms of performance metrics like sensitivity, specificity, accuracy, or specific thresholds for leakage rates or device passage force. Instead, the "acceptance criteria" in this context appear to be met by demonstrating substantial equivalence to a predicate device through various non-clinical tests.

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

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Pass: Biocompatibility testing was performed in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1.
Physical Performance	Pass: Design verification and validation testing performed.
Simulated Use Performance	Pass: Design verification and validation testing performed.
Reliability	Pass: Design verification and validation testing performed.
Safety	Pass: Design verification and validation testing performed.
Clinical Attributes	Equivalent to predicate.
Technological Characteristics	Equivalent to predicate (attached to proximal biopsy channel port, aids in insertion/use/removal of accessories, minimizes leakage, used in hospitals/sub-acute care/surgery centers/doctor's office, single-patient disposable). The only stated difference is the rotation mechanism vs. pull-up mechanism.
Expected Performance	Comparable to legally marketed predicate (K111821).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any of the bench or biocompatibility tests. It also does not mention data provenance (country of origin) or whether the tests were retrospective or prospective, as these are non-clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a mechanical endoscopic valve, and the evaluation involved non-clinical performance and biocompatibility testing, not expert interpretation of medical images or data requiring ground truth established by medical experts in that context.

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

Not applicable. As noted above, this was a non-clinical evaluation that did not involve human adjudication for ground truth.

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 a medical device (endoscopic valve), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is a medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this type of device would be established by engineering specifications, material standards, and performance test methods. For example:

Biocompatibility: Adherence to ISO 10993 standards and FDA guidance.
Physical/Simulated Use/Reliability/Safety: Meeting pre-defined engineering specifications and performance benchmarks (e.g., specific force to pass a device, seal integrity tests, durability tests) that are typically established by the manufacturer and validated by test results.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.

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

Not applicable. As there is no training set for a machine learning model, this question is not relevant.

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