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The FemSpec disposable vaginal speculum is indicated for diagnostic procedures of the cervix.

The FemSpec disposable vaginal speculum consists of a soft plastic inflatable bladder, which once inserted into the vagina is inflated to uniformly press the vaginal wall open. Once inflated the bladder generates an annular space for diagnostic procedures of the cervix.

The provided text is a 510(k) summary for the FemSpec Disposable Vaginal Speculum. It describes the device, its intended use, and its substantial equivalence to a predicate device, but it does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information from the given text. The FDA 510(k) summary is generally a declaration of substantial equivalence, and while it references testing that would have occurred, it does not explicitly detail the acceptance criteria or study results for performance.

To answer your request, I would need a different document, such as a test report, a clinical study summary, or a more detailed performance evaluation report that specifies acceptance criteria and observed performance.

Here's what I can extract from the provided text based on your prompt, explaining why certain sections are not applicable:

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

   • Not Applicable. The document does not define specific acceptance criteria (e.g., specific thresholds for mechanical strength, inflation time, or viewing area) nor does it report detailed device performance metrics against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.

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

   • Not Applicable. The document does not describe a clinical or performance test set, sample size, or data provenance.

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. No ground truth establishment is described as there is no performance test set detailed.

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

   • Not Applicable. No test set or adjudication method is described.

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 device is a physical medical instrument (a vaginal speculum), not an AI-powered diagnostic system. Therefore, an MRMC study or AI-related metrics are irrelevant.

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

   • Not Applicable. As noted above, this is a physical device, not an algorithm.

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

   • Not Applicable. No ground truth is mentioned. The device's function is to provide access for diagnostic procedures, not to perform a diagnosis itself that would require ground truth comparison for its own performance.

8. The sample size for the training set:

   • Not Applicable. This is a physical device, not a machine learning algorithm. There is no concept of a "training set" in this context.

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

   • Not Applicable. As above, no training set or ground truth for it.

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