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The MatrixBrush™ Endometrial Sampler is used to obtain endometrial cells for microscopic examination and/or for microbiology cultures.

The MatrixBrush Endometrial Sampler is a sterile, single-use endometrial tissue sampling device. The MatrixBrush shaft is comprised of a spirally twisted stainless steel core covered by plastic with marked gradations. A nylon brush head at the distal end of the device collects a tissue sample and an atraumatic plastic bulb located on the extreme distal end protects the patient from penetration. A moveable plastic sheath overlies the brush head and device shaft.

This document is a 510(k) summary for the MatrixBrush™ Endometrial Sampler. It establishes substantial equivalence to a predicate device based on non-clinical testing. Therefore, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria, specific study designs, or reader-based evaluations.

However, based on the provided text, I can infer and summarize the available information:

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

The document mentions "in vitro testing to evaluate adherence of the bristles and brush head was completed" and states, "Non-clinical mechanical test results demonstrate the MatrixBrush performance is satisfactory and suitable for its intended use." It also states, "This premarket notification has demonstrated the differences between the MatrixBrush Endometrial Sampler and predicate device do not raise any questions regarding its safety and effectiveness."

Without access to the full submission or the specific test report, the explicit acceptance criteria are not detailed in this summary. The "reported device performance" is a general statement of satisfaction and suitability rather than specific quantitative metrics.

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

• Sample size for test set: Not specified in the provided 510(k) summary. The document only mentions "in vitro testing."
• Data provenance: "In vitro testing" implies laboratory-based testing, not human or animal studies. No country of origin is specified for the data, but the submission is to the U.S. FDA by a U.S.-based company. The nature of the testing (in vitro) means it is not directly retrospective or prospective in the sense of patient data.

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

This information is not applicable to the "in vitro testing" described. The testing likely involved mechanical or material engineers evaluating physical properties, not medical experts establishing ground truth for diagnostic outcomes.

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

Not applicable. This type of adjudication method is used for resolving discrepancies in expert interpretations of diagnostic data, which is not what was performed in the "in vitro testing" mentioned.

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. The device is an endometrial sampler, not an AI diagnostic tool. No MRMC study or AI assistance is mentioned.

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

Not applicable. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used:

For the "in vitro testing" mentioned, the "ground truth" would likely be engineering specifications, material standards, or established mechanical performance criteria for similar devices. It is not expert consensus, pathology, or outcomes data, as those relate to clinical diagnostic performance.

8. The sample size for the training set:

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this device type.

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