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The Tao Brush™ I.U.M.C. Endometrial Sampler is used to obtain endometrial cytological and histological samples.

The Tao Brush™ I.U.M.C. Endometrial Sampler has a working length of 26.9 centimeters and a 9.3 French outer sheath measuring 21.5 centimeters in length. The outer sheath slides forward and back to cover or expose the bristles of the brush and thus provides protection from contamination when inserting or removing the brush into/from the uterus for the collection of endometrial cell samples. The 9.5 French acrylonitrile butadiene styrene (ABS) ball tip allows for an atraumatic insertion of the device through the cervix and into the uterus. The nylon brush bristles cover a 3.5 centimeter length of the stainless steel wire shaft, near the distal tip, and form a brush diameter of 6 millimeters. Additionally, there are two indicators to aid physicians in the use of The Tao Brush" I.U.M.C. Endometrial Sampler. The first indicator is a notch on the handle of the device which allows the physician to track rotations of the brush while collecting endometrial cell samples. The second indicator is a black ink mark located on the outer sheath about 7 centimeters from the distal tip of the device. Through visual observation of this marker, the physician can more accurately gauge how far the brush has entered the uterus. The Tao Brush I.U.M.C. Endometrial Sampler is sterilized using ethylene oxide, packaged in a Tyvek® polyethylene peel-open pouch, and has a shelf life of three years. The device is intended for one time use.

The provided text describes a medical device, the Tao Brush™ I.U.M.C. Endometrial Sampler, and its regulatory submission. It details performance testing conducted to demonstrate substantial equivalence to a predicate device, but does not describe a study involving detailed acceptance criteria for diagnostic performance, nor does it involve AI, human readers, or ground truth established by experts/pathology in the context of diagnostic accuracy.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to engineering and biocompatibility tests, not diagnostic performance.

Therefore, the requested information, specifically regarding diagnostic performance criteria, sample sizes for test/training sets, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth types related to diagnostic accuracy, cannot be extracted from this document, as it is not present. The device is a physical sampling tool, not a diagnostic algorithm.

However, I can extract the information that is present regarding the engineering acceptance criteria and the engineering studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance (for engineering/physical properties):

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

• Sample Size for Test Set: Not specified for any of the performance tests. The document mentions "testing" was performed, but does not provide specific numbers of units tested.
• Data Provenance: Not specified. The tests were conducted internally or by a contracted lab to support the 510(k) submission.

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

• Not applicable as the tests described are for physical device properties and biocompatibility, not for establishing diagnostic ground truth with expert review.

4. Adjudication method for the test set:

• Not applicable.

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:

• No. This is a physical device, not an AI diagnostic tool.

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

• No. This is a physical device.

7. The type of ground truth used:

• For the physical tests, the "ground truth" would be the predetermined engineering and material specifications/standards and the pass/fail criteria established for each test (e.g., a certain force causes failure, or a certain level of cytotoxicity is unacceptable).

8. The sample size for the training set:

• Not applicable. This is not a machine learning device.

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

• Not applicable.

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Used to obtain endometrial cytological and histological samples.

The Tao Brush™ I.U.M.C. Endometrial Sampler is a brush assembly fitted inside a shaft. A coaxial sheath promotes sample protection and there are positioning marks on the end of the shaft. The brush head procures and adequate representative sample of the endometrial and the tip protects the patient from abrasion. The devices are provided sterile and are intended for one time use.

The provided text describes the 510(k) submission for the Tao Brush™ I.U.M.C. Endometrial Sampler. However, it does not contain specific details about acceptance criteria, a dedicated study proving device performance against such criteria, sample sizes for test or training sets, data provenance, expert qualifications for ground truth, adjudication methods, or MRMC comparative effectiveness studies. The submission states that "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards. Testing data and information is included in this submission," but the actual data and methodology are not included in the provided snippets.

Therefore, the following information is based only on what is explicitly stated or can be inferred from the provided text. Many fields will be marked as "Not provided in the text."

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided text does not explicitly define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present a table of reported device performance against such criteria for the Tao Brush™ I.U.M.C. Endometrial Sampler. It generally states that "performance testing" was conducted.

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

• Sample Size for Test Set: Not provided.
• Data Provenance: Not provided. The text only states that testing was performed, but doesn't mention the country of origin of data or whether it was retrospective or prospective.

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

• Number of Experts: Not provided.
• Qualifications of Experts: Not provided.

4. Adjudication method for the test set

• Adjudication Method: Not provided.

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

• MRMC Study: No. This device is an endometrial sampler, a physical medical device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

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

• Standalone Study: Not applicable. This is a physical sampling device, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: Not explicitly stated for performance testing. Given the device's purpose ("used to obtain endometrial cytological and histological samples"), the ground truth for evaluating sampling efficacy would typically involve laboratory analysis (e.g., pathology reports) of the procured samples, but this is an inference, not directly stated.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

• How Ground Truth for Training Set was Established: Not applicable. This is a physical device, not an AI algorithm.

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