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The Utepreva Endometrial Sampler (UP01) is used to obtain endometrial cytological and histological samples.

The Utepreva Endometrial Sampler (UP01) is a single-use, sterile device designed to obtain endometrial cytological and histological samples. The device is an Rx device that functions as follows: The Utepreva Endometrial Sampler is gently inserted though the cervix into the uterus. The skirt (guard) will reach the cervix indicating to the clinician to stop inserting the device. The brush is then extended by pushing the handle until resistance is felt when the tip meets the fundus of the uterus. The sponge on the tip is intended to minimize the risk of piercing of the fundus by the tip of the brush and enables additional tissue sampling by absorption of the fluid and the cells from the uterus. The Utepreva Endometrial Sampler is rotated in a clockwise or counterclockwise manner for four or five 360° rotations. Upon completion of the rotations, the handle is pulled back so that the brush and tip are withdrawn into the outer sheath. The suction created by the plunger located inside of the sheath provides aspiration of the cells and prevents loss of the sample from the brush, sponge and any fluid that was aspirated can then be immersed into the preservative solution to be used by the pathology lab.

The device materials consist of polydimethylsiloxane, high density polyethylene, cyanoacrylate adhesive, Loctite, Permabond polyolefin primer, stainless steel, Nylon, polycarbonate, and polypropylene. The device is packaged in a Tyvek® pouch. One pouch is then packaged in a unit box. Fifteen unit boxes are packaged within a single master box to create the final shipped product.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) premarket notification letter from the FDA, and it focuses on the substantial equivalence of the "Utepreva Endometrial Sampler (UP01)" to a predicate device.

While it mentions non-clinical performance testing (biocompatibility, visual & dimensional inspection, tensile strength, torque, bristle retention, fluid retention, fluid transfer) and states that these tests "passed," it does not:

1. Provide a table of specific acceptance criteria and reported device performance values. It only states "Pass" for each test.
2. Detail the sample size used for the test set.
3. Specify the data provenance (e.g., country of origin, retrospective/prospective).
4. Mention the number or qualifications of experts used to establish ground truth.
5. Describe any adjudication method.
6. Indicate if a multi-reader multi-case (MRMC) comparative effectiveness study was done.
7. Discuss standalone performance (algorithm only without human-in-the-loop).
8. Elaborate on the type of ground truth used (expert consensus, pathology, outcomes data, etc.).
9. Provide the sample size for the training set.
10. Explain how the ground truth for the training set was established.

The document's purpose is to establish substantial equivalence based on indications for use, technological characteristics, and general performance testing, not to provide a detailed clinical or performance study breakdown with specific metrics and methodologies.

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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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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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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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