(84 days)
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):
| Acceptance Criteria Category | Reported Device Performance (Results) |
|---|---|
| Tensile Strength | Predetermined acceptance criteria were met (tensile force during proper clinical use should not fracture materials and bonds). |
| Torque | Predetermined acceptance criteria were met (torque applied during clinical use should not damage the device). |
| Bristle Retention | Predetermined acceptance criteria were met (bristle adhesion when subjected to forces expected during proper clinical use). |
| Biocompatibility | Proposed device is non-cytotoxic, non-sensitizing, and non-irritating. |
| Shelf life and Packaging Integrity | Package system and materials provide an acceptable sterile barrier and a three-year device sterility period. |
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.
§ 884.1100 Endometrial brush.
(a)
Identification. An endometrial brush is a device designed to remove samples of the endometrium (the mucosal lining of the uterus) by brushing its surface. This device is used to study endometrial cytology (cells).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(2) Labeling:
(i) Indication: Only to evaluate the endometrium, and
(ii) Contraindications: Pregnancy, history of uterine perforation, or a recent cesarean section, and
(3) Design and testing:
(i) The sampling component is covered within the vagina, and
(ii) For adherence of the bristles and brush head.