(108 days)
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.
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Not explicitly stated (implied: compliance with FDA guidance and international standards) | Performed (details not provided) |
| Sterility | Not explicitly stated (implied: compliance with FDA guidance and international standards) | Performed (details not provided) |
| Performance (general sampling efficacy) | Not explicitly stated (implied: adequate representative sample retrieval) | "procures an adequate representative sample of the endometrial" (from device description); Performance testing performed (details not provided) |
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.
§ 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.