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The device is intended for the use of physicians and other professionals authorized to take sample cells from the cervix of the uterus, transfer them to a fluid suspension (or smear them on a slide, in the case of a traditional PAP test) for further preparation of cytological slides. CYTOPREP® was designed for use in conjunction with Liquid Based Cytology procedures. However, recent tests at the University of Munich. Germany, have proven it equally effective as a sampling device for the traditional PAP smear test.

The device is used to sample the cervix of patients for the purpose of obtaining ecto-cervical, endo-cervical and T-zone sample cells. These sample cells are used for the "PAP" test.

While the product is designed to be used in conjunction with liquid based cytology procedure (monolayer method), it can also be used in conjunction with the traditional "PAP" test procedure.

CYTOPRED® consists of two parts, the handle and the head.

The handle is 214mm in length, cylindrical and on one end it carries the name of the product. On the other end , there are two recesses (female) to accommodate the bottom part of the head. These two recesses, along with a special edge (male) on the bottom of the head. secure the head. When the physician has inserted the head in the endocervical canal and is turning the handle to obtain sample cells, the head turns (follows the physician's manipulations) and there is no slippage. Tests made (see XI Performance for attached laboratory report), prove that it will be impossible for a bristle to break and remain in the patient's cervix and almost impossible for the head to accidentally separate from the handle and remain in the cervix.

The head consists of:

The "male" edge on the bottom that is secured in the handle recess (female), stabilizing the head on the handle;

The base, upon which sit lengthy bristles on both sides of the center brush.

The center brush end sits upon the base of the head and its center stem extends beyond the lengthy bristles. On its center stem, perpendicular to the lengthy bristles, sit bristles which extend from the base of the head to the end of the center stem.

Here's a summary of the acceptance criteria and study information for the CYTOPREP® device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for the Test Set and Data Provenance:

• Sample Size: Over 60,000 CYTOPREP® devices were used by physicians in the testing stage.
• Data Provenance: The studies were conducted at the University of Geneva and independent laboratories. The document also mentions "recent tests at the University of Munich, Germany," proving its effectiveness for traditional PAP smear tests, but the primary clinical performance data cited for the acceptance criteria seems to stem from the Geneva/independent lab studies. The nature of the studies (retrospective or prospective) is not explicitly stated, but the mention of "testing stage of the device's development" suggests a prospective evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth within the 60,000+ device usage context, beyond "physicians who have used more than 60,000 CYTOPRED devices." For the morphology comparison, it states "morphology of the collected cells is maintained in 95% of the cells, as compared to 80% for the conventional sampling techniques," which implies expert evaluation, but the specifics are not detailed.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth regarding cell collection or morphology in the studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

No MRMC comparative effectiveness study involving human readers and AI assistance was mentioned. The comparison is between the CYTOPREP® device and the combined use of Spatula and Cytobrush®, not an AI-assisted human reading scenario.

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

This device is a physical cervical brush, not an AI algorithm. Therefore, no standalone algorithm-only performance study was conducted or is applicable.

7. The Type of Ground Truth Used:

The ground truth appears to be based on:

• Expert assessment: Physicians observed the presence of endo-cervical cells, total cell count, and maintained cell morphology.
• Comparison to established standards: The performance metrics (e.g., "93-95% of the cases" for endocervical cells, "equal to or exceeding" total cell count, "95%... as compared to 80%" for morphology) are presented in relation to reported results of the "most widely used sampling method, i.e., the combined use of Spatula and Cytobrush®," and "conventional sampling techniques."

8. The Sample Size for the Training Set:

The document does not mention a "training set" in the context of machine learning or AI. The development of the device involved "tests made" for mechanical properties (bristle breakage, head separation) and clinical observations/studies from the 60,000+ devices. This information pertains to the evaluation and validation of the physical device's performance directly.

9. How the Ground Truth for the Training Set Was Established:

As there's no mention of a "training set" in the AI/ML sense, this question is not applicable. The device's "training" was through iterative design and physical testing, with performance validated through clinical usage and studies as described.

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