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To obtain endocervical cells for Pap smear cytology test

The Puritan Histobrush consists of nylon bristles secured by stainless steel to a plastic handle. The device is used to obtain endocervical samples for Pap smear cytology. The device is for single use only and is non-sterile.

The provided text is a 510(k) summary for a medical device called "Histobrush Model 2188," a cervical cytology brush. This type of submission focuses on demonstrating substantial equivalence to a predicate device for safety and effectiveness, rather than proving performance against specific acceptance criteria through a standalone clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and human expert involvement is not applicable or not provided in this document.

Here's an analysis of the provided information based on your request:

1. A table of acceptance criteria and the reported device performance

This document does not specify formal "acceptance criteria" in the way a performance claim for an AI/diagnostic device would. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. The "reported device performance" is essentially the equivalence shown through these tests and comparisons.

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

For the non-clinical tests (biocompatibility, tensile strength, fiber removal force, wire removal force), the sample sizes are not specified in this document.
The data provenance is not specified regarding country of origin or whether it's retrospective/prospective, as no clinical study on human subjects is described. The tests are non-clinical (laboratory-based).

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

Not Applicable. This document describes non-clinical engineering and materials testing, not a study requiring human experts to establish ground truth for a diagnostic outcome.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. As there's no diagnostic test set or human expert review, there's no adjudication method described.

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. This device is a manual medical instrument (cervical cytology brush), not an AI or imaging diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant here.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests would be the established engineering and material standards for the specific tests conducted (e.g., specific force thresholds for tensile strength, biocompatibility standards). These are implied standards relevant to the predicate devices, as the comparison is one of substantial equivalence. No pathology or outcomes data is referenced.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device that requires a training set.

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

Not Applicable. As above, no training set for an algorithm is relevant here.

In summary:

This 510(k) submission for the Histobrush Model 2188 demonstrates substantial equivalence by comparing its technological characteristics and non-clinical test results (biocompatibility, mechanical strength) to previously cleared predicate devices. It does not involve clinical studies with human participants, AI algorithms, or the establishment of diagnostic ground truth by experts from patient data. The "study" referenced is a series of non-clinical, laboratory-based tests to ensure the new device performs similarly and safely to existing products.

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