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The Disposable Cervical Brush is intended for the collection of cervical cells for analysis by Pap smear methods. It is not intended for use in pregnant women and should be used by a clinician or other qualified health professional only.

The Disposable Cervical Brush is a non-sterile, disposable, colored cytological cervical spatula intended for collecting cytological materials from the surface of the cervix. This device consists of two components: a white colored head and a pink colored handle. The head contains a brush and a connection portion. The head and handle are physically connected through a male/female connection mechanism. The handle is made of Polypropylene (PP) and the head is made of low density polyethylene (LDPE). This device has a 3-years shelf-life.

The provided documentation is a 510(k) summary for a Disposable Cervical Brush, a medical device used for collecting cervical cells for Pap smear analysis. It outlines the device's technical specifications, intended use, and comparison to a predicate device to establish substantial equivalence.

Based on the provided text, here's a detailed breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative "acceptance criteria" for clinical performance. Instead, it focuses on demonstrating safety and performance through non-clinical testing and comparison to a predicate device. The underlying acceptance criterion for a 510(k) is substantial equivalence to a predicate device, meaning it is as safe and effective as the legally marketed predicate.

The reported performance is primarily derived from meeting established standards for biocompatibility and mechanical integrity, which implicitly demonstrate that the device performs as intended and is safe for its intended use.

Study Information

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • The document describes non-clinical (bench) testing for biocompatibility, mechanical performance, and chemistry. It does not mention a "test set" in the context of clinical data, as it's a 510(k) for a Class II manual instrument where clinical studies are often not required if substantial equivalence can be demonstrated through other means.
   • For the non-clinical tests, specific sample sizes are not provided, nor is the country of origin of the testing data or whether it was retrospective or prospective. It is implied these were prospective tests conducted to evaluate the device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable. The document describes non-clinical testing, not a study involving expert-established ground truth on patient data.

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

   • Not applicable. This is not a clinical study involving adjudication of human-interpreted data.

4. 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 is not an AI/software device, and no MRMC study is mentioned. The device is a manual instrument for cell collection.

5. 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.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   • For the non-clinical tests, the "ground truth" or reference standards were established laboratory testing standards and methods for biocompatibility, mechanical properties, and chemical composition. For instance, cytotoxicity tests adhere to recognized protocols to determine the biological response.

7. The sample size for the training set

   • Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device.

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

   • Not applicable. As there's no training set, there's no ground truth established for it.

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