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The Cervical Cytology C-Brush is intended for the collection of cervical cells for Pap smear analysis and /or for sexually transmitted disease (STD) testing. The Cervical Cytology C-Brush is not intended for use in pregnant women.

Indication for use are the endocervical collection of specimens used in Pap smear, chlamydia and HPV testing.

The Cervical Cytology C-Brush has a truncated cone-shaped brush head composed of nylon bristles joined to a wire shaft. The brush head on the wire shaft is bonded to a plastic handle. To collect cervical cells, the brush end of the Cervical Cytology C-Brush is inserted 1.0 to 1.5 cm into the cervical os until the longest outer bristles of the brush touch the ectocervix. The brush is rotated two full turns in counter - clockwise direction and withdrawn. The brush is then used to spread the specimen onto a glass slide for a Pap smear.

The provided text is a 510(k) summary for the Canadian Medical Brush Inc. Cervical Cytology C-Brush. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Based on the provided text, there is no information about a study that describes acceptance criteria for device performance, nor any reported device performance metrics tied to such criteria.

The document primarily focuses on establishing "substantial equivalence" of the Cervical Cytology C-Brush to a predicate device (Team Technologies, Inc. - Cytology Brush, K971849) in terms of:

• Design
• Materials
• Manufacturing processes
• Physical properties
• Intended use
• Principles of operation

The FDA's finding of substantial equivalence means that the device is considered as safe and effective as the predicate device, and thus does not require a new premarket approval (PMA) pathway which would typically involve extensive clinical trials with specific performance metrics and acceptance criteria.

Therefore, I cannot provide the requested information, as it is not present in the provided 510(k) summary. The document does not describe any specific performance acceptance criteria or a study designed to demonstrate the device meets such criteria through quantitative performance metrics.

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