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The Digene Cervical Brush is intended for the collection of cervical cells for Pap smear analysis and/or for sexually transmitted disease (STD) testing.

The Digene Cervical Brush has a truncated cone-shaped brush head composed of bristles joined to a wire shaft; the brush head on the wire shaft is bonded to a plastic handle. The distal end of the wire shaft is embedded in solidified glue. To collect cervical cells, the brush end of the Digene Cervical 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 The brush is rotated three full turns in a counter-clockwise direction and withdrawn. The brush is then used to spread the specimen onto a glass slide for a Pap smear or is inserted into a transport tube for use in STD testing.

The provided text describes a 510(k) submission for the "Digene Cervical Brush," a specimen collection device. It focuses on establishing substantial equivalence to a predicate device, the Medscand Cytobrush, rather than demonstrating meeting specific performance criteria through a study with defined acceptance criteria for the device itself.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided document, as it's a submission for a collection device, not a diagnostic device with performance claims.

Here's a breakdown of what can be extracted and what information is missing:

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: The document does not describe performance criteria, sensitivity, specificity, or other typical metrics associated with diagnostic devices. It focuses on equivalence for a collection tool.
• Sample size used for the test set and the data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is discussed.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication is mentioned.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a physical collection brush, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for this type of submission.
• The sample size for the training set: Not applicable, as this is not an algorithm being trained.
• How the ground truth for the training set was established: Not applicable.

What is available: The Basis for Substantial Equivalence

The submission argues for substantial equivalence to a predicate device, the Medscand Cytobrush (K832986), based on the following characteristics:

• Intended Use: Both are for the collection of cervical cells for Pap smear analysis and/or for sexually transmitted disease (STD) testing.
• Design: Both have a truncated cone-shaped brush head composed of bristles joined to a wire shaft, with the brush head bonded to a plastic handle.
• Materials: Implied to be similar based on the equivalence claim.
• Manufacturing Processes: Implied to be similar based on the equivalence claim.
• Physical Properties: Implied to be similar based on the equivalence claim.
• Principles of Operation: Both collect cervical cells by insertion into the cervical os, rotation, and withdrawal.

In summary, the "acceptance criteria" for the Digene Cervical Brush were effectively that it demonstrated "substantial equivalence" to the legally marketed Medscand Cytobrush, meaning it raised no new questions of safety or effectiveness, as confirmed by the FDA's decision letter (K971586). The study proving this was a comparison of its characteristics to the predicate device, rather than a clinical performance study with specific endpoints.

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