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The Puritan Foam Tip Swab is used to obtain a Pap smear sample from the endocervix.

The Puritan Foam Tip Swab consists of a polyurethane foam tip bonded to a high impact polystyrene shaft with hot melt adhesive. The device is for single use only and non-sterile.

This document, K961934, is a 510(k) Summary of Safety and Effectiveness for the Puritan Foam Tip Swab, dated July 9, 1996. It describes a medical device, not an AI/ML device, and therefore does not contain the information requested in your prompt regarding acceptance criteria and studies for AI/ML performance.

The document outlines the following:

• Device: Puritan Foam Tip Swab
• Intended Use: To obtain a Pap smear sample from the endocervix.
• Predicate Devices: Absorbent Tip Applicator (Hardwood Products Co. K902338) and Cell Collecting Brush (Anderson Winn Paper Co. K924908).
• Non-clinical tests: Biocompatibility of polyurethane foam and tip adhesion testing (showing comparability to the Cell Collecting Brush).
• Functional Clinical Performance: A study comparing Pap smears from the Puritan Foam Tip Swab to the Cell Collecting Brush, concluding that the new device is "as effective... for obtaining and transferring to a slide cervical cytological specimens that are adequate for diagnosis."

Since the device is a physical medical swab and not an AI/ML diagnostic tool, the requested information regarding AI/ML acceptance criteria, study details (sample sizes for test/training sets, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance), and ground truth establishment methods for AI/ML are not applicable and not present in this document.

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