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The Ontex Unscented Tampons with Colored Plastic Applicators are inserted into the vagina to absorb menstrual discharge.

Tampons included in this submission are conventional unscented menstrual tampons consisting of an absorbent pledget (viscose material in a W-shape wadding form), polyester/cotton withdrawal cord, and a polymeric overwrap. The tampon component of this submission is identical to that cleared in the predicate submission (K122603).

Tampons included in this submission are placed in the vagina using a polyethylene applicator. The applicator is available in two sizes: full size (long) or compact size. The full size applicator is ready for use. The compact size consists of an inner and outer tube that requires the inner tube to be retracted prior to use. Applicators included in this submission are provided in different colors including green, yellow, lilac, orange and pink.

The provided text is a 510(k) Summary for a medical device (tampons). It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain the kind of detailed study information (like acceptance criteria, sample sizes for test/training sets, expert ground truth qualifications, or MRMC studies) that would be present for a diagnostic AI/ML device.

Therefore, I cannot fulfill your request for information about acceptance criteria and the study that proves the device meets them, as this document does not contain that level of detail for this type of medical device submission.

Here's why the requested information isn't available in the provided text:

• Type of Device: The device is a physical product (tampon) and not a diagnostic AI system or software. The "performance" being discussed relates to physical properties and material safety, not diagnostic accuracy.
• Regulatory Pathway: A 510(k) submission for a Class II device like a tampon focuses on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves performance tests for physical characteristics and biocompatibility, rather than clinical efficacy studies with expert ground truth validation in the way an AI diagnostic tool would require.
• Lack of AI/ML Component: The request specifically asks about "device performance" in a context usually applied to AI/ML or diagnostic devices, which this tampon is not.

If you have a document describing an AI/ML diagnostic device, I would be able to extract the requested details.

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