(63 days)
Not Found
Not Found
This document does not describe a medical device that uses AI or machine learning, nor does it involve the kind of "study" described in the prompt's request for acceptance criteria and performance data related to AI devices.
Instead, the provided text is a summary of safety and effectiveness tests for an epoxy-coated applicator (RAD-KOTE K261). The tests are focused on material biocompatibility and physical integrity, not diagnostic or AI-driven performance.
Therefore, I cannot fulfill the request as it is framed for an AI-enabled medical device. The information provided does not contain:
- Acceptance criteria for an AI algorithm's performance (e.g., sensitivity, specificity, AUC).
- Details about test sets, training sets, data provenance, expert ground truth, or MRMC studies for AI.
- Any mention of AI, machine learning, or algorithms.
The document lists safety tests and their results for a physical medical product component.
§ 884.5460 Scented or scented deodorized menstrual tampon.
(a)
Identification. A scented or scented deodorized menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).