(65 days)
Disposable Barrier Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Barrier Sleeves." This document is a regulatory clearance for a physical medical device (barrier sleeves), not an AI/software as a medical device (SaMD).
Therefore, the document does not contain any of the information requested in your prompt regarding acceptance criteria and study details for an AI/SaMD. Specifically:
- No AI/SaMD Performance: The device is a physical barrier sleeve, completely unrelated to AI performance metrics.
- No Test Set/Ground Truth: There is no mention of a test set, data provenance, expert ground truth, adjudication, or MRMC studies because these concepts are not applicable to the clearance of a disposable physical barrier.
- No Training Set: Similarly, there is no training set for a physical product.
The document indicates that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its 510(k) clearance. The focus of the regulatory review for this product would have been on material safety, physical dimensions, intended use, and substantial equivalence to existing devices, not on algorithmic performance.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.