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The provided document is an FDA 510(k) clearance letter for Medline Disposable Surgical Drapes and Gowns. This letter confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does NOT contain information regarding:
- Detailed acceptance criteria for specific performance metrics of the surgical drapes and gowns.
- A study that quantitatively proves the device meets specific performance acceptance criteria.
- Any details about sample sizes, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth types.
- Training set information.
The letter focuses on regulatory clearance based on substantial equivalence to existing devices, not detailed performance study results that would typically be found in a clinical study report or a more technical submission.
Therefore, I cannot fulfill your request for the specific information points as they are not present in the provided text.
§ 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.