(69 days)
The AMSINO TRACHEOSTOMY CARE TRAY is intended for use in the cleaning and maintenance of Tracheostomy sites.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device (Amsino Tracheostomy Care Tray). This type of document is a regulatory approval, not a scientific study describing the performance of a device against acceptance criteria. It primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device rather than detailing specific performance metrics from a technical study.
Therefore, the input document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The letter simply states that the device is "substantially equivalent" to predicate devices for its intended use.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data, a design verification report, or a clinical study report that outlines the device's technical specifications, performance goals, and the results of tests conducted to meet those goals.
§ 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.