(240 days)
The Securline Operating Room Drape is a drape accessory made of synthetic material intended to be used as a protective patient covering such as to isolate a site of surgical incision from microbial and other contamination.
The Securline Operating Room Camera Drape, Model #3600 is a drape accessory made of synthetic material.
The provided document is a 510(k) premarket notification letter from the FDA regarding a medical device, the 'Securline Operating Room Camera Drape, Model #3600'. This document is a regulatory approval letter, not a scientific study report.
Therefore, the input you provided does not contain the information needed to describe acceptance criteria and a study that proves a device meets those criteria. Specifically, it lacks:
- Acceptance criteria: There are no performance metrics or thresholds defined for the device.
- Reported device performance: No data on how the device performed against any criteria is present.
- Study details: There is no mention of a clinical trial, performance study, or any other type of study. Consequently, information such as sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details are entirely absent.
This letter simply states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not contain the detailed study information you requested for an AI/device performance evaluation.
§ 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.