(632 days)
Surgical Drapes (EO Sterilized) is a single use product used as a protective barrier for patient, such as to isolate a site of surgical incision from microbial and other contamination.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for "Plus Surgical Drapes (EO Sterilized), PMDB-XXX," indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.
The document discusses:
- The FDA's review and determination of substantial equivalence.
- Regulatory classifications and requirements.
- Contact information for various FDA divisions.
- The intended use of the surgical drapes.
It does not contain details about:
- Acceptance criteria and reported device performance (in a table or otherwise).
- Sample size for test set or data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
These details are typically found in a 510(k) submission's performance data section, which is not included in this FDA clearance letter.
§ 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.