(135 days)
Busse Surgical Drape IV is intended to be used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using Ethylene Oxide.
Surgical drapes described in this submission are one piece, single use, designed to provide an absorbent sterile barrier & protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.
The provided document is a 510(k) premarket notification for a medical device, specifically Busse Surgical Drape IV. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies with detailed acceptance criteria and performance metrics typically associated with AI/software devices.
Therefore, many of the requested categories related to AI/software performance studies, such as sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this document. The document describes a comparison to a predicate device based on material characteristics and safety testing.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not present or not applicable for this type of submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Predicate Equivalent) | Reported Device Performance (Busse Surgical Drape IV) |
|---|---|
| Biocompatibility (Cytotoxicity) | Met testing requirements, found acceptable for intended use. |
| Biocompatibility (Sensitization) | Met testing requirements, found acceptable for intended use. |
| Biocompatibility (Irritation) | Met testing requirements, found acceptable for intended use. |
| Flammability | Met testing requirements, found acceptable for intended use. |
| Lint | Met testing requirements, found acceptable for intended use. |
| Overall (Substantial Equivalence) | Subject device is substantially equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document. The testing refers to "All materials used in the fabrication," implying material-level tests, not a clinical test set with a specific number of patients/cases.
- Data Provenance: Not specified. The tests were performed on the materials of the device.
- Retrospective or Prospective: Not applicable for material testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth as typically understood for clinical performance studies (e.g., disease presence) is not established here. The "truth" is whether the materials meet specified safety standards. The document doesn't detail the personnel conducting these material tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for expert review of images or clinical data, which is not the nature of this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a physical medical device (surgical drape), not an AI/software device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's acceptance is based on adherence to established material safety standards for medical devices (biocompatibility, flammability, lint), which are typically defined by regulatory bodies (e.g., ISO) and demonstrated through standardized laboratory tests.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. See #8.
§ 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.