(79 days)
The Busse Surgical Drape 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. This is the same intended use as a previously cleared for the Busse Surgical Drape II, K083424.
The Laminated Non-Woven 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 text describes a 510(k) submission for "Busse Surgical Drapes III." The primary focus of this document is to demonstrate substantial equivalence to a predicate device, "Busse Surgical Drapes II (K083424)," not to provide a detailed study proving the device meets new, objective performance criteria in the way AI/ML medical devices often do.
Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this 510(k) submission for a traditional medical device (surgical drapes).
However, I can extract the relevant information regarding acceptance criteria and the "study" that demonstrates compliance based on the document's content.
Here's a breakdown:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Test Performed | Reported Device Performance |
|---|---|
| Biocompatibility Testing: | The materials met the testing requirements and were found acceptable for the intended use. |
| 1. Kligman Maximization Test | Acceptable |
| 2. Intracutaneous Injection Test | Acceptable |
| 3. Systemic Injection Test | Acceptable |
| 4. Rabbit Pyrogen Test | Acceptable |
| 5. L929 Mem Elution Test | Acceptable |
| Technological Characteristics Equivalence: | The subject device has the same Technological Characteristics as the legally marketed predicate device (Busse Surgical Drapes II, K083424). |
| Intended Use Equivalence: | The intended use is the same as the predicate device (Busse Surgical Drape II, K083424): to isolate a site of surgical incisions from microbial and other contamination. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided document. Biocompatibility tests typically use a small number of animal subjects or cell cultures, but the exact count is not given.
- Data Provenance: Not specified. The tests are standard biological qualification safety tests, generally performed in specialized labs. Whether these were conducted in the US or elsewhere is not stated. The data would be prospective for these specific tests on the device materials.
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. This is a traditional medical device (surgical drape), not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the material tests would be the established safety thresholds and methodologies for biocompatibility, as defined by international standards (e.g., ISO 10993). The interpretation of these results is done by qualified toxicologists/biocompatibility specialists, but specific numbers and qualifications are not provided in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is not an AI/ML device involving human interpretation of results, there is no adjudication method in the context described.
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 traditional medical device; therefore, no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a traditional medical device; therefore, no algorithm or "standalone" performance is relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the reported tests is established through pre-defined scientific methods and acceptance criteria for biocompatibility testing. These criteria are based on established toxicology and material science principles, typically referenced in standards like ISO 10993. The test results (e.g., cell viability, irritation response) are compared against these predetermined thresholds.
8. The sample size for the training set
Not applicable. This is a traditional medical device; there is no "training set" in the context of an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is not relevant.
§ 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.