(119 days)
The Busse Surgical Drape is intended for external use only and is used is as a protective patient covering, such as to isolate a site of surgical incisions from it a vacu is a a provided steries using ethylene oxide.
Surgical drapes are intended to provide protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.
The document describes a 510(k) premarket notification for the Busse Surgical Drape. The stated goal is to demonstrate substantial equivalence to a predicate device (3M Company, Drapes, K031287). The acceptance criteria and the study performed are focused on the safety and material compatibility of the new device.
There is no mention of an algorithm or AI in this document, as it pertains to a physical medical device (surgical drapes). Therefore, many of the requested points related to AI performance metrics (e.g., effect size of human readers with AI, standalone algorithm performance, training set details) are not applicable.
Here's an analysis of the provided information concerning acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance and Evidence |
|---|---|
| Biocompatibility and Safety for Intended Use | All materials used in the fabrication were evaluated through biological qualification safety tests. Materials met testing requirements. |
| Equivalence in Design, Material, and Intended Use to Predicate | "The surgical drapes are generally identical to 3M Surgical Drapes in design, material & intended use." (This is a claim of equivalence rather than a specific performance metric, but it forms the basis of the 510(k) submission.) |
| Compliance with specific biocompatibility tests | Performed and met requirements for: |
- Kligman Maximization Test
- Intracutaneous Injection Test
- Systemic Injection Test
- Rabbit Pyrogen Test |
2. Sample size used for the test set and the data provenance
The document specifies biocompatibility tests were performed on the materials used in the surgical drapes. Regarding "sample size used for the test set," this would refer to the number of samples of the material tested in each biological assay, or the number of animals used for the in vivo tests. However, the document does not explicitly state the number of samples or animals for these tests.
The data provenance is internal to Busse Hospital Disposables, as they commissioned or performed these tests. It is a prospective evaluation of their device materials. The country of origin of the data is not specified but is implicitly the United States given the FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the context of biocompatibility testing for a physical device. Ground truth for these types of tests is established by standardized laboratory protocols and scientific interpretation of results (e.g., observation of reactions in animal models, or cell culture changes), not by expert consensus in the way medical image analysis or clinical diagnosis might be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Biocompatibility tests have predefined endpoints and interpretation criteria, and do not typically involve an adjudication process by multiple experts for results.
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 medical device (surgical drape), not an AI/CAD system for interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (surgical drape), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility testing, the "ground truth" is derived from standardized biological testing protocols and laboratory observations/measurements. For example:
- Kligman Maximization Test: Assesses skin sensitization. Ground truth would be the presence/absence and severity of allergic reactions in test subjects.
- Intracutaneous Injection Test: Assesses local tissue reaction. Ground truth would be the presence/absence and severity of erythema/edema.
- Systemic Injection Test: Assesses systemic toxicity. Ground truth would be observations of general toxicity signs/symptoms.
- Rabbit Pyrogen Test: Detects pyrogens. Ground truth would be the presence or absence of a fever response in rabbits.
These are objective, biologically defined endpoints.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
§ 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.