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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. There are various models of drapes: Non-woven drapes, Tissue Drape, & SMS Drapes with round, oval & square fenestration shapes.

Device Description

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Busse Surgical Drapes." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way a clinical trial for a new therapeutic or diagnostic device would.

Therefore, many of the typical data points requested for clinical studies (like reader performance, MRMC studies, ground truth establishment for a training set, etc.) are not applicable to this type of regulatory submission. The assessment here is primarily focused on biocompatibility and technological characteristics compared to an already approved device.

Here's the information extracted from the document relevant to your request, with an explanation for the non-applicable sections:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	1. Kligman Maximization Test	Acceptable for intended use	Met testing requirements, found acceptable for intended use.
	2. Intracutaneous Injection Test	Acceptable for intended use	Met testing requirements, found acceptable for intended use.
	3. Systemic Injection Test	Acceptable for intended use	Met testing requirements, found acceptable for intended use.
	4. Rabbit Pyrogen Test	Acceptable for intended use	Met testing requirements, found acceptable for intended use.
	5. L929 Mem Elution Test	Acceptable for intended use	Met testing requirements, found acceptable for intended use.
Technological Characteristics	Comparison to Predicate Device	Same Technological Characteristics as legally marketed predicate device	Stated to have the same Technological Characteristics as the predicate device (3M Company, Drapes, K031287).
Intended Use	Protective patient covering, isolating surgical site from contamination	Met for intended use	"A Surgical Drape is a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination."
Sterilization	Ethylene Oxide sterilization	Provided sterile	"They are provided sterile using ethylene oxide."

Explanation of Acceptance Criteria and Performance:
The document states, "All materials used in the fabrication of the surgical drapes were evaluated through biological qualification safety tests" and that these materials "have met the testing requirements and were found to be acceptable for the intended use." The explicit quantitative acceptance criteria are not detailed in this summary for each test but are implied by the statement of "meeting testing requirements" and "found to be acceptable." The primary "performance" metric for a 510(k) submission for this type of device is demonstrating substantial equivalence to a predicate, rather than achieving specific performance thresholds in a clinical study.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document refers to "All materials used... were evaluated," suggesting material samples were tested. This is not a human subject test set.
Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing by Busse Hospital Disposables for biocompatibility and comparison with the predicate device. It is a retrospective comparison against an existing predicate device for substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This submission is for a medical device (surgical drape) where ground truth is established through laboratory material testing (biocompatibility) and comparison of technical specifications, not through expert review of clinical cases.

4. Adjudication Method for the Test Set

Not Applicable. As explained above, this isn't a study involving human readers or clinical case adjudication.

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 device is a surgical drape, not an AI-powered diagnostic or therapeutic device. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a physical surgical drape, not an algorithm or AI.

7. The Type of Ground Truth Used

Technical Specifications and Biocompatibility Test Results: The "ground truth" for this type of submission is based on established industry standards for material biocompatibility and physical characteristics, and the technical specifications of a legally marketed predicate device (3M Company, Drapes, K031287). The "truth" is whether the Busse Surgical Drapes meet these established safety and performance benchmarks and are comparable to the predicate.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this 510(k) submission for a surgical drape. This is not a machine learning or AI-driven device.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As explained above, there is no "training set" for this device.

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