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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

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.

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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. 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

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.

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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.

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) 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

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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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

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.

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