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These devices are intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is latex-free rubber. This submission includes drapes that will be sold both sterile and non-sterile.

Non-sterile drapes are to be sold to OEMs for EO sterilization according to ANSIIAMMIIISO 11135. Sterile drapes are to be sold directly to users after EO sterilization validation to ANSIIAMMIIISO 11135

The IMC Surgical Drape devices are patient protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is made of non-latex rubber.

The Bladder Suspension Drape, the GYN Drape and the TUR drape have the same features and same materials but have different dimension of drape and aperture.

The provided text describes a 510(k) submission for the IMC Surgical Drape and focuses on establishing substantial equivalence to predicate devices. It does not present a study designed to evaluate the device's performance against specific acceptance criteria in the context of clinical or diagnostic accuracy. Instead, it outlines the device's characteristics and compares them to predicate devices, referencing performance tests for material properties.

Therefore, many of the requested details about acceptance criteria and study design are not applicable to the information provided.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document lists performance characteristics and test methods for material properties, demonstrating that the IMC Surgical Drape "Meets Intended use" for each. These are implicitly the acceptance criteria for those specific material properties, equating to being "acceptable for the intended use" or meeting the specified standard.

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 for the performance tests. The document only states that "These materials were tested." It does not detail how many samples of each material were tested.
• Data Provenance: Not specified. It's likely that the testing was conducted by the manufacturer or a contracted lab, but the location or whether it was retrospective/prospective is not mentioned.

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 device is a surgical drape, not a diagnostic or AI-driven device requiring expert-established ground truth for a test set. The "ground truth" for material properties is determined by standardized test methods and their defined pass/fail criteria (e.g., Class I for flammability, meeting "intended use" for hydrostatic pressure).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As above, this is a material property evaluation, not an interpretation task requiring adjudication by experts.

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 not an AI-assisted diagnostic device.

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

• Not Applicable. This is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Material Standard Compliance: For the performance characteristics listed, the "ground truth" is adherence to established industry standards and test methods (e.g., 16 CFR Part 1610 for flammability, AATCC 127-2008 for hydrostatic pressure, ISO 10993-x for biocompatibility). The claim is that the materials "were found to be acceptable for the intended use" based on these tests.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established

• Not Applicable. This is not an AI/machine learning device.

In summary: The provided 510(k) summary for the IMC Surgical Drape focuses on demonstrating substantial equivalence to predicate devices through comparisons of material composition, design features, and performance characteristics as measured by established material testing standards. It is not an AI-driven or diagnostic device, and therefore, many of the requested details related to "acceptance criteria" in a clinical/diagnostic context and associated study methodologies (like expert review, sample sizes for test/training sets, MRMC studies) are not pertinent to this submission.

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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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