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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 Plastic LOR Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of resistance technique; it will be filled with air and/or saline during use. The Busse Plastic LOR syringe is not intended for injection or aspiration. The syringe will be sold sterile individually packaged and as part of a sterile kit.

The LOR plastic syringe is a single use device which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The syringe will be available in luer lock and luer slip.

This document describes a 510(k) premarket notification for the Busse Plastic LOR Syringe. The information provided heavily emphasizes the device's substantial equivalence to a predicate device and safety testing of its materials, rather than detailed performance criteria or clinical study results in the context of typical AI/ML device evaluations.

Therefore, many of the requested categories for acceptance criteria and the study proving device meets acceptance criteria cannot be fully addressed in the way they would for an AI/ML or diagnostic device. I will extract what is available and note where information is absent or not applicable given the nature of the submission.

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)

This information is not explicitly provided in the document. The testing mentioned (biocompatibility tests) are bench/laboratory tests, not clinical performance studies with patient data.

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)

This information is not applicable. The "ground truth" for this type of device (a mechanical/physical medical device) is based on its physical properties, material safety, and functional equivalence, not on expert interpretation of clinical data in the same way an AI/ML diagnostic device would be. The biocompatibility tests have established protocols and pass/fail criteria, likely interpreted by laboratory specialists.

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

Not applicable. This concept pertains to resolving discrepancies in expert interpretations for establishing ground truth in diagnostic studies, which is not relevant for this device's 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 not an AI-assisted device, nor is it a diagnostic device that would typically undergo MRMC studies. The submission is for a physical medical device (syringe).

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

Not applicable. This is not an algorithm-based device.

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

The "ground truth" for this device's submission is based on:

• Material Biocompatibility Standards: Compliance with established biological qualification safety tests (Kligman Maximization, Intracutaneous Injection, Systemic Injection, Rabbit Pyrogen, L929 Mem Elution Tests).
• Technological Equivalence: Direct comparison to a legally marketed predicate device (Loss of Resistance Syringe - K061737) to demonstrate similar design, materials, and functional characteristics.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device being a physical syringe. The submission relies on substantial equivalence and material safety testing.

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

Not applicable, as there is no training set. The "ground truth" for the device's suitability is established through adherence to recognized biocompatibility standards and demonstration of technological equivalence to a predicate device already on the market.

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