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The Bissinger bipolar cable/cord is intended for use in electrosurgical procedures to provide transmission of electrical power from the bipolar output of an electrosurgical generator to a bipolar foot-activated instrument.

This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

Bissinger cables are a line of non-sterile, reusable bipolar foot activated cables fitting Erbe, Martin, Valleylab, Aesculap GK50, Codman CMC II, and other ES units.

This document is a 510(k) premarket notification for a medical device (Bissinger Cables), not a study report detailing acceptance criteria and performance. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not present in the provided text.

However, based on the context of a 510(k) submission, the "acceptance criteria" can be inferred as substantial equivalence to predicate devices. The "study that proves the device meets the acceptance criteria" is the comparison to predicate devices presented in the document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not explicitly present a table of acceptance criteria in the format typically used for a performance study (e.g., sensitivity, specificity, accuracy thresholds). Instead, the "acceptance criteria" for a 510(k) are met by demonstrating "substantial equivalence" to legally marketed predicate devices. The "reported device performance" is a comparison of characteristics to those predicates.

Here's an adaptation of the requested table format, using the substantial equivalence comparison:

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: Not applicable. This document describes a comparison of device specifications, not a clinical or performance study with a "test set" in the context of data analysis. No patient or sample data is involved.
• Data Provenance: Not applicable. The "data" here refers to the device's technical specifications and intended use, which are provided by the manufacturer (Günter Bissinger Medizintechnik GmbH) from Germany.

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. There is no "test set" and no "ground truth" in the clinical or diagnostic sense within this 510(k) submission. The FDA reviews the provided information to determine substantial equivalence based on accepted regulatory standards and the comparison to predicate devices.

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

• Not applicable. There is no "test set" requiring adjudication in this technical comparison.

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 510(k) submission for an electrosurgical cable, not an AI-powered diagnostic 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 not an algorithmic or AI device.

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

• Not applicable in the direct sense of diagnostic "ground truth." The "ground truth" for a 510(k) in this context is established by the accepted specifications and performance of the legally marketed predicate devices and compliance with relevant industry standards (IEC, ANSI, AAMI).

8. The sample size for the training set

• Not applicable. There is no machine learning or AI training set involved.

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

• Not applicable. There is no machine learning or AI training set involved.

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