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To electrically connect monopolar/bipolar electrosurgical instruments to an electrosurgical generator.

Sutter Electrosurgical Cables are electrosurgical accessories designed to transfer electrosurgical power to monopolar and bipolar instruments from an electrosurgical generator. The cables are designed to fit standard monopolar/bipolar instruments and generator connectors. Sutter Electrosurgical Cables are supplied non-sterile, and can be reused after cleaning and steam sterilization.

This 510(k) summary is for electrosurgical cables, which are accessories for a medical device. The document states that the cables were validated through "testing that supports the compliance of the devices to the Standards mentioned in Section 17 of this submission." However, the provided text does not contain Section 17, nor does it detail specific acceptance criteria or the reported device performance in a quantifiable manner. It primarily asserts substantial equivalence to predicate devices based on design concepts, technologies, and materials, and general safety and effectiveness claims.

Therefore, much of the requested information cannot be extracted from the provided text.

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

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

• Acceptance Criteria: Not explicitly stated in the provided text. The submission refers to "Standards mentioned in Section 17," which is not included.
• Reported Device Performance: Not explicitly stated in the provided text in a quantifiable manner (e.g., specific thresholds or measurements). The conclusion states: "Testing demonstrates that these devices are as safe, as effective, and perform as well as or better than the legally marketed devices."

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.
• Data Provenance: Not specified. The submitter is "Sutter Medezintechnik GmbH, Tullastrasse 87, 79108 Freiburg Germany," suggesting the testing might have occurred in Germany, but this is not explicitly stated as the provenance of the test data. The submission also states the cables are "supplied non-sterile, and can be reused after cleaning and steam sterilization," which implies certain sterilization validation tests would have occurred, but details are not provided.

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/Not mentioned. This type of information is typically relevant for studies involving subjective interpretation of medical images or clinical outcomes, which is not the case for electrosurgical cables. Testing for such devices usually involves engineering and performance standards.

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

• Not applicable/Not mentioned. This is typically used in clinical studies with human assessors.

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-enabled device.

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

• Not applicable. This is not an AI-enabled device. This refers to the performance of the electrosurgical cables themselves in a simulated or actual use environment according to engineering standards. The document only generically states "testing," without providing specifics of whether it was standalone performance or involved human components of a system.

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

• Not applicable in the human interpretation sense. For electrosurgical cables, "ground truth" would likely refer to established engineering performance standards (e.g., electrical conductivity, insulation integrity, mechanical strength, biocompatibility, sterilization efficacy) as defined by the "Standards mentioned in Section 17." The document explicitly states "Sutter Electrosurgical Cables were validated through testing that supports the compliance of the devices to the Standards mentioned in Section 17 of this submission."

8. The sample size for the training set

• Not applicable. This is not an AI-enabled device that uses a "training set."

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

• Not applicable. This is not an AI-enabled device that uses a "training set."

Summary of available information:

The provided 510(k) summary for Sutter Electrosurgical Cables primarily focuses on demonstrating substantial equivalence to predicate devices. It states that "Sutter Electrosurgical Cables were validated through testing that supports the compliance of the devices to the Standards mentioned in Section 17 of this submission." However, the specific details of these standards, the acceptance criteria derived from them, and the quantitative performance results are not included in the provided text. The document asserts that "Testing demonstrates that these devices are as safe, as effective, and perform as well as or better than the legally marketed devices."

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