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HF cables for electrosurgical use in laparoscopic, and open surgery in combination with compatible active accessories and compatible electrosurgical generators

The HF-cables (see Table 2.1) subject to this submission are reusable, non-sterile devices, that connect electrosurgical generators as sender to compatible active accessories as receiver for electrosurgical use in laparoscopic, endoscopic, and open surgery. The devices are used as part of a system.

The HF-cables are class II medical device accessories under the regulation number 878.4400 and the product code GEI - "Electrosurgical cutting and coagulation device and accessories". Regulation Medical Specialty: General & Plastic Surgery.

There are monopolar as well as bipolar HF-cable models subject of this submission. All of the subject HF-cables are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the cables must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use.

The HF-cables are available with different cable lengths and with different plugs for the working element/instrument as well as for the electrosurgical generator side. The different plugs allow different compatibilities in accordance with their respective labeling.

Based on the provided text, the device in question is a set of HF-cables (reusable) for electrosurgical use. The document outlines the performance data and testing conducted to demonstrate the safety and effectiveness of these cables for a 510(k) premarket notification.

It's crucial to understand that this document describes the data provided for a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy from scratch like a PMA might. As such, the types of studies and acceptance criteria are focused on demonstrating that the new device performs similarly and safely compared to the predicate, and does not raise new questions of safety or effectiveness.

Here's an analysis of the acceptance criteria and study detailed in the document, keeping in mind the context of a 510(k) submission for reusable HF-cables:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a direct "table of acceptance criteria and reported device performance" in the typical AI/diagnostic software study format (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly met by successful completion of various engineering and safety tests according to recognized standards. The "performance" is the successful completion of these tests.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes engineering bench testing and compliance with standards, not performance on a clinical test set with patient data. Therefore, the concept of "sample size used for the test set" (referring to patient data) and "data provenance" (country of origin, retrospective/prospective) is not applicable to this type of device and submission. The "samples" would be physical units of the HF-cables. The document does not specify the number of cable units tested, which is common for this type of submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable as the ground truth for this device is not established by expert clinical review of data (e.g., medical images). Instead, the "ground truth" is established by the successful passing of engineering and safety tests against predefined, recognized standards and internal specifications.

4. Adjudication Method for the Test Set:

This is not applicable as it's not a study involving human readers or interpretation of clinical data that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This is not applicable. An MRMC study is relevant for AI or diagnostic imaging devices where human reader performance is being evaluated, with or without AI assistance. This submission is for electrosurgical cables.

6. Standalone (Algorithm Only) Performance:

This is not applicable. This concept applies to AI algorithms. The HF-cables are a physical accessory, not an algorithm. Their "performance" is based on their physical and electrical characteristics when used in a system.

7. The Type of Ground Truth Used:

The "ground truth" for this device is based on:

• Engineering Specifications: The design and functional requirements for the cables.
• Recognized Consensus Standards: International and national standards (e.g., IEC 60601 series, ISO 14971) that define safety, electrical performance, thermal limits, and other critical aspects for electrosurgical accessories.
• Validation of Reprocessing Methods: Verification that cleaning and sterilization procedures are effective.

It is not based on expert consensus, pathology, or outcomes data in a clinical sense as would be the case for a diagnostic device.

8. The Sample Size for the Training Set:

This is not applicable. The concept of a "training set" refers to data used to train machine learning models. This submission is for a physical medical device (HF-cables), not an AI algorithm.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable for the reasons stated in point 8.

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