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The HF-Resection Electrodes are a bipolar instrument series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft tissue and where hemostasis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedures for which the devices can be used for are transurethral resection in saline (TURis), transurethral prostatectorny, transurethral resection of the prostate (TURP) for benign prostatic hypertplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment. These devices are not intended to be used for treating cancer of the prostate.

The HF-Resection Electrode for Plasma Vaporization is a bipolar instrument designed and intended for use in urological surgical procedures involving the vaporization, ablation, coagulation, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue indications include use in the prostate, bladder neck. The specific treatment indications include benign prostate hyperplasia BPH, bladder cancer, tumors, The specific urological indications include transurethral and neoplasms. lesions electrovaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate.

The HF-Resection Electrodes and HF Resection Button Electrode for Plasma Vaporization consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft).

The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, bands, rollers, needles or buttons.

The system includes Electrodes, working elements, and an HF bipolar cable that can be connected to an electrical surgical unit.

HF Resection Electrodes (K100275) can now be used with the newly compatible electrosurgical generator, the ESG-400 (K103032). For the HF Resection Electrodes to be used with the ESG-400, an additional HF cable is needed (WA00014A). The WA00014A bipolar reusable cable is an electrosurgical accessory designed to transfer electrosurgical power to electrosurgical working elements from the electrosurgical generator ESG-400 (K103032). The cable is designed to connect the working elements WA22366A and WA22367A (K100275).

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel clinical study with acceptance criteria in the typical sense of evaluating a new therapeutic or diagnostic claim. The "study" here is a set of performance tests to ensure the new device (specifically, a new cable) does not raise new safety concerns and maintains the same functionality as the predicate device.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "sample size" in the context of a clinical trial or a dataset for an AI model. This is a submission for a physical medical device (electrosurgical electrodes and a new cable) demonstrating equivalence, not a data-driven AI device.

• Sample Size (Test Set): Not applicable in the context of a dataset; refers to the testing of the physical device components. The document implies sufficient units were tested to perform design verification, electrical safety tests, and risk analysis.
• Data Provenance: Not applicable in the context of clinical data. The tests performed are bench tests and risk analyses conducted by the manufacturer, Olympus Winter & Ibe GmbH, in Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. "Ground truth" in this context would refer to the established engineering and safety standards (e.g., IEC standards, ISO 14971) against which the device's performance was measured. These standards are developed by expert committees, but the specific individuals involved in this particular submission's verification of adherence to those standards are not listed.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of expert adjudication or consensus methods for evaluating the results of the bench tests or risk analysis. The results are compared directly against established engineering and safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (e.g., imaging AI) to compare human reader performance with and without AI assistance. This submission is for surgical instruments, not a diagnostic or AI-assisted device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This is not an AI-driven device. The "performance" refers to the physical and electrical characteristics of the surgical electrodes and cable.

7. The Type of Ground Truth Used

The "ground truth" for this submission consists of:

• Established engineering and performance specifications: The device is expected to function according to its intended use, which is defined by its design.
• International Consensus Standards:
  • IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
  • IEC 60601-2-2: Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.
  • ISO 14971:2007: Medical devices – Application of risk management to medical devices.

These standards serve as the objective benchmarks against which the device's safety and performance were evaluated.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable, as there is no training set for an AI model.

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