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Endoscopic Monopolar Instruments and Accessories are used in laparoscopic and other minimally invasive procedures for cutting, dissection, fixation and taking of biopsy samples, depending on the design of the tip. They are also intended to control bleeding by use of monopolar high-frequency electrical current.

Device Description

Endoscopic Monopolar Instruments and Accessories comprises three systems: Modular Three-Piece System, Modular Two-Piece System and Eco-Line. The respective components (handle, shaft and tip) of the Three-Piece and Two-Piece Systems can be used interchangeably, while Eco-Line consists of an assortment of insulated, single-piece instruments. All shafts and several modular handles are insulated and may be used with appropriate tip inserts to control bleeding in monopolar electrosurgical procedures. Additional insulated and non-insulated modular handles are intended for general manual (non-electrical) surgical use according to the design of the chosen tip.

AI/ML Overview

The provided document is a 510(k) summary for the Endoscopic Monopolar Instruments and Accessories. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or performance against specific, quantifiable acceptance criteria through detailed clinical studies typical of software or AI/ML devices.

Therefore, the information requested in the prompt, such as acceptance criteria, reported device performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone performance, is not applicable to this type of device and submission. The study presented here is a bench test, not a clinical trial.

However, I can extract information related to the comparison with the predicate device, which is the "acceptance criteria" for regulatory clearance in this context.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" in this context are demonstrating substantial equivalence in technological characteristics and indications for use compared to the predicate device. The "reported device performance" is the comparison outlined in the "Technological Characteristics" table.

Feature	Acceptance Criteria (Predicate Device)	Reported Device Performance (Subject Device)
Indications for Use	Used in laparoscopic and other minimally invasive procedures for cutting, dissection, fixation, and taking of biopsy samples, and to control bleeding by use of monopolar high-frequency electrical current.	Used in laparoscopic and other minimally invasive procedures for cutting, dissection, fixation, and taking of biopsy samples, and to control bleeding by use of monopolar high-frequency electrical current. (Determined to be equivalent)
Materials	Stainless steel, PPSU, Halar S, Nylon insulation (mentioning K033249 for modular handle instruments).	Stainless steel, PPSU, Halar S, Nylon. (Determined to be equivalent)
Sterility	Non-sterile	Non-sterile (Determined to be equivalent)
Reusability	Reusable	Reusable (Determined to be equivalent)
Sterilization Method	Steam	Steam (Determined to be equivalent)
Electrical Safety	IEC 60601-2-18	IEC 60601-1, IEC 60601-2-2 (2006). Note: While different standards are cited, this difference did not prevent a substantial equivalence determination, implying the subject device met current safety standards deemed equivalent or superior.
Design	Two and Three-Piece Modular System, with single-piece instruments cleared under K930666.	Two and Three-Piece Modular System, Single-Piece Instruments. (Determined to be equivalent based on similar configurations and market clearance of components for electrosurgical cutting and coagulation).

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for a "test set" in the context of device performance metrics. The study involved "bench testing" to characterize thermal spread and mechanical functions/robustness. The number of devices or components tested is not detailed.
Data Provenance: Not applicable in the context of clinical data. The "bench testing" would have been conducted in a laboratory setting by the manufacturer (BEMA GmbH & Co. KG, Germany).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device does not involve expert-established ground truth in a clinical or imaging context. The evaluation is based on engineering and material specifications, and performance against defined physical properties.

4. Adjudication method for the test set:

Not applicable. There is no expert adjudication process described for this type of bench testing.

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 not an AI/ML device, and no MRMC study was performed.

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

Not applicable. This is not an algorithm or software device.

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

Ground truth: For bench testing, the "ground truth" would be the established engineering standards, material properties, and functional requirements for electrosurgical instruments (e.g., thermal spread limits, mechanical strength, electrical insulation integrity). The document states "Bench testing was provided to characterize thermal spread and mechanical functions and robustness."

8. The sample size for the training set:

Not applicable. No training set is mentioned as this is not a machine learning device.

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

Not applicable. No training set is mentioned.

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