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The Beamer Argon Snare Probe is used in conjunction with the Beamer system generator for the delivery of gas and electrosurgical current through a flexible endoscope to an electrode wire snare at the operative site.

Device Description

The Beamer Snare Probe consists of connectors for attachment to the output of an Argon Beam Coagulation Unit. The device also consists of catheter tubing for delivering argon gas to the operative site within the patient, as well as an internal wire to carry high frequency (HF) electrosurgical current to the electrosurgical snare. The snare probe device is provided in two lengths 160 cm and 230 cm for use in flexible bronchoscopes, gastroscopes, colonoscopes and duodenoscopes.

The electrosurgical snare is provided in a symmetrical loop (braided or monofilament oval) in sizes of 15mm and 30mm and can be positioned back into the catheter tube, such that it does not contact the patient's tissue during the argon beam coagulation procedure.

The Beamer Argon Snare Probe consists of a stainless steel wire that extends from the probe connector to the distal end of the probe. The proximal end of the stainless steel wire is locked into the connector be The distal end of the wire is soldered to a snare shaped wire located at the distal end of the probe. In its retracted position the snare wire is in electric contact to a tungsten electrode. The distal end of the Beamer Probe has a ceramic tip which provides a thermal insulation barrier for the tubing to prevent heat degradation during coagulation. The tungsten electrode remains recessed in the ceramic tip such that there is no tissue contact during the argon beam coagulation procedure.

There are five configurations of the Beamer Argon Snare Probe. The probes vary in length and loop configuration to accommodate the procedure performed by the physician. The Beamer Argon Snare Probes are provided sterile by ethylene oxide and are single use only.

AI/ML Overview

The provided text describes the ConMed Endoscopic Technologies Beamer™ Argon Snare Probe, a medical device for electrosurgical cutting and coagulation. It's a 510(k) summary, aiming to demonstrate substantial equivalence to legally marketed predicate devices rather than proving specific performance against acceptance criteria through a detailed clinical study.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit from 'testing passed')	Reported Device Performance
Performance Testing	Functional equivalence to predicate devices for gas and electrosurgical current delivery, snare operation, and safety during use with a Beamer system generator.	"All testing passed the predetermined performance specifications." This indicates the device met its internal design and functional requirements. Specific numerical targets or detailed results are not provided in this 510(k) summary. The comparison is against predicate devices in "intended use, technological characteristics and materials."
Biocompatibility	Compliance with biocompatibility standards to ensure patient safety (e.g., non-toxic, non-irritating, non-sensitizing).	"Biocompatibility... have been performed to demonstrate equivalence of the Beamer Argon Snare Probes to their predicate devices." This implies the device materials are safe for human contact as per established medical device standards. Specific tests or results are not listed.

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

The document does not specify any sample sizes for a clinical test set. The testing mentioned is "Biocompatibility and bench testing." These typically involve material testing and functional evaluations in a lab setting, not human clinical trials. Thus, there is no information on data provenance (country of origin, retrospective/prospective).

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

This information is not provided as the submission describes bench and biocompatibility testing, not a clinical study requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided as the submission describes bench and biocompatibility testing, not a clinical study requiring an adjudication method.

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

No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on demonstrating substantial equivalence through bench and biocompatibility testing against predicate devices, not on evaluating human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. The device is a physical electrosurgical probe, not an AI-driven algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically understood in AI/imaging studies (e.g., expert consensus, pathology, outcome data) is not applicable here. For bench testing, the "ground truth" would be the engineering specifications and performance standards that the device is designed to meet. For biocompatibility, it refers to regulatory standards for material safety.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not a machine learning model, so there is no training set.

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

This information is not applicable for the same reason as above.

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