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The Genii ArC Smart™ Argon Probe is a flexible probe indicated for use in argon enhanced coagulation of tissue.

The Genii ArC Smart™ Argon Probe is a flexible, single patient use catheter accessory which delivers argon gas and energy for non-contact coagulation therapy in conjunction with an argon equipped electrosurgery generator such as the Genii gi4000. It is intended for flexible endoscopic applications.

The Genii ArC Smart™ Argon Probe consists of a hollow polytetrafluroethylene (PTFE) tube containing a stainless steel wire that extends from a probe connector to the distal end of the probe. The proximal end of the stainless steel wire is crimped into the connector body. The distal end of the wire is crimped to an electrode made of tungsten in a configuration specifically designed to enhance the ionization of argon gas as the gas passes through the open lumen of the PTFE tube. The electrode remains recessed in the PTFE tube such that there is no direct tissue contact during the electrosurgery procedure.

The ArC Smart™ Probe is fabricated in several sizes (2.3mm to 3.2 mm outer diameters; 220 to 330cm lengths) to accommodate the various sizes of flexible endoscopes used by a physician performing various argon assisted coagulation procedures. The devices accommodate an argon flow rate of 0.1 to 2.0 liters per minute over all probe sizes. The clinical use maximum is 90 watts.

The ArC Smart™ argon probes are shipped sterile in sealed Tyvek pouches and are single use only. Sterilization is by ethylene oxide.

This looks like documentation for a medical device 510(k) submission, specifically for the Genii ArC Smart™ Argon Probe. A 510(k) is a premarket submission made to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. This process typically relies on demonstrating substantial equivalence rather than defining and proving acceptance criteria against specific performance metrics for novel devices.

Therefore, the document does not present "acceptance criteria" in the traditional sense of a specified threshold for performance metrics (e.g., "sensitivity must be >90%"). Instead, it focuses on demonstrating that the Genii ArC Smart™ Argon Probe performs comparably to its predicate device, the ConMed Beamer Argon Probe (K081644). The "study" referenced is a set of ex vivo tissue tests designed to show this comparable performance.

Here's the breakdown of the information requested, based on the provided text:

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

As explained above, there are no explicitly stated numerical acceptance criteria in the document. The general "acceptance criteria" for a 510(k) are to demonstrate substantial equivalence to a predicate device. The performance is assessed comparatively.

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

• Sample Size for Test Set: The document mentions "Two Ex Vivo tissue tests using three tissue types." It does not specify the number of individual tissue samples or experimental runs within these tests.
• Data Provenance: Ex vivo tissue tests. The country of origin is not specified, but typically, these tests would be conducted in a laboratory setting for the manufacturer or a contract research organization. The study is retrospective in the sense that the device was fully developed before these tests were conducted for regulatory submission.

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

The document does not mention the use of experts to establish a "ground truth" for the ex vivo tissue tests. The comparison of "zones of coagulation" would likely be a direct measurement or observation performed by trained laboratory personnel, rather than subjective interpretation by medical experts.

4. Adjudication method for the test set

Not applicable. The ex vivo tissue tests for "zones of coagulation" do not involve adjudication by multiple readers or experts in the way clinical studies for diagnostic devices might. It's a direct observation/measurement.

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 an argon probe for electrosurgery, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI assistance.

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

Not applicable. This is not an algorithmic or AI device.

7. The type of ground truth used

The "ground truth" in this context is the measured and observed "zones of coagulation" on the ex vivo tissue samples, compared between the investigational device and the predicate device. It is a direct measurement from a physical test, not an expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no training set.

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

Not applicable, as there is no training set.

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