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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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The gi 4000 Electrosurgery Generator is intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas in flexible endoscopic applications. The integrated lavage pump is intended to wash tissue or mucosa within the gut when used in conjunction with washing catheters or bipolar endoscopic probes, endoscope water jet channels, or endoscope working channels. The Genii ArConnect™ Conducting Adapter is intended for use with the gi 4000 during argon assisted coagulation.

The gi 4000 has seven monopolar outputs, a monopolar argon assisted coagulation output, and a bipolar output. Users make selections from a touch screen that displays stored default power setting start points, convenience and safety information, as well as indications as to current selection mode and return electrode monitoring status.

The gi 4000 has an integrated peristatic lavage pump designed to provide lavage washing in the gut, either by accessories connected directly to endoscopes which have dedicated washing channels, or by accessories which introduce lavage fluid into the biopsy port of an endoscope or via dedicated washing channels incorporated into a therapeutic accessory such as a bipolar endostasis probe. The system is operated by a dual pedal footswitch which controls the lavage pump and power delivery.

The argon output is designed for an argon assisted coagulation method. This method uses 99.99% pure argon gas to provide ionized RF arcs to the targeted tissue. The monopolar outputs are designed for cutting and coagulation methods. The unit is designed with a standard monopolar active cord receptacle (foot switch activated).

Endoscopic accessories connect to the monopolar receptacle via a widely available detachable active cord accessory. Both the monopolar and argon outputs require the use of a patient return electrode (grounding pad) to return the RF energy from the patient back to the generator. The unit is designed with a standard GI bipolar single jack receptacle. No patient return electrode (grounding pad) is needed for bipolar methods. The output power of the argon, monopolar and bipolar methods are independently controlled through a touch panel LCD display located on the front panel of the generator.

The argon gas for the argon output is exclusively supplied by the disposable Genii Argon Gas Canister. Each canister contains 49 liters of ultra-high purity (99.999% pure) argon gas (certified). When using the Argon Coagulation Method, the ArConnect is intended for single-use only and will be supplied as a non-sterile, disposable item. The ArConnect has been designed to allow the delivery of monopolar high frequency electrosurgical energy and argon gas to a single use argon coagulation probe sold separately. The ArConnect is supplied individually packaged in disposable packaging and is not to be reprocessed or re-used.

The provided text describes the Genii gi 4000 Electrosurgical Generator and its comparison to predicate devices, focusing on technical characteristics and safety/effectiveness testing. However, it does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in the manner one might see for novel technologies.

Here's a breakdown of what is and is not in the provided text, related to your request:

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

• Not present. The document includes a comparison table (Section 2 and 3) that lists technical specifications of the gi 4000 and its predicate devices (Olympus AFU-100, Erbe APC 300, Erbe ICC 200). This table outlines characteristics like flow rate, dimensions, max voltage peak, frequency, output power limit, gas flow rate, and gas purity. While these are performance specifications, they are not presented as acceptance criteria with corresponding explicit "reported device performance" results against those criteria. Instead, they are presented as comparative data points to establish substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not present. The document mentions an "In vitro tissue study" but provides no details on sample size, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not present. The study mentioned is an in vitro tissue study comparing lesion creation, not a clinical study involving experts establishing ground truth for diagnostic or prognostic purposes. Therefore, there's no mention of experts or their qualifications for ground truth in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not present. As this was an in vitro tissue study, there would not be an adjudication method for a "test set" in the sense of clinical image interpretation or similar expert-driven assessment.

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/Not present. This device is an electrosurgical generator, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or AI assistance effect sizes are not relevant and are not mentioned.

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

• Not applicable/Not present. This is an electrosurgical device, not an algorithm.

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

• Implied, but not explicitly stated or detailed. For the "in vitro tissue study," the ground truth for comparison would be the characteristics of the lesions created by both the subject device and the predicate device. This would likely involve visual assessment or measurement of the lesions, but the method (e.g., expert assessment of tissue damage, histological analysis) is not specified. The document simply states the study "demonstrated substantial similarity between lesions created."

8. The sample size for the training set

• Not applicable/Not present. As this is not an AI/machine learning device, there is no "training set."

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

• Not applicable/Not present. Again, no training set for this type of device.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through technical comparison and specific non-clinical bench testing (electrical safety, EMC, biocompatibility, software verification/validation, and an in vitro tissue study). It does not present detailed acceptance criteria with corresponding device performance results in the format requested, nor does it describe studies involving expert ground truth, sample sizes for test/training sets, or MRMC studies, as those are typically relevant for different types of medical devices (e.g., diagnostic software, AI algorithms).

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