(139 days)
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).
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.