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The gi 4000 Electrosurgical 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 was 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.

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This is an FDA clearance letter for a medical device (gi-4000 Electrosurgical Generator), not a study report. Therefore, it does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, or study methodologies. The document's purpose is to confirm that the FDA has reviewed the device and determined it is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

While the document references "Indications for Use," it does not provide data from studies to support these indications or detail how the device's performance meets specific acceptance criteria.

Therefore, I cannot provide the requested information from this document.

To answer your request, I would need a clinical study report or a technical performance report for the gi-4000 Electrosurgical Generator.

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The gi 4000 Electrosurgical 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 layage pump is intended to was 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.

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This document is an FDA 510(k) clearance letter for the gi-4000 Electrosurgical Generator. It confirms that the device has been found substantially equivalent to existing legally marketed predicate devices.

However, this document does not contain the acceptance criteria or a study demonstrating that the device meets acceptance criteria.

The 510(k) clearance process primarily evaluates substantial equivalence to a predicate device, focusing on safety and effectiveness. While testing is certainly conducted by the manufacturer, the detailed results and acceptance criteria are typically part of the manufacturer's submission to the FDA, which is not publicly available in this clearance letter.

Therefore, I cannot provide the requested information based on the given text.

To give you an idea of what that typically looks like for a medical device cleared via 510(k), here's a general outline of the information you've requested, and why it's not present in this specific document:

1. A table of acceptance criteria and the reported device performance: This would typically involve specific quantifiable metrics for the device's performance (e.g., power output accuracy, coagulation time, safety parameters) and the pre-defined thresholds for acceptable performance. This is part of the manufacturer's test report.
2. Sample size used for the test set and the data provenance: This refers to the number of units tested, conditions, and origin of the data. Again, internal testing by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Less applicable to an electrosurgical generator in terms of "ground truth" like in AI/imaging; more relevant to clinical evaluation if human assessment was part of performance testing (e.g., assessment of tissue effects).
4. Adjudication method: Not directly applicable to the type of device or information found in this letter.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is primarily relevant for diagnostic imaging devices or AI algorithms that assist human interpretation, not electrosurgical generators.
6. Standalone performance (algorithm only without human-in-the-loop performance): This is specific to AI algorithms. The gi-4000 is a physical electrosurgical generator, so this concept doesn't apply.
7. Type of ground truth used: For an electrosurgical device, "ground truth" would relate to objective measurements of its physical output and effects, often against a gold standard instrument or validated test methods, not expert consensus or pathology in the same way as an imaging diagnostic.
8. Sample size for the training set: Not applicable for this type of device, as it's not an AI/machine learning product that requires training data.
9. How the ground truth for the training set was established: Not applicable for this type of device.

In summary, the provided FDA clearance letter confirms the regulatory status of the gi-4000 Electrosurgical Generator but does not contain the detailed technical performance data, acceptance criteria, or study results that would typically be part of the manufacturer's 510(k) submission.

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