(52 days)
The Voyant electrosurgical generator is indicated for use with Voyant devices in open and laparoscopic surgical procedures where the electrosurgical ligation of vessels or tissue bundles is desired.
The Applied Medical Voyant Electrosurgical Generator (ESG) is a tabletop radiofrequency (RF) power supply designed for use in electrosurgery. It operates outside the sterile field and is equipped with a receptacle for Voyant hand piece devices. The ESG enclosure is constructed of various metals and polymers and houses all electrical hardware and software components. The front panel features an LCD and buttons for the navigation, adjustment, and selection of ESG settings.
This document is a 510(k) Premarket Notification from the FDA regarding the Voyant Electrosurgical Generator. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel AI/ML device that requires extensive acceptance criteria for predictive performance.
Therefore, many of the requested elements for an AI/ML device cannot be found in this document because they are not applicable to the type of device and study presented. The "device" in question is an electrosurgical generator, not an AI model.
Here's a breakdown of the information that can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in the format typically seen for AI/ML performance metrics (e.g., accuracy, sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by demonstrating "substantial equivalence" to a predicate device. The performance is assessed through various engineering and system tests comparing the subject device to its predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrically and Software compliant with relevant standards (IEC 60601 series, FDA guidances) | The Voyant ESG was designed and evaluated in accordance with relevant standards of the IEC 60601 series for electromagnetic compatibility and electrical testing. Software functional testing verified all software requirements were met. Unit, integration, and system level software testing were conducted. |
| Substantially equivalent burst pressure performance with Voyant hand pieces compared to predicate. | "The results of the study demonstrated that the subject generator has substantially equivalent performance to the predicate generator with each Voyant hand piece." |
| Substantially equivalent thermal spread damage performance with Voyant hand pieces compared to predicate. | "Analysis of the measurements demonstrated that the subject generator has substantially equivalent performance to the predicate generator with each Voyant hand piece." |
| No new issues of safety and efficacy compared to the predicate device. | "The subject Voyant Electrosurgical Generator is substantially equivalent in performance to the predicate Voyant Electrosurgical Generator with respect to intended use (i.e. vessel sealing performance and local tissue effects) and does not raise any new issues of safety and efficacy." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described (burst pressure, thermal spread, electrical safety, software testing) suggests engineering and bench testing, not a clinical "test set" of patient data as would be used for an AI/ML model. The provenance would be the lab where testing was conducted, but details are absent.
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)
This is not applicable/provided. Since this is not an AI/ML diagnostic device, there is no "ground truth" established by human experts in the sense of image interpretation or disease diagnosis. The "ground truth" for the engineering tests would be derived from the physical properties and measurements from the predicate device and the subject device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable/provided. No adjudication method for expert review of a test set is mentioned, as it's not relevant to this type of device submission.
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
There was no MRMC study done. This is not an AI-assisted diagnostic device. The study focused on the substantial equivalence of the electrosurgical generator itself, not on improving human reader performance. In fact, the document explicitly states: "No chronic survival or clinical studies were required to demonstrate the safety and efficacy of the subject device in support of this application for premarket clearance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm, but an electrosurgical generator. Its performance is inherent to its electrical and mechanical design.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" (or basis for comparison) in this context is the performance of the legally marketed predicate device. For specific tests:
- Burst pressure and thermal spread: Measured physical properties directly compared to the predicate.
- Electrical safety and EMC: Compliance with international standards (IEC 60601 series).
- Software: Verification against software requirements.
8. The sample size for the training set
This is not applicable/provided. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable/provided. As above, there is no AI/ML training set.
§ 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.