(25 days)
The Valleylab FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. When used with compatible ablation devices, it is indicated for cardiac tissue ablation. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium.
The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.
The Valleylab™ FT10 Energy Platform (VLFT10GEN) provides radio frequency (RF) energy for monopolar and bipolar surgical applications, tissue-fusion and vessel-sealing applications (LigaSure vessel-sealing function), and cardiac ablation. It is a combination of a full-featured general-surgery electrosurgical unit, a bipolar vessel sealing system, and an ablation unit. The monopolar and bipolar sections, including the LigaSure section of the system, are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery. The LigaSure vessel-sealing section of the system provides power for vessel sealing. The cardiac ablation feature of the device is only available when used with compatible Cardioblate™ instruments.
The VLFT10GEN is used in hospitals and other health care facilities where surgical procedures are carried out.
The VLFT10GEN can be used with a variety of legally marketed accessories including monopolar and bipolar instruments, footswitches, and return electrode pads. The VLFT10GEN connects to electrical mains and operates at an input line frequency of 47-63 Hz.
This FDA 510(k) summary does not contain the information requested for a detailed description of acceptance criteria and a study proving a device meets them.
The document is a regulatory approval letter for the Valleylab FT10 Energy Platform, indicating its substantial equivalence to a predicate device. It describes the device, its intended use, and general performance characteristics, but it explicitly states that no clinical performance data was relied upon for this premarket submission.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to the performance evaluation of a device through specific studies, which this summary confirms were not clinically focused.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document describes general performance characteristics and compliance with standards (e.g., thermal spread, system functionality, electrical safety, usability), but it does not list specific quantitative acceptance criteria or corresponding reported device performance metrics in a table format.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document mentions "ex vivo testing using porcine tissue" for thermal spread, but it does not specify the sample size for this testing (e.g., number of porcine tissue samples). It also does not mention the country of origin of the data or whether it 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)
- Cannot be provided. Since no clinical performance study involving human interpretation or "ground truth" establishment is detailed, this information is not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. Similar to point 3, without a clinical performance study involving multiple human readers and ground truth, there is no adjudication method described.
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
- Cannot be provided. The document does not mention any MRMC study, AI assistance, or human reader improvement. The device described is an electrosurgical generator, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. The device is an electrosurgical generator; the concept of "standalone algorithm performance" is not applicable in the context presented.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No clinical "ground truth" is discussed for the performance evaluation in this document. The "ground truth" for the ex vivo testing would likely relate to objective measurements of thermal spread in the tissue samples, but the methodology is not detailed.
8. The sample size for the training set
- Cannot be provided. The document discusses software verification and validation, but it does not mention a "training set" in the context of an AI/ML algorithm or a similar data-driven model. The software testing mentioned is for embedded device software, not a learning algorithm.
9. How the ground truth for the training set was established
- Cannot be provided. As there is no mention of a "training set," this information is not applicable.
In summary, the provided document focuses on regulatory clearance based on substantial equivalence and non-clinical verification and validation activities (e.g., bench testing, software testing, electrical safety). It explicitly states that clinical performance data was not used for this submission, which means the detailed information about acceptance criteria, specific study designs, sample sizes, and ground truth methodologies (especially as they relate to human or AI performance) is absent.
§ 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.