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The Valleylab FT10 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. 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 coagulation for sterilization procedures. Do not use this function for these procedures.

The Valleylab™ FT10 Electrosurgical Platform (VLFT10) provides radio frequency (RF) energy for monopolar and bipolar surgical applications, and tissue-fusion and vessel-sealing applications (LigaSure function). It is a combination of a full-featured general-surgery electrosurgical unit and a LigaSure vessel sealing system. The monopolar and bipolar sections, including the advanced bipolar/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 section of the system provides power for vessel sealing.

The VLFT10 is used in hospitals and other health care facilities where surgical procedures are carried out.

The VLFT10 can be used with a variety of legally marketed accessories including monopolar and bipolar instruments, footswitches, and return electrode pads. The VLFT10 connects to electrical mains and operates at an input line frequency of 47-63 Hz.

The provided document is a 510(k) summary for the Valleylab™ FT10 Electrosurgical Platform. It describes the device, its intended use, technological characteristics, and performance testing to demonstrate substantial equivalence to a predicate device (ForceTriad™ Energy Platform).

However, the document does not describe acceptance criteria or a specific study that proves the device meets those acceptance criteria in the format requested. Instead, it outlines a series of tests performed to establish substantial equivalence.

Here's an analysis of the provided text in relation to your request:

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

The document lists several types of testing performed, but it does not explicitly state specific quantitative acceptance criteria for each test nor present the reported device performance in a comparative table against those criteria. It generally states that tests were "successfully completed" or showed "comparable performance."

For example, for ex vivo and in vivo testing, it states "showed comparable performance with regard to thermal effects, and vessel sealing capabilities. Some incremental improvements in procedural speed were seen with the VLFT10." This is a qualitative statement rather than a quantitative comparison against defined acceptance criteria.

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

• Sample Size: The document mentions "ex vivo and in vivo testing using porcine tissue and a porcine model," but does not specify the sample size (e.g., number of tissue samples, number of animals) used for these tests.
• Data Provenance: The document does not specify the country of origin of the data. The testing appears to be prospective as it was conducted specifically for the device's validation.

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 information is not provided in the document. The tests described (e.g., thermal effects, vessel sealing capabilities, electrical safety) are typically assessed through objective measurements and engineering analysis rather than expert review to establish "ground truth" in the way it might be for a diagnostic imaging device.

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

This information is not applicable and therefore not provided, as the tests described do not involve subjective interpretation requiring adjudication among experts.

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:

This information is not applicable as the device is an electrosurgical generator, not a diagnostic imaging device that would involve human readers or AI assistance in interpretation.

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

The device is an electrosurgical generator. It has "tissue sensing algorithms" and a "LigaSure algorithm" that have been refined. This suggests some algorithmic control or processing. However, the document does not describe "standalone algorithm performance" in terms of clinical outcomes independent of the surgical procedure and human operator. The performance is assessed in the context of the device's function (cutting, coagulation, sealing) during surgical tasks, inherently involving human interaction.

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

For the "ex vivo and in vivo testing," the "ground truth" would likely involve direct measurements of physiological effects such as thermal spread, tissue integrity, burst pressure of sealed vessels, and potentially histological examination of tissue, rather than expert consensus on subjective assessments. The document doesn't explicitly detail the "ground truth" type but implies objective biophysical measurements.

8. The sample size for the training set:

This information is not applicable as the document describes a hardware device with embedded algorithms, not a machine learning model that undergoes a distinct "training" phase with a labeled dataset in the conventional sense. The "refinement" of algorithms (e.g., tissue sensing, LigaSure algorithm) would likely involve iterative development and testing, but not a formally defined "training set" with a specified size.

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

This information is not applicable for the same reasons as point 8.

In summary:

The document focuses on demonstrating substantial equivalence through compliance with electrical safety and EMC standards, ex vivo and in vivo testing (thermal effects, vessel sealing, procedural speed), system verification (functionality, specifications), software verification and validation, and usability testing. While these tests are designed to show the device performs as intended and is safe and effective compared to its predicate, it does not structure this information as a direct comparison against pre-defined, quantitative "acceptance criteria" for clinical performance.

For a regulatory submission of this nature, "acceptance criteria" are often embedded within the test protocols and engineering specifications, which are not fully detailed in this summary. The "reported device performance" is generally described as meeting these implicit criteria or being "comparable" to the predicate.

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