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VLFT10GEN: 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 7mm thick tissue (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.

Valleylab ™FT10 Electrosurgical Generator (VLFT10FXGEN): The VLFT10FXGEN is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.

Valleylab ™FT10 Vessel Sealing Generator (VLFT10LSGEN): The VLFT10LSGEN is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics.

Valleylab™ FT10 Energy Platform (VLFT10GEN): The Valleylab™ FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. The generator provides radio frequency (RF) energy for monopolar and bipolar surgical applications, tissue-fusion, and vessel-sealing applications (LigaSure/vessel sealing function) and cardiac applications. It is a combination of a full-featured general surgery electrosurgical unit and a bipolar vessel sealing system. The monopolar and bipolar sections, including the LigaSure/Bipolar section of the system, are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery.

Valleylab™ FT10 Electrosurgical Generator (VLFT10FXGEN): The Valleylab™ FT10 Electrosurgical Generator is a high frequency electrosurgical only version of the VLFT10GEN Energy Platform. It is intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.

Valleylab™ FT10 Vessel Sealing Generator (VLFT10LSGEN): The Valleylab™ FT10 Vessel Sealing Generator is the vessel sealing only version of the VLFT10GEN Energy Platform. It is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics.

The provided text is a 510(k) summary for a medical device, the Valleylab™ FT10 Energy Platform Software Version 5.0. It describes the device, its intended use, a comparison to a predicate device, and performance data. However, this document does not contain details about a study evaluating a device based on AI/ML. Instead, it describes an electrosurgical generator and highlights performance data related to electrical safety, EMC, software verification/validation, and mechanical testing.

Therefore, I cannot extract information pertaining to:

1. A table of acceptance criteria and the reported device performance regarding AI/ML performance metrics (e.g., sensitivity, specificity, AUC). The document refers to "acceptance criteria" for engineering and safety tests, not for AI performance.
2. Sample sizes used for the test set and the data provenance for AI/ML evaluation.
3. Number of experts used to establish the ground truth for an AI/ML test set and their qualifications.
4. Adjudication method for an AI/ML test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done for AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done for an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI/ML.
8. The sample size for the training set for an AI/ML algorithm.
9. How the ground truth for the training set was established for an AI/ML algorithm.

The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This means that no clinical studies (which would typically involve human readers for an MRMC study or large datasets for standalone AI performance) were conducted or included in this 510(k) submission. The "Software verification and validation testing" mentioned is general software quality assurance, not specific to AI/ML model performance.

In summary, the provided text does not contain the information requested about AI/ML device performance and testing.

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