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The VIDAMED Model 7600 RF Generator is indicated for use as part of the VIDAMED TUNA System to deliver RF energy and record patient treatment data. The VIDAMED TUNA System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

The VIDAMED Model 7600 RF Generator is capable of delivering up to 30W (15W/channel) of RF energy and is designed for use with VIDAMED accessory electrodes including the TUNA Catheter. When used with VIDAMED accessory electrodes, the VIDAMED Model 7600 RF Generator is capable of reading, recording, and storing data obtained from thermocouple sensors within the electrode. Software within the RF generator and controls the RF energy output to the tissue.

This 510(k) summary describes a medical device, the VIDAMED Model 7600 RF Generator, which is indicated for use in treating benign prostatic hyperplasia (BPH). However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to its clinical efficacy or performance in terms of diagnostic accuracy, sensitivity, specificity, or similar metrics.

This document is focused on demonstrating substantial equivalence to previously cleared devices (VIDAMED Model 7205 RF Generator and VIDAMED Model 7312 RF Generator Data Recorder) and compliance with electrical safety standards (ANSI, AAMI, UL). This is a common approach for 510(k) submissions where the new device is substantially similar to an existing one, and thus, extensive new clinical performance studies are often not required to demonstrate safety and effectiveness for predicate devices.

Therefore, I cannot provide the requested information for the following items based solely on the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not define numerical acceptance criteria for clinical performance (e.g., success rates of BPH treatment, or specific device output parameters that define success). It primarily describes the capabilities of the device (delivering RF energy, recording data) and its indication for use.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical performance study with a test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. The device is an RF generator, not a diagnostic imaging device typically associated with MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an RF generator used by a clinician, not a standalone algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What can be inferred from the document regarding "acceptance criteria" and "study" in a broader sense:

The "acceptance criteria" for the submission itself are primarily related to demonstrating:

• Substantial Equivalence: The primary "study" or justification provided is the comparison of the Model 7600 RF Generator to the predicate devices (Model 7205 and Model 7312). The "acceptance criterion" here is that the new device does not raise new questions of safety or effectiveness and performs as intended, similar to the cleared predicate devices. The document explicitly states it "is substantially equivalent" to the two previously cleared devices.
• Compliance with Electrical Safety Standards: The document states the device "is designed to be in compliance with ANSI, AAMI and UL electrical safety standards." This implies that testing (a form of "study") was performed or design specifications were met to ensure electrical safety. The "acceptance criterion" would be meeting the specifications outlined in those standards.

In summary, the provided text is a summary for a 510(k) submission focused on substantial equivalence and regulatory compliance for a device that delivers RF energy. It does not include the type of performance metrics, study designs, or ground truth information typically associated with evaluating a diagnostic or AI-driven device's clinical performance against specific acceptance criteria.

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