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The Prostiva RF Therapy 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 cm³.

Prostiva RF Therapy is a minimally invasive treatment for patients with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The Prostiva RF Therapy System uses precisely focused radio frequency (RF) energy to ablate prostate tissue.

This document is a 510(k) summary for the Prostiva RF Therapy System, which is an electrosurgical cutting and coagulation device. The submission is for a modification to an existing device, primarily involving the incorporation of lubricant in additional locations within the Hand Piece.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance bench testing and biocompatibility testing for the modified Prostiva Hand Piece. However, it does not provide specific, quantifiable acceptance criteria or detailed numerical performance data. Instead, it states that the testing ensured the device "maintains mechanical and electrical integrity" and that "required design specifications were met." For the biocompatibility tests, it simply states "All of the testing yielded passing results."

2. Sample Size for the Test Set and Data Provenance:

The document refers to "Performance bench testing" and "biocompatibility testing" but does not specify the sample sizes used for these tests. There is no information regarding data provenance (e.g., country of origin, retrospective or prospective data), as the tests described are laboratory/bench tests, not clinical studies involving patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable as the tests described are bench and biocompatibility tests, not studies requiring expert review for ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission focuses on the substantial equivalence of a modified device through bench and biocompatibility testing, not on comparative effectiveness with human readers or AI assistance.

6. Standalone Performance Study:

The document describes "Performance bench testing" and "biocompatibility testing" of the device itself. While these could be considered standalone tests for the device's physical and functional properties, they do not represent a standalone performance study in the context of an algorithm or AI as you might expect (i.e., algorithm-only performance without human interaction). The device is a physical medical instrument.

7. Type of Ground Truth Used:

For the performance bench testing and biocompatibility testing, the "ground truth" would be established by the predefined engineering specifications and internationally recognized standards for biocompatibility. The tests assess whether the device meets these established physical, mechanical, electrical, and biological safety parameters.

8. Sample Size for the Training Set:

This information is not applicable. This submission is for a physical medical device and its modification, not an AI or algorithm that would require a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as above.

In summary:

The provided document describes a 510(k) submission for a modification to an existing electrosurgical device. The "acceptance criteria" are implied engineering and biological safety standards, and the "study" consists of bench and biocompatibility testing. The document lacks the detailed statistical performance metrics, clinical study design, and AI-specific information that your questions primarily relate to. This is common for predicate device submissions where the focus is on substantial equivalence to an already cleared device, especially when the modification is minor and does not significantly alter the fundamental scientific technology or indications for use.

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