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The SURx TV System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence due to hypermobility in women not eligible for major corrective surgery.

The SURx TV System consists of two components: the SURx TV Generator and the SURx TV Applicator. The SURx TV Applicator connects to the Generator. The Applicator also provides irrigation to the treatment site. The SURx TV Applicator is supplied sterile and intended for single use. The Applicator uses a bipolar design, which means that a return pad is not required for operation. The tip of the Applicator contains a thermistor to monitor temperature at the targeted area. The SURx TV Generator is a radiofrequency (RF) electronic instrument. Software is utilized in the operation of the SURx TV Generator.

The provided text details the 510(k) summary for the SURx TV System, which is an electrosurgical system for treating stress urinary incontinence. While it states that "clinical evaluations were used to demonstrate that the SURx TV System functioned as clinically intended," the document does not provide the specific acceptance criteria or detailed results of a study that proves the device meets those criteria. The focus of this 510(k) summary is primarily on demonstrating substantial equivalence to a predicate device based on design, materials, and principle of operation, and on stating that clinical data supports its intended function without elaborating on the specifics of that data or how it addresses acceptance criteria.

Therefore, I cannot fulfill most of the requested information based on the provided text.

Here's a breakdown of what can and cannot be extracted:

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

• Cannot be provided. The document does not specify any quantitative acceptance criteria or report specific performance metrics from a study against such criteria. It generally states that the device "performs as clinically intended" and "demonstrates that the SURx TV System functioned as clinically intended."

2. Sample size 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 "clinical evaluations" and "clinical studies" but does not give any details about sample sizes, study design (retrospective/prospective), or data provenance.

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. There is no mention of ground truth establishment, experts, or their qualifications.

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

• Cannot be provided. There is no information regarding adjudication methods.

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 SURx TV System is an electrosurgical device, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI would not be relevant or performed for this type of device.

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

• Not applicable. This device is an electrosurgical system, not an algorithm.

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

• Cannot be provided directly. While it implied "clinical performance data" for a device indicated for "shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence," the specific type of ground truth (e.g., objective measurement of shrinkage, patient-reported outcomes, physician assessment) is not detailed.

8. The sample size for the training set:

• Not applicable. This is a physical electrosurgical device, not a machine learning model, so there is no "training set."

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

• Not applicable. As above, no training set.

Summary from the provided text:

The document states that:

• "Results of clinical evaluations were used to demonstrate that the SURx TV System functioned as clinically intended."
• "Sufficient data have been gathered from clinical studies to determine that the SURx TV System performs as clinically intended and that no new issues of safety and effectiveness are introduced."

However, these are general statements and do not provide the detailed evidence requested. The 510(k) summary explicitly focuses on substantial equivalence based on technological characteristics and indications for use compared to a predicate device, rather than detailed clinical performance metrics from de novo studies.

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