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The SURx RF System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence due to hypermobility.

The SURx RF System consists of two components: the SURx Radiofrequency (RF) Generator and the SURx Applicator. The SURx Applicator connects to the Generator. The SURx Applicator is supplied sterile and intended for single use. The Applicator uses a bipolar design, such that no return pad is required for operation. The tip of the Applicator contains a thermistor to monitor temperature at the targeted area. Two applicators are available: one for use when performing this procedure using a laparoscopic approach (LP Applicator), the other applicator is used during a transvaginal approach (TV Applicator). The SURx Transvaginal (TV) Sizer is an optional accessory for use with the SURx TV Applicator. The SURx TV Sizer confirms the exposed area for treatment is adequate to Applicator. The SON blunt dissection is required prior to applying the SURx TV Applicator tip on the tissue to treated.

This submission is a 510(k) premarket notification for a labeling change to the SURx RF System. The original 510(k) for the device (K011190) cleared the SURx LP System, and K020126 cleared the SURx TV System. This document specifically discusses the SURx RF System and its associated applicators (LP and TV).

Acceptance Criteria and Study for Device Performance:

The provided document describes a labeling change and primarily focuses on demonstrating substantial equivalence to predicate devices. It does not present acceptance criteria or a detailed study plan with specific metrics to "prove the device meets acceptance criteria" in the way typically seen for a new device's performance evaluation. Instead, it justifies the expanded indication for use based on existing clinical data and comparison to predicate devices.

Therefore, many of the requested elements for a detailed study on device performance cannot be answered from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document's purpose is to support a change in the "Indications for Use" statement for an already cleared device. It asserts that the device already performs as intended and that the changes do not introduce new safety or effectiveness concerns. It does not set new performance acceptance criteria to pass, but rather reviews existing evidence to support a broader claim.

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

• Sample Size for Test Set: Not specified. The document refers to "clinical studies" but does not provide details on their design, sample sizes, or methodology for a "test set" in the context of this submission.
• Data Provenance: "Sufficient data have been gathered from clinical studies." These studies are not further detailed (e.g., country of origin, retrospective or prospective nature). The document also mentions a "Literature Review" on devices cleared for the treatment of female urinary incontinence as "additional supporting documentation."

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

• Not applicable/Not specified. This document is not describing a study where expert-established ground truth was generated for a new device performance evaluation. It refers to existing clinical data.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified.

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

• Not done. The document does not describe any MRMC study or comparison of human readers with and without AI assistance. This is a medical device (electrosurgical system) and not an AI-based diagnostic tool.

6. Standalone Performance Study (Algorithm Only):

• Not applicable. The SURx RF System is an electrosurgical cutting and coagulation device, not an algorithm or AI model. Therefore, a standalone (algorithm only) performance study would not be relevant.

7. Type of Ground Truth Used:

• The implicit "ground truth" for the device's original clearance and this labeling change is likely clinical outcomes data from the "clinical studies" mentioned. These studies would have assessed the effectiveness of the device in treating stress urinary incontinence and tracked any adverse events. The submission asserts that the device "performs as clinically intended."

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning device that would require a training set.

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

• Not applicable. (See #8)

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