Search Results

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)

Ask a specific question about this device

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.

Ask a specific question about this device

The SURx Laparoscopic Probe (LP) Radio Frequency (RF) 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 LP System consists of two components: the SURx LP Generator and the SURx LP Applicator. The SURx LP Applicator connects to the Generator. The Applicator also provides irrigation to the treatment site. The SURx LP 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 LP Generator is a radiofrequency (RF) electronic instrument. Software is utilized in the operation of the SURx LP Generator.

The provided text describes the regulatory clearance of a medical device and mentions clinical evaluations but does not contain the detailed information required to fill out the table of acceptance criteria or the specifics of a study proving a device meets those criteria.

Specifically, the document states:

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

However, it does not provide:

• A specific table of acceptance criteria (e.g., minimum accuracy, sensitivity, specificity thresholds).
• The reported device performance metrics against such criteria.
• The sample size for the test set or its provenance.
• Details about ground truth establishment (number/qualifications of experts, adjudication method, type of ground truth).
• Information on MRMC studies or standalone algorithm performance.
• Sample size for and ground truth establishment methods for a training set.

Therefore, based only on the provided text, I cannot complete the requested table or provide a detailed description of the study as requested. The document's purpose is to confirm regulatory clearance based on substantial equivalence, not to detail the full clinical study methodology and results.

Ask a specific question about this device