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The NEEDLELESS SLING is indicated for the treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency

The NEEDLELESS SLING is included in the sling techniques for the treatment of female stress urinary incontinence. This device is a vaginal sling that permits for the regulation of continence in the female incontinent patient. This system uses a mesh sling, placed under the urethra, that can be regulated during the intervention and just after it to achieve continence. The sling is passed through the endopelvic fascia, creating a fibrosis that supports the mid urethra as a limitation to its descending and thus providing continence.

The provided text describes a medical device called "NEEDLELESS SLING" and its clearance through the FDA 510(k) process. This document is a 510(k) notification, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device.

For such a submission, the acceptance criteria and study proving performance are described based on the concept of substantial equivalence to a predicate device, rather than a traditional performance study with specific numerical metrics like sensitivity, specificity, or accuracy, as would be common for AI/ML devices.

Here's an analysis based on the provided text, structured to address your specific points:

Since the provided document is a 510(k) notification for a medical device (a surgical sling) and not an AI/ML powered device, the typical metrics and study designs requested in your prompt (e.g., sample size for test sets, number of experts for ground truth, MRMC studies) are not applicable or detailed in this type of submission. The primary "study" is a demonstration of substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable in the traditional sense for this 510(k) summary. This document does not describe a clinical study with a "test set" of patient data like an AI/ML algorithm would. The "performance data" mentioned refers to verification testing, which typically involves bench testing or animal studies for device safety and functional integrity, not patient data in the context of diagnostic accuracy.
• The comparison is primarily based on technical specifications, indications for use, and existing knowledge/literature on the predicate devices.

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

• Not applicable. The concept of "ground truth" established by experts for a test set is not relevant to this type of device submission. The "ground truth" for the device's efficacy and safety is implicitly derived from the long-standing use and FDA clearance of its predicate devices and the manufacturer's internal verification testing.

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication method" in the context of a test set, as no clinical image or diagnostic data is being evaluated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is not relevant for this device. This type of study is typically conducted for diagnostic devices (especially imaging-based AI) to assess how human readers perform with and without AI assistance. The NEEDLELESS SLING is a surgical implant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a surgical sling, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" is established through pre-clinical (bench and potentially animal) verification testing for material properties, mechanical integrity, and functionality, and implicitly by the clinical history and regulatory clearance of the predicate devices. The efficacy and safety are linked to the established performance of similar, previously cleared devices.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable.

Summary of Approach for This Device:

The 510(k) submission for the NEEDLELESS SLING focuses on demonstrating substantial equivalence to existing legally marketed predicate devices primarily through:

• Comparison of Indications for Use: Showing identical or very similar clinical applications.
• Comparison of Technological Characteristics: Demonstrating similar materials, design, mechanism of action, and performance.
• Verification Testing: Internal tests conducted by the manufacturer to ensure the new device meets its own established performance specifications (e.g., tensile strength, biocompatibility, sterility). These results are typically summarized rather than detailed extensively in the 510(k) summary.

The presented information confirms that the device meets the criteria for substantial equivalence to its predicates (GYNECARE TENSION FREE VAGINAL TAPE SYSTEM and GYNECARE TVT SECUR SYSTEM) based on shared indications and similar technological characteristics, with verification testing supporting its established performance requirements.

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