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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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The Male Remeex System is intended to be used as a pubourethral sling for the treatment of male stress urinary incontinence

The MALE REMEEX SYSTEM (EXternal MEchanical REqulation) is included in the sling techniques for the treatment of urinary incontinence. This system is comprised of a pubourethral sling that permits the patient continence level regulation. This system use a sling, placed under the urethra that can be regulated at any time to get the most adequate bladder neck angle for a particular patient. The sling is connected by traction threads to the prosthesis. The prosthesis is situated over the fascia of the abdominal rectus muscle and is a mechanism that permits the regulation of the sling level.

The provided text does not contain information about specific acceptance criteria or a study that rigorously proves the device meets those criteria with statistical measures. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria.

However, based on the provided text, here’s an attempt to extract relevant information and note what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information Regarding Acceptance Criteria and Performance:

• No quantitative acceptance criteria are defined for clinical outcomes (e.g., success rate, reduction in leakage, quality of life improvement).
• No specific performance metrics are reported from the clinical evaluations. The statements are general affirmations of function.

Study Details:

The provided document highlights that "Results of in vitro and clinical evaluations were used to show that the Male Remeex System functioned as clinically intended." However, it does not provide granular details about these studies. Therefore, much of the requested information is not available in the given text.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It only mentions "clinical evaluations."

3. Number of Experts and Qualifications for Ground Truth:

• Not specified. The document does not detail how the results of the "clinical evaluations" were formally assessed or how ground truth for clinical intended function was established by experts.

4. Adjudication Method:

• Not specified.

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

• No. This type of study (comparing human readers with and without AI assistance) is not applicable to this medical device, which is a physical surgical implant (a pubourethral sling), not an AI diagnostic or image analysis tool.

6. Standalone (Algorithm Only) Performance Study:

• No. This is not an AI algorithm but a physical medical device.

7. Type of Ground Truth Used:

• Implicitly, the "clinical evaluations" would have relied on clinical outcomes data related to urinary continence, subjective patient reports, and potentially objective measures associated with the sling's function. However, the specific methodology for establishing "ground truth" (e.g., through physical examination by urologists, patient diaries, objective stress tests) is not detailed.

8. Sample Size for the Training Set:

• Not applicable/Not specified. This device is a physical product, not a machine learning model that requires a training set.

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

• Not applicable.

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The Remeex System is intended to be used as a pubourethral sling for treatment of female stress urinary incontinence (SUI) resulting from urethral hypomobility or hypermobility and / or intrinsic sphincter deficiency.

The REMEEX SYSTEM (EXternal MEchanical REgulation) is included in the sling techniques for the treatment of urinary incontinence. This system is comprised of a pubourethral sling that permits the patient continence level regulation. This system use a sling, placed under the urethra that can be regulated at any time to get the most adequate bladder neck angle for a particular patient. The sling is connected by traction threads to the prosthesis. The prosthesis is situated over the fascia of the abdominal rectus muscle and is a mechanism that permits the regulation of the sling level.

The provided text K033310 ("Specialities Remeex International, s.l. Remeex System") is a 510(k) premarket notification for a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific, pre-defined acceptance criteria through a full clinical trial.

Therefore, the document does not contain the specific information requested in your prompt regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance data.

Here's why and what information can be gleaned:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. The document explicitly states that "Results of in vitro and clinical evaluations were used to show that the Remeex System functioned as clinically intended. Sufficient data has been gathered from clinical testing to assess that the Remeex System performs as clinically intended." However, it does not provide quantifiable acceptance criteria or a table comparing performance against such criteria. The basis for clearance is substantial equivalence to the predicate device (Ethicon/Gynecare Pubourethral Sling, K974098), implying that if the device performs comparably to the predicate, it is considered safe and effective for its intended use.

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

• Not provided. The document mentions "clinical evaluations" and "clinical testing" but does not specify the sample size, design of the study (retrospective or prospective), or the country of origin of the data.

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

• Not applicable/Not provided. In a 510(k) submission based on substantial equivalence, the concept of "ground truth" established by experts for a test set, in the way it's used for AI/diagnostic device validation, is generally not present. The assessment is usually through clinical outcomes in a comparative study or by demonstrating similar performance to the predicate device.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. Since there's no mention of a diagnostic performance study requiring ground truth establishment, adjudication methods are not discussed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• Not provided. There is no mention of an MRMC study or any assessment of human reader improvement with or without AI assistance. This device is a surgical mesh, not an AI-powered diagnostic tool.

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

• Not applicable. This device is a physical surgical implant, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

• Not explicitly defined in the context of typical AI/diagnostic device validation. For a surgical device like this, "ground truth" would generally refer to observed clinical outcomes (e.g., resolution of stress urinary incontinence, complication rates) in a clinical evaluation, compared to the predicate device or a recognized standard of care. The document states "Results of in vitro and clinical evaluations were used to show that the Remeex System functioned as clinically intended," implying clinical outcomes were assessed, but the specifics are not detailed.

8. The Sample Size for the Training Set:

• Not applicable/Not provided. This device is not an AI algorithm that requires a training set.

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

• Not applicable/Not provided. As there is no AI algorithm or training set, this information is not relevant.

Summary based on the document:

The 510(k) submission for the Remeex System relies on demonstrating substantial equivalence to a predicate device (Ethicon/Gynecare Pubourethral Sling, K974098). The claim of substantial equivalence is supported by:

• Technological Characteristics: Both the new device and the predicate device are described as "meshes that provide pubourethral support" and utilize accessories for surgical procedures, with no differences raising new questions of safety and effectiveness.
• Performance Data: The document states that "Results of in vitro and clinical evaluations were used to show that the Remeex System functioned as clinically intended" and "Sufficient data has been gathered from clinical testing to assess that the Remeex System performs as clinically intended." However, specific quantitative data, sample sizes, or detailed methodology for these evaluations are not included in the provided excerpts.

The document does not provide the detailed information requested in your prompt regarding acceptance criteria tables, specific sample sizes for test/training sets, expert qualifications, or adjudication methods, as these are typically required for different types of device submissions (e.g., new technology requiring de novo classification or devices with AI components).

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