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The 'NuTracTM Pelvator' Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress urge and mixed urinary incontinence in women

The 'NuTrac™ Pelvator' Pelvic Muscle Trainer is a small lightweight battery powered dual channel neuromuscular stimulation device supplied with a vaginal two electrode stimulation probe. The probe connects to the control unit by cable and plug.

The provided text is a 510(k) summary for the 'NuTrac™ Pelvator' Pelvic Muscle Trainer. It does not contain specific acceptance criteria, detailed study results, or information typically found in a clinical trial report.

Based on the provided text, here's what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria are mentioned in the provided text. The document refers to "Performance testing [...] to demonstrate the integrity, suitability and substantial equivalence of the device" but does not detail what those performance tests were, nor does it provide any quantitative results or metrics against which acceptance criteria would be measured.

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

No information regarding a "test set" sample size or data provenance is provided. The document states "Performance testing was conducted," but no details about the datasets used are given.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. No information about expert review or ground truth establishment is mentioned in the context of performance studies.

4. Adjudication Method:

Not applicable. No information about adjudication methods is provided.

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

No, an MRMC comparative effectiveness study is not mentioned. The document focuses on demonstrating "substantial equivalence" to a predicate device, which typically involves comparing technical characteristics and indications for use, rather than a direct comparison of human reader performance with or without AI assistance. The device in question is a pelvic muscle trainer, not an AI-assisted diagnostic tool.

6. Standalone Performance Study (Algorithm Only):

Not applicable. The 'NuTrac™ Pelvator' is a physical device (an electrical stimulator) for pelvic muscle training, not a standalone algorithm. Therefore, "algorithm only" performance is not relevant in this context. The document mentions "Performance testing" of the device itself.

7. Type of Ground Truth Used:

Not applicable. The concept of "ground truth" as typically used in the context of AI or diagnostic device performance evaluation is not relevant here. The device's performance likely relates to electrical stimulation parameters, safety, and functionality, rather than diagnostic accuracy against a definitive "truth."

8. Sample Size for the Training Set:

Not applicable. There is no mention of a "training set" as this device is not an AI-driven diagnostic or analytical tool that undergoes machine learning training.

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

Not applicable, as there is no training set mentioned.

Summary of Available Information from the Provided Text:

The provided document is a 510(k) summary from 2009 for the 'NuTrac™ Pelvator' Pelvic Muscle Trainer. Its primary purpose is to demonstrate substantial equivalence to a predicate device ("Kegel8" Pelvic Muscle Trainer, K0181480).

• Study: Performance testing was conducted on the device to demonstrate its integrity, suitability, and substantial equivalence.
• Conclusion: Based on the indications for use and performance studies, the device was deemed substantially equivalent for its intended use.
• Missing Information: The document explicitly lacks the detailed clinical study design, acceptance criteria, specific performance metrics, sample sizes, data provenance, expert involvement, or any information related to ground truth that would be necessary to answer the questions posed. The focus is on regulatory equivalence rather than a detailed scientific performance report.

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