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The 'Kegel8' 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 'Kegel8' 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 'Kegel8' is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women

The provided text is a 510(k) summary for the 'Kegel8' Pelvic Muscle Trainer. It states that "Performance testing was conducted on the Kegel8 Pelvic Muscle Trainer to demonstrate the integrity, suitability and substantial equivalence of the device." However, it does not include any specific acceptance criteria or the results of the performance study itself. Instead, it concludes that the device is substantially equivalent to a predicate device (Athena Pelvic Muscle Trainer II - K033256) based on its indications for use and general performance studies.

Therefore, the requested information cannot be fully extracted from the provided text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document states that performance testing was conducted, but it does not specify any acceptance criteria (e.g., specific thresholds for electrical output, safety limits, or clinical effectiveness metrics) nor does it report the actual performance results of the device against any such criteria.

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 "performance studies" but gives no details about the sample size, type of study (e.g., clinical trial, bench test), 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 and is not applicable. This type of information is typically relevant for studies involving diagnostic or screening devices where expert interpretation is crucial for establishing ground truth. The 'Kegel8' is a therapeutic device (pelvic muscle trainer), so "ground truth" would likely be objective physiological measurements or patient-reported outcomes rather than expert consensus on image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided and is not applicable. Similar to point 3, adjudication methods are usually applied in expert review scenarios for diagnostic outputs, which is not the primary function of this device.

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 and is not applicable. An MRMC study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The 'Kegel8' is a physical device for muscle stimulation, not an AI diagnostic tool.

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

• Cannot be provided and is not applicable. This concept applies to AI algorithms. The 'Kegel8' is an electrical stimulation device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be explicitly provided, but inferred not applicable to the context. For a pelvic muscle trainer, "ground truth" in a clinical study would typically involve objective measurements of pelvic floor muscle strength (e.g., using manometry or electromyography) or patient-reported outcomes related to incontinence symptoms. The document does not specify what type of data was collected in its "performance studies."

8. The sample size for the training set

• Cannot be provided and is not applicable. The device is a physical electromyostimulator, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

• Cannot be provided and is not applicable. As mentioned in point 8, this device does not utilize a training set in the context of AI.

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