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The device 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 and to maintain urinary continence in women.

Levina Pelvic Floor Muscle Stimulator is a non-implantable, home use device for the treatments of stress, urge, and mixed urine incontinence through the intravaginal probe's electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions, which help users to achieve pelvic floor muscle strengthening for maintaining urinary continence in women. The subject device includes a remote control, a stimulator pod and a vagina stimulation probe. Both the remote control and the stimulator pod are powered by an off-the-shelf 3.7V lithium-ion polymer battery. The remote control has a 1.77" TFT LCD screen and 4 buttons to control the stimulator pod. The stimulator pod has two output channels and will perform electrical stimulation according to the parameter settings sent by the remote control. The device is supplied with a reusable (single-patient use) vaginal, dual-electrode, stimulation probe.

The provided text is a 510(k) summary for the Levina Pelvic Floor Muscle Stimulator, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria based on clinical outcomes or diagnostic accuracy. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of clinical performance metrics (like sensitivity, specificity, human reader improvement with AI, etc.) is not present.

However, the document does contain information about "Non-Clinical Testing" with "pre-determined acceptance criteria" which were met. I will extract and organize the available information based on your request.

Here's a breakdown of the available information:

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

The document states: "All pre-determined acceptance criteria were met." but does not provide specific numerical targets or the results from the non-clinical tests in a detailed table format. It lists the types of tests performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This document primarily discusses non-clinical engineering and software testing. It does not refer to "test sets" in the context of clinical data (e.g., patient cases) or population-based data. Therefore, this information is not applicable or available in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the document does not describe a clinical study involving experts establishing ground truth for a test set.

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

This information is not applicable as the document does not describe a clinical study involving adjudication of a test set.

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:

This information is not applicable. The device is a "Pelvic Floor Muscle Stimulator," an electrical therapy device, not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable as the device is a physical stimulator and not an algorithm-only diagnostic or AI solution. The "Software Verification and Validation Testing" refers to the embedded software in the device, not a standalone AI algorithm for interpretation.

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

For the non-clinical tests, the "ground truth" would be defined by the technical specifications and requirements outlined in the referenced international standards (e.g., ISO 10993, IEC 60601 series). For example, electrical safety "ground truth" would be the specified limits for leakage current or dielectric strength. There is no clinical "ground truth" discussed in this document.

8. The sample size for the training set:

This information is not applicable. The document describes a physical medical device and its non-clinical engineering and software testing, not a machine learning model that would require a "training set."

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

This information is not applicable for the same reasons as point 8.

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