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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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As a powered muscle stimulator the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:

· Relaxation of muscle spasm

· Prevention or retardation of disuse atrophy

·Increasing local blood circulation

· Muscle re-education

·Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

· Maintaining or increasing range of motion

As a biofeedback device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions: · Biofeedback, relaxation and muscle re-education purposes

As a nonimplanted electrical continence device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:

· Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles.

·Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles.

This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.

There are two models of Biofeedback Nerve and Muscle Stimulator which are KM530 and KM531. Their intended use, working principle, product structure and major parameters are all same, apart from the difference of product appearance, and KM531 has several more programs than KM530.

The device is battery-powered with a display screen and offers the user a choice of EMG Test (Only for EMG acquisition, not for electrical stimulation), EMG Game (6 biofeedback responsebased vivid games, active training for the user to contract the muscles of the treatment area, no electrical stimulation is generated), ETS (electromyography triggered stimulation; Only when the EMG value reaches the set threshold, the electrical stimulation is triggered; This module is a combination of active and passive treatment module, which exercise the self-contracting ability of the user), and STIM (Neuromuscular stimulation with fixed programs and customized programs of which parameters can be adjusted under the directions of physicians or professionals).

The device is supplied with vaginally inserted probe used with the device to stimulate the muscle of the pelvic floor (the probe is identical to that used in the model KM518 with 510(k) number K163288). Anal probe is optional, user can choose to purchase qualified probe. The device is supplied with biofeedback reference lead wire with skin electrodes. The device main unit connects directly to the vaginal electrode and reference wire by cable and plug. The device provides independent dual-channel EMG signals acquisition and dual-channel electrical stimulation output which is convenient for the treatment of different sites.

I am designed to extract acceptance criteria and information about studies that prove a device meets those criteria. However, the provided document is a 510(k) summary for a "Biofeedback Nerve and Muscle Stimulator" and does not contain acceptance criteria in the format typically associated with performance metrics for clinical studies.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices by comparing technical characteristics (e.g., electrical output specifications, EMG performance, safety standards compliance) and indications for use. It outlines the non-clinical tests performed to ensure the device meets design specifications and relevant safety standards.

Therefore, many of the requested fields regarding acceptance criteria, sample size for test sets, expert ground truth, adjudication methods, MRMC studies, or specific effect sizes are not applicable in this context, as the document does not describe a clinical performance study with such endpoints.

Here's a breakdown of the information that is available in the provided text:

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

The document doesn't present specific acceptance criteria in a table; rather, it compares the technical specifications and performance characteristics of the proposed device ("Targeted device") against a "Predicate device" and "Reference devices." The "acceptance" can be inferred as being "similar" or "within the range" of the predicate devices.

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

• Not Applicable. The document describes non-clinical engineering and bench tests, not a clinical study involving human subjects or data sets that would have a "sample size" or "data provenance" in the traditional sense. Tests were conducted to verify compliance with design specifications and relevant standards.

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)

• Not Applicable. Ground truth, in this context, would refer to defined engineering specifications and international standards, not expert assessments of clinical cases. The "experts" would be the engineers and regulatory compliance personnel who developed and tested the device and verified its adherence to the standards.

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

• Not Applicable. Adjudication methods are relevant for studies where there is ambiguity or disagreement in truth determination, typically in clinical assessments. This document pertains to objective engineering and electrical performance tests.

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

• Not Applicable. This device is a Biofeedback Nerve and Muscle Stimulator, not an AI-assisted diagnostic or interpretive device for human "readers." No MRMC study was performed.

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

• This device is not an algorithm, but a physical medical device. Its "standalone" performance refers to its ability to meet its technical specifications and safety standards independent of user interaction (e.g., electrical output, EMG acquisition accuracy, battery performance), which was evaluated through the non-clinical tests mentioned. Specific quantitative standalone performance metrics beyond "meets design specifications" are not provided in this summary.

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

• For the non-clinical tests, the "ground truth" was based on:
  • Design Specifications: The manufacturer's own internal design requirements for the device.
  • International Standards: Compliance with recognized international standards for medical electrical equipment (e.g., IEC 60601 series) and biological evaluation of medical devices (e.g., ISO 10993 series).
  • Predicate Device Characteristics: The performance parameters and characteristics of legally marketed predicate devices, against which the new device was compared to establish substantial equivalence.

8. The sample size for the training set

• Not Applicable. This document does not describe the development of an AI algorithm or a study with a training set.

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

• Not Applicable. No training set was used.

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