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The device 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 and to maintain urinary continence in women.

The Biofeedback Nerve and Muscle Stimulator (Model: KM530B, KM531B, KM537) is a type of biofeedback and neuromuscular electrical stimulation therapy device for patients with pelvic floor muscle dysfunction. Through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment it helps to strengthen weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women.

The device is battery-powered with a touch screen Liquid Crystal Display (LCD) and offers the user a choice of electromyography (EMG) triggered stimulation (ETS) mode (The device provides a passive pulse stimulation when the level of active contraction of the pelvic floor muscles reaches a threshold by means of electrical feedback from the pelvic floor muscles. 17 (KM536, KM537) or 22 (KM530B, KM531B) pre-set sow-frequency pulses stimulate pelvic floor muscles Electrical Stimulation (STIM) programs with 6 pre-set biofeedback response-based EMG games and the EMG therapy are available for the users. The differences between the model KM536 are only the model's name and the number of STIM Programs. The differences between the model KM531B and KM537 are also only the model's name and the number of STIM Programs.

The provided document is a 510(k) summary for the Shenzhen Konmed Technology Co.,Ltd. Biofeedback Nerve and Muscle Stimulator. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain the specific acceptance criteria for performance or a detailed study proving the device meets those criteria, especially in terms of clinical effectiveness.

The document focuses on demonstrating substantial equivalence primarily through technical specifications and compliance with general safety and performance standards. While it mentions "Performance testing according to IEC 60601-2-10, Medical electrical equipment -- Part 2-● 10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators," this standard generally covers electrical safety and functional performance of the stimulator itself, not necessarily clinical efficacy for treating urinary incontinence.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, ground truth, and expert involvement are not available in this 510(k) summary.

Here's a breakdown of what can be gleaned from the document regarding the requested information:

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

The document does not provide a table of specific clinical acceptance criteria (e.g., reduction in incontinence episodes) and reported device performance against those criteria. It lists various safety and performance tests performed to demonstrate compliance with standards:

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

This information is not provided in the document. The document primarily refers to technical testing against standards, not clinical trials with patient data.

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)

This information is not provided as there is no mention of a test set requiring expert-established ground truth in a clinical context.

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

This information is not provided.

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

An MRMC comparative effectiveness study was not conducted. This device is a biofeedback nerve and muscle stimulator, not an AI-assisted diagnostic or interpretation system that would involve "human readers" in that context.

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

This question is not applicable in the typical sense for this type of device. The device itself is a standalone medical electrical device. Performance testing against relevant IEC standards (e.g., IEC 60601-2-10) would assess the algorithm/device's performance without a "human-in-the-loop" in terms of its core stimulator functions, but not in a way that relates to diagnostic accuracy or interpretation, which is what this question usually implies.

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

Given the nature of the device and the provided document, the "ground truth" used was compliance with established international electrical and medical device safety and performance standards (e.g., IEC 60601 series, ISO 10993). Clinical outcomes data for the subject device are not detailed in this summary; rather, its effectiveness is asserted through substantial equivalence to the predicate device, which presumably had established its own clinical effectiveness.

8. The sample size for the training set

This information is not provided. This device is not described as utilizing a machine learning algorithm that would require a "training set" in the context of AI.

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

This information is not provided as it's not applicable to the type of device and submission described.

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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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