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The Konmed Incontinence Stimulation Electrode include Vaginal Probe KM-504, KM-505, KM-506, KM-507, KM-5013 & Rectal Probe KM-502. KM-5018 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

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I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Konmed Incontinence Stimulation Electrode" does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

This document is a standard FDA clearance letter, which primarily states that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and other administrative requirements.

To answer your request, a document detailing the verification and validation (V&V) testing performed by the manufacturer, including specific acceptance criteria and study results, would be necessary. This information is typically found in the 510(k) submission itself, which is not fully provided here.

Therefore, I cannot populate the table or answer the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement, as that data is absent from the provided text.

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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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The Pelvifine Pelvic Muscle Trainer (Model: KM518) is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.

The Pelvifine Pelvic Muscle Trainer is a product designed to give women the opportunity to strengthen their pelvic floor muscles. This device is a dual-channel stimulator combining several treatment programs into one unit. Channel B is for the Junior User (who use the device no more than 5 times) and Channel A is for the Senior User (who use the device more than 5 times). It offers full control of Pulse Widths, Rates, Ramp up times, and Work/Rest cycles.

The provided text is a 510(k) Summary for the Pelvifine Pelvic Muscle Trainer. It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence for regulatory approval.

However, this document does not contain information about clinical study acceptance criteria, device performance results from a clinical study, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies. The "Test Summary" section explicitly states that the device was evaluated by lab bench testing and usability testing, not clinical studies assessing its efficacy in treating urinary incontinence.

Therefore, I cannot fulfill your request for the comprehensive information about acceptance criteria and a study proving the device meets them, as the provided document does not contain this type of data.

The relevant section, "6. Test Summary," states:
"The Pelvifine Pelvic Muscle Trainer (Model: KM518) has been evaluated the safety and performance by lab bench testing and usability testing as following:

• Electrical safety test according to IEC 60601-1 and IEC 60601-2-10 standards
• Electromagnetic compatibility test according to IEC 60601-1-2 standard
• Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
• Usability test according to IEC 62366 standard
• Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
• The waveform test report has also been conducted to characterize the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning"

This clearly indicates a focus on technical and safety performance, not clinical efficacy. The substantial equivalence argument relies on the similarity of the new device's technical specifications and intended use to those of already approved predicate devices, rather than on proving its therapeutic effectiveness through a new clinical trial.

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The proposed device is intended for use as the disposable, conductive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with legally marketed electrical stimulators, i.e. TENS (Transutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It's for Over-the-Counter (OTC) use.

The proposed Electrodes with snap / Electrodes with pigtail are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydro gel, no securing materials are required to secure the product to the patient's skin. The proposed product mainly consists of electrode pad and snap or pigtail. The electrode pad is available in Round Shape Electrode, Rectangular Shape Electrode, Palm shape Electrode, Elliptical Shape Electrode, and Calabash Shape Electrode.

The provided document is a 510(k) summary for medical electrodes, not an AI/ML device. Therefore, it does not contain the information requested in points 2-9 regarding AI/ML model performance, training, and validation.

However, I can extract the acceptance criteria and reported device performance for the physical electrodes as presented in the "Test Summary" and "Comparison to predicate device" sections.

Acceptance Criteria and Reported Device Performance

Study Details (for physical device, not AI/ML):

The document describes a 510(k) submission, which demonstrates "substantial equivalence" to a legally marketed predicate device, rather than a clinical study proving new performance. The "Test Summary" indicates that safety and performance were evaluated by "lab bench testing."

• Sample size used for the test set and the data provenance: Not specified in terms of sample size for the tests, but the data would be from lab bench testing (likely within China, given the company's location). This is not retrospective or prospective in the sense of a clinical trial; it's product testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical/electrical tests with objective measurements, not judgment-based assessments requiring experts for ground truth.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is for a physical medical device (electrodes), not an AI/ML diagnostic or assistive tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Physical measurements and adherence to specified performance standards (e.g., ISO 10993, IEC 60601-1, specific impedance/strength values).
• The sample size for the training set: Not applicable, as this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

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Electrodes with silver conductive as Glove style, Wristbands Style, Wrist sleeve, Elbow Pads Style and Knee Pads Style, Elbow Sleeve, are intended for use with legally marketed TENS stimulating device. The electrodes with silver conductive will deliver stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include such as hands (gloves), feet (socks), wrist, elbow and knee.

Electrodes with silver conductive are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, wrist sleeve and knee sleeve. The conductivity is derived from the silver content of the Nylon yarn. The electrodes are available in free size. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The electrodes can be used dry or wet when in contact with the skin. The entire surface of each electrode is very conductive having a resistance of less than 2ohms per inch. This low resistance provides low current density with uniform current distribution.

This document is a 510(k) Summary for a medical device (Electrodes with silver conductive) and focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets new acceptance criteria through extensive clinical studies. Therefore, much of the requested information regarding detailed study design, ground truth establishment, reader studies, and sample sizes for training and test sets is not available in this type of regulatory submission.

The document primarily relies on bench testing and a comparison of technical specifications to a previously cleared predicate device to assert safety and effectiveness.

Here's the information that can be extracted or inferred from the provided text, along with an explanation of why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, "acceptance criteria" predominantly revolve around demonstrating substantial equivalence to a predicate device, as well as meeting basic biocompatibility standards and electrical resistance specifications. The performance is reported in terms of these comparisons.

Regarding the specific questions you asked for deeper study details:

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

• Not applicable/Not provided: This document relies on bench testing and comparison to a predicate device, not a large-scale clinical test set for performance evaluation in the way an AI/software device would. The "test summary" only mentions "Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards." These would involve in vitro (cell culture) and potentially in vivo (animal, not human) tests, but not a "test set" of human data in the context of device performance as you might expect for an AI algorithm. The provenance would be the lab where these biocompatibility tests were conducted.

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/Not provided: There is no "ground truth" derived from expert consensus on patient data described, as this is a physical device (electrodes) and not an AI or diagnostic tool requiring such expert review of images or clinical outcomes.

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

• Not applicable/Not provided: See explanation for #3.

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/Not provided: This device is physical conductive electrodes, not an AI software. Therefore, MRMC studies are irrelevant here.

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

• Not applicable/Not provided: This is not an algorithm. Bench tests were done to evaluate electrical properties and biocompatibility.

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

• Not applicable/Not provided: For the physical and chemical properties assessed (e.g., impedance, biocompatibility), the "ground truth" is established by laboratory measurement standards (e.g., resistance meters, cell viability assays, irritation scores) rather than clinical expert consensus or pathology data.

8. The sample size for the training set

• Not applicable/Not provided: There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable/Not provided: See explanation for #8.

Summary regarding the nature of this submission:

This document is a 510(k) Pre-market Notification, which primarily aims to demonstrate substantial equivalence to a predicate device already legally marketed. For devices like these electrodes, this often means showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The "study" here is not a clinical performance trial in the sense of evaluating diagnostic accuracy or clinical outcomes, but rather a series of bench tests (e.g., impedance, physical dimensions) and biocompatibility tests to ensure the device performs as expected and is safe for contact with the human body, compared against established standards and the predicate device's performance.

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