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The Compact II is indicated for:

• Relaxation of muscle spasms;
• Prevention or retardation of disuse atrophy;
• Increasing local blood circulation;
• Muscle re-education;
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
• Maintaining or increasing range of motion.

The Compact II device generates (or induces) electric current in targeted tissues. affected by a high induction magnetic field to stimulate those tissues to treat the indicated conditions.

The device includes a transducer, which is used to provide the magnetic stimulation, which creates electrical fields by pulse current flowing from a capacitor according to the principle of Faraday's Law. Whenever the capacitor bank is discharged by the action of the control system, a pulse of current flows through the stimulating coil. The magnetic stimulation creates intense, rapidly changing magnetic electrical fields.

The Compact II device consists of a console and transducer for magnetic stimulation. The function of magnetic stimulation is operated by adjusting parameters such as Mode, Intensity and Time. These parameters can be controlled by users on the LCD Touch Screen.

N/A

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EMS is used for:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

TENS is used for:

• Symptomatic relief and management of chronic, intractable pain
• Post-surgical acute pain
• Post-trauma acute pain

EVE Synergy has Synergy handpiece (1EA), Pro handpiece (2EA), Micro cable, Tip (Ball type, T type, COMB type) and Power adaptor & cable.

EVE Synergy has Synergy mode and Pro mode.

Synergy mode has radio frequency and low frequency functions using a synergy handpiece. The Synergy handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43℃.

Pro mode has low frequency function that uses the Pro handpiece with tip.

It should be noted that the device has radio frequency (RF Mode) indicated for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. This RF mode was previously reviewed by the FDA under K212253 and was cleared under regulation 21 CFR 878.4400 (Product code PBX). In the subject submission, there are no changes being proposed related to the RF Mode, and, hence, the review of the RF Mode is not within the scope of the subject 510(k) submission.

The provided text is a 510(k) clearance letter and an accompanying 510(k) summary for the EVE Synergy (EVE-20M) device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria through a comparative effectiveness study involving AI assistance or human-in-the-loop performance.

Therefore, many of the requested details regarding acceptance criteria for AI performance, specific study designs (MRMC, standalone), ground truth establishment for AI training/test sets, and sample sizes for these, are not present in this type of regulatory submission. This document primarily describes the physical and electrical characteristics of the device and compares them to predicate devices, along with standard electrical safety, EMC, and software validation testing.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

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

The document does not present "acceptance criteria" in the traditional sense of a specific performance metric (like accuracy, sensitivity, specificity) for a clinical outcome or an AI model's performance. Instead, it demonstrates compliance with safety and performance standards and similarity to predicate devices.

The "acceptance criteria" are implicitly met by showing:

• Compliance with various IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62304) for electrical safety, EMC, and software.
• The device's technical specifications (e.g., output voltage, current, pulse width, frequency, power density) are comparable to or within the safe limits established by the predicate devices.

Table of Performance (extracted from comparison tables):

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

This document does not describe a test set or data derived from human subjects. The testing described is non-clinical bench testing:

• Electrical safety tests
• Electromagnetic compatibility tests
• Performance tests (measuring output parameters against specifications)
• Software verification and validation
• Usability testing (presumably, for the device's user interface, not clinical user performance)

There is no mention of "country of origin for data" or "retrospective/prospective" as these are not relevant to bench testing for device parameters.

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 is not applicable. "Ground truth" in the context of AI or clinical diagnostic studies (e.g., for radiologists interpreting images) is not established or referenced here because this is a physical medical device (muscle stimulator) undergoing bench testing for safety and performance specifications, not an AI diagnostic tool.

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

Not applicable. There are no clinical or image-based test sets requiring adjudication by experts.

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 muscle stimulator, not an AI-assisted diagnostic tool. No MRMC study was performed or required for this type of submission.

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

Not applicable. There is no AI algorithm being cleared as a standalone device. The "software validation testing" mentioned (IEC 62304) relates to the safe and effective operation of the device's inherent control software, not an AI-driven clinical function.

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

Not applicable in the context of AI or clinical ground truth. For this submission, "ground truth" implicitly refers to the engineering specifications and established safety limits as defined by relevant IEC standards and comparison with predicate devices. The device's output parameters were measured against these defined standards and specifications.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model. There is no training set for an AI algorithm mentioned or required.

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

Not applicable. As above, there is no AI training set.

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For Prescription and Home Use by prescription from a medical professional:
The TrainFES advanced is a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.

As a powered muscle stimulator, TrainFES advanced is indicated for the following conditions:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• increasing local blood circulation
• immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion
• Muscle re-education

As an external functional neuromuscular stimulator (FES), TrainFES Advanced is indicated for the following conditions:

• Helps to relearn voluntary motor functions of the extremities.

TrainFES' Advanced intended population is anybody aged 22 or over.

Environments of use: TrainFES Advanced devices can be used by both therapists and patients, in the clinic, hospitals or at home.

Platform: TrainFES is a battery-powered, wireless device, accessible through software.

TrainFES Advanced is a portable functional electrostimulator with 6 channels designed for use in the clinics and hospitals by the medical professionals as well as in the home environment by the patient. This device generates electrical impulses to stimulate the musculature of paralyzed seqments and facilitate both the relearning of movement and neuromodulation of tone.

TrainFES Advanced is a battery-powered, wireless device, configurable from the TRAINFES App, available for Smartphone and Tablets, which allows you to adjust different parameters and follow a training plan from your smartphone. Session settings can be retrieved from the PC or Cloud.

The provided document describes the FDA 510(k) premarket notification for the "TrainFES Advanced" device, a neuromuscular electrical stimulator. The purpose of this submission is to demonstrate substantial equivalence to a predicate device (Stella BIO, K210002).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for the device's performance in a quantitative manner (e.g., target accuracy, sensitivity, specificity). Instead, the substantial equivalence justification relies on demonstrating that the TrainFES Advanced device performs similarly to or meets the safety and effectiveness standards of the predicate device, K210002.

The table below summarizes the comparison of key technical characteristics between the TrainFES Advanced and its predicate, Stella BIO, highlighting where "performance" is discussed in terms of meeting relevant standards or being considered equivalent. The reported "performance" for TrainFES Advanced is intrinsically linked to its compliance with these standards and the assertion that differences do not raise new safety or effectiveness concerns.

2. Sample Size for the Test Set and Data Provenance:

The document explicitly states: "No clinical testing was performed in support of this submission."
Therefore, there is no test set in the sense of clinical data from human subjects described in this document. The evaluation relies on non-clinical (bench) testing, comparison to a predicate device, and compliance with recognized standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Given that no clinical testing was performed, there were no "experts" involved in establishing ground truth for a clinical test set from human subjects. The assessment relies on the expertise of the engineers and regulatory professionals who performed the non-clinical testing and drafted the 510(k) submission, confirming compliance with engineering standards.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The submission relies entirely on non-clinical testing and comparison to a predicate device, without involving human readers or a comparative effectiveness study with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, this question doesn't directly apply here. The "TrainFES Advanced" is a physical medical device (a neuromuscular electrical stimulator) that includes software control, not an AI algorithm intended for diagnostic or prognostic purposes on its own. The "device performance" is assessed through its electrical and mechanical characteristics and compliance with safety standards, not through an algorithm's standalone interpretative accuracy.

7. The Type of Ground Truth Used:

For this device, the "ground truth" for the non-clinical testing is based on:

• Engineering specifications and regulatory standards: The device is tested against established limits and requirements defined in standards like IEC 60601 series, IEC 62133, IEC 62304, IEC 62366, and ISO 14971.
• Predicate device characteristics: The predicate device (Stella BIO, K210002) serves as a benchmark for comparison, implying that its established safety and effectiveness characteristics represent a "ground truth" for what is acceptable in this device class.

8. The Sample Size for the Training Set:

Not applicable, as no AI/machine learning algorithm training using a specific dataset is referenced or implied in the context of this 510(k) submission for this type of medical device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no AI/machine learning algorithm training using a specific dataset is referenced.

In summary: The submission for TrainFES Advanced demonstrates substantial equivalence primarily through comprehensive non-clinical (bench) testing against recognized industry standards (IEC series, ISO 14971) and a detailed comparison of its technical specifications to a previously cleared predicate device (K210002). The core argument is that any differences in characteristics do not raise new questions of safety or effectiveness. No clinical studies, human reader studies, or AI algorithm performance evaluations against clinical ground truth were conducted or presented in this document.

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Quantum Mitohormesis Medical Device is intended for:

• Stimulating healthy limb muscles to improve and facilitate muscle performance.
• Preventing or retardation of disuse atrophy of muscles.

Quantum Mitohormesis (QMT) is a medical device that uses unique pulsed electromagnetic fields for muscle therapy. Users (adults ≥ 22 years old) place one group of muscles in the lower limbs into the field applicator of QMT device, which for a defined duration generates specific electromagnetic fields that stimulates healthy muscles to improve and facilitate muscle performance, and prevents and retards muscle disuse atrophy.

QMT is applied directly to muscles (without direct contact) to stimulate muscle activity. In order to achieve optimized treatment outcome, QMT is applied to muscles on a weekly basis, once or twice a week, with each treatment application lasting a brief 10-minutes.

The device consists of the following high-level components:

• Base unit, which includes signal generator, power amplifier, and micro-controller unit.
• Field applicator, which includes electro-magnetic coils generating specific magnetic pulses.
• User Interface Panel, which allows users to operate the device and display necessary device information.
• Signal cord.
• Height and tilt adjustment knobs, which allow users to adjust the height and tilt of field applicator; and

The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA to QuantumTX Pte. Ltd. regarding their Quantum Mitohormesis (QMT) device. It confirms the device's substantial equivalence to legally marketed predicate devices, allowing its marketing.

The document discusses:

• Regulatory information: Device classification, regulation numbers, and general controls.
• Device description: How the QMT device works (pulsed electromagnetic fields for muscle therapy) and its components.
• Intended Use/Indications for Use: Stimulating healthy limb muscles to improve and facilitate muscle performance, and preventing or retarding disuse atrophy of muscles.
• Comparison to Predicate Devices: A detailed table comparing the QMT device with two predicate devices (Storz Medical MAGNETOLITH Muscle Stimulator and Bemer Classic & Pro) across various parameters (device name, manufacturer, intended use, principle of action, technical specifications, etc.). This comparison aims to demonstrate substantial equivalence, not to prove performance against specific acceptance criteria.
• Summary of Non-Clinical Testing: States that the QMT device passed various non-clinical performance tests (biocompatibility, electrical safety, electromagnetic disturbance/immunity, and software verification/validation) in accordance with relevant ISO and IEC standards. These are safety and engineering compliance tests, not performance studies against specific clinical acceptance criteria for the intended use.
• Summary of Clinical Testing: Explicitly states, "There is no clinical data submitted with this submission."

Therefore, I cannot provide the requested information, particularly the table of acceptance criteria and reported device performance, the sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text. The submission relies solely on non-clinical testing and substantial equivalence to predicate devices, not on a clinical performance study.

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EMS is used for:

• · Relaxation of muscle spasms
• · Prevention or retardation of disuse atrophy
• · Increasing local blood circulation
• · Muscle re-education
• · Maintaining or increasing range of motion
• · Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

eMVFit has MULTI handpiece, EMS handpiece, patient switch, cradle, distilled water injection hose & funnel, key switch and power cable.

eMVFit has a user interface including an LCD touch screen and has MULTI mode and EMS mode. MULTI mode has RF and EMS functions that use the MULTI handpiece.

In the case of RF, the target temperature can be set and a vacuum can be used together, and a cooling function can be used as a safety system to prevent burns on the skin surface.

In addition, the MULTI handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43 ℃.

EMS mode has an EMS function that uses the EMS handpiece.

The provided text is a 510(k) Summary for the eMVFit (MVF-10M) device, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to predicate devices through various comparisons and non-clinical performance data.

However, the document does not contain information on acceptance criteria for a study demonstrating device performance in terms of clinical outcomes, nor does it describe a study involving human subjects or expert readers to prove the device meets specific acceptance criteria for diagnostic or clinical effectiveness.

The document primarily details:

• Device Description and Indications for Use: What the device is and what it's used for (muscle spasms, disuse atrophy, circulation, re-education, range of motion, DVT prevention).
• Predicate Device Comparison: A detailed table comparing the eMVFit's technical specifications (electrical parameters, dimensions, operation modes) with three predicate devices (INMODE LTD.'s Evolve System with T3 and Tone Applicators, and TimeWaver Production GmbH's TimeWaver Frequency).
• Substantial Equivalence Discussion: Explains that differences between the subject device and predicates do not raise new questions of safety or effectiveness, often citing compliance with IEC standards.
• Non-Clinical (Bench) Performance Data: Lists a series of standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, IEC 60601-1-6, ISO 10993-10, ISO 10993-23, IEC 62304) to which the device was tested to demonstrate basic safety, essential performance, EMC, risk management, usability, biocompatibility, and software functions. It states the device passed all testing.

Therefore, I cannot fulfill your request for: a table of acceptance criteria and reported device performance (in the context of clinical outcomes), sample size, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The document describes technical compliance and safety testing against engineering standards, not direct clinical performance or effectiveness studies with human data or expert evaluations. The "performance data" referred to is "Non-Clinical (Bench) Performance Data," meaning lab tests, not clinical trials.

The FDA's 510(k) pathway often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical efficacy studies, especially for devices with well-understood mechanisms of action like muscle stimulators. The information provided aligns with this regulatory pathway.

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BTL-899MS is indicated to be used for:

· Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.

• · Strenathening, toning and firming of buttocks, thighs and calves.
• · Improvement of muscle tone and firmness, for strengthening muscles in arms.

The BTL-899MS device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The BTL-899MS device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.

Indications for Use for Muscle Stimulators:

• · Relaxation of muscle spasms
• · 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

The BTL-899MS is a non-invasive therapeutic device. The device is comprised of a main unit and applicators that deliver electromagnetic energy to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators.

The application of electromagnetic energy to the patient's feeling of magnetic stimulation of underlying tissue accompanied by a pleasant feeling of warming in the application area, which may contribute to increased local blood circulation and help the patient to relax and make the treatment more comfortable.

The BTL-899MS is equipped with a large color touch-screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are set using the touch screen of the device. During the therapy, the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.

Based on the provided FDA 510(k) summary for the BTL-899MS device (K240234), here is an analysis of its acceptance criteria and the study proving it meets them:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing detailed clinical study results for a novel device. Therefore, the information regarding acceptance criteria, specific performance metrics, and detailed study methodologies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for novel AI/software devices) is limited or absent. This document primarily outlines compliance with safety and performance standards relevant to a medical device's physical and electrical characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, the "acceptance criteria" are primarily related to meeting established electrical safety, electromagnetic compatibility, usability, risk management, and biocompatibility standards, and demonstrating substantial equivalence to predicate devices in terms of technological characteristics and intended use. There isn't a table of quantitative performance metrics for disease detection or diagnostic accuracy in this submission because it's a physical therapy device, not an AI diagnostic tool.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states "Clinical Testing: Not applicable" on page 6. This indicates that a clinical study with real patient data (test set) for performance evaluation, as would be expected for an AI/software device, was not conducted or deemed necessary for this 510(k) submission. The evaluation was based on non-clinical testing (bench testing) and comparison to predicate devices, focusing on the device's physical and electrical characteristics and mechanism of action.

Therefore, questions regarding sample size, data provenance (country, retrospective/prospective), experts, and adjudication methods for a test set are not applicable in this context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no clinical test set for performance evaluation was conducted.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as no clinical test set for performance evaluation was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a powered muscle stimulator, not an AI diagnostic device intended to assist human readers (e.g., radiologists interpreting images).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical device, not an algorithm, and its functionality is not standalone in the sense of an AI model's performance.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's acceptance is based on:

• Compliance with established international and national technical standards (e.g., IEC 60601-1, ISO 14971) for safety, EMC, usability, and biocompatibility.
• Demonstrated substantial equivalence to previously cleared predicate devices, meaning its intended use and technological characteristics are similar enough that it does not raise new questions of safety or effectiveness. The "ground truth" for this equivalence often relies on the established safety and efficacy of the predicate devices themselves, backed by their own clearances or long-standing market presence.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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The MYOTouch Muscle Stimulator is indicated for use as an adjunct in the treatment of high and low anorectic malformations by helping with the identification of striated muscles to be used in anal reconstructions. The MYOTouch device is intended for use by trained personnel who are competent to apply the appropriate stimuli.

MYOTouch is a hand-held device designed to be used for surgical correction of neonatal anorectal malformations. MYOTouch is intended for prescription use. The device is a 9V battery-powered, one-channel muscle stimulator. The device is supplied with a Sterile Stylus, which connects to the control unit by cable and plug. The MYOTouch muscle stimulator has been specially designed to meet the requirements of pediatric surgeons who need a reliable and easy to use muscle locating stimulator when carrying out the Pena, "Pull-through", or posterior sagittal anorectoplasty (PSARP) anorectal reconstruction technique. A trained professional or pediatric surgeon must use the MYOTouch device. The pediatric surgeon uses manual, push-button controls to control the electrical stimulation level. The unit is intended for prescription use and is designed with simplicity and ease of use. It has two preset modes available.

I am sorry, but the provided text is a 510(k) premarket notification for a medical device called the MYOTouch Muscle Stimulator. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

However, the document explicitly states in Section VIII, "No clinical tests were submitted to support this 510(k)."

Therefore, based on the information provided, I cannot answer your request regarding the acceptance criteria and the study that proves the device meets those criteria, as no such study is presented in this document. The submission relies on demonstrating substantial equivalence to a legally marketed predicate device through technical comparisons and compliance with recognized standards, rather than direct performance studies against acceptance criteria.

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PA&PR series:
The PA&PR series are a neuromuscular electrical stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, PA&PR series are indicated for the following conditions:

• · Relaxation of muscle spasms,
• · Prevention or retardation of disuse atrophy,
• · Increasing local blood circulation,
• · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
• · Maintaining or increasing range of motion,
• · Muscle re-education.
  Environments of Use: Clinics, hospital. Patient population: Adults
  S&Q series:
  The S&O series are a neuromuscular electrical stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
  As a powered muscle stimulator, S&Q series are indicated for the following conditions:
• · Relaxation of muscle spasms,
• · Prevention or retardation of disuse atrophy,
• · Increasing local blood circulation,
• · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
• · Maintaining or increasing range of motion,
• · Muscle re-education.
  As a transcutaneous electrical nerve stimulator for pain relief, S&Q series are indicated for the following conditions:
  · Symptomatic relief and management of chronic (long-term), intractable pain,
• · Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.
  Environments of Use: Clinics, hospital and home environments.
  Patient population: Adults

Subject device have four series, which are PA series, PR series, Q series and S series. These four series are all electrical stimulating devices.

This document is an FDA 510(k) clearance letter for the "Stimulation System" manufactured by Edan Instruments, Inc. It asserts substantial equivalence to a predicate device, STIWELL med4 (K080950).

The provided text does not contain acceptance criteria for an AI-powered device, nor does it describe a study proving such a device meets acceptance criteria.

Instead, this document is a regulatory submission for a medical device (neuromuscular and transcutaneous electrical nerve stimulators) that appears to be hardware-based, with "software/firmware/microprocessor control" mentioned generally, but not as the primary component being evaluated for AI performance. The document focuses heavily on bench testing (electrical safety, EMC, performance to standards) and comparison to a predicate device's physical and electrical specifications, not on AI performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance for an AI device.
• Sample sizes, data provenance, ground truth establishment, or expert involvement related to AI performance.
• MRMC studies or standalone AI performance.

The document's "Performance Data" section explicitly states: "Clinical data: Not applicable." This further confirms that no clinical studies (which would be necessary to prove performance of an AI system in a clinical context) were conducted or presented for this submission.

In summary, the provided text does not describe an AI medical device or its performance criteria/study.

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The accufit is indicated for use for Relaxation of muscle spasms, Prevention or retardation of disuse atrophy, Increase local blood circulation, Muscle re-education, Maintaining or increasing range of motion, Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen, and Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.

The principle of operation of the accufit device is to provide direct electrical stimulation of muscles which produces muscle contractions in and around the area of the treatment electrodes. The accufit generates electrical stimulation to contract the muscles to achieve the desired intended use using unique IntelliPhase waveforms and IntelliSTIM electrodes. It offers two unique IntelliPhase waveforms, Biphasic and Interferential (4P), that are designed to optimize muscle re-education and activation for patients. The four IntelliPhase waveform protocols are twist, hold, grip, and tap. Each protocol may be used for 15, 30, or 45 minutes. Not only are there four IntelliPhase protocols, but there is also a fully automated protocol (IntelliCycle) that integrates all the above listed waveforms in a comprehensive, interlaced series. This engages all the targeted muscles in a continuous program to maximize muscle effects with the touch of a button. accufit is both the proprietary-trade name and generic name. accufit is a supplement to existing treatments and does not replace any traditional treatment or therapy. The system console is the heart of the accufit and contains the Touch LCD/GUI, electrodes, and power supply module. The main console also includes a key switch used to turn the power on and off, and an emergency stop push button that quickly de-energizes the system in emergency situations. There are 4 casters in the console base that can be used when moving the system.

The accufit device is a Powered Muscle Stimulator (Product Codes IPF, NGX) indicated for various muscle-related therapies, including:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
• Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.

The device operates by providing direct electrical stimulation to muscles, causing contractions using unique IntelliPhase waveforms (Biphasic and Interferential (4P)) and IntelliSTIM electrodes. It offers four IntelliPhase waveform protocols (twist, hold, grip, and tap), each usable for 15, 30, or 45 minutes, as well as a fully automated IntelliCycle protocol.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details a clinical study primarily focused on the improvement of muscle tone and firmness, specifically for strengthening muscles in the arms. While acceptance criteria in a quantitative sense (e.g., a specific percentage increase in strength) are not explicitly stated, the study's overall finding that "most patients saw improvement in muscle strength" serves as the reported device performance against an implied criterion of demonstrating clinical effectiveness for its new indication.

Given the available information, here is a summary related to the clinical study and its findings:

2. Sample Size and Data Provenance for Test Set

• Sample Size: 45 subjects were enrolled in the study.
• Data Provenance: Not explicitly stated regarding the country of origin. The study appears to be prospective as subjects were "enrolled" and "treated" with the device, and follow-up assessments were conducted.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This was a clinical study assessing the physiological effect of the device on muscle strength, not an AI/image-based diagnostic device requiring expert interpretation for ground truth. Muscle strength was measured objectively using a dynamometer.

4. Adjudication Method for Test Set

Not applicable. Muscle strength was measured using a dynamometer, which provides objective, quantitative data, thus negating the need for an adjudication method typically used for subjective assessments or interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a clinical trial assessing the direct effect of the device on muscle strength in human subjects.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a powered muscle stimulator for direct application to the human body, not an algorithm-only or AI-driven diagnostic tool. Its performance is intrinsically linked to human-device interaction.

7. Type of Ground Truth Used

The ground truth used in the clinical study was objective physiological measurement: muscle strength measured by a dynamometer at specified time points (baseline, final treatment, 30-day post-treatment, and 90-day post-treatment).

8. Sample Size for Training Set

Not applicable. This device is a physical therapeutic device, not an AI/machine learning model that requires a "training set" in the conventional sense of data-driven algorithm development. The "training" for the device would be its engineering and design based on established principles of electrical muscle stimulation.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no specific "training set" for the type of device described. The device's design and operational parameters would be based on scientific and engineering principles for powered muscle stimulators. Its effectiveness for specific indications is then demonstrated through clinical studies, as detailed above.

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This Zynex device has been designed for muscle re-education, prevention of disuse atrophy, increase local blood circulation, maintain, or increase range of motion, and relaxation of muscle spasms.

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I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a device called "M-Wave," a powered muscle stimulator. It outlines the regulatory approval process and requirements but does not detail any performance studies, acceptance criteria tables, or specifics on how the device's efficacy was verified. Therefore, I cannot fulfill your request for that specific information based on the given input.

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