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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):

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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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The eMVFit (MVF-10M) Radio frequency is used for:
· Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.
· Temporary reduction in the appearance of cellulite.

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

The provided text describes the eMVFit (MVF-10M) device and its 510(k) summary for substantial equivalence to a predicate device (INMODE LTD. Embody System, K183450). This document primarily focuses on bench testing and compliance with standards to demonstrate safety and effectiveness for a medical device rather than a study with a human test set, expert readers, or ground truth in the context of clinical performance or diagnostic accuracy.

Therefore, many of the requested details, such as sample size, data provenance, number of experts, adjudication methods, MRMC studies, and ground truth types related to human performance or clinical outcomes, are not applicable in this regulatory submission. The acceptance criteria and "proof" in this context are for demonstrating the device's technical specifications, safety, and electromagnetic compatibility through non-clinical testing.

Here's a breakdown of the information that is available or NA (Not Applicable) based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with international standards for medical electrical equipment. The "reported device performance" is that the device passed all these tests.

Study Proving Device Meets Acceptance Criteria

As noted, this is a non-clinical, bench testing-focused submission, not a human-in-the-loop or clinical study.

1. A table of acceptance criteria and the reported device performance:
   (See table above)

2. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable. The "test set" here refers to the device and its components undergoing bench testing, not a dataset of patient cases.
   • Data Provenance: Not applicable in terms the requested format. The data comes from internal laboratory testing conducted by the manufacturer (WEERO Co.,Ltd.). This is reported as non-clinical (bench) performance data.

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

   • Not Applicable. Ground truth, in the sense of expert consensus on clinical findings, is not established for this type of non-clinical, hardware/software compliance testing. The "ground truth" for these tests is the established requirements and limits defined by the international standards themselves.

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

   • Not Applicable. Adjudication methods are relevant for subjective interpretations of clinical data by multiple readers. This refers to objective measurements and compliance against specific technical standards.

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:

   • No. This device is an electrosurgical cutting and coagulation device and accessories, intended for therapeutic use (e.g., muscle aches, cellulite), not a diagnostic device involving human readers or AI assistance in image interpretation. Therefore, an MRMC study is not relevant or performed for this submission.

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 AI algorithm for diagnostic interpretation that would have "standalone" performance metrics in the way described. The device's performance is assessed through its physical outputs and safety mechanisms.

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

   • Regulatory Standards and Design Specifications. The "ground truth" for the non-clinical testing is adherence to the specified technical parameters, safety limits, and performance requirements outlined in the referenced international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2) and internal design specifications. Biocompatibility used data from ISO 10993 testing.

8. The sample size for the training set:

   • Not Applicable. This device submission does not describe a machine learning model that requires a "training set" in the context of supervised learning for diagnostic accuracy. The "training" for this device would be its own design and manufacturing process to meet performance specifications.

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

   • Not Applicable. (See point 8).

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