(181 days)
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.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance |
|---|---|
| Basic Safety and Essential Performance (IEC 60601-1:2005/A2:2020) | Passed all testing. |
| Electromagnetic Disturbances (IEC 60601-1-2:2014/A1:2020) | Passed all testing. |
| High Frequency Surgical Equipment (IEC 60601-2-2:2017/A1:2023) | Passed all testing. |
| Risk Management (ISO 14971:2019) | Documented by referring to the standard. |
| Usability (IEC 60601-1-6:2010/A2:2020) | Documented by referring to the standard. |
| Biocompatibility (ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021) | Passed testing; materials confirmed biocompatible. |
| Software Verification and Validation (IEC 62304:2015) | Tested and evaluated according to the standard. |
| Performance and Electrical Safety (Internal and FDA Guidance) | Met all requirements; output parameters measured. |
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.
-
A table of acceptance criteria and the reported device performance:
(See table above) -
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
How the ground truth for the training set was established:
- Not Applicable. (See point 8).
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.