(238 days)
The NuEra Tight Family, EMS Model, is intended for:
- improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen;
- strengthening, toning and firming of buttocks, thighs and calves;
- improvement of muscle tone and firmness, for strengthening muscles in arms.
NuEra Tight Family, EMS Model, is a family of devices designed to:
- produce an electromagnetic field that induces electrical current in the muscles. By muscle stimulation, the system helps to strengthen, tone and firm the abdomen, buttocks, thighs and calves.
The device belonging to the NuEra Tight Family, EMS Model, generates an intense magnetic field which is used to stimulate muscles trough two EMS handpieces, one small and one large, which can treat body parts of different sizes.
This document is a 510(k) summary for the NuEra Tight Family, EMS Model, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria based on clinical outcomes.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, especially in terms of clinical performance, cannot be fully extracted as such a study is not part of this 510(k) submission. This document primarily addresses safety, electrical compatibility, and functional equivalence to a predicate device already on the market.
However, I can extract information related to the performance data presented within the context of demonstrating substantial equivalence.
1. A table of acceptance criteria and the reported device performance
The document does not detail specific acceptance criteria for clinical efficacy or the reported performance of the device against such criteria. Instead, it focuses on demonstrating compliance with safety and technical standards and functional equivalence to a predicate device.
The performance data provided relates to:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety | In compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-10/A1. |
| Software Verification and Validation | Software verification was conducted to FDA regulations, standards, and guidance document requirements. Results conclude the software has met these requirements. |
| Functional Testing (Technical Specifications) | Functional tests performed confirmed alignment with device technical specifications. |
| Biocompatibility | Assessed in accordance with ISO 10993-1:2018 and FDA guidance. The device has no contact with patient skin. |
| Risk Management | In compliance with ISO 14971. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This 510(k) summary does not describe any clinical study with a "test set" of patients or data provenance in the context of clinical performance. The testing mentioned (electrical safety, software, functional) is laboratory or engineering-based.
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. This information pertains to clinical performance evaluations, which are not detailed in this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication is described.
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 powered muscle stimulator, not an AI-assisted diagnostic or therapeutic tool with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device for muscle stimulation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe clinical ground truth establishment. For the technical performance aspects:
- Electrical Safety & EMC: Compliance with international standards (IEC 60601 series).
- Software V&V: Compliance with FDA regulations, standards, and guidance.
- Functional Testing: Device technical specifications served as the "ground truth" for these tests.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI-driven device.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).