(245 days)
- 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.
The proposed device is a type of the most advanced electromagnetic noninvasive treatment machine (with attachments). It is used for muscle tension enhancement and muscle strengthening on abdomen, hips, thighs, arms, etc. Three models (SHE-MSP003, SHE-MSP002 and SHE-MSP001) are included in HI-EMT MAGSHAPE series products, and they have the same intended purposes, working theories and specifications.
The provided document is a 510(k) summary for the HI-EMT MAGSHAPE device. It outlines the device details, intended use, comparison to a predicate device, and conclusions regarding substantial equivalence. However, it explicitly states:
"No clinical study is included in this submission." (Page 7)
Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria from a clinical perspective. The acceptance criteria discussed are related to non-clinical tests (e.g., electrical safety, EMC) and performance specifications compared to the predicate device.
Here's an analysis of the information that is available, and what is missing based on your request:
Information Available from the Document:
1. A table of acceptance criteria and the reported device performance:
The document provides "Performance Comparison" (Tables 2 and 3) which effectively serves as a comparison of the proposed device's specifications against those of the predicate device. While not explicitly labeled "acceptance criteria," the predicate device's specifications represent the benchmark for equivalence.
| Acceptance Criteria (Predicate Device Specification) | Reported Device Performance (HI-EMT MAGSHAPE) | Remark |
|---|---|---|
| Product Code: NGX | NGX | Same |
| Regulation Number: 21 CFR 890.5850 | 21CFR 890.5850 | Same |
| Indications for Use: | Same as predicate | Same |
| - 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. | ||
| Principle of Operation: Initiating action potential of nerves results in muscle contraction. | Initiating action potential of nerves results in muscle contraction. | Same |
| Type of use: Prescription use | Prescription use | Same |
| Electronic Protection Class: Class II, Type BF | Class I, Type B | Similar (Note 1 - differences don't raise new safety/effectiveness issues) |
| User Interface: Touch screen | Touch screen | Same |
| Type of Energy: Magnetic field | Magnetic field | Same |
| Magnetic Field Intensity: BTL 299-6: 0.5 - 1.8 T ±20%, BTL 299-7: 0.7 - 2.0 T ±20% | 0-2 T | Similar (Note 2 - differences don't raise new safety/effectiveness issues) |
| Pulse Repetition Rate: 1-150 Hz | F1:1-10Hz, F2:1-100Hz | Similar (Note 2 - differences don't raise new safety/effectiveness issues) |
| Pulse Duration: BTL 299-6: 280 ± 20% µs, BTL 299-7: 190 ± 20% µs | 300 µs | Similar (Note 2 - differences don't raise new safety/effectiveness issues) |
| Selection of parameters (Intensity, Time): Yes | Yes | Same |
| Therapy Time: Up to 60 min | Up to 60 min | Same |
| Energy Source: 100-240 V AC, 50-60 Hz | AC110V, 60Hz | Similar (Note 1 - differences don't raise new safety/effectiveness issues) |
| System Dimensions (D × W × H): 580 × 580 × 1380 mm (23 × 23 × 55 in) | MSP001: 5204401240mm, MSP002: 5304001140mm, MSP003: 5504001140mm (Tolerance: ≤ ±5%) | Similar (Note 3 - appearance differences don't affect effectiveness/performance) |
| Ambient Temperature: -10°C ~ +55°C | + 16°C ~ + 35°C | Similar (Note 4 - passed accelerated aging test) |
| Relative Humidity: 10% to 85% | 80%, No Condensation | Similar (Note 4 - passed accelerated aging test) |
| Environmental Specifications: For indoor use only | For indoor use only | Same |
| Electrical safety: Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same |
| EMC: Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
Missing Information (as per your request, due to no clinical study):
- Sample sized used for the test set and the data provenance: Not applicable, no clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical ground truth established from experts.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no clinical test set.
- 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 not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this device is not an algorithm-only product.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, no clinical ground truth used as no clinical study was performed for this submission. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
- The sample size for the training set: Not applicable, no training set as no machine learning or AI models are mentioned.
- How the ground truth for the training set was established: Not applicable.
§ 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).