(266 days)
The device is indicated to be used for:
· Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- · Strengthening, Toning and Firming of buttocks and thigh
The Electromagnetic Stimulator Device, with models FlexPulse, MagnaCore, and MagnetiKa, consists of a main unit, handpiece tools, and a power cable. The main unit has a power supply unit, a control unit, and a cooling unit. The control unit has a control element and a liquid crystal display. The handpiece tools have electromagnetic induction coils and cooling fans, it is a non-invasive device.
The device generates an electromagnetic field that interacts with human body tissues, aiding in muscle stimulation to strengthen and tone the abdomen, buttocks, and thighs. With two outputs, it allows simultaneous treatment using two applicators.
This document is a 510(k) summary for a medical device (Electromagnetic Stimulator Device, EMS) for muscle conditioning. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about clinical study acceptance criteria and device performance based on those criteria, which would be typical for an AI/ML medical device.
Therefore, many of the requested items (e.g., acceptance criteria for diagnostic accuracy, sample size for test sets, expert adjudication methods, MRMC studies, standalone performance, ground truth for training/test sets) are not present in this document because they are characteristic of a different type of medical device submission (e.g., an AI-based diagnostic tool) and are not required for demonstrating substantial equivalence for a physical muscle stimulator.
The provided text details non-clinical tests and comparisons of physical and functional characteristics.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" in terms of diagnostic accuracy metrics or clinical outcomes with corresponding performance values that would be typical for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence in terms of technical characteristics and safety/performance standards.
The acceptance criteria here are implicitly related to meeting the "substantial equivalence" definition, meaning the device is as safe and effective as the predicate. The "performance" is shown through the comparison table and non-clinical testing.
Implicit Acceptance Criteria and Reported Performance (from the Comparison Table and Non-Clinical Tests Summary):
| Acceptance Criteria Category | Acceptance Criteria (Implied) | Reported Device Performance (Subject Device) |
|---|---|---|
| Intended Use/Indications for Use | Must be identical to the predicate device. | Identical: Improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen; Strengthening, toning, and firming of buttocks and thighs. |
| Principle of Action | Must be identical to the predicate device. | Identical: Initiating action potential of nerves results in muscle contraction. |
| Energy Type | Must be identical to the predicate device. | Identical: Magnetic field. |
| Magnetic Field Intensity | Within acceptable range of the predicate device. | Maximum Magnetic Field Intensity at Applicator Center Surface: 1.0T ± 20%. The document states: "The maximum field intensity at the center surface of the applicator is 1.0T, in comparison to 1.154T for the predicate device. Nonetheless, the magnetic field intensity falls within the acceptable range of the predicate device." |
| Pulse Repetition Rate | Identical to the predicate device. | 1 – 150 Hz. Identical to predicate. |
| Pulse Duration | Within acceptable range, demonstrating safety and effectiveness. | 270 ± 20% µs. The document states: "The subject device has a slightly shorter pulse width compared to the predicate device but falls within the range between the predicate and reference devices." This is implicitly accepted as equivalent or safer. |
| Induced Current in Tissues | Comparable to or safer than the predicate device while achieving the same effect. | 20.6mA. The document states: "The current induced in the tissue by the subject device is lower than that of the predicate device (28-30mA), making it safer while achieving the same effect." This is implicitly accepted as safer and equivalent for effect. |
| Safety and Essential Performance | Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10. | Non-clinical tests demonstrated compliance with these standards (ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010((R)2012; IEC 60601-1-2:2014; IEC60601-2-10:2016). |
| Usability | Conformance to IEC 60601-1-6. | Non-clinical tests demonstrated compliance with IEC 60601-1-6: 2013. |
| Biocompatibility | Conformance to ISO 10993-5, ISO 10993-10. | Non-clinical tests demonstrated compliance with ISO 10993-5:2009 and ISO10993-10:2010. |
| Software Verification & Validation (V&V) | Software V&V testing conducted as per FDA guidance for "moderate" level of concern software. | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff... The software was considered as a 'moderate' level of concern." This indicates the V&V was successful per the guidance. |
| Physical Characteristics (e.g., dimensions) | Any differences in physical characteristics should not impact safety or effectiveness. | System Dimensions: 525x433x1279mm/640×560×1390mm (varying from predicate's 500×1380×580 mm). The document states: "The varying dimensions do not impact the safety or effectiveness of the device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes non-clinical engineering and safety compliance tests, not clinical performance studies with patient data.
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 information is not applicable and not provided. Ground truth establishment by experts is relevant for AI-based diagnostic devices where human interpretation is the gold standard or part of the evaluation. This document is for a physical muscle stimulator.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are used in clinical studies, particularly for diagnostic accuracy assessments, which are not detailed here.
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
This information is not applicable and not provided. MRMC studies are typically for AI-assisted diagnostic devices to assess the impact of AI on human reader performance. This device is not an AI-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. Standalone performance is a metric for AI algorithms. This device does not feature such an algorithm. It's a physical muscle stimulator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. "Ground truth" in the context of this submission refers to the performance of the predicate device and the established safety and performance standards (like IEC and ISO). There isn't a "ground truth" derived from patient outcomes or expert consensus on a diagnostic task, as this is not a diagnostic device.
8. The sample size for the training set
This information is not applicable and not provided. This device is not an AI/ML device that requires machine learning training sets.
9. How the ground truth for the training set was established
This information is not applicable and not provided. Similar to point 8, this is not an AI/ML device requiring labeled training data.
§ 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).