(13 days)
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance
BEMER therapy systems are a family of noninvasive physical medicine devices that can be used as a supportive therapy to increase local blood circulation. BEMER systems improve local blood distribution via electromagnetic stimulatory principles. The indications for use allow application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance. The BEMER devices are noninvasive, fully reusable (no disposable components such as electrodes), and have configurations allowing both patient/home and professional/office use. This submission is specifically requesting to add the applicators, B.BODY and B.SIT to the already cleared BEMER Therapy System. The device contains firmware that controls the user interface. It also contains that controls the pulse generator, battery charger, audion and pushbutton controller.
The provided text is a 510(k) premarket notification document for a medical device, the BEMER Classic Set and BEMER Pro-Set, specifically requesting to add new applicators (B.BODY and B.SIT) to an already cleared system.
This document does not contain information about a study proving the device meets acceptance criteria related to a diagnostic AI or imaging-based device. The context is for a powered muscle stimulator. Therefore, the questions about acceptance criteria for AI algorithms, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and effect sizes are not applicable to this document's content.
The document focuses on demonstrating substantial equivalence to a predicate device (K151834) for new accessories (applicators B.BODY and B.SIT). The "acceptance criteria" here are based on similarity to the predicate device and compliance with relevant electrical safety, EMC, and biocompatibility standards.
Here's a breakdown of the relevant information from the document, tailored as much as possible to the spirit of your request, but acknowledging the difference in device type:
Device Type: Powered Muscle Stimulator (Non-invasive tissue stimulation via magnetic field induction)
Indications for Use:
- To temporarily increase local blood circulation in healthy leg muscles.
- To stimulate healthy muscles in order to improve and facilitate muscle performance.
Instead of "Acceptance Criteria for AI Performance," the document discusses "Substantial Equivalence" to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance (as inferred from "Comparison of Technological Characteristics" and "Non-clinical Testing"):
| Characteristic / "Acceptance Criteria" (Predicate Baseline) | Subject Device (New Applicators: B.BODY & B.SIT) Performance | Justification/Comment |
|---|---|---|
| Classification Code (Primary: NGX 890.5850) | Same (NGX 890.5850) | Substantially Equivalent |
| Indications for Use | Same as predicate | Substantially Equivalent |
| Primary Mode of Action (Non-invasive tissue stimulation via magnetic field induction) | Same | Substantially Equivalent |
| Treatment of large and/or multiple regions simultaneously | Yes | Substantially Equivalent |
| Intensity Settings (1-10) | B.BODY: 1-6 (Basic Plan Treatment); B.SIT: 1-10 | B.BODY has lower max intensity as it's for superficial muscles |
| Treatment Time (8-20 minutes) | B.BODY: 8 min; B.SIT: 8-20 min | Substantially Equivalent for B.SIT. B.BODY is fixed 8 min. |
| Average Flux Density (max. level) | B.BODY: ≈ 35 µT (Basic), ≈ 50 µT (Plus); B.SIT: ≈ 100 µT (Basic), ≈ 150 µT (Plus) | B.BODY is lower than predicate (100/150 µT) due to superficial target. B.SIT is same. |
| Power Consumption (System) (30 Watt max.) | Same (30 Watt max.) | Substantially Equivalent |
| Input/Output (System) | Same (100-240 VAC 50-60 Hz, 0.6A; 12-15.1 VDC, 2.0A; Optional 7.2 V Li-Ion battery) | Substantially Equivalent |
| Biocompatibility | Yes (tested to ISO 10993-5, ISO 10993-10) | Meets standards |
| Number of output modes (1) | Same (1) | Substantially Equivalent |
| Number of output channels/ports (2 for each) | Same (2 for each) | Substantially Equivalent |
| Software/Firmware/Microprocessor controlled | Yes (Unchanged from predicate) | No new concerns |
| Timer Range (8-20 minutes) | Same | Substantially Equivalent |
| Compliance with voluntary standards (IEC 60601-1, IEC 60601-1-2, EN 60601-1-6, EN 62366, EN 60601-1-11) | Yes (Unchanged but evaluated under these standards for new design) | Meets standards |
| Sterilization (Not provided sterile) | Same (Not provided sterile) | Substantially Equivalent |
| Performance Testing (Signal waveform current output, magnetic flux output) | Performance testing demonstrated equivalence. | Data supports equivalence, though specific values not detailed beyond max flux density. |
2. Sample Size and Data Provenance:
- This document describes non-clinical performance testing of electrical and magnetic outputs, not a clinical study with human subjects or a test set of patient data.
- Therefore, concepts like "sample size used for the test set" (in the context of patient data) and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are not applicable. The testing was laboratory-based, comparing the new applicators' performance characteristics to the already cleared predicate.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable. Ground truth in the context of AI/medical imaging refers to expert interpretation of patient data. This document describes performance validation of physical device characteristics against engineering specifications and predicate device performance. No expert human interpretation of medical images or patient outcomes data for ground truth establishment is mentioned or required for this type of device and submission.
4. Adjudication Method:
- Not applicable. This refers to methods for resolving discrepancies in expert ground truth for medical data. Not relevant here.
5. MRMC Comparative Effectiveness Study:
- Not applicable. This is a study design for evaluating the impact of AI on human reader performance. This submission is for a physical therapy device, not a diagnostic AI system, and does not involve human readers interpreting AI output.
6. Standalone Performance (Algorithm Only):
- Not applicable. This relates to AI algorithm performance without human intervention. The BEMER device is a physical therapy device; there is no "algorithm only" performance in the sense of an AI model's output.
7. Type of Ground Truth Used:
- For this device, the "ground truth" (or basis for comparison) is the technical specifications and measurable electromagnetic outputs of the predicate device, along with adherence to recognized international standards for medical electrical equipment (e.g., IEC 60601 series, ISO 10993 series). No patient pathology or outcomes data is used as "ground truth" for this type of submission.
8. Sample Size for the Training Set:
- Not applicable. There is no AI training set involved in this 510(k) submission for a physical therapy device.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, no training set or its ground truth establishment is relevant to this document.
§ 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).