(133 days)
As an NMES device, indications are for the following conditions:
- Retarding or preventing disuse atrophy
- Maintaining or increasing range of motion
- Re-educating muscles
- Relaxation of muscle spasms
- Increasing local blood circulation
- Prevention of venous thrombosis of the calf muscles immediately after surgery
As a TENS device, indications are for the following conditions:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
As a Pulsed Current device, indications are for the following conditions:
- Reduction of edema (under negative electrode)
- Reduction of muscle spasm
- Influencing local blood circulation (under negative electrode)
- Retardation or prevention of disuse atrophy
- Facilitation of voluntary motor function
- Maintenance of increase of range of motion
As an FES device, the indications for the following condition:
- Stimulation of the leg and ankle muscles of partially paralyzed patients to provide flexation of the foot, thus improving the patient's GAIT.
Not Found
The provided text is a 510(k) summary for the Empi Continuum device, a powered muscle stimulator. It details the device's indications for use, classification, and substantial equivalence to predicate devices, along with regulatory compliance information. However, it does not contain information about any specific study that proves the device meets acceptance criteria related to its performance characteristics.
The document focuses on regulatory compliance and substantial equivalence, which is a key aspect of the 510(k) process. Substantial equivalence generally means that the new device is as safe and effective as a legally marketed predicate device. This often involves demonstrating that the new device has the same intended use and technological characteristics as the predicate, or that any differences do not raise new questions of safety and effectiveness.
Here's an breakdown of the requested information based on the provided text, and where the text is lacking:
Acceptance Criteria and Device Performance Study Information
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Specific metrics, thresholds) | Reported Device Performance (Measurements, results) |
|---|---|---|
| Electrical Safety | Compliance with UL 60601-1: 2003, 1st Edition | Complies with UL 60601-1: 2003, 1st Edition |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2: 2001 +Amendment 1:2004, 2nd Edition | Complies with IEC 60601-1-2: 2001 +Amendment 1:2004, 2nd Edition |
| Nerve and Muscle Stimulator Safety | Compliance with IEC 60601-2-10: 1987 +Amendment 1:2001 | Complies with IEC 60601-2-10: 1987 +Amendment 1:2001 |
| Clinical Performance (e.g., efficacy for pain relief, muscle re-education, etc.) | Not provided in the document. | Not provided in the document, as no clinical performance study results are detailed. |
2. Sample size used for the test set and the data provenance
- Not provided. The document does not describe a clinical test set or the use of human subjects to evaluate device performance against specific clinical outcomes. The compliance mentioned relates to recognized consensus standards for safety and EMC, which typically involve laboratory testing, not human subject testing in the context of efficacy claims for de novo devices. For 510(k) submissions based on substantial equivalence, clinical data might not always be required if technological characteristics are sufficiently similar to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. No clinical test set requiring expert ground truth establishment is described in this document.
4. Adjudication method for the test set
- Not applicable/Not provided. No clinical test set 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/Not provided. This device is a muscle stimulator, not an imaging device or an AI-powered diagnostic tool, so an MRMC study and AI assistance are not relevant to its stated functionalities.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This device is not an algorithm or an AI product; it's a physical medical device. Performance would be assessed based on its electrical output characteristics and clinical outcomes when applied to a patient, not through standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided for clinical claims. For the compliance declarations, the "ground truth" is defined by the technical specifications and test methodologies within the cited consensus standards (UL 60601-1, IEC 60601-1-2, IEC 60601-2-10). These standards themselves specify test conditions and acceptable ranges for various parameters (e.g., leakage current, electromagnetic emissions, output accuracy).
8. The sample size for the training set
- Not applicable/Not provided. As there is no AI/machine learning component described, there is no training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no AI/machine learning component described, there is no training set or ground truth for it.
Summary of Device Acceptance:
The acceptance of the Empi Continuum device, as described in this 510(k) summary, is primarily based on demonstrating substantial equivalence to legally marketed predicate devices and conformity to recognized safety and electromagnetic compatibility consensus standards. The document states:
- "The Empi Continuum devices comply with the following FDA recognized Consensus Standards:" followed by a list of UL and IEC standards for medical electrical equipment safety and EMC. This compliance is the "study" demonstrating that the device meets safety and compatibility "acceptance criteria" as defined by these standards.
- The FDA's review resulted in a determination that the device is "substantially equivalent... to legally marketed predicate devices." This substantial equivalence finding implies that the device's intended use and technological characteristics (including performance) are considered safe and effective in comparison to the predicates, and therefore acceptable for marketing. No specific clinical performance studies showing efficacy against distinct acceptance criteria are detailed, which is common for devices cleared through the 510(k) pathway leveraging substantial equivalence to well-established predicate technologies.
§ 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).