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510(k) Data Aggregation
(292 days)
The device is intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities. It is also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis. Environments of Use: Clinics, hospital and home environments Patient Population: Adult
The PM710 is a wearable electrotherapy device that is designed to alleviate chronic, acute and arthritic muscle leg pain. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology through the simple, convenient control on the main unit. The reusable, self-adhesive contouring pads allow for discreet and convenient placement on the pain locations below the knee. The device contains one main TENS unit which is rechargeable and can be attached to a single sized gel and a medium or large band (model number follow by "-M" / "-L") which helps to attach the device to the leg. The pad with attached TENS unit can then be applied to intact skin at the desired location below the knee for therapy and pain relief. Control of the PM710 TENS system is through the control buttons on the main unit and the intensity of the therapy is displayed by the Intensity Level Indicators during treatment. The PM710 will be packaged with an Instruction Manual which provides details on setting up the device for use, setting and controlling intensity levels, and troubleshooting. The system accessories include one charger, one AC adapter for the charger, and one pad holder and storage case.
Here's a summary of the acceptance criteria and study information for the Omron Focus TENS Therapy, Model PM710-M/-L, based on the provided FDA 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a formal table of "acceptance criteria" against which a clinical study's performance metrics are directly compared. Instead, it demonstrates substantial equivalence through extensive non-clinical testing and comparison of technological characteristics with predicate and reference devices. The "performance data" provided refers exclusively to these non-clinical tests.
However, based on the comparison tables, we can infer some "performance criteria" that the device implicitly meets by matching or being within acceptable ranges of the predicate and reference devices.
| Feature/Parameter | Acceptance Criteria (Inferred from Predicate/Reference) | Reported Device Performance (Omron Focus TENS PM710-M/-L) |
|---|---|---|
| Classification Regulation | 21 CFR§882.5890, Transcutaneous electrical nerve stimulator for pain relief | 21 CFR§882.5890, Transcutaneous electrical nerve stimulator for pain relief |
| Product Code | NUH and NYN (Transcutaneous electrical nerve stimulator for pain relief) | Primary: NUH, Secondary: NYN |
| Indications for Use | Relief of pain associated with sore or aching muscles (lower back, arms, legs, shoulders, or feet) due to strain from exercise or normal household work activities; symptomatic relief and management of chronic, intractable pain, and relief of pain associated with arthritis. The Quell reference device also includes temporary relief of pain associated with sore and aching muscles in the lower extremities due to strain from exercise or normal household and work activities, and symptomatic relief and management of chronic intractable pain. | Intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities. Also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis. (Narrower than Avail but similar to Quell for lower extremities and chronic pain/arthritis). |
| Environments of Use | Clinics, hospital, and home environments (for predicate Avail and implied for other TENS devices) | Clinics, hospital, and home environments |
| Patient Population | Adult | Adult |
| Contraindications | Avoid use with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices. | Same as predicate and reference devices regarding cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices. |
| Electrical Parameters | Output parameters within the range of predicate Avail device, and within IEC60601-2-10:2012 (Clause 201.4.2) limit of <2mA/cm² for current density. Waveforms should achieve similar therapeutic outcomes. | Max current density: 0.97 mA/cm² (well below 2 mA/cm² limit). Max average power density: 7.59x10⁻³ W/cm². Waveform: Biphasic Rectangular. Pulse Duration: 60 µsec. Frequency: 1-250 Hz. Net Charge: 0 µC per pulse. |
| Treatment Duration | Selectable time ranges for TENS therapy, commonly 5-60 minutes, or 30-180 minutes, with reference devices offering 30 or 60 minutes. | Fixed timer duration for 30 minutes. (Matches R-T1 reference, within predicate range). |
| Safety Standards | Compliance with ES 60601-1, IEC60601-1-2, IEC60601-2-10, IEC 60601-1-11. | ES 60601-1, IEC60601-1-2, IEC60601-2-10, IEC 60601-1-11. |
| Biocompatibility | Patient-contacting components must demonstrate biocompatibility. | Tested to demonstrate biocompatibility. |
| Software/Firmware | Verification and validation to ensure the device performs as intended. | Software verification and validation completed. |
2. Sample Size for Test Set and Data Provenance
The submission explicitly states: "Clinical testing was not performed to support this 510(k) submission." Therefore, there is no "test set" in the context of clinical data, no sample size, and no data provenance for a clinical test set. The evaluation relies entirely on non-clinical (bench) testing and comparison to legally marketed predicate devices.
3. Number of Experts and Qualifications for Ground Truth of Test Set
Not applicable, as no clinical test set was used to establish ground truth in this submission.
4. Adjudication Method for Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done, as traditional clinical studies were not performed. The submission does not discuss human reader improvement with or without AI assistance as this is a TENS device, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a medical device, not an AI algorithm. Its performance is evaluated through its physical and electrical characteristics as a TENS unit.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on engineering specifications, adherence to international and national standards (e.g., IEC 60601 series), and the demonstrated performance of legally marketed predicate and reference TENS devices. The "truth" is that the device's electrical outputs and functional characteristics are safe and effective by being substantially equivalent to these established devices.
8. Sample Size for the Training Set
Not applicable, as no AI model or learning algorithm is described, and no clinical "training set" was used. The device is a TENS unit, not a machine learning system.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned in the submission.
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