(248 days)
The SimulCare II™ is intended for the temporary relief of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic pain.
The SimulCare II Multi-function Therapeutic Device is modified from the SimulCare and ComboCare 2000 devices previously cleared under 510(k)s K083202 & K081141 and includes improved interface features, EMI filters, additional audible alarm and battery monitoring circuit drain prevention.
Portable, lightweight, rechargeable unit consisting of a hand-held controller with digital control of stimulation parameters and an attached flexible pad that produces battery-charged therapy consisting of red light emitting diodes, infrared light emitting diodes, micro current, macro current (E-stim), permanent magnets and vibratory massage.
The document provided is a 510(k) premarket notification for a medical device called SimulCare II™. It asserts substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies is not applicable to this type of submission.
Here's a breakdown of what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document describes the SimulCare II™ device and compares it to two predicate devices (SimulCare™ K083202 and ComboCare 2000™ K081141) to establish substantial equivalence. It does not present explicit "acceptance criteria" in the traditional sense of performance targets that the device itself must meet independently through a clinical trial. Instead, the "acceptance" is based on demonstrating that the new device is as safe and effective as existing legally marketed devices for the same intended use. The comparison tables highlight the similarities and differences in technological characteristics and electrical parameters.
| Feature | Predicate Device Performance (SimulCare™ K083202 & ComboCare 2000™ K081141) | Proposed Device Performance (SimulCare II™) |
|---|---|---|
| Intended Use | Temporary relief of minor muscle and joint pain, relaxation of muscle tissue, symptomatic relief and management of chronic intractable pain, adjunctive relief of post-surgical or post-traumatic pain.ComboCare 2000™ did not state an intended use for temporarily increasing local blood circulation. | Temporary relief of minor muscle and joint pain, promoting relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic pain. |
| Design (Control) | Analog control of stimulation parameters | Digital control of stimulation parameters |
| Material (Conductive Medium) | Conductive Gel | Conductive Spray |
| Magnetic Feature (present) | SimulCare™: Yes; ComboCare 2000™: No | Yes |
| Number of Channels | 1 | 1 |
| Maximum Output Current (E-stim mode) | 0-40 mA / 500 Ω load | 0-40 mA / 500 Ω load |
| Maximum Output Current (microcurrent mode) | 0-14.4 mA / 500 Ω load | 0-14.4 mA / 500 Ω load |
| Maximum Output Voltage (E-stim mode) | 0-30 V / 1 KΩ load | 0-30 V / 1 KΩ load |
| Maximum Output Voltage (microcurrent mode) | 0-9.3 V / 1 KΩ load | 0-9.3 V / 1 KΩ load |
| Pulse Rate / Frequency (E-stim mode) | Fixed at 68 pps/Hz | Nominal factory settings: 72 pps/Hz (Fixed at 68 pps/Hz based on comparison table #2) |
| Pulse Rate / Frequency (microcurrent mode) | Fixed at 3.5 pps/Hz | Nominal factory settings: 8 pps/Hz (Fixed at 3.5 pps/Hz based on comparison table #2) |
| TENS Pulse Width | 200 microseconds | 200 microseconds |
| µTENS Pulse Width | SimulCare™ & ComboCare 2000™: 62 milliseconds | 143 milliseconds |
| Waveforms | Asymmetrical Pulse Train ~68 Hz (TENS); Asymmetrical biphasic square wave (µTENS) | Asymmetrical Pulse Train ~68 Hz (TENS); Asymmetrical biphasic square wave (µTENS) |
| Other Features (IR/Red LED, Magnets, Vibrator) | Largely similar/identical, with differences in what was included in older predicate models (e.g., ComboCare 2000™ lacked magnets) | Included: Pulsed IR/Red LEDs, static magnetic field, vibratory massage |
2. Sample size used for the test set and the data provenance:
- Not applicable (N/A). The submission states "Clinical tests submitted or relied upon: None" (page 3). The evaluation is based on a comparison to predicate devices, not on a new clinical study with a test set. Non-clinical tests included "Safety & EMC Testing" (page 3), but details on sample size or data provenance for these engineering tests are not provided in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No test set or ground truth established by experts is mentioned, as no clinical study was conducted for this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. No test set or adjudication process is mentioned, as no clinical study was conducted.
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:
- N/A. This device is an electrical nerve stimulator, not an AI-powered diagnostic or interpretive device. No MRMC study or AI assistance is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not involve an algorithm or AI that would have standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. No ground truth was established, as no clinical study was conducted. The basis for clearance is substantial equivalence to legally marketed predicate devices, meaning their safety and effectiveness (previously established) are considered the "ground truth" for comparison.
8. The sample size for the training set:
- N/A. The device is not an AI/machine learning model, so there is no training set.
9. How the ground truth for the training set was established:
- N/A. No training set or ground truth for a training set exists for this device.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).