(147 days)
Interferential Stimulation (INF) is used for symptomatic relief and management of chronic (Iongterm) intractable pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.
External electrical neuromuscular stimulation (NMES) using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of caff muscles to prevent venous thrombosis.
Transcutaneous Electrical Nerve Stimulation (TENS) is used for the symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.
The Impulse 3 is a portable two channel, battery operated combination electrical neuromuscular stimulator (NMES), interferential stimulator (INF), and transcutaneous electrical nerve stimulator (TENS) unit for pain control, and muscle stimulation. This device, supporting symmetric biphasic, pulsed sine, and asymmetrical biphasic waveforms can be used with the preprogrammed protocols or can be manually configured. A graphical display is provided to provide the user a verbose interface to assist in programming the configurable protocols.
The device is supplied with electrodes and electrode leads, non-replaceable batteries, wall adapter, instruction manual, and carrying case.
The provided text describes a 510(k) premarket notification for the Sterling Medical Impulse 3 Stimulator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving enhanced effectiveness through clinical studies. Therefore, the information typically found in a clinical study report for an AI/ML device (e.g., sample size, expert qualifications, adjudication methods, effect size of AI assistance, standalone performance) is not directly applicable or available in this document.
Instead, the acceptance criteria for this device are based on demonstrating that its technological characteristics and performance are substantially equivalent to existing predicate devices, and that any differences do not raise new questions of safety or effectiveness. The study that proves this is a non-clinical performance summary based on bench testing and comparison to the specifications of predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the parameters of the predicate devices. The device performance is reported by comparing its specifications directly against those of the predicate devices. Due to the extensive nature of the comparison, only a summary of key parameters is provided below. The full details are elaborated in the tables within the original document.
| Parameter Category | Acceptance Criteria (based on predicate ranges/values) | Reported Device Performance (Impulse 3) |
|---|---|---|
| General Device Parameters | ||
| Power Source (Primary) | Comparable to predicate lithium-ion/AA/9V batteries | 2x 750mA, 3.7V, Li-ion, rechargeable |
| Patient Leakage Current (Normal Condition) | ≤ 11µA (predicate range) | 7µA |
| Patient Leakage Current (Single Fault) | ≤ 116µA (predicate range) | 98µA |
| Avg DC Current (device on, no pulses) | ≤ 1µA (predicate) | 1µA |
| Output Modes | TENS, NMES, INF (combination of predicates) | 3 (TENS, NMES, INF) |
| Number of Output Channels | 2 or 4 (predicate range) | 2 |
| Regulated Current/Voltage | Regulated Current (all predicates) | Regulated Current |
| Software/Firmware/Microprocessor Control | Yes (all predicates) | Yes |
| Automatic No-Load Trip | Yes or No (some predicates have it) | Yes (turns off after 1 minute) |
| Automatic Shut Off | Yes (all predicates) | Yes (after prescribed program) |
| User Override Control | Yes (all predicates) | Yes |
| Indicator Displays | On/Off, Low Battery, Voltage/Current (all predicates) | Yes (all) |
| Timer Range | 1-60 minutes (all predicates) | 1-60 minutes |
| Compliance to Voluntary Standards | Yes (all predicates) | Yes |
| Compliance to 21 CFR 898 | Yes (all predicates) | Yes |
| Weight | 4.48 oz. to 11.4 oz. (predicate range) | 6.50 oz. |
| Dimensions | Comparable to predicate devices | 3.1" x 4.8" x 1.3" |
| Housing Materials | Plastic, ABS plastic | ABS 94 HB Plastic Body |
| TENS Mode Parameters | ||
| Waveform | Pulsed asymmetrical biphasic (predicates) | Pulsed asymmetrical biphasic |
| Shape | Rectangular (predicates) | Rectangular |
| Max Output Voltage | Varies, e.g., 27.5V-96V @ 500Ω (predicate range) | 40.6V @ 500Ω (within range) |
| Max Output Current | Varies, e.g., 43mA-96mA @ 500Ω (predicate range) | 81.3mA @ 500Ω (within range) |
| Pulse Duration | 10-450µs (predicate range) | 50-300µs |
| Frequency | 1-120 pps (all predicates) | 1-120 pps |
| Max Phase Charge | 16.5µC - 24.0µC @ 500Ω (predicate range) | 21.7µC @ 500Ω (within range) |
| Max Current Density | 0.42mA/cm² - 0.74mA/cm² @ 500Ω (predicate range) | 0.70mA/cm² @ 500Ω (within range) |
| Max Avg Current | 1.98mA - 3.60mA (predicate range) | 2.61mA (within range) |
| Max Avg Power Density | 2.18mW/cm² - 6.91mW/cm² (predicate range) | 4.81mW/cm² (within range) |
| Burst Mode (Pulses per burst, Bursts per second, Burst duration, Duty Cycle) | Comparable to Sterling TENS & QuadStar II | Comparable |
| Effect of battery/charger voltage variations | None, output not affected (QuadStar II baseline) | None, output not affected |
| INF Mode Parameters | ||
| Waveform | Symmetrical biphasic (predicates) | Symmetrical biphasic |
| Shape | Sinusoidal, Square (predicates) | Sinusoidal |
| Max Output Voltage | Varies, e.g., 17.1V-40.6V @ 500Ω (predicate range) | 26.7V @ 500Ω (within range) |
| Max Output Current | Varies, e.g., 34mA-66mA @ 500Ω (predicate range) | 53mA @ 500Ω (within range) |
| Pulse Duration | 250µs (predicates) | 250µs |
| Frequency | 4000-4150Hz (predicates) | 4000-4150Hz |
| Max Phase Charge | 4.28µC-5.73µC @ 500Ω (predicate range) | 4.72µC @ 500Ω (within range) |
| Max Current Density | 1.37mA/cm² - 1.92mA/cm² @ 500Ω (predicate range) | 1.92mA/cm² @ 500Ω (within range) |
| Max Avg Current | 34.2mA - 45.8mA (predicate range) | 37.8mA (within range) |
| Max Avg Power Density | 23.4mW/cm²-42.0mW/cm² (predicate range) | 36.3mW/cm² (within range) |
| NMES AC Mode Parameters | ||
| Waveform | Pulsed symmetrical biphasic (predicates) | Pulsed symmetrical biphasic |
| Shape | Rectangular (predicates) | Rectangular |
| Max Output Voltage | Varies, e.g., 28.6V-66.4V @ 500Ω (predicate range) | 26.4V @ 500Ω (comparable) |
| Max Output Current | Varies, e.g., 53mA-64mA @ 500Ω (predicate range) | 53mA @ 500Ω (comparable) |
| Pulse Duration | 50-400µs (predicate range) | 50-300µs |
| Frequency | 1-120 pps (predicates) | 1-120 pps |
| Max Phase Charge | 31.7µC-34.3µC @ 500Ω (predicate range) | 31.7µC @ 500Ω (within range) |
| Max Current Density | 0.62mA/cm² - 0.72mA/cm² @ 500Ω (predicate range) | 0.72mA/cm² @ 500Ω (within range) |
| Max Avg Current | 3.8mA - 4.13mA (predicate range) | 3.8mA (within range) |
| Max Avg Power Density | 4.74mW/cm² - 5.11mW/cm² (predicate range) | 5.11mW/cm² (within range) |
| Burst Mode ON/OFF Time | 0-99 seconds / 0-99 seconds (predicates) | 1-99 seconds / 0-99 seconds |
| NMES Russian Mode Parameters | ||
| Waveform | Gated symmetrical biphasic (predicates) | Gated symmetrical biphasic |
| Shape | Rectangular (predicates) | Rectangular |
| Max Output Voltage | Varies, e.g., 28.7V-36.6V @ 500Ω (predicate range) | 26.4V @ 500Ω (comparable) |
| Max Output Current | Varies, e.g., 57mA-17.3mA @ 500Ω (predicate range) | 53mA @ 500Ω (comparable) |
| Pulse Duration | 400µs (predicates) | 400µs |
| Frequency | 50Hz (predicates) | 50Hz |
| Max Phase Charge | 21.1µC-23.0µC @ 500Ω (predicate range) | 21.1µC @ 500Ω (within range) |
| Max Current Density | 1.6mA/cm² - 1.9mA/cm² @ 500Ω (predicate range) | 1.9mA/cm² @ 500Ω (within range) |
| Max Avg Current | 26.4mA - 28.7mA (predicate range) | 26.4mA (within range) |
| Max Avg Power Density | 33.0mW/cm²-35.5mW/cm² (predicate range) | 35.5mW/cm² (within range) |
| Burst Mode ON/OFF Time | 1-99 seconds / 0-99 seconds (predicates) | 1-99 seconds / 0-99 seconds |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of an electrical stimulator 510(k) submission based on bench testing. The "test set" here refers to the device itself and its measured output parameters.
- Data Provenance: The data comes from the technical specifications and measurements of the Sterling Medical Impulse 3 Stimulator and the predicate devices. This is non-clinical, controlled bench testing data, not human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" for electrical stimulation parameters is established through engineering measurements and adherence to industry standards, not expert medical opinion.
- Qualifications of Experts: N/A.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. The "test set" involves comparing technical specifications and measurements, which are quantitative and objectively verifiable, not subjective interpretations requiring adjudication.
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
- MRMC Study: No. This is not a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is an electrical stimulator, not an algorithm, and does not have "human-in-the-loop" performance in the sense of a diagnostic AI. Its performance is inherent in its electrical output and functional controls.
7. The type of ground truth used
- Ground Truth Type: Engineering specifications, measured electrical parameters (voltage, current, pulse duration, frequency, etc.), and compliance with voluntary standards (e.g., IEC 60601-1). The "ground truth" is established by these objective, quantifiable technical measures.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device does not use an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.
§ 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).