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510(k) Data Aggregation
(106 days)
The NeuroMetrix SENSUS device is intended for use as a transcutaneous electrical nerve stimulator for the symptomatic relief and management of chronic intractable pain.
SENSUS is a one-channel transcutaneous electrical nerve stimulator with a single output mode. The stimulator utilizes a microprocessor running embedded software to control a high-voltage circuit that generates stimulating pulses with specific technical characteristics including waveform shape, current intensity, waveform duration and frequency. The stimulator is powered by a permanent rechargeable Lithium-Ion battery that is recharged through a USB cable connected to an AC adapter. The stimulator delivers electrical stimulation to the patient through two disposable, single-patient use electrodes placed on the patient's body. The stimulator, as labeled, is for use with legally available electrodes. The electrodes should be self-adhering with an electrical connection made through a male medical snap connector and an electrode area ≥ 20 cm2. The stimulator connects to the electrodes through a patient cable consisting of two lead-wires that terminate in an insulated female medical snap connector. The stimulator has a push-button that initiates and halts stimulation. Taps to the stimulator enclosure, detected by an embedded accelerometer, control the stimulation intensity. The push button serves the dual purpose of powering up the device from a standby state and initiating and halting stimulation.
The NeuroMetrix SENSUS is a transcutaneous electrical nerve stimulator (TENS) intended for the symptomatic relief and management of chronic intractable pain.
Here's an analysis of its acceptance criteria and the study that proves its adherence, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the NeuroMetrix SENSUS are primarily based on demonstrating substantial equivalence to a predicate device, the EMPI Active Transcutaneous Nerve Stimulator (K090922). This involves showing similar intended use, technological characteristics, and safety and effectiveness profiles. There are no explicit quantitative acceptance criteria for performance metrics in the provided document beyond being "within the range of output parameters of legally-marketed transcutaneous electrical nerve stimulators."
The device performance is reported by comparing its specifications to the predicate device.
| Parameter | Acceptance Criteria (Substantial Equivalence to Predicate) | Reported Device Performance (NeuroMetrix SENSUS) | Predicate Device Performance (Empi Active Transcutaneous Nerve Stimulator, K090922) |
|---|---|---|---|
| Intended Use | Same intended use: symptomatic relief and management of chronic intractable pain. | Intended for use as a transcutaneous electrical nerve stimulator for the symptomatic relief and management of chronic intractable pain. | Intended for symptomatic relief and management of chronic intractable pain (and additionally for arthritis and post-surgical/post-trauma acute pain). |
| Basic Technological Characteristics | Similar characteristics (one stimulation channel, single output mode, patient controlled intensity, LED indicators, rechargeable battery). Differences should not raise new questions of safety or effectiveness. | One stimulation channelSingle output modePatient controlled intensityLED indicators (no intensity display)Powered by 1 rechargeable 3.7V Lithium-Ion batteryMethod of Line Current Isolation: Physically isolated; device cannot connect to electrodes and battery recharger concurrentlyNormal Condition Patient Leakage Current: < 10 µA, battery poweredSingle Fault Condition Patient Leakage Current: < 100 µA, battery poweredAverage DC current through electrodes (on, no pulse): < 1 μΑRegulated Current or Regulated Voltage: CurrentSoftware/Firmware/Microprocessor Control: YesAutomatic Overload Trip? YesAutomatic No-Load Trip? YesAutomatic Shut Off? Yes after timer elapsesUser Override Control? Yes, press STIM buttonOn/Off Status Indicator: Yes, upon pressing STIM buttonLow Battery Indicator: YesVoltage/Current Level Indicator: NoTimer Range: 60 minutesCompliance with Voluntary Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304:2006Compliance with 21 CFR 898: YesWeight: 95g (3.4 oz)Dimensions: 22mm (0.9") x 66mm (2.6") x 108mm (4.3")Housing Materials & Construction: Plastic | One stimulation channelSingle output modePatient controlled intensityLED indicators (no intensity display)Powered by 1 rechargeable battery (type unknown)Method of Line Current Isolation: Physically isolated; device cannot connect to electrodes and battery recharger concurrentlyNormal Condition Patient Leakage Current: UnknownSingle Fault Condition Patient Leakage Current: UnknownAverage DC current through electrodes (on, no pulse): UnknownRegulated Current or Regulated Voltage: Nominally constant voltage in the positive phase, nominally constant current in the negative phaseSoftware/Firmware/Microprocessor Control: YesAutomatic Overload Trip? NoAutomatic No-Load Trip? NoAutomatic Shut Off? Yes if left at 0 mA for 5 minutesUser Override Control? Yes, press POWER buttonOn/Off Status Indicator: Yes, status LED flashes when onLow Battery Indicator: YesVoltage/Current Level Indicator: NoTimer Range: N/ACompliance with Voluntary Standards: IEC 60601-1-2, UL: 60601-01, CAN/CSA C22.2 No.601.1-M90 with Amendment A2.2005Compliance with 21 CFR 898: YesWeight: 0.99 ozDimensions: 0.57"x1.94"x2.54"Housing Materials & Construction: Plastic |
| Output Specifications | Output parameters are within the range of legally-marketed TENS. Differences should not raise new questions of safety or effectiveness. Specific comparison focuses on pulse waveform, duration, max output voltage/current, and pulse pattern, arguing that these differences are minor and do not affect safety/effectiveness. | Waveform: BiphasicShape (output current): RectangularMaximum Output Voltage (10 +/- %): 50 V @500 Ω, 100 V @2000 Ω, 100 V @10000 ΩMaximum Output Current (10 +/- %): 100 mA @500 Ω, 50 mA @2000 Ω, 10 mA @10000 ΩDuration of primary (depolarizing) phase: 100 μsPulse Duration (both phases): 230 μs, includes 30 μs inter-phase delayFrequency: Constant, 80 HzMultiphasic, Symmetrical phases: YesNet Charge (per pulse): Nominally 0 μC @ 500Ω, zero net currentMaximum Phase Charge: 10 μC @ 500Ω, 10 μC @ 1000ΩMaximum Current Density (r.m.s.): 0.63 mA/cm² @ 500ΩMaximum Average Current: 1.6 mA @ 500 ΩMaximum Average Power Density: 4 mW/cm² @ 500ΩBurst Mode: N/A (all)ON/OFF Time: N/A (all)Additional Features: N/A | Waveform: BiphasicShape (output current): Approximately rectangular initial phase, slowly decaying second phaseMaximum Output Voltage (10 +/- %): 25 V @500 Ω, 35 V @2000 Ω, 39 V @10000 ΩMaximum Output Current (10 +/- %): 50 mA @500 Ω, 18 mA @2000 Ω, 4 mA @10000 ΩDuration of primary (depolarizing) phase: 400 μs at maximum intensityPulse Duration (both phases): Approximately 1 msec, exact duration unspecified due to slowly decaying second phaseFrequency: Modulated, 2-125 HzMultiphasic, Symmetrical phases: NoNet Charge (per pulse): Nominally 0 μC because pulse shape is described as balancedMaximum Phase Charge: 17 μC @ 500Ω, 10 μC @ 1000ΩMaximum Current Density (r.m.s.): 1.73 mA/cm² @ 500ΩMaximum Average Current: 10 mA @ 500ΩMaximum Average Power Density: 8 mW/cm² @ 500ΩBurst Mode: N/A (all) if not specifiedON/OFF Time: N/A (all) if not specifiedAdditional Features: N/A |
| Safety | Demonstrated conformity to relevant voluntary standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304) and 21 CFR 898. | Yes, conforms to listed standards. Electrical, mechanical, and software verification testing. | Yes, conforms to listed standards. |
| Effectiveness | Demonstrated through substantial equivalence to predicate device for the intended use and technological characteristics, particularly that differences in output do not raise new questions of effectiveness. | Non-clinical (bench) testing was sufficient to demonstrate safety and effectiveness. | Established through existing market history and 510(k) clearance. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document indicates that no clinical testing was performed to demonstrate the safety and effectiveness of the NeuroMetrix SENSUS. NeuroMetrix determined that non-clinical (bench) testing was sufficient. Therefore, there is no "test set" in the context of patient data, nor any data provenance information from patient studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As there was no clinical testing involving patient data, there was no ground truth established by experts for a test set. The "ground truth" for showing substantial equivalence relies on comparing the device's technical specifications and intended use against those of the legally marketed predicate device and relevant industry standards.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
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. The NeuroMetrix SENSUS is a Transcutaneous Electrical Nerve Stimulator (TENS) device, not an AI-powered diagnostic or interpretive device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable to the NeuroMetrix SENSUS. It is a physical medical device that delivers electrical stimulation, not a software algorithm that performs diagnostic or interpretive functions. Its performance is evaluated based on its electrical output characteristics and functionality, not an "algorithm-only" performance in a diagnostic sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the submission is primarily the technical specifications and established safety/effectiveness of the predicate device (EMPI Active Transcutaneous Nerve Stimulator, K090922), combined with adherence to international voluntary standards (IEC 60601 series, IEC 62304) and FDA regulations (21 CFR 898). Essentially, the "ground truth" is that devices with similar specifications and intended use have been deemed safe and effective by regulatory bodies.
8. The sample size for the training set
Not applicable. As a TENS device, the NeuroMetrix SENSUS did not involve machine learning or AI models requiring a "training set" of data.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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