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510(k) Data Aggregation
(263 days)
StimOn™ Pain Relief System (GM2439) is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain.
StimOn™ Pain Relief System (GM2439) is a hand-held stimulator designed to pass electrical signals via surface electrodes through the skin to the underlying nerves. It may be used as a TENS device to aid the blocking of pain signals traveling to the brain.
The document describes the StimOn™ Pain Relief System (GM2439) and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) for an AI/algorithm-based device, nor does it detail a study proving the device meets such criteria in terms of AI performance.
Instead, the document focuses on the regulatory clearance of a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, primarily through comparison with existing predicate devices and compliance with relevant electrical safety and performance standards. The "performance testing" mentioned refers to these safety and electrical performance standards, not to clinical efficacy measured by AI performance metrics.
Therefore, many of the requested items regarding acceptance criteria and study details for an AI-based device's performance cannot be extracted from this document.
Here's the information that can be extracted, and where the document does not provide the requested information:
1. A table of acceptance criteria and the reported device performance:
The document does not specify quantified acceptance criteria for AI performance (e.g., sensitivity > X%, specificity > Y%). Instead, it discusses the device's technical characteristics and how they compare to predicate devices. The "performance testing" section refers to compliance with electrical safety and performance standards, not AI accuracy.
| Characteristic | Acceptance Criteria (Not explicitly stated for AI performance) | Reported Device Performance (from "Table 1. Comparison table" and subsequent descriptions) |
|---|---|---|
| Intended Use | Same as predicate devices | Symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain. |
| Product Code | GZJ | GZJ |
| Power Supply | Not explicitly stated as acceptance criteria, but compared to predicates | One 3.7V, 125mAh rechargeable Lithium polymer battery |
| Treatment Timer Maximum | Not explicitly stated as acceptance criteria, but compared to predicates | 15 minutes |
| Number of Output Modes | Not explicitly stated as acceptance criteria | 1 (RF Mode) |
| Number of Waveforms | Not explicitly stated as acceptance criteria | 1 |
| Waveform | Not explicitly stated as acceptance criteria | Biphasic (Sine Wave) |
| RF Stimulation Mode | Not explicitly stated as acceptance criteria | Transcutaneous Pulsed Radio-frequency (PRF) mode |
| RF Frequency | Not explicitly stated as acceptance criteria | 500 kHz fixed |
| Burst Time | Not explicitly stated as acceptance criteria | 25ms |
| Burst Frequency | Not explicitly stated as acceptance criteria | 2Hz |
| Electrode Contact | Not explicitly stated as acceptance criteria | Hydrogel pad |
| Load Impedance | Not explicitly stated as acceptance criteria, but stated as a shutdown threshold | 1 k Ohm, Over this load, the system will automatically shut off. |
| Maximum Output Voltage | Not explicitly stated as acceptance criteria | 7.4 V+/-10% (6.6 V +/- 20% @@500Ω with Electrode Pad) |
| Maximum Output Current | Not explicitly stated as acceptance criteria | 14.8 mA (Peak)@500Ω (13.2 mA (Peak)@500Ω with Electrode Pad) |
| Maximum Average Current (Over primary phase) | Not explicitly stated as acceptance criteria | 9.43 mA (Peak)@500Ω (8.41mA(Peak)@500Ω with Electrode Pad) |
| Maximum Average Power Density (Smallest electrode area) “P” | Must be within value range of predicates | 112.81 µW/mm² @500Ohm with Electrode |
| Maximum Current (RMS) Density (mA/mm²) | Not explicitly stated as acceptance criteria | 0.0242 mA /mm² @500Ω with Electrode |
| Net Charge | Not explicitly stated as acceptance criteria | The theoretical value is 0. |
| Maximum average phase charge | Not explicitly stated as acceptance criteria | 0.00942μC |
| Electrical Safety & Performance | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ANSI/AAMI NS4 | Device underwent testing and demonstrated compliance (implied by substantial equivalence). |
| Biocompatibility | Meet standards for electrodes leveraged from K180865 | Leveraged from cleared electrodes (K180865). |
| Usability | Compliance with IEC 62366: Medical devices Part 1: Application of usability engineering to medical devices | Device complies with IEC 62366 and is similar to K180943 (BioWaveGO) cleared for OTC use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document states "No Human Clinical Performance Testing have been required" for this application. The performance testing refers to electrical and safety standards, not clinical performance data from a test set of patients/cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. No clinical test set requiring expert ground truth was used for assessing the device's efficacy, as per the submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No clinical test set requiring adjudication 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 / Not provided. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI-assisted diagnostic or interpretative device that augments human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. This device is hardware for pain relief, not an algorithm/AI system in the sense of a diagnostic or predictive tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No clinical ground truth was established for "performance" as it relates to AI or clinical efficacy. The "performance testing" was for electrical safety, electromagnetic compatibility, and biocompatibility, which rely on technical standards and laboratory measurements.
8. The sample size for the training set
- Not applicable / Not provided. Not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. Not an AI/algorithm-based device requiring a training set.
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