(82 days)
The device is an high voltage TENS device with TENS indications used for symptomatic relief and management of chronic intractable pain.
The GM3X3HV is the device which generates twin high voltage pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.
The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of regulatory submission historically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not typically found in these summaries.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The document primarily indicates compliance with recognized standards. It does not define specific performance acceptance criteria in terms of clinical outcomes or statistical measures like sensitivity, specificity, or accuracy. The acceptance is implied by meeting the regulatory requirements for substantial equivalence.
Reported Device Performance: No quantitative performance data for the device (GEM-HV TENS) is presented in this summary. The "performance" is implicitly deemed equivalent to the predicate device through compliance with standards and a lack of significant differences in technological characteristics.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Compliance with ANSI/AAMI NS4-1985 | Met |
| Compliance with EN 60601-1 | Met |
| Compliance with EN 60601-1-1 | Met |
| Compliance with EN 60601-1-2 | Met |
| Software Verification (FDA guidance) | Carried out |
| Maintain same safety and effectiveness as predicate device (K946299) | Demonstrated through technological characterization and engineering differences not affecting intended use or fundamental scientific technology. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This summary does not describe a test set with human subjects or a dataset for performance evaluation in the way requested for AI/diagnostic devices. The "test set" here refers to the device itself being tested for compliance with engineering and safety standards, rather than a clinical trial.
- Data Provenance: Not applicable. The "data" refers to engineering specifications, testing reports for compliance, and software verification reports, not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth establishment by experts is not described, as this summary focuses on engineering and regulatory equivalence, not clinical performance evaluation against a gold standard.
4. Adjudication Method for the Test Set
Not applicable. No adjudication method is mentioned, as there is no human-based expert review or clinical outcome assessment described for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is not mentioned or implied in this 510(k) summary. This type of study is relevant for evaluating the impact of a new diagnostic or interpretative device on human reader performance, which is not the focus of this TENS device submission.
6. Standalone Performance Study (Algorithm Only)
No. A standalone performance study for an algorithm is not relevant or described. The device in question is a hardware medical device (TENS) that generates electrical pulses, not an AI algorithm.
7. Type of Ground Truth Used
Not applicable. The concept of "ground truth" (e.g., pathology, expert consensus, outcomes data) as it applies to diagnostic or prognostic devices is not relevant to this TENS device's 510(k) submission. The "truth" being established here is that the device meets safety and performance standards for its specified function and is substantially equivalent to a predicate device.
8. Sample Size for the Training Set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, the establishment of its "ground truth" is also not applicable.
§ 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).