(17 days)
The L-TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
The L-TENS is a handheld battery powered TENS device, which is used for pain relief. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain. L-TENS has one output channel and four preset programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 14 steps.
This is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device called "L-TENS". This type of device, used for pain relief, is typically cleared based on substantial equivalence to a predicate device rather than extensive clinical studies with specific acceptance criteria that demonstrate performance against a 'ground truth' in the way AI/ML devices often are.
Therefore, the requested information elements related to acceptance criteria, ground truth, expert adjudication, multi-reader multi-case studies, and standalone performance for AI/ML devices are not applicable to this 510(k) submission.
Here's a breakdown of why and what information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable. For a TENS device seeking 510(k) clearance, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (FDTENS 2010, K994266) regarding its intended use and fundamental technological characteristics, along with compliance to relevant non-clinical standards. The device is not making claims that require specific performance metrics (like sensitivity, specificity, or AUC) against a clinical ground truth for a diagnostic or AI/ML algorithm.
2. Sample size used for the test set and the data provenance:
- Not Applicable. There was no "test set" in the context of clinical data for performance evaluation as would be done for an AI/ML device. The clearance is based on technological comparison and compliance with non-clinical standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No ground truth was established for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. 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. This is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The device did not rely on a clinical "ground truth" for its 510(k) clearance, but rather on demonstrating equivalence to an existing device and meeting safety standards through non-clinical testing.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there was no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. There was no training set or associated ground truth.
Summary of available information from the document:
- Device Name: L-TENS
- Predicate Device: FDTENS 2010 (K994266)
- Intended Use: Symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
- Technological Comparison: Substantially equivalent to the predicate. Both are battery-powered with adjustable output. The L-TENS has one channel (predicate has dual) and an added "open-circuit detection feature" to prevent output increment in the absence of load. Both comply with "shrouded patient cable connectors" rule.
- Non-clinical Testing:
- Compliance to voluntary standards: ANSVAAMI NS4-1986, EN 60601-1, EN 60601-1-1, and EN 60601-1-2.
- Software verification carried out according to FDA software guidance.
- Clinical Testing: "Not Applicable as there are no new or innovative aspects that have been introduced."
- Conclusion: The device is substantially equivalent to the predicate and poses no new questions of safety and effectiveness.
§ 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).