(35 days)
TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.
A portable TENS device for pain control.
The CLASSIC TENS™ device, a transcutaneous electrical nerve stimulator (TENS) for pain relief, did not require a study proving its performance against acceptance criteria in the traditional sense, as it was cleared through the 510(k) pathway based on substantial equivalence to a predicate device.
Instead of clinical performance testing, the submission focused on comparing the technological characteristics and labeling of the CLASSIC TENS™ to a legally marketed predicate device (Matrix I, K895473).
Here's a breakdown of the information based on the provided text, addressing your points as much as possible within the context of a 510(k) submission for a TENS device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Technological Equivalence to Predicate Device | The CLASSIC TENS™ "has technological characteristics which are substantially equivalent to those of the predicate device, as determined by bench testing." It differs only by the use of jacks and cables compliant with FDA's Final Rule "Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables". |
| Electrical Output Equivalence | Bench testing demonstrated that the output characteristics of CLASSIC TENS™ "are substantially equivalent to that of the predicate device." |
| Safety and Effectiveness | Any differences between the devices "do not pose new questions of safety and effectiveness." |
| Labeling Equivalence | The labeling of the CLASSIC TENS™ "is substantially equivalent to that of the predicate device." |
| Intended Use Equivalence | Intended use matches the predicate: "symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not applicable. The device relies on bench testing for technological comparison, not a "test set" of patient data in the typical sense.
- Data Provenance: Not applicable. The "testing" involved bench testing of the device itself against the predicate device's specifications, not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. Ground truth in this context refers to the characteristics and performance of the predicate device, established by previous FDA clearance and regulatory standards, not by individual experts assessing a test set.
4. Adjudication Method for the Test Set
- Not applicable. There was no "test set" of cases requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No Multi-Reader Multi-Case (MRMC) study was done. This type of study is typically used for diagnostic or screening devices where human interpretation is a key component, often comparing human performance with and without AI assistance. This TENS device is a therapeutic device, and its clearance was based on substantial equivalence through bench testing, not clinical performance studies involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in essence, a standalone evaluation was done, but not in the context of an "algorithm." The "Nonclinical Testing" section states "Bench testing demonstrated that the output characteristics or CLASSIC TENS™ are substantially equivalent to that of the predicate device." This means the device's electrical output and technological features were directly evaluated and compared to the predicate without human intervention in operating the device for patient therapy during the evaluation.
7. The Type of Ground Truth Used
- The ground truth used was the established performance and safety profile of the predicate device (Matrix I, K895473), as determined by its prior FDA clearance and existing regulatory standards for TENS devices. The "bench testing" served to confirm that the CLASSIC TENS™ adhered to these established parameters.
8. The Sample Size for the Training Set
- Not applicable. As a TENS device, there is no "training set" in the context of machine learning. The device's design and manufacturing are based on established engineering principles and regulatory standards for TENS units.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set for this device.
Summary of the Study (Bench Testing and Comparison):
The "study" in this context refers to the bench testing performed to demonstrate the substantial equivalence of the CLASSIC TENS™ to its predicate device, Matrix I (K895473).
- Objective: To show that the CLASSIC TENS™ has comparable technological characteristics, electrical output, and intended use as the predicate device, and that any differences do not raise new questions of safety or effectiveness.
- Methodology:
- Technological Comparison: The physical design, components (specifically, the jacks and cables), and overall technological characteristics of the CLASSIC TENS™ were compared to the predicate. The only noted difference was the use of FDA-compliant jacks and cables.
- Nonclinical Testing (Bench Testing): Specific tests were performed on the CLASSIC TENS™ to measure its electrical output characteristics (e.g., waveform, intensity, frequency) and these were compared directly to the known output characteristics of the predicate device.
- Labeling Comparison: The proposed labeling for the CLASSIC TENS™ was reviewed and compared to the predicate device's labeling to ensure consistency in indications for use, warnings, and instructions.
- Results/Conclusion: The bench testing and comparisons demonstrated that the CLASSIC TENS™ is "substantially equivalent" to the predicate device. This equivalence formed the basis for the FDA's 510(k) clearance, allowing the device to be marketed.
§ 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).