(113 days)
The FD TENS 2030 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 FD TENS 2030 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.
FD TENS 2030 has two output channels and five preset programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 20 steps.
Here's an analysis of the provided text regarding the FD TENS 2030 device and its acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the device is a TENS unit, and its performance is assessed through non-clinical testing for compliance with voluntary standards. There are no explicit "acceptance criteria" presented in terms of specific performance metrics for the device itself (e.g., pain reduction percentage, battery life). Instead, the acceptance is based on meeting safety and technical standards and demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Safety and Technical | Compliance to ANSVAAMI NS4-1986 | "Compliance to applicable voluntary standards includes ANSVAAMI NS4-1986" |
| Compliance to EN 60601-1-2 | "as well as the EN 60601-1-2 requirements." | |
| Software Verification | "software verification has been carried out according to the FDA software guidance." | |
| Substantial Equivalence to Predicate | "The FD TENS 2030 has the same intended use and similar technical characteristics as the FDTENS 2010 (K994266)." | |
| Absence of New Safety/Effectiveness Questions | "The information supplied in this 510(k) illustrates that the device do not pose any new questions of safety and effectiveness." | |
| Functional Features | Detects open-circuit | "FD TENS 2030 possesses an open-circuit detection feature. It means that FD TENS 2030 could check the continuity between the output terminals, and avoid increment of output in the absence of load." |
| Uses "shrouded patient cable connectors" | "All units use 'shrouded patient cable connectors' to comply with the FDA's Final Rule 'Medical Devices: Establishment of Performance Standards for Electrode Lead Wires and Patient Cables.'" |
2. Sample Size for the Test Set and Data Provenance
The document explicitly states: "10.8 Clinical Testing: Not Applicable as there are no new or innovative aspects that have been introduced."
This indicates that no clinical testing with a test set was performed for this device. Therefore, there is no information on:
- Sample size used for the test set
- Data provenance (country of origin, retrospective/prospective)
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical testing (and thus no test set to establish ground truth) was performed, this information is not applicable and not provided in the document.
4. Adjudication Method for the Test Set
As no clinical testing with a test set was performed, an adjudication method for a test set is not applicable and not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed. The document states "Clinical Testing: Not Applicable." Therefore, there is no information on the effect size of human readers improving with or without AI assistance. (Note: This device is a physical TENS unit, not an AI-powered diagnostic or assistive tool, so an MRMC study in the context of AI would not typically apply).
6. Standalone (Algorithm Only) Performance Study
No standalone performance study of an algorithm was performed. The device is a physical TENS unit. The text only mentions "software verification has been carried out according to the FDA software guidance," which refers to the internal software quality and not an algorithmic performance study for a clinical task.
7. Type of Ground Truth Used
No clinical ground truth (expert consensus, pathology, outcomes data) was used because clinical testing was "Not Applicable." The acceptance of the device is based on engineering and safety standards compliance and substantial equivalence to a predicate device.
8. Sample Size for the Training Set
No clinical training set was used, as clinical testing was "Not Applicable."
9. How the Ground Truth for the Training Set Was Established
No clinical training set was used, and therefore, no ground truth for a training set was established. The "ground truth" for the device's acceptance is based on its adherence to established electrical safety and medical device standards.
§ 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).