(125 days)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
The subject device is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-the-counter use to temporarily relieve pain in different body areas. The subject device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse to the user's skin through the electrode pads for pain relief. According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.
The provided document is an FDA 510(k) Pre-Market Notification for an Electronic Pulse Stimulator. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain a study that proves the device meets acceptance criteria in the way typically expected for an AI/ML medical device submission.
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices based on technical characteristics and adherence to recognized electrical safety and electromagnetic compatibility standards. There is no mention of a clinical study or performance metrics related to diagnostic accuracy, sensitivity, specificity, etc., which are common for AI/ML device evaluations.
Therefore, many of the requested fields cannot be directly answered from the provided text. I will address the points that can be gleamed from the document.
Acceptance Criteria and Device Performance for Electronic Pulse Stimulator (K141260)
Based on the provided FDA 510(k) summary, the "acceptance criteria" are related to demonstrating substantial equivalence in technical specifications (electrical output parameters, pulse characteristics), intended use, and compliance with recognized safety standards. Performance is reported in terms of these technical specifications compared to predicate devices. There is no explicit acceptance criteria for efficacy beyond demonstrating similar technical function to predicate devices and adherence to general safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied: Similar to Predicate Devices & within specified ranges) | Reported Device Performance (Subject Device - PL-029BL / PL-029K Ranges) | Predicate Device Performance (K131921 / K131290 Ranges) |
|---|---|---|---|
| Electrical Output Parameters (+/- 20% tolerance listed for voltage/current) | |||
| Max Output Voltage (500Ω) | Consistent with predicate devices | 24.0 - 75.2 V (PL-029BL), 37.2 - 71.2 V (PL-029K) | 49.6 V (K131921), 32 - 64 V (K131290) |
| Max Output Voltage (2kΩ) | Consistent with predicate devices | 46.4 - 121 V (PL-029BL), 64.8 - 122 V (PL-029K) | 99.2 V (K131921), 64 - 94.4 V (K131290) |
| Max Output Voltage (10kΩ) | Consistent with predicate devices | 85.6 - 134 V (PL-029BL), 96.8 - 146 V (PL-029K) | 114 V (K131921), 96.8 - 129 V (K131290) |
| Max Output Current (500Ω) | Consistent with predicate devices | 48.0 - 150.4 mA (PL-029BL), 74.4 - 142.4 mA (PL-029K) | 18 mA (K131921), 64 - 128 mA (K131290) |
| Max Output Current (2kΩ) | Consistent with predicate devices | 23.2 - 60.5 mA (PL-029BL), 32.4 - 61 mA (PL-029K) | 3.2 mA (K131921), 32 - 47.2 mA (K131290) |
| Max Output Current (10kΩ) | Consistent with predicate devices | 8.5 - 13.4 mA (PL-029BL), 9.7 - 14.6 mA (PL-029K) | 0.6 mA (K131921), 9.7 - 12.9 mA (K131290) |
| Pulse Width (µSec) | Similar to predicate devices | 100 µSec (PL-029BL), 50-100 µSec (PL-029K) | 50-140 µSec (K131921), 100 µSec (K131290) |
| Pulse Period (mSec) | Similar to predicate devices | 6.1-824 mSec (PL-029BL), 12-832 mSec (PL-029K) | 40 mSec (K131921), 10-840 mSec (K131290) |
| Frequency (Hz) | Similar to predicate devices | 1.2-164.4 Hz (PL-029BL), 1.2-83.3 Hz (PL-029K) | 86 Hz (K131921), 1.2-100 Hz (K131290) |
| Max Phase Charge (µC) at 500Ω | Similar to predicate devices | 9.2 - 31.3 µC (PL-029BL), 3.7 - 33.0 µC (PL-029K) | 23 µC (K131921), 12.8 - 27.3 µC (K131290) |
| Max Current Density (mA/cm²) at 500Ω | Similar to predicate devices | 1.92-6.02 (PL-029BL), 4.65-8.90 (PL-029K) | 1.4 (K131921), 2.56-5.12 (K131290) |
| Max Avg Power Density (mW/cm²) at 500Ω | Similar to predicate devices | 0.07-3.45 (PL-029BL), 0.12-3.10 (PL-029K) | Not explicitly listed for all modes (K131921), 0.08-3.75 (K131290) |
| Safety and EMC Standards | Compliance with IEC 60601-1, -1-2, -2-10 | All tests performed, design validated, and conformance assured. | Predicate devices also complied with relevant standards. |
| Software Verification | Conformance with FDA Guidance for Software Contained in Medical Devices | Verification performed according to FDA Guidance. | Not explicitly mentioned but assumed for predicate devices. |
| Biocompatibility | Electrodes meet safety requirements | Electrodes meet safety requirements. | Not explicitly mentioned but assumed for predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This submission relies on engineering bench testing and comparison to predicate device specifications, not a clinical test set with patient data.
- Data Provenance: Not applicable in the context of clinical studies. The data related to electrical output parameters are from bench tests of the subject device and specifications of the predicate devices.
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" in the clinical sense was established by experts for a test set. The validation focused on whether the device's technical specifications met engineering requirements and were comparable to predicate devices.
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 device is an Electronic Pulse Stimulator, not an AI/ML diagnostic or assistive device that would involve human readers or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm. The device's performance is standalone in the sense of its physical output, but there's no "algorithm-only" performance study in the context of AI/ML.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. For this type of device, "ground truth" relates to the accurate measurement of electrical output parameters and compliance with recognized safety standards (e.g., IEC 60601 series). The "truth" is whether the device produces the specified electrical pulses safely and reproducibly.
8. The sample size for the training set:
- Not applicable. There is no AI/ML component, thus no training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI/ML component, thus no training set or associated ground truth.
Summary of the Study (Device Evaluation):
The "study" presented is a non-clinical evaluation demonstrating substantial equivalence of the Electronic Pulse Stimulator (K141260) to previously cleared predicate devices (K131921 and K131290).
- Methodology: The evaluation involved comparing the subject device's technical characteristics (e.g., maximum output voltage and current, pulse width, frequency, phase charge, current density, power density) with those of the predicate devices. Deviations in these parameters were assessed for their impact on safety and effectiveness.
- Key Findings: The submission states that "The differences, such the output voltage and current, between the subject device and the predicate devices are insignificant in terms of safety or effectiveness."
- Supporting Tests: The device underwent several non-clinical tests to ensure safety and performance, including:
- IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
- IEC 60601-1-2: Electromagnetic Compatibility requirements and tests.
- IEC 60601-2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
- Verification of software in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- Biocompatibility assessment of the electrode pads.
- Conclusion: Based on these non-clinical tests and the comparison of technical specifications, the submitter concluded that the subject device is substantially equivalent to the predicate devices and is as safe and effective for its intended over-the-counter use for temporary pain relief.
§ 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).