(271 days)
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (Choose Mode B or C).
To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode A).
To temporarily increase local blood circulation in healthy muscles (Choose Mode A).
Pain Therapy Device is a household multifunctional device, it can stimulate healthy muscles in order to improve and facilitate muscle performance, and temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Pain Therapy Device has three operation modes and two channels, which can give certain electrical pulse through 2 pairs of electrode pads on the skin.
The electronic stimulatory main units have the operating elements of ON/OFF knob, Mode Selection key and Time Selection key which can be user-friendly controlled.
The device is equipped with accessories of electrode pads and an electrode wire. The electrode wire is used to connect the pads to the main unit. All the accessories can only be changed by local distributor. "Large Patch Electrode" and "Small Patch Electrode" are cleared in K090198.
"Insole Electrode", "Sole Plant Electrode A" and "Sole Plant Electrode B" are cleared in K151693.
The provided document is a 510(k) Summary for a Pain Therapy Device (K163611). It primarily focuses on demonstrating substantial equivalence to predicate devices based on safety and performance through bench testing and comparison of technical specifications.
Therefore, it does not describe acceptance criteria for a study demonstrating device performance against specific targets, nor does it detail a clinical study with human subjects, ground truth establishment, or multi-reader multi-case analyses.
The document outlines the following information relevant to the device's validation:
1. A table of acceptance criteria and the reported device performance:
The document does not present a table of specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) and the device's reported performance against those. Instead, it demonstrates compliance with recognized standards and substantial equivalence to predicate devices through technical specifications.
The "Test Summary" section (page 4) lists the following tests and their compliance:
| Acceptance Criterion (Standard Compliance) | Reported Device Performance |
|---|---|
| Electrical safety (IEC 60601-1 and IEC 60601-2-10) | Complies |
| Electromagnetic compatibility (IEC 60601-1-2) | Complies |
| Biocompatibility (ISO 10993-5 and ISO 10993-10) | Complies (all user directly contacting materials) |
| Usability (IEC 62366) | Complies |
| Software verification and validation (FDA Guidance for Software in Medical Devices) | Complies |
| Electrode wire compliance (21 CFR 898 by IEC 60601-1 version 3.1, clause 8.5.2.3) | Complies |
The "Comparison to predicate device and conclusion" tables (pages 5-12) provide a detailed comparison of the subject device's technical specifications and intended uses against three predicate devices. The "Remark" column consistently states "SE" (Substantially Equivalent), indicating that the subject device's performance characteristics are considered equivalent to those of the legally marketed predicate devices, and that differences do not raise new issues of safety or effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not Applicable. The provided document does not describe a clinical study involving a test set, human subjects, or data provenance in the context of device performance. The testing was primarily bench testing to ensure compliance with standards and equivalence to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not Applicable. As no clinical study or test involving human subjects with a "ground truth" was described, this information is not present. The "ground truth" for the technical comparisons is rooted in the specifications and regulatory clearances of the predicate devices and the relevant international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not Applicable. No clinical test set or adjudication method is described.
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 a Pain Therapy Device (Transcutaneous Electrical Nerve Stimulator, TENS/EMS). It is not an AI-powered diagnostic imaging device or similar system where "human readers" or "AI assistance" would apply. Therefore, no MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not Applicable. This is a hardware medical device; the concept of "standalone algorithm performance" is not relevant in the context of this 510(k) submission. The "software verification and validation test" mentioned (page 4) refers to the embedded software within the device and its compliance with FDA guidance, not a standalone algorithm for diagnostic or interpretative purposes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not Applicable. For a device of this type, demonstrating "substantial equivalence" relies on technical specifications, safety testing (electrical, EMC, biocompatibility, usability), and comparison of intended use to legally marketed predicate devices. The "ground truth" for this regulatory submission is compliance with established standards and the characteristics of the predicate devices. There is no mention of clinical outcomes data in the sense of a dedicated clinical trial to establish efficacy against a "ground truth" condition.
8. The sample size for the training set:
Not Applicable. The document does not describe the development or training of an AI algorithm, therefore, no training set or its sample size is mentioned.
9. How the ground truth for the training set was established:
Not Applicable. As there is no training set for an AI algorithm, this information is not provided.
§ 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).