(287 days)
The nu-beca Transcutaneous Electrical Nerve Stimulation is indicated for temporary relief of pain associated with sore and aching muscles in the lower back and upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
The nu-beca Transcutaneous Electrical Nerve Stimulation consists of following components and accessories: TENS Stimulator, Electrode Pad, nu-beca Gel Pad, Charging Cable, Storage Pad. The device releases electrical current with adjustable frequencies and voltages to temporarily relief sore and aching muscles. It has only one model: TN0001. The treatment time for one session use is 15 minutes.
The provided document is a 510(k) summary for the nu-beca Transcutaneous Electrical Nerve Stimulation device. It details a comparison to predicate and reference devices and summarizes non-clinical testing. However, it does not contain a specific study that proves the device meets predefined acceptance criteria for clinical performance, nor does it include information about human reader studies or ground truth establishment in the context of clinical efficacy for pain relief.
The document primarily focuses on demonstrating substantial equivalence through technological characteristics and safety testing (e.g., electrical safety, EMC, biocompatibility, performance of electrical current specifications). The "acceptance criteria" discussed in the document refer to the criteria for these technical and safety tests, which the device met.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
The document discusses various performance tests with general statements that "All test results met acceptance criteria." However, it does not present a single consolidated table of quantitative acceptance criteria and corresponding device performance values for all parameters. Instead, these are mentioned in the "11. Non-Clinical Testing Summary" section for specific tests.
Here's an attempt to extract some of the performance criteria and reported outcomes based on the text:
| Characteristic / Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety (Overall) | Compliance with IEC 60601-1:2012, IEC 60601-1-11:2015, IEC 60601-2-10:2016 | Met (passed all tests) |
| EMC | Compliance with IEC 60601-1-2:2014 | Met (passed all tests) |
| Waveform and Shape | - | Verified (met acceptance criteria) |
| Pulse Duration | Electrical pulse outputted within claimed time interval (same as predicate) | Verified (met acceptance criteria, same as predicate) |
| Net Charge per Pulse | - | Verified (met acceptance criteria; 7.50 µC, similar to reference K160052 at 7.16µC) |
| Maximum Average Power Density | Less than 0.25 Watts/cm² (per FDA Guidance) | 0.062 Watts/cm² (within safe range) |
| Intensity Verification (Output Voltage) | Compliance with IEC 60601-2-10:2016 | Verified (met acceptance criteria) |
| Frequency and Output Current Verification | Compliance with IEC 60601-2-10:2016 | Verified (met acceptance criteria) |
| Biocompatibility (Cytotoxicity) | Compliance with ISO 10993-5:2009 | Performed (results met acceptance criteria) |
| Biocompatibility (Sensitization) | Compliance with ISO 10993-10:2021 | Performed (results met acceptance criteria) |
| Biocompatibility (Irritation) | Compliance with ISO 10993-23:2021 | Performed (results met acceptance criteria) |
| Storage Stability | Safety and effectiveness suitable for shelf life | Performed (ensured suitable for use) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document describes non-clinical bench tests. These tests typically do not involve human subjects or "test sets" in the clinical sense. Therefore, there is no mention of sample size for a clinical test set or data provenance in terms of country of origin or retrospective/prospective nature. The tests are benchtop evaluations of device specifications and safety standards.
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. This document pertains to the regulatory clearance of a Transcutaneous Electrical Nerve Stimulation device, which is based on demonstrating substantial equivalence to existing devices through engineering and safety testing, not on diagnostic accuracy evaluated by experts. The "ground truth" here is the adherence to established engineering standards and safety limits.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for clinical studies where there are multiple interpretations or classifications to resolve, or for reviewing adverse events. This document describes technical product testing.
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. MRMC studies are used for evaluating diagnostic devices, particularly those involving human interpretation of images or other data, often in the context of AI assistance. The nu-beca Transcutaneous Electrical Nerve Stimulation is a therapeutic device for pain relief, not a diagnostic one. No AI component is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical TENS unit for direct patient use, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to established engineering standards and safety limits (e.g., IEC 60601 series, ISO 10993 series, FDA Guidance Document for Powered Muscle Stimulator 510(k)s). The device's performance was compared against these predefined technical benchmarks, not clinical outcomes or expert consensus on a disease state.
8. The sample size for the training set
Not applicable. The device is a hardware product, and the document describes its manufacturing specifications and testing against standards, not the development of a trained AI model.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned, as this is not an AI/ML-based device.
§ 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).