(84 days)
Temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
The ALEVE Direct Therapy device is a battery powered transcutaneous electrical nerve stimulator (TENS) for applying an electrical current to electrodes on a patient's skin to relieve pain. The device reduces the perception of pain by electrically stimulating peripheral nerves across the skin. The design of the device limits the application for use to the anatomical site of the back.
The device is comprised of a TENS unit with integral electrodes, one pair of replaceable electroconductive hydrogel pads, batteries for the remote and TENS unit, and a remote control. The user can turn the device on/off by pressing a button on the TENS unit. The hydrogel pads are adhesive and gently adhere the TENS unit to the user's skin on the lower back. There is also a remote control for the device, which the user turns on/off, and by which the user adjusts the intensity of stimulation.
This document is a 510(k) summary for the ALEVE Direct Therapy TENS device, claiming substantial equivalence to a predicate device (Pain Pilot™ / WiTouch® K120500). As such, it focuses on demonstrating similarity rather than presenting a detailed de novo study with specific acceptance criteria and performance against those criteria in the way a novel device might.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of acceptance criteria and the reported device performance
The document does not present a formal "acceptance criteria" table with specific quantitative thresholds for the device's clinical performance (e.g., pain reduction scores). Instead, it relies on demonstrating substantial equivalence to a predicate device, meaning its performance is expected to be similar or identical.
The performance data primarily focuses on engineering and safety standards, and a single usability study.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety Standards Compliance | Conformance with a suite of ISO and IEC standards including: |
- ISO 14971:2007 (risk management)
- AAMI/ANSI ES60601-1:2005/(R)2012 (general basic safety and essential performance)
- IEC 60601-1-2 Ed 4.0 2014-02 (EMC)
- IEC 60601-1-11 Ed 1.0 2010-04 (home healthcare environment)
- IEC 60601-2-10 Ed 2.0 2012-06 (nerve and muscle stimulators) |
| Biocompatibility Standards Compliance | Conformance with ISO standards: - AAMI/ANSI/ISO 10993-1:2009/(R) 2013 (biological evaluation, risk management)
- AAMI/ANSI/ISO 10993-5:2009/(R) 2014 (in vitro cytotoxicity)
- AAMI/ANSI/ISO 10993-10:2010 (irritation and skin sensitization)
(Note: The document states "The safety of this colorant has been demonstrated (Section 12, Biocompatibility).") |
| Software Verification and Validation (Moderate Level Concern) | Software verification and validation testing conducted, documentation provided in accordance with FDA's guidance for "Moderate level concern device." |
| Device Output Characteristics | Data in support of the device waveform and verification of output characteristics provided. (The specific characteristics are listed in the "Basic Unit Characteristics Comparison" table on page 5, which are all "IDENTICAL" or "Substantially Equivalent" to the predicate, implying conformity to the predicate's established performance). |
| Usability | A 15-subject usability study was conducted for the predicate device (K120500) and reported to the FDA. The submitter (Bayer HealthCare, LLC) references this study due to the devices and labeling being "sufficiently similar." This implies the predicate device met usability criteria, and by extension, the new device is considered to meet them. |
| Substantial Equivalence | The overall acceptance criterion is "substantial equivalence" to the predicate device (Pain Pilot™ / WiTouch® K120500). The document concludes: "The electrical safety, EMC, biocompatibility, software verification and validation, basic unit characteristics, and output specifications information provided in the 510(k) submission is sufficient to demonstrate substantial equivalence to the predicate device. As the ALEVE Direct Therapy TENS device is nearly identical to the predicate device, with identical indications for use and essentially identical technological characteristics, the ALEVE Direct Therapy TENS device is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- For the usability study (which is the only human-based performance data mentioned), the sample size was 15 subjects.
- No other human clinical "test set" data is explicitly described for performance on the primary indication (pain relief). The submission relies on the predicate device's established effectiveness.
- Data Provenance: The usability study was conducted by Hollywog (the original manufacturer of the predicate device). The document doesn't specify the country of origin for this study, nor does it explicitly state if it was retrospective or prospective, though usability studies are typically prospective.
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 device is a TENS unit for pain relief, not an AI/imaging diagnostic device. Ground truth, in the sense of expert annotation, is not relevant to the usability study or the engineering/safety tests described. Pain relief, if directly measured in a clinical trial, would typically rely on patient-reported outcomes, not expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as described in point 3.
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 is not an AI-assisted diagnostic or interpretation device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device (TENS unit), not a software algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the usability study, the "ground truth" would be the direct experience and feedback of the 15 subjects regarding the device's ease of use and functionality. For the safety and engineering tests, the "ground truth" is compliance with recognized standards or objective measurements of electrical characteristics. For the primary indication (pain relief), the justification relies on the predicate device's established clinical effectiveness, which would have been based on patient outcomes data (e.g., pain scores) in its original approval.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI that would require a "training set."
9. How the ground truth for the training set was established
Not applicable, as described in point 8.
§ 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).