(261 days)
For 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. For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The ALEVE® Direct Therapy® device is a battery powered transcutaneous electrical nerve stimulator (TENS) device for relieving lower back pain. The device is comprised of a TENS generator with integral electrodes, two replaceable "AAA" size batteries, replaceable electroconductive hydrogel pads (Gel Pads), and a Mobile App to control the TENS device via Bluetooth® connection, which installs to Apple® iOS® 9.0 or higher or Android® 4.4 or higher smartphone platforms. Additionally, the TENS intensity may be increased or decreased using onboard mechanical buttons on the TENS unit enclosure. The TENS device offers an optional handheld, wireless remote control via Radio Frequency (RF) connection which is sold separate and comes with one replaceable CR2032 Lithium-ion coin battery.
The provided text is a 510(k) summary for the ALEVE® Direct Therapy® medical device, which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief.
Based on the provided document, the device is a TENS unit, and the acceptance criteria and study proving it meets these criteria are related to its safety and performance based on engineering and laboratory testing, rather than clinical efficacy studies for AI/ML performance.
Therefore, I cannot provide information on AI/ML specific criteria such as:
- A table of acceptance criteria and reported device performance related to AI/ML metrics (e.g., sensitivity, specificity, AUC).
- Sample sizes for test sets in an AI/ML context.
- Number of experts and their qualifications for ground truth establishment for an AI/ML test set.
- Adjudication methods for an AI/ML test set.
- MRMC comparative effectiveness studies.
- Standalone (algorithm-only) performance.
- Type of ground truth used in an AI/ML context.
- Sample size for a training set (AI/ML).
- How ground truth for a training set was established (AI/ML).
Here's a breakdown of what can be extracted from the document regarding the device's acceptance criteria and the study that proves it meets them, framed in the context of a medical device submission (Premarket Notification 510(k)) that relies on substantial equivalence to predicate devices:
Device: ALEVE® Direct Therapy® (Second Generation) - Transcutaneous Electrical Nerve Stimulator (TENS) for Pain Relief
1. Table of Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence and Non-Clinical Testing):
The document does not present a formal table of explicit acceptance criteria with numerical performance targets for a new device. Instead, it demonstrates substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if the device performs as safely and effectively as the predicates through a series of non-clinical tests and shows comparable technological characteristics.
| Acceptance Criteria Category (Implied by 510(k) Process) | Reported Device Performance / How Met (Based on Non-Clinical Testing and Comparison) |
|---|---|
| Safety & Effectiveness (Overall) | Demonstrated by substantial equivalence to legally marketed predicate devices. "does not raise new or different questions about safety or effectiveness." |
| Technological Characteristics | Very similar to Predicate 1 (ALEVE Direct Therapy TENS, first-generation) in intended use, outer dimensions, buttons, electrodes, materials, remote control, RF communication, pulse amplitude. |
| Similar to Predicate 2 (Chattem SmartRelief) in indications for use and output specifications (pulse amplitude, frequency, duration). | |
| Performance Verification | Met established specifications through: |
- Unit level testing
- System testing
- Software verification and validation |
| Usability Engineering | Testing performed and results contributed to meeting established specifications. |
| Biocompatibility | Met requirements per ISO 10993-1. |
| Electrical Safety | IEC 60601-1:2005 Ed. 3 + C1:2009 + A1:2012 (FDA Recognition Number 19-4) compliant. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 Ed. 4 (FDA Recognition 19-8) compliant. |
| Home Healthcare Environment | IEC 60601-1-11 Edition 2.0 2015-01 (FDA Recognition Number 19-14) compliant. |
| TENS Specific Safety | IEC 60601-2-10 Edition 2.0 2012.06 (FDA Recognition Number 17-11) compliant. |
| Risk Management | ISO 14971 Second edition 2007-03-01 (FDA Recognition Number 5-40) compliant. |
| Software Life Cycle Processes | IEC 62304 Edition 1.1 2015-06 (FDA Recognition Number 13-79) compliant. |
| Chemical Characterization (Materials) | AAMI/ANSI/ISO 10993-10:2010 (FDA Recognition Number 2-173) compliant (implied by biocompatibility). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a "sample size" in the conventional sense of a clinical trial or a machine learning test set. The validation is based on non-clinical bench and safety testing of the device itself (e.g., electrical safety, software validation, biocompatibility), not a dataset of patient data or clinical images. Therefore, the "test set" would refer to the physical units of the device tested in the laboratory. The document does not specify how many units were tested.
- Data Provenance: Not applicable in the context of patient data. The data provenance is from laboratory testing performed by the manufacturer, Bayer HealthCare LLC. The document does not specify the country where these tests were conducted, but the company is based in Whippany, New Jersey, USA. The testing is retrospectively reported as part of the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- Not applicable. Ground truth for a TENS device's safety and performance in the context of a 510(k) is established through adherence to recognized international and national standards (e.g., IEC, ISO, ANSI/AAMI) verified by laboratory testing, not by expert consensus on clinical data or images.
4. Adjudication Method for the Test Set:
- Not applicable. There is no human adjudication process involved in verifying the compliance of a TENS device with electrical safety, EMC, or biocompatibility standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is relevant for AI/ML diagnostic devices where human readers interpret medical images. This device is a therapeutic TENS unit.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an AI/ML algorithm. The "standalone" performance here refers to the device's ability to operate according to its specifications (e.g., output electrical pulses within specified parameters) without human intervention during its operational cycle, which is verified through bench testing. The mobile app controls the device, but the "performance" validated is of the TENS output, not the app's diagnostic or interpretive capabilities.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's acceptance is its compliance with pre-defined technical specifications, safety standards, and performance characteristics as demonstrated through non-clinical bench testing, software verification/validation, and adherence to recognized standards (e.g., electrical safety, EMC, biocompatibility, risk management). It is essentially engineering and regulatory standard compliance.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, this is not an AI/ML 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).