(163 days)
Prescription Use:
The Strive™ TENS device is used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment for post-surgical and post-trauma acute pain.
As a TENS device, indications are for the following conditions:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
Over the Counter Use:
The Strive™ TENS device is used for:
-temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.
-the symptomatic relief and management of chronic, intractable pain associated with arthritis.
The Strive device is a handheld Transcutaneous Electrical Nerve Stimulation (TENS) unit which delivers electrical pulses transmitted by electrodes to cutaneous (surface) and afferent (deep) nerves of the body for pain management. The device provides simple user interface and programming, and is aimed to be used with lead wires and electrodes. Strive will be marketed as either Prescription (RX for U.S. Only) or Over-the-Counter (OTC), with each configuration having its own set of labeling, as appropriate.
The Strive device utilizes electrodes which are single patient use only. The device embeds a rechargeable battery that cannot be removed. The device is inoperable while the battery is charging.
This document is a 510(k) summary for the Strive™ Transcutaneous Electrical Nerve Stimulator (TENS) device. It details the device's characteristics and compares them to predicate devices to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" paired with "reported device performance" in a single table format. Instead, it presents performance testing results against recognized standards and claims substantial equivalence to predicate devices. The comparisons provided in Tables 1a, 1b, 2, 3, and 4 effectively serve as the device's reported performance against established benchmarks (predicate devices' specifications and general standards for TENS devices).
Here's a synthesized table based on the information provided, focusing on the Strive device's performance against relevant standards and the finding of substantial equivalence:
| Acceptance Criteria (Standards/Benchmarks) | Reported Device Performance (Strive™) |
|---|---|
| Electrical Safety & Electromagnetic Compatibility (EMC) | Compliance demonstrated with: |
| - IEC 60601-1 (Basic safety and essential performance) | Met |
| - IEC 60601-1-2 (EMC) | Met |
| - IEC 60601-1-11 (Use in home healthcare environment) | Met |
| - IEC 60601-2-10 (Performance of nerve and muscle stimulators) | Met |
| Software Verification | In accordance with FDA guidance "General Principles of Software Validation, January 11, 2002": |
| - Software meets design requirements | Met (software testing demonstrated that requirements were met) |
| Usability/Human Factors | In accordance with IEC 60601-1-6: |
| - Established usability requirements met | Met |
| - Design appropriate for intended users and use environment | Met (substantiated acceptability of use-related risks) |
| Coexistence Testing | Performance evaluated in environments with other devices (Bluetooth, Wi-Fi, Microwave Oven, clinical devices): |
| - Meets specified requirements in presence of other devices | Met all specified requirements |
| Substantial Equivalence to Predicate Devices (EMPI Select, EMPI Phoenix, SmartRelief) | Conclusion based on performance testing and similarities of Indications for Use and technological characteristics: |
| - Similar Indications for Use | Similar |
| - No new questions of safety or effectiveness raised by differences | Concluded to be as safe and effective as, and substantially equivalent to, predicate devices. |
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 does not specify the sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for any of the performance tests (Electrical Safety and EMC, Software Verification, Usability/Human Factors, Coexistence Testing). These types of tests typically involve testing the device itself or a representative number of devices, rather than a clinical dataset of patients.
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)
The document does not mention the use of experts to establish a "ground truth" for any test sets in the way that would apply to diagnostic imaging or clinical trials. The tests performed are primarily engineering and simulated user environment tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is mentioned or implied, as the nature of the tests (electrical safety, software verification, usability, coexistence) does not typically involve human adjudication of results in the way a clinical study or expert review of images would.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a TENS unit for pain relief, not an AI-assisted diagnostic or interpretation device that would involve human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Strive™ device is a medical device (TENS unit) that delivers electrical stimulation. It does not employ an "algorithm" in a diagnostic or interpretive sense that would operate "standalone" versus "human-in-the-loop." Its performance is about its physical outputs and safety, not an interpretive algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., expert consensus, pathology, outcomes data) is not applicable here. The "truth" for the performance tests mentioned (electrical safety, software, usability, coexistence) is conformance to the specified standards or design requirements.
8. The sample size for the training set
This question is not applicable. The Strive™ device is a TENS unit, not an AI/machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this 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).