(223 days)
The Empi® SELECT Transcutaneous Electrical Nerve Stimulator 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.
The SELECT® is a portable, dual channel TENS device with ten pre-programmed operational modes. It is powered by 3 standard AAA alkaline or rechargeable batteries. All operational modes produce the Empi Bi-Sourced® waveform. The user selects a pre-programmed mode by either pressing a Quick Select button with the picture of a body part needing treatment or by using the Program buttons to select one of ten program options. The user is able to adjust the intensity up or down. The lock mode prevents inadvertent changes to the intensity or the program option. The SELECT® is intended for use in the clinic or in the home with a prescription. A belt clip allows the patient to wear the Empi SELECT® on a belt or pants waistband. The SELECT® battery icon on the LCD will flash when the batteries need replacement. Compliance data can be retrieved by the clinician including number of sessions, average session length, and average intensity.
This device, the Empi SELECT® TENS System, is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for pain relief. The provided documentation does not include specific acceptance criteria with quantifiable metrics for device performance in the traditional sense of a diagnostic or predictive medical device. Instead, the focus is on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance/Evidence |
|---|---|---|
| Safety | The device must be safe for its intended use. (Implicit criteria include electrical safety, biocompatibility of materials, and mechanical integrity). | "Non-clinical testing demonstrates that the Empi SELECT® TENS System is safe..." (This statement broadly claims safety without detailing specific tests or thresholds. It is implied that standard electrical and mechanical safety tests for TENS devices were performed and passed.) |
| Effectiveness | The device must be effective for its intended use (symptomatic relief/management of chronic pain, relief of pain associated with arthritis, adjunctive treatment for acute pain). | "Non-clinical testing demonstrates that the Empi SELECT® TENS System... performs as well as the predicate devices." (Effectiveness is primarily demonstrated through substantial equivalence to existing TENS devices (Empi Epix VT® TENS System, Chattanooga Group Forte CPS 400 Stim and Forte CPS 200 Stim), which are presumably already deemed effective. No new clinical effectiveness data is presented for the SELECT® itself.) The device has the "same indications for use as the predicate devices." |
| Performance (Technical) | The device must meet its product specifications over a range of operating and storage conditions. This would include electrical output parameters (waveform, intensity, frequency), battery life, and mechanical durability. | "Verification of the Empi SELECT® TENS System includes electrical and mechanical tests to show that the device meets its product specifications over a range of operating and storage conditions." "The Empi SELECT® TENS System continues to record the number of sessions, the average session length, and the average intensity for data retrieval by a clinician." "The SELECT® battery icon on the LCD will flash when the batteries need replacement." "All operational modes produce the Empi Bi-Sourced® waveform." (Specific numerical performance metrics are not given, only the confirmation that tests were conducted and specifications were met.) |
| User Needs | The device must meet user needs according to marketing requirements, particularly regarding the user interface. | "Validation testing for the Empi SELECT® TENS System includes testing to show the device meets user needs according to marketing requirements." (The document highlights user interface changes from the predicate device (larger LCD, keymat style push buttons, Quick Select buttons), implying these changes addressed user needs or improved usability.) |
| Substantial Equivalence | The device must be demonstrably as safe and effective as legally marketed predicate devices. | The entire submission is based on demonstrating substantial equivalence to predicate TENS devices (K970203, K982828). The conclusion explicitly states, "The non-clinical testing demonstrates that the Empi SELECT® TENS System is safe, effective, and performs as well as the predicate devices." The device features "the same indications for use as the predicate devices" and "no changes to the output modes (waveforms)." |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not applicable/Not explicitly stated. The evaluation relies on non-clinical testing (electrical and mechanical tests, and validation for user needs), not a clinical 'test set' with patient data.
- Data provenance: Not applicable. The "tests" refer to engineering and functional verification/validation of the device hardware and software, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As this is non-clinical testing and validation, there is no "ground truth" derived from expert consensus on patient data. The "ground truth" for electrical and mechanical tests would be the device's technical specifications and industry standards. For user needs validation, it would be marketing requirements and presumably user feedback/testing, but no details are provided about this.
4. Adjudication method for the test set
- Not applicable. There is no clinical test set requiring adjudication.
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
- No. This device is a TENS unit, not an AI-powered diagnostic or interpretive device. Therefore, a MRMC study involving human readers and AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in a sense. The "non-clinical testing" and "validation testing" described are standalone evaluations of the device's inherent safety and performance characteristics (electrical, mechanical, meeting specifications, user needs). There is no "algorithm" in the context of an AI device, but the device's own functional performance was tested independently.
7. The type of ground truth used
- For electrical and mechanical tests: Device specifications, engineering standards, and regulatory requirements (e.g., for safety).
- For validation testing (user needs): Marketing requirements and potentially user feedback/usability studies (though details are not provided).
- For substantial equivalence: The established safety and effectiveness profiles of the predicate devices.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The device's design and programming are based on established engineering principles and the intended physiological effects of TENS.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set. The "ground truth" for the device's functionality is its design specifications and compliance with relevant standards for TENS devices.
§ 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).