(149 days)
The FD2050 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
The FD2050 is a handheld battery powered TENS device. which is used for pain relief. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.
FD2050 has two output channels and five preset programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 20 steps.
The provided text describes a 510(k) premarket notification for the FD2050 (Slide TENS) device, comparing it to a predicate device (SMART TENS). This document primarily focuses on demonstrating substantial equivalence to a previously cleared device, rather than presenting a study designed to establish acceptance criteria for a novel device's performance in a clinical setting.
Therefore, many of the requested categories for a study proving device performance (such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established for the training set) are not applicable or not available in this type of regulatory submission. This document confirms the device's technical specifications and safety compliance.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the predicate device's specifications and compliance with relevant safety and EMC standards. The "reported device performance" is a comparison of the FD2050's output specifications against those of the predicate device.
| Parameter | Acceptance Criteria (Predicate Device: SMART TENS - K091045) | Reported Device Performance (FD2050 / Slide TENS - K111645) |
|---|---|---|
| Waveform | Asymmetrical Bi-Phasic Rectangular Waveform | Asymmetrical Bi-Phasic Rectangular Waveform |
| Max Voltage | 61V @500Ω, 76V @2kΩ, 90V @10kΩ | 60V @500Ω, 75V @2kΩ, 83V @10kΩ |
| Max Output Current | 122 mA @500Ω, 38 mA @2kΩ, 9 mA @10kΩ | 120 mA @500Ω, 37 mA @2kΩ, 8 mA @10kΩ |
| Max Pulse Width | 250 μs | 250 μs |
| Max Frequency | 100Hz | 150Hz |
| Max Output Charge Per Phase | 28.4μC @500Ω, 21.3μC @1kΩ, 13.9μC @2kΩ, 3.9μC @10kΩ | 23.0μC @500Ω, 17.1μC @1kΩ, 11.9μC @2kΩ, 3.4μC @10kΩ |
| Max Output Net Charge Per Phase | 14.4μC @500Ω, 6.5μC @1kΩ, 2.9μC @2kΩ, 0.4μC @10kΩ | 11.9μC @500Ω, 6.2μC @1kΩ, 2.9μC @2kΩ, 0.4μC @10kΩ |
| Max Output RMS Current | 14.4 mArms @500Ω, 10.0 mArms @1kΩ, 6.3 mArms @2kΩ, 1.7 mArms @10kΩ | 13.1 mArms @500Ω, 8.4 mArms @1kΩ, 5.3 mArms @2kΩ, 1.4 mArms @10kΩ |
| Max Current Density | 0.11 mA/cm2 @500Ω | 0.22mA/cm2 @500Ω |
| Max Power Density | 4.2 mW/cm2 @500Ω | 5.3 mW/cm2 @500Ω |
| Treatment Timer | 5 selectable times (Continuous, 15, 30, 45, 60 min) | 5 selectable times (Continuous, 15, 30, 45, 60 min) |
| Continuous Stimulation (CONTS) | 100Hz, selectable 20µs to 250µs | 150µs, Selectable 1Hz to 150Hz |
| Burst (BURST 1 & 2) | 32Hz, selectable 20µs to 250µs, 2 burst/sec, 7 pulses/burst | Burst 1: 28Hz, 150µs, 2 bursts/sec, 7 pulses/burst; Burst 2: 80Hz, 150µs, 1 burst/2sec, 80 pulses/burst |
| Pulse Width Modulation (MODUL 1) | 20µs -> max pulse width in 5 sec, max pulse width ->20µs in 5sec, repeat; 23 selectable max pulse width | 50µs -> 250µs in 6sec, 250µs -> 50µs in 6sec, repeat; 42 selectable pulse rate |
| Frequency Modulation (MODUL 2) | Not Available | Pulse width 150µs, 20Hz -> 100Hz in 6sec, 100Hz -> 20Hz in 6sec, repeat |
Note on Differences: While many parameters are similar, some show differences (e.g., Max Frequency, Max Current Density, Max Power Density, and specific modulation programs). The submission argues these differences do not raise new questions of safety or effectiveness, as the overall electrical stimulus characteristics remain within generally accepted ranges for TENS devices.
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission is a 510(k) for a TENS device, which typically relies on demonstrating substantial equivalence to a predicate device through engineering similarity, performance testing (bench testing), and compliance with recognized standards. It does not involve human subject testing to establish efficacy or safety from a "test set" of patients or data in the way a diagnostic AI device would.
- The data provenance mentioned (e.g., country of origin, retrospective/prospective) is not relevant in this context.
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. No clinical ground truth from human experts was established for this type of device. The ground truth for performance is the technical specifications and safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical adjudication was performed as part of this submission.
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 a hardware medical device (TENS) and does not involve AI or human "readers" (e.g., radiologists, pathologists). Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a TENS unit. While it contains software, its "performance" is its ability to generate specific electrical pulses, not to perform an algorithmic diagnosis or interpretation. Its functionality is inherently "standalone" in generating the electrical output once parameters are set by the user, but this term is not used in the context of standalone AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's acceptance is its compliance with recognized electrical safety and EMC standards (EN60601-1, EN60601-1-2) and its technical electrical output specifications which are compared to a legally marketed predicate device. Additionally, biocompatibility testing was performed on the material (ABS) to ensure safety.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
§ 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).