(331 days)
The Epix XL TENS Unit is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.
The Epix XL is a dual channel TENS device with four conventioual modes of operation, eight preprogrammed regimens and a choice of two levels of output (0-40mA or 0-60mA). It is powered by a standard 9V alkaline or NiCad rechargeable battery. All operation modes produce the Empi Bi-Sourced® waveform.
The Epix XL System requires the use of a set of leadwires and one or two pair of cutaneous stimulation electrodes.
The provided text describes the 510(k) submission for the Epix XL TENS Unit, Model 995. This submission focuses on demonstrating substantial equivalence to a predicate device, the Epix XL Model 989, rather than presenting a de novo clinical study with a novel device.
Therefore, the typical acceptance criteria and study design elements you've requested (like sample size for test/training sets, expert qualifications for ground truth, MRMC studies, etc.) are not applicable in this context.
Here's an analysis based on the provided information, addressing the spirit of your request:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Epix XL Model 995, as evidenced by the 510(k) submission, were to demonstrate that its technical and performance specifications are substantially equivalent to the predicate Epix XL Model 989, and that any changes do not raise new questions of safety or effectiveness. The study demonstrating this was a non-clinical performance evaluation through functional testing against product specifications, rather than a clinical trial.
| Acceptance Criteria | Reported Device Performance (Epix XL Model 995) |
|---|---|
| Indications for Use: Symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain. | Met: Identical to Model 989. |
| Output Channels: 2 | Met: Identical to Model 989. |
| Safety Standards Compliance: AAMI/ANSI NS4-1985, IEC 601-2-10, IEC 601-1-2 | Met: Identical to Model 989. |
| Control Mechanism: Microprocessor, masked | Met: Identical to Model 989. |
| Amplitude (voltage) Range: 0-40Vpp (normal), 0-60Vpp (high) | Met: Identical to Model 989. |
| Maximum Output Voltage: 120Vpp, 1MΩ | Met: Identical to Model 989. |
| Channel Interaction: ≤ 5% | Met: Identical to Model 989. |
| Pulse Width: 0-400µs at 50% of peak amplitude | Met: Identical to Model 989. |
| Waveform: Symmetrical, bi-phasic | Met: Identical to Model 989. |
| Zero Net DC: Yes; achieved through transformer | Met: Identical to Model 989. |
| Max. Charge per Pulse: 20µC into a 500 Ohm load | Met: Identical to Model 989. |
| Adjustable Pulse Rates: 2, 10, 20, 40, 60, 80, 100, 150 Hz | Met: Identical to Model 989. |
| Standard Output Modes: Continuous (C), Burst (B), Modulated Rate (R), Multi-Modulated (M) | Met: Identical to Model 989. |
| Preprogrammed Output Modes: ELF, DP, HF, BM, RB, MA, ARB, RAM | Met: Identical to Model 989. |
| Housing Materials: ABS Plastic | Met: Identical to Model 989. |
| Output Type: Constant voltage, 200Ω - 1kΩ | Met: Identical to Model 989. |
| Minimum Electrode Size (active area): NeuroEase .25in² (1.6cm²) | Met: Identical to Model 989. |
| Maximum RMS Current Density: 30.9mA/in² (4.88mA/cm²) | Met: Identical to Model 989. |
| Maximum Power Density: 243 W/in² (38 mW/cm²) | Met: Identical to Model 989. |
| Maximum Average Phase Current (200Ω load): 77mA | Met: Identical to Model 989. |
| Maximum Enclosure Leakage Current: 100μA | Met: Identical to Model 989. |
| Maximum Patient Leakage Current: 100μA | Met: Identical to Model 989. |
| Size: 3.7in.x2.5in.x0.84in. | Met: Identical to Model 989. |
| Weight: 145 gm with battery | Met: Identical to Model 989. |
| Power Source: 9 V Alkaline Battery or equivalent, Empi rechargeable battery | Met: Identical to Model 989. |
| Output Indicator: Red LED (predicate); Green LED (new device) | Met: Change from red to green LED; no testing needed as it's a cosmetic/technical change not affecting performance. |
| Low Battery Indicator: Yellow | Met: Identical to Model 989. |
| High Amplitude Shutdown (Output Interlock): Addition of this feature to meet international device standards, preventing rapid current increase from a no-output condition. | Met: This is an added safety feature that does not impact device performance with respect to its intended therapeutic use. Functional testing confirmed it meets requirements. |
Here's why the other requested information is not applicable to this 510(k) submission:
- Sample size for the test set and the data provenance: Not applicable. This was a non-clinical, bench-testing comparison of specifications and functional verification, not a study involving patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There was no "ground truth" established by experts in the clinical sense, as no clinical data or diagnostic interpretations were being evaluated. The "ground truth" was the predicate device's established performance and the engineering specifications.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical adjudication was performed.
- 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 device, nor a device requiring human interpretation for its function.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a TENS unit, not an algorithm-based device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" was based on the predicate device's established technical specifications and performance, and industry safety standards, rather than clinical outcomes or pathological findings.
- The sample size for the training set: Not applicable. There was no machine learning model or "training set" involved.
- How the ground truth for the training set was established: Not applicable.
In summary: The Epix XL Model 995 demonstrated substantial equivalence through a direct comparison of product specifications (indicating identical or acceptably minor/beneficial differences like the LED color or added safety feature) and non-clinical functional testing to ensure the device met its engineering requirements. No clinical studies or patient data were required due to the nature of the changes and the device type.
§ 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).