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510(k) Data Aggregation
(30 days)
Wireless Pain Relieve Device Model: LT5018C
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
The Wireless Pain Relieve Device includes TENS, EMS (including MASSAGE Program) mode. Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, drug free method of controlling pain. EMS works by sending electronic pulses to the muscle needing treatment; this causes the muscle to exercise passively. The Wireless Pain Relieve Device is controlled by means of an APP on a mobile device (phone or table) and remote control. The communication is done via Bluetooth Low Energy. The APP operates on IOS and Android platforms (IOS 8.0 or greater, Android 5.0 or greater).
The provided text describes the 510(k) summary for the Wireless Pain Relieve Device, Model LT5018C, and its comparison to a predicate device (Smart Pain Reliever LT5019). It doesn't detail a study to prove acceptance criteria in the typical sense for assessing diagnostic or prognostic performance (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are related to established safety and performance standards for electrotherapy devices, and the "study" is a series of engineering tests and comparisons to the predicate device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are compliance with recognized electrical safety, electromagnetic compatibility (EMC), and software standards, as well as maintaining similar output specifications to a predicate device.
| Acceptance Criterion (Standard or Characteristic) | Reported Device Performance (Wireless Pain Relieve Device, LT5018C) |
|---|---|
| Electrical Safety (IEC 60601-1, IEC 60601-1-11) | Complies |
| Specific Safety for TENS/EMS (IEC 60601-2-10) | Complies. Evaluated and passed tests. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies |
| FCC Part 15 C (Radio Frequency Devices) | Complies |
| Software Verification & Validation (FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304) | Conducted and documentation provided. "Moderate" level of concern. |
| TENS Mode Output Specifications | (Compared to Predicate LT5019) |
| Waveform | Biphasic (Same) |
| Shape | Rectangular (Same) |
| Max Output Voltage (500Ω) | 31V (Similar to 31.2V, passed IEC60601-2-10) |
| Max Output Voltage (2kΩ) | 66V (Similar to 69.6V, passed IEC60601-2-10) |
| Max Output Voltage (10kΩ) | 66V (Similar to 69.6V, passed IEC60601-2-10) |
| Pulse Duration | 150-250µs (Same) |
| Frequency | 2-100Hz (Same) |
| Max Phase Charge (500Ω) | 31µC (Similar to 30µC, passed IEC60601-2-10) |
| Max Current Density (500Ω) | 0.48mA/cm² (Similar to 0.32mA/cm², passed IEC60601-2-10) |
| Max Average Current (500Ω) | 1.2mA (Same) |
| Max Average Power Density (500Ω) | 2.88 mW/cm² (Similar to 1.9 mW/cm², far lower than 250mW/cm² FDA guidance for Powered Muscle Stimulator) |
| EMS Mode Output Specifications | (Compared to Predicate LT5019) |
| Waveform | Biphasic (Same) |
| Shape | Rectangular (Same) |
| Max Output Voltage (500Ω) | 31V (Similar to 31.2V, passed IEC60601-2-10) |
| Max Output Voltage (2kΩ) | 66V (Same as 66V) |
| Max Output Voltage (10kΩ) | 66V (Similar to 69.6V, passed IEC60601-2-10) |
| Pulse Duration | 200-370µs (Same) |
| Frequency | 3-55 Hz (Similar to 3-75Hz, passed IEC60601-2-10) |
| Max Phase Charge (500Ω) | 44.4µC (Similar to 24µC, passed IEC60601-2-10) |
| Max Current Density (500Ω) | 0.484mA/cm² (Similar to 0.248mA/cm², passed IEC60601-2-10) |
| Max Average Current (500Ω) | 1.22mA (Similar to 0.72mA) |
| Max Average Power Density (500Ω) | 2.93 mW/cm² (Similar to 1.2 mW/cm², far lower than 250mW/cm² FDA guidance for Powered Muscle Stimulator) |
| MASSAGE Program Output Specifications | (Compared to Predicate LT5019) |
| Pulse Duration | 50-250µs (Similar to 250µs, passed IEC60601-2-10) |
| Frequency | 2-90Hz (Similar to 10-80Hz, passed IEC60601-2-10) |
2. Sample Size Used for the Test Set and Data Provenance
This document describes technical performance testing rather than clinical study. Thus, concepts of "test set" sample size and data provenance (country of origin, retrospective/prospective) are not directly applicable in the way they would be for a diagnostic AI device.
- Test Set: The "test set" consisted of the physical device (Model LT5018C) undergoing various engineering tests (biocompatibility, electrical safety, EMC, software).
- Data Provenance: The tests are standard engineering evaluations of the device's hardware and software against recognized international standards. The provenance is from the manufacturer's testing or test labs conducting these certification tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth, in this context, is adherence to technical standards and the specifications of the predicate device, which is determined by testing against predefined objective criteria rather than expert interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. The "test set" here refers to the device being tested against technical standards, not a set of cases requiring adjudication for ground truth.
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 device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) for pain relief and muscle conditioning. It is not an AI-assisted diagnostic or prognostic device that would involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the device's function as a TENS/EMS unit. The device operates independently (albeit controlled by an app or remote control) to deliver electrical stimulation. The performance measured is its adherence to output specifications and safety standards, both of which are "standalone" in the sense that they assess the device's intrinsic characteristics. The regulatory submission primarily focuses on the device's adherence to these standards and its substantial equivalence to a legally marketed predicate via bench testing and comparison of technical specifications.
7. The Type of Ground Truth Used
The "ground truth" for this submission is:
- Compliance with recognized international standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-1-2, IEC 62304.
- Demonstrated performance within acceptable ranges: As compared to the predicate device (Smart Pain Reliever LT5019), and often also against general FDA guidance for Powered Muscle Stimulators (e.g., maximum average power density
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