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510(k) Data Aggregation
(136 days)
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, 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.
The Wireless Pain Relieve Device includes TENS mode. Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, drug free method of controlling pain. TENS uses tiny electrical impulses sent through the skin to nerves to modify your pain perception. TENS does not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves. For Transcutaneous Electrical Nerve Stimulation (TENS) Self-adhesive electrodes are placed on the skin close to the area of pain. The user can choose 23 pre-set TENS programs. In each program, the intensity can be adjusted. The Wireless Pain Relieve Device is controlled by means of an APP on a mobile device (phone or table) or remote control. The communication is done via Bluetooth Low Energy. The APP operates on iOS or Android platforms (iOS 8.0 or greater, Android 5.0 or greater).
This document is a 510(k) summary for the Wireless Pain Relieve Device, Model LT5011C, seeking substantial equivalence to a predicate device (Wireless Pain Relieve Device LT5018C). It does not contain information about a clinical study with acceptance criteria and device performance in the manner typically seen for clinical trials. Instead, it focuses on demonstrating substantial equivalence through comparison of technological characteristics and compliance with electrical safety, EMC, and software standards.
Therefore, many of the requested items (acceptance criteria, device performance from a clinical study, sample sizes, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, and ground truth for training) cannot be extracted because this document describes a premarket notification for a Class II medical device based on substantial equivalence, not a detailed clinical study demonstrating new efficacy or performance.
However, I can extract information related to the technical performance and standards compliance tests performed to demonstrate safety and effectiveness for this type of device.
Here's a summary of the available information:
1. Table of acceptance criteria and the reported device performance (based on technical specifications and safety/EMC standards):
| Acceptance Criteria (based on standards/predicate) | Reported Device Performance (LT5011C) |
|---|---|
| Electrical Safety (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10): | Compliant |
| Patient Leakage Current (Normal Condition) | 0 uA (Same as predicate) |
| Patient Leakage Current (Single Fault Condition) | 2.0 uA (Same as predicate) |
| Average DC current through electrodes (device on, no pulses) | 0 (Same as predicate) |
| Method of Channel Isolation | By Electrical Circuit and Software (Evaluated and passed IEC60601-1) |
| Automatic Overload Trip | Yes (Same as predicate) |
| Automatic No Load contact Trip | Yes (Same as predicate) |
| Automatic Shut off | Yes (Same as predicate) |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2, FCC Part 15 Subpart C): | Compliant |
| Output Waveform Specifications (IEC 60601-2-10): | Verified via oscilloscope tracing diagrams to meet specifications |
| Max Output Voltage (V) ±20% (at 500Ω) | 30.5V (Similar to predicate 31V, evaluated and passed IEC60601-2-10) |
| Max Output Voltage (V) ±20% (at 2kΩ) | 65V (Similar to predicate 66V, evaluated and passed IEC60601-2-10) |
| Max Output Voltage (V) ±20% (at 10kΩ) | 65V (Similar to predicate 66V, evaluated and passed IEC60601-2-10) |
| Pulse Duration (µsec) | 100 |
| Frequency (Hz) | 2~100Hz (Same as predicate) |
| Maximum Phase Charge (uC) 500Ω | 24 uC (Similar to predicate 31 uC, evaluated and passed IEC60601-2-10) |
| Maximum Current Density 500Ω | 0.295mA/cm² (Similar to predicate 0.48mA/cm², evaluated and passed IEC60601-2-10) |
| Maximum Average Current (average absolute value), mA, 500Ω | 1.2mA (Same as predicate) |
| Maximum Average Power Density, (mW/cm²).500Ω | 1.74 mW/cm² (Similar to predicate 2.88 mW/cm², evaluated and passed IEC60601-2-10) |
| Biocompatibility (ISO10993-5/10): | The materials (electrodes, enclosure) are the same as the predicate device (K173462), which already received 510(k) clearance and was presumably tested for biocompatibility. No new biocompatibility testing was performed for LT5011C. |
| Software Verification and Validation (IEC 62304, FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"): | Compliant; Software considered "Moderate" level of concern. Verification and validation testing conducted and documentation provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This submission relies on technical testing and comparisons to a predicate device, not a clinical study involving patients or a test set of data in the sense of AI/ML evaluation.
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 ground truth establishment by experts for a test set is mentioned. The assessment is based on compliance with established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method for a test set is mentioned.
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) for pain relief, not an AI-assisted diagnostic or interpretive system. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI/algorithm-only device. Its performance is assessed through its electrical output characteristics and safety features.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" here is adherence to engineering specifications and international safety standards (IEC 60601 series, ISO 10993).
8. The sample size for the training set:
Not applicable. There is no training set in the context of an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable.
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