(266 days)
Portable Electro-Stimulation Therapy Device, model LGT-235 is indicated for the Symptomatic relief of chronic intractable pain, Post-traumatic pain and Post-surgical pain of the arms and legs.
The Portable Electro-Stimulation Therapy Device, model LGT-235 is a stimulator which sends gentle electrical current to underlying nerves via electrodes (Knee brace or self-adhesive electrode) applied on the skin with two operational modes and powered by rechargeable lithium battery; the device system is made up of mobile app MStim Arth, main unit and electrodes (Knee brace and self-adhesive electrode).
The Mobile App MStim Arth provides access to treatment controls for Portable Electro-Stimulation Therapy Device from a compatible mobile device for selecting a pre-programmed output mode and treatment time.
The main unit provides access to adjust the intensity up or down, put ON/OFF the main unit.
The two modes that Portable Electro-Stimulation Therapy Device, model LGT-235 employs are transcutaneous electrical stimulation (TENS) and Microcurrent (MCR).
TENS and MCR are both specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. TENS and MCR use tiny electrical impulses sent through the skin to nerves to modify the pain perception. TENS and MCR do not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves. Knee brace is placed on the leg or arm close to the area of pain.
The provided text describes the Portable Electro-Stimulation Therapy Device, model LGT-235, and its substantial equivalence to a predicate device (Sonicator Plus 920, Model ME 920), which implies that it meets certain performance criteria. However, the document does not explicitly list quantitative acceptance criteria for the device's performance in terms of clinical efficacy or diagnostic accuracy. Instead, it focuses on demonstrating equivalence through technical specifications and compliance with recognized safety standards.
Therefore, many of the requested fields cannot be filled as they relate to clinical studies or performance metrics that are not detailed in this 510(k) summary.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria for clinical performance (e.g., pain reduction percentage, accuracy). Instead, it compares the technical characteristics and output specifications of the subject device to the predicate device, with the implicit acceptance criterion being "similar" or "same," meaning the differences do not raise new questions of safety or effectiveness.
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Subject Device) |
|---|---|---|
| Classification | Same as Predicate | 21 CFR 882.5890 (Same) |
| Product Code | Same as Predicate | GZJ (Same) |
| FDA Class | Same as Predicate | 2 (Same) |
| Intended Use | Same as Predicate | Symptomatic relief of chronic intractable pain, Post-traumatic pain, Post-surgical pain (Same) |
| Principle of operation | Same as Predicate | Sends gentle electrical current to muscle group via electrodes applied on the skin (Same) |
| Target Population | Same as Predicate | Adults (Same) |
| Anatomical Site | Same as Predicate | Arm and legs (Same) |
| Waveform | Same as Predicate | Symmetrical biphasic (Same) |
| Maximum Output Voltage | Similar to Predicate, acceptable differences | TENS: 50V @ 500 Ω, 115 V @ 2 kΩ, 125 V @ 10 kΩ; MCR: 0.45 V@ 500 Ω, 1.8 V@ 2 kΩ, 7.4 V @ 10 kΩ (Similar, acceptable error in MCR) |
| Maximum Output Current | Similar to Predicate, acceptable differences | TENS: 100 mA@ 500 Ω, 58 mA@ 2 kΩ, 13 mA@ 10 kΩ; MCR: 0.92 mA@ 500 Ω, 0.90 mA@ 2 kΩ, 0.74 mA@ 10 kΩ (Similar, acceptable error in MCR) |
| Pulse Width (TENS) | Similar to Predicate | 100 ~ 600 µs (Similar, within safe/effective range of predicate) |
| Pulse Width (MCR) | Similar to Predicate | 1.25 ms ~ 1.67 s (Similar, within safe/effective range of predicate) |
| Frequency (TENS) | Similar to Predicate | 0.5 ~ 250 Hz (Similar, predicate range overriding proposed device suggests safety) |
| Frequency (MCR) | Similar to Predicate | 0.3 ~ 400 Hz (Similar, predicate range overriding proposed device suggests safety) |
| Maximum Intensity | Same as Predicate | 100 mA (Same) |
| Net Charge (µC/pulse) | Same as Predicate | 0 µC @ 500Ω (Same) |
| Maximum Phase Charge | Similar to Predicate | TENS: 60 (µC) @ 500Ω; MCR: 75 (µC) @ 500Ω (Similar, predicate range overriding proposed device suggests safety) |
| Maximum Current Density | Similar to Predicate, acceptable differences | TENS: 1.97 (mA/cm²) @ 500Ω; MCR: 0.026 mA/cm² @ 500Ω (Similar, TENS proposed device is overriding predicate; for MCR, slightly larger but proven safe by IEC 60601-2-10) |
| Maximum Power Density | Similar to Predicate, acceptable differences | TENS: 8.26 mW/cm² @ 500Ω; MCR: 0.016 W/cm² @ 500Ω (Similar, TENS proposed device is overriding predicate; MCR within acceptable limits per guidance) |
| Biocompatibility | Pass ISO 10993-5 and 10 | Knee brace demonstrated safety by passing ISO 10993-5 and -10. (Meets) |
| Electrical Safety | Pass ANSI AAMI ES60601-1 | Demonstrated electrical safety by passing ANSI AAMI ES60601-1 and meeting relevant chapters. (Meets) |
| Electromagnetic Compatibility (EMC) | Pass IEC 60601-1-2 | Demonstrated EMC by passing IEC 60601-1-2. (Meets) |
| Safety of Nerve & Muscle Stimulators | Pass IEC 60601-2-10 | Demonstrated safety by passing IEC 60601-2-10. (Meets) |
| Home Healthcare Environment Safety | Pass IEC 60601-1-11 | Demonstrated safety by passing IEC 60601-1-11. (Meets) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission focuses on non-clinical (engineering, safety, and performance) testing, and does not describe a clinical test set or its provenance.
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)
This information is not applicable/not provided. The document describes non-clinical testing and equivalency to a predicate device, not a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. There is no described clinical test set with ground truth 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
This information is not applicable/not provided. The device is an electro-stimulation therapy device for pain relief, not an AI-assisted diagnostic or interpretative device that would typically involve human "readers" or MRMC studies for AI improvement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. The device is a therapy device, not an algorithm, and its performance is assessed against electrical and safety standards, not standalone diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided. The "ground truth" for the non-clinical tests involved comparing the device's measured electrical outputs and safety characteristics against established international standards (ISO, ANSI, IEC) and the specifications of the predicate device.
8. The sample size for the training set
This information is not applicable/not provided. As this is a 510(k) for a physical medical device (electro-stimulation therapy), not an AI/ML algorithm, there is no "training set" in the conventional sense.
9. How the ground truth for the training set was established
This information is not applicable/not provided. See response to point 8.
§ 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).