Search Results
Found 2 results
510(k) Data Aggregation
(180 days)
NEUROLUMEN, LLC
The Neurolumen is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
The Neurolumen is also indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-traumatic acute pain.
The Neurolumen is a medical therapy device that delivers Transcutaneous Electrical Nerve Stimulation (TENS) and Low Level Laser Therapy (LLLT) to a patient's limbs.
The Neurolumen consists of a control unit and six wraps. Each wrap contains two laser diodes, 4 light emitting diodes, and one or two TENS gel pads. After applying the wraps to the feet, ankles, and legs, the control unit is able to provide up to 30 minutes of therapy on a single charge of the internal lithium-ion battery. A charger is provided for recharging the internal battery.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Neurolumen PN-1000 device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel clinical efficacy. Therefore, a formal table of explicit acceptance criteria and device performance as might be seen for a new drug or Class III device is not explicitly present.
However, we can infer some performance aspects from the device testing results provided:
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Ability to raise skin temperature to 40-45 degrees C for at least 10 minutes. | "The testing results confirmed that the unit is capable of raising and maintaining these temperatures." (for laser diodes) |
| Compliance with national and international safety standards. | "The New Device has been fully tested to national and international safety standards for medical devices, including IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-10, and IEC 60825-1." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Three subjects.
- Data Provenance: The document does not specify the country of origin for the data or if it was retrospective or prospective. Given the small number of subjects, it was likely an internal, prospective test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" in this context refers to direct measurements of skin temperature, not expert assessment of a condition or image.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The testing involved direct physical measurements of temperature, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document describes safety and thermal effect testing, not comparative clinical efficacy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the thermal testing for the laser diodes was a standalone performance test of the device's physical output (temperature generation) without human intervention in operating the core function being measured.
7. The Type of Ground Truth Used
- The ground truth for the specific test described (laser diode thermal output) was direct physical measurement (skin temperature).
8. The Sample Size for the Training Set
- Not applicable. This device is a therapeutic medical device, not an AI/ML algorithm that requires a training set in the typical sense. The firmware for the microcontroller was developed, but the term "training set" doesn't apply here.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set in the AI/ML context. The firmware development followed the FDA guidance document on medical devices containing software, which implies a structured development and validation process rather than machine learning training.
Ask a specific question about this device
(258 days)
NEUROLUMEN, LLC
LED Stimulation for therapeutic heat
The NeurolumenPN is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated
TENS Stimulation
The symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-traumatic acute pain.
NeurolumenPN System, Model 1000
The provided text is a 510(k) premarket notification letter from the FDA regarding the NeurolumenPN device. This document confirms the substantial equivalence of the device to legally marketed predicate devices and outlines regulatory responsibilities. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested.
Therefore, I cannot provide the requested table and study details. The document is primarily an FDA communication approving the marketing of the device, not a technical report on its performance or the studies conducted for that purpose.
Ask a specific question about this device
Page 1 of 1