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The MedX HOME System Console System is an infrared lamp system, The Medx HOME System Console of Stations of Station of Call heating as per 21 CFR 890.5500. as per 21 CFR 090155001 Title temporary increase in local blood when neat is indicated "relief of minor muscle and joint aches, pains Circulation, temporary relier of muscles; for muscle spasms, and minor pain and stiffness associated with arthritis".

MedX HOME console powers one to two SLD Accessories. It uses the MedX 600 accessory, called the MedX 601 SLD accessories for the HOME unit and a smaller console, based on the MedX 1100 Console. The MedX HOME console powers one to two SLD accessories. The MedX HOME Console includes semiconductors and assembly, electronics, controls, liquid crystal display, front panel and labels. The front panel contains the membrane switch with command keys to enter data and select options. The port on the right side of the console is dual purpose. First, with the use of a programming key, the clinician can access software to sets the specific treatment parameters for individual patients. Without this key plugged in the software is not visible. The second purpose of the port is for the patient to pluq in the SLD accessories. This only provides access to a limited area of the software, allowing the patient to select one of potentially 5 different treatment numbers associated with a pre-programmed treatment. The left side of the console panel has the ON/OFF switch and the plug for the electrical outlet. The liquid crystal display provides 4 lines of 15 characters each line for prompting, options, and selections. The main label is located on the rear panel of the console. The MedX HOME uses the MedX 600 SLD accessory, called the MedX 601 for this purpose, to generate therapeutic heating, to comply with the heating category, ILY requirements. The SLD accessory use 633 nm and 870 nm superluminous diodes to produce the heat required for topical heating, resulting in the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, and minor pain and stiffness associated with arthritis. The SLD device generates 500 mW of power to produce therapeutic heat. The accessories are powered by the console and can be set to pulse from 1 – 2000 pulses per second. The console automatically turns itself off after the set treatment time has been delivered.

Here's a breakdown of the acceptance criteria and study information for the MedX HOME device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. The submission states, "No clinical research was conducted for this specific 510(k) submission."
• Data Provenance: Not applicable for clinical testing. For non-clinical testing, it was "Internal testing." The device also notes Health Canada Medical Device Branch Therapeutic Devices Directorate approval (Canada).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not applicable, as no clinical research was conducted for this specific submission to establish ground truth for a test set. The claims for therapeutic heating effects are based on "Clinical practice and academic research" for infrared lamps generally, not specific to this device's clinical trial.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical research was conducted for this specific submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. The submission explicitly states "No clinical research was conducted for this specific 510(k) submission."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This device is a therapeutic heating device, not an AI/algorithm-based diagnostic or assistive system. Therefore, the concept of "standalone (algorithm only)" performance is not relevant. The device operates as intended by delivering physical energy (heat).

7. Type of Ground Truth Used

• For the device's safety and functional performance, the ground truth appears to be based on engineering standards compliance (UL 2601, international and US medical electrical equipment standards) and internal testing results demonstrating the device's physical output (e.g., warming surface temperature, power output).
• For the therapeutic claims (e.g., temporary relief of muscle aches), the ground truth is implicitly based on existing clinical consensus and academic research regarding the known effects of therapeutic heating from infrared lamps, as applied to the predicate device and the general class of devices.

8. Sample Size for the Training Set

• Not applicable. The MedX HOME is a physical medical device that delivers therapeutic heat, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as the device doesn't use a training set in the context of machine learning.

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