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The Erchonia® FX-635 laser is indicated for the following two indications:

• a. as an adjunct to provide relief of minor chronic low back pain of musculoskeletal origin.
  b. as an adjunct to reducing chronic heel pain arising from plantar fasciitis.

The Erchonia® FX-635 (Model#: HPS) is low level laser system that uses three semi-conductor diodes (visible red-light) 630nm to 650mm. The Erchonia® FX-635 (Model#: HPS) is a variable hertz device. The variable hertz feature of the Erchonia® FX-635 (Model#: HPS) is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX 635 (Model#: HPS) has been classified by the FDA/EC as a Class II/Ila device and a Class II/2 Laser. Erchonia® FX-635 (Model#: HPS) is indicated for use as an adjunct to provide relief of minor chronic low back pain of musculoskeletal origin. Erchonia® FX-635 (Model#: HPS) is also indicated for use as an adjunct to reducing chronic heel pain arising from plantar fasciitis.

The components of the device include a mobile base which plugs into the wall, using a hospital grade power cord, equipped with a medical grade transformer. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power. Four (4) antistatic wheels that enable ease for maneuverability. A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The laser diodes can only be on or off; there is no user interface that allows the end user to alter the laser diode output. The low back protocol and heel pain protocol is factory set and cannot be altered by the end user, 20 minutes for providing relief of minor chronic low back pain of musculoskeletal origin, or 10 minutes for reducing chronic heel pain arising from plantar fasciitis, prior clearance K132940. The device has an adjustable main arm that is attached to the mobile base with the laser head assembly located at the end. The adjustable main arm is capable to collapse into the mobile base for storage and transporting or extends to position the laser heads above the area of involvement. The laser head assembly that is attached to the adjustable main arm that is manually raised and lowered, utilizes internal mechanics that collects the light emitted from each of the three (3) laser diodes that rotate in a spiraling circle pattern that is totally random and independent of the other diodes. The laser head assembly is positioned 3-4 inches from the patient's skin to deliver treatment for low back pain or treatment for heel pain. This assembly can be rotated 120 degrees for proper positioning to patient for accurate treatment. The laser head assembly includes arms and pivots that allow the three (3) laser output heads to be rotated, tilted, and raised / lowered independently. The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons; work in conjunction with the component platform to ensure the device operates as intended.

The associated accessories include:

• Hospital grade power cord ●
• Patient protective eyewear
• Power safety lockout kevs .

The Erchonia® FX-635 laser is indicated as an adjunct to provide relief of minor chronic low back pain of musculoskeletal origin and as an adjunct to reducing chronic heel pain arising from plantar fasciitis.

Here's an analysis of the acceptance criteria and the study that supports it:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance (for the Low Back Pain Study)

• Sample Size: 58 subjects completed the study.
  • 29 subjects randomized to the active procedure group.
  • 29 subjects randomized to the placebo group.
• Data Provenance: The document does not specify the country of origin for the data. The study was described as a "multi-center design," implying data from multiple locations, but not specific countries. The study appears to be prospective as it describes a controlled clinical trial where subjects actively participated in interventions and follow-up.

3. Number of Experts and Qualifications (for Ground Truth Establishment)

• This information is not provided in the document. The study relied on self-reported Visual Analog Pain Scale (VAS) ratings and Oswestry Disability Index (ODI) scores, as well as objective range of motion measurements. There is no indication that external experts were used to establish a 'ground truth' for individual cases, but rather standard clinical outcome measures were utilized.

4. Adjudication Method (for the Test Set)

• This information is not applicable in the context of this study. The primary outcome measures were self-reported pain ratings and validated disability questionnaires, not a diagnostic interpretation requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This study evaluated the direct effectiveness of the laser device compared to a placebo, not the comparative effectiveness of human readers with vs. without AI assistance. The device is a therapeutic laser, not a diagnostic AI tool for image interpretation.

6. Standalone Performance (Algorithm Only)

• Yes, a standalone study was done in the sense that the device was tested as an independent intervention (the "active procedure") against a placebo. Since this is a therapeutic device, not an AI algorithm, the concept of "algorithm only without human-in-the-loop performance" doesn't directly apply in the same way it would for a diagnostic AI. The device itself performs the therapeutic action.

7. Type of Ground Truth Used

• The "ground truth" for evaluating the device's effectiveness was established through:
  • Self-reported patient outcomes: Visual Analog Scale (VAS) for pain and Oswestry Disability Index (ODI) for disability. These are standardized and widely accepted patient-reported outcome measures in clinical research for pain and musculoskeletal conditions.
  • Objective physiological measurements (secondary): Flexion, extension, and lateral flexion range of motion (ROM) measurements.

8. Sample Size for the Training Set

• Not applicable. This device is a physical therapeutic laser, not a machine learning model that requires a training set in the conventional sense. The "training" for the device would be its engineering and manufacturing to specific parameters, not data input.

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

• Not applicable. (See point 8). The device's operational parameters (e.g., wavelength, power, treatment time) are based on physical and biological principles, and possibly prior research and predicate device characteristics, rather than a machine learning "ground truth" derived from a dataset. The device's "programming" (fixed protocols for low back pain and heel pain) is factory-set, not learned from data.

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