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The Erchonia® FX-405 laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.

The Erchonia® FX-405 (Model#: MLS-AC) is low level laser system that uses three semi-conductor diodes (visible light) 630nm to 650nm with a mean power output of 17.25mW per diode and one semi-conductor diode 395nm to 415nm with a mean power output of 23.00mW. The Erchonia® FX-405 (Model#: MLS-AC) is a variable hertz device. The variable hertz feature of the Erchonia® FX-405 (Model#: MLS-AC) is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX-405 (Model#: MLS-AC) has been classified by the FDA/EC as a Class II device and a Class 2 Laser.

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. 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 can only be on or off; there is no user interface that allows the end user to alter the laserdiode output. 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 four (4) laser diodes and processes each through a proprietary patented lens which redirects the beam with a line refracted light is then bent into a spiraling circle pattern that is totally random and independent of the other diodes. 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 four (4) 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 exterior materials consist of 6061 T6 AL, Kydex 430 and Copolymer Acetal with powder coating and carbon fiber finish. The associated accessories include: (1) Hospital grade power cord, (1) Patient protective eyewear (sufficiently and effectively block the laser light spectrum at OD 2+ @ 635nm, OD 0.75 @ 405nm VLT60), (2) Power safety lockout keys.

The provided text describes an FDA 510(k) premarket notification for the Erchonia® FX-405 device, a low-level laser system indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.

Crucially, the document states: "No new clinical study results are being submitted as part of this [submission]. Clinical data previously reviewed in 510(k) submissions of the predicate device, the Erchonia® FX-635 Laser K190572, as well as the reference device, the Erchonia® EVRL Laser K191257 were provided to demonstrate safety of using the red and violet diodes simultaneously."

This means there is no new performance data or a new clinical study specifically conducted to establish acceptance criteria or prove device performance for the Erchonia® FX-405 in this submission. Instead, the submission relies on the substantial equivalence to previously cleared devices (predicate and reference devices) and data from their respective clinical trials.

Therefore, many of the requested details regarding acceptance criteria, study design, sample size, ground truth, and expert involvement for a new study are not applicable to this specific submission. The information provided relates to the comparison justifying substantial equivalence based on the technological characteristics and previously collected clinical data.

Based on the available information, here's a breakdown of what can and cannot be answered:

Acceptance Criteria and Reported Device Performance

There are no explicit "acceptance criteria" presented for a new clinical study of the FX-405 device in this document, as no new clinical study was performed. The "performance" being demonstrated is the substantial equivalence to the predicate and reference devices, implying that the FX-405 would achieve similar results as those demonstrated by the previous devices.

The table below summarizes the comparison of shared characteristics between the subject device (FX-405) and the predicate device (FX-635), which is used to argue substantial equivalence, rather than a direct performance outcome table for the FX-405 itself.

1. A table of acceptance criteria and the reported device performance

As stated above, no new clinical study was conducted for the FX-405. The "performance" is implicitly tied to the performance of the predicate and reference devices. The document does not provide a table of performance outcomes for the FX-405, but rather a comparison of its technical specifications to the predicate device leading to the conclusion of substantial equivalence.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable for a new study of the FX-405. The submission refers to clinical data from previous 510(k) clearances (K190572 for FX-635 and K191257 for EVRL). The sample sizes for those studies are not detailed in this document.
• Data Provenance: Not specified in this document for the previously conducted studies (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable: No new study with a "test set" and "ground truth" establishment was conducted for this specific submission of the FX-405. These details would pertain to the clinical trials supporting the predicate and reference devices, but are not provided here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable: Similar to point 3, no details on adjudication methods for establishing ground truth are provided.

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: The device is a low-level laser system for pain relief, not an AI-assisted diagnostic device involving human readers or image interpretation. Therefore, an MRMC study and AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable: This is a physical therapy device, not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Relevant to previous studies: For the previous clinical studies that supported the predicate and reference devices, the "ground truth" for the device's efficacy would have been outcomes data related to nociceptive musculoskeletal pain relief (e.g., pain scores, functional improvement). The specifics are not detailed in this document.

8. The sample size for the training set

• Not Applicable: This is not an AI/machine learning device with a "training set." The term "training set" is typically used in the context of data used to train AI models.

9. How the ground truth for the training set was established

• Not Applicable: See point 8. No training set for an algorithm is discussed. The "ground truth" for previous clinical studies (on which this submission relies) would have been established through clinical assessments and patient-reported outcomes for pain relief, but the methodology details are not included in this document.

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