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ELIXIR MDTM use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.

The red light (633±10nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.

The blue light (417±10 nm wavelength); is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The Yellow light (590±10nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.

The infrared light (835±15nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

The ELIXIR MD™ uses specific wavelengths of light, produced by LEDs (light emitting diodes), to manage aesthetic conditions.

The device produces light in the red-light region of the spectrum (633 ± 10m), in the blue light regions of the light spectrum (417 ± 10m), the yellow light area (590 ± 10nm) and the infrared light region of the light spectrum (835 ± 15m).

The ELIXIR MD™ is equipped with two irradiators. The RBY irradiator has five panels, each of which emits three different colors of light sources (red light, yellow light); The RBI irradiator has five panels. Each panel emits three different colors of light sources (red light, blue light, infrared light).

This document is a 510(k) Premarket Notification from the FDA for a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on clinical performance. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating diagnostic or treatment efficacy, will not be present in this document.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Device Performance:

The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device (K222751 LED Light Therapy Device, KN-7000L). The device's performance is not independently evaluated against pre-defined clinical success metrics. Instead, its technical specifications and intended use are compared to the predicate device.

The table in Section 8 provides a direct comparison demonstrating "same" or "—" (indicating a difference in proprietary name or manufacturer, not affecting substantial equivalence) across various parameters. This table serves as the performance "proof" by showing the proposed device matches the predicate.

Table of Acceptance Criteria (from a regulatory perspective - Substantial Equivalence) and Reported Device Performance:

The following points are mostly not applicable (N/A) for this type of 510(k) submission, as it relies on substantial equivalence to an existing device and not on a de novo clinical study proving performance from scratch.

2. Sample size used for the test set and the data provenance: N/A. This is a technical comparison for substantial equivalence, not a clinical trial with a "test set" of patients. The "test" mentioned refers to non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. No human expert "ground truth" was established for clinical performance evaluation in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A. No clinical test set 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: N/A. This device is an LED light therapy device for dermatological conditions and pain, not an AI-assisted diagnostic or imaging device used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. Not an algorithm-only device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A. The "ground truth" for this submission is the established safety and effectiveness of the predicate device, which the new device is demonstrated to be equivalent to based on technical and indications for use similarity and compliance with relevant safety standards.
8. The sample size for the training set: N/A. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: N/A. Not an AI/ML device.

What the document does describe regarding "proof" of meeting criteria:

• Non-Clinical Tests Performed (Section 10): This is the primary "study" proving the device meets safety and performance criteria (as defined by industry standards), analogous to specific acceptance criteria for a technical device.
  • Tests:
    • Electrical Safety and Electromagnetic Compatibility Testing (IEC 60601-1, -1-2, -2-57)
    • Photobiological Safety Testing (IEC 62471:2006)
    • Software Verification and Validation (for moderate level of concern software)
    • Bench Test Summary: Covering Appearance, Spectral peak wavelength, Effective irradiance, Timing and functions, Effective radiation area, Stand adjustment, Changeable treatment head, Uniformity of effective red light irradiance, Working noise, Protective grounding impedance, Continuous leakage current at normal operating temperature, Dielectric strength at normal operating temperature, Packing inspection.
  • Acceptance: The device "passed all the tests mentioned above."
  • Data Provenance: The tests are likely performed by the manufacturer or accredited testing labs, following international standards. The document doesn't specify the location of the testing.
• Conclusion (Section 11): States that "Based on comparing to predicate device, the proposed device... are determined to be Substantially Equivalent (SE) to the predicate device, in respect of safety and effectiveness." This is the ultimate "acceptance" for a 510(k) submission.

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