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To: 1) temporarily relieve minor pain, stiffness and muscle spasms; and 2) temporarily increase the local blood circulation.

Elysiom™ Polychromatic LED Light Therapy (PLLT) System is a pulsed light emitting diode (LED) device providing a temporary increase in local circulation and temporary relief of minor pain. The LED lights provide gentle warmth. Elysiom™ uses a unique timed sequence of emissions, known as pulses, to create an environment in which change occurs regularly and rapidly.

The provided text describes a 510(k) premarket notification for a medical device called the Elysiom Polychromatic LED Light Therapy System. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the demonstration of substantial equivalence to a predicate device, as opposed to a clinical study proving standalone effectiveness against specific clinical endpoints with predefined acceptance criteria for sensitivity, specificity, etc.

Here's a breakdown of the information based on your request, interpreted in the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission like this, "acceptance criteria" are typically defined by demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness as a predicate device. Performance is shown through non-clinical testing and comparison to the predicate.

• Both are pulsed infrared devices using a separate controller to power flexible pads attached by a cable.
• Both contain an array of light-emitting diodes from the same LED supplier.
• Both controllers are designed to power more than one pad at a time.
• Both are powered by power supplies converting power to 12VDC.
• Both operate with a microprocessor, a timer, and an auto shut-off feature.
• Both have designs to allow the controller to fail in the SAFE MODE (power down completely).
• Both use 5 pin DIN plugs.
• Key specifications (e.g., output power increments, power requirements, energy, beam diameter, LED output wavelengths) are highly similar or within comparable ranges.
• Minor differences like port configurations (2 and 6 for Elysiom vs. 2, 3, or 4 for HealthLight) and number of available pads (9 for Elysiom vs. 7 for HealthLight) were deemed not to adversely impact safety and effectiveness. |
  | Performance Data (Non-Clinical): Verification of software, electrical safety, and electromagnetic compatibility. | Met:
• Software Verification and Validation: Conducted by a third-party professional organization. All actual results matched expected results for both 2/Port and 6/Port configurations. "No deviations/failures. All tests passed indicating all [...] software requirements were met."
• Electromagnetic Compatibility and Electrical Safety (IEC 60601-1 and IEC 60601-1-2): Tested by UL, LLC. The test results demonstrated that both 2/Ports and 6/Ports Elysiom™ Polychromatic LED Light Therapy (PLLT) System met IEC Electronic Safety and Electromagnetic Compatibility criteria (IEC 60601-1-1/IEC62471:2008 and IEC60601-1-2, 3rd Edition). The risks for the device were deemed "extremely low and can always be mitigated." |
  | Safety and Effectiveness: Demonstration that any differences do not raise new questions of safety or effectiveness. | Met: The submission explicitly states, "The differences identified above do not adversely impact the safety and effectiveness of the In Light Wellness Systems Elysiom™ device." This is a fundamental conclusion required for 510(k) clearance. |

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

The document does not describe a traditional "test set" in the sense of patient data for a diagnostic algorithm. Instead, the "testing" refers to non-clinical engineering and software validation tests.

• Software Verification and Validation: The "test set" would be the conditions and scenarios created to test the software functions (e.g., 2/Port Reconciliation, 6/Port Reconciliation). No specific sample size (e.g., number of test cases) is given, but it is implied a comprehensive set was used as "All Actual Results matched the Expected Results."
• Electromagnetic Compatibility and Electrical Safety: The "test set" here refers to the device prototypes (2/Ports and 6/Ports Elysiom™ systems) subjected to the specific IEC standards tests.

Data Provenance: The tests were conducted by professional organizations (Business & Decision for software, UL, LLC for electrical safety/EMC). This is non-human, non-clinical data, so country of origin or retrospective/prospective is not applicable in the typical sense.

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

Not applicable. This device is an LED therapy system for pain relief and circulation, not a diagnostic device requiring expert interpretation of medical images or data to establish ground truth. The "ground truth" for the non-clinical tests was the expected behavior/performance according to engineering specifications and regulatory standards.

4. Adjudication Method (for the test set)

Not applicable. There was no expert adjudication process involved as described for diagnostic device performance. The "adjudication" was the Pass/Fail determination against established engineering and regulatory test standards by the testing organizations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This is a 510(k) clearance for a physical therapy device based on substantial equivalence, not a study of AI assistance for human readers in a diagnostic context.

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

Not applicable. This device is not an algorithm, it is a physical therapy device. The non-clinical tests (software, electrical safety, EMC) assessed the device's inherent functional performance at a component and system level, which could be considered analogous to "standalone" performance for a physical device.

7. The Type of Ground Truth Used

For the non-clinical tests:

• Software Verification and Validation: Ground truth was defined by the software requirements and expected results/behavior derived from design specifications.
• Electromagnetic Compatibility and Electrical Safety: Ground truth was defined by the requirements of the international standards (IEC 60601-1, IEC 60601-1-2, IEC 62471:2008).

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable, as there is no training set.

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