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ALM S.A. PrismAlix® (PRX) Surgical Lights with Energix™ Power Supply are intended to be used to provide visible illumination of the surgical area or the patient. The Energix™ Power Supply is intended for use with surgical light systems.

The PrismAlix® (PRX) Surgical Light System is an existing product line that will allow modification via the use of an updated Energix™ Power Supply as its means to control the surgical lighthead illumination levels. The updated Energix™ Power Supply contains software that enables additional features and capabilities not available on the earlier version of Energix™ Power Supplies. These include:

• a) The power supply and regulators,
• b) one or two touch-pad units that provide the user the ability to:
  • i) turn on/off one or two lightheads,
  • ii) adjust illumination intensity levels and
  • iii) additional Light Emitting Diodes (LEDs) are used to indicate:
    • (1) the illumination level,
    • (2) bulb failure sensing and
    • (3) power supply mode: Mains supply: green LED or the switching to a battery back-up system results in the LED indicator changing its color to red.
      An optional RS232 Communication Motherboard is also a new feature that allows shifting An optional ROZOE Ochinanicaa specified distance (50m, 164 ft.) away from the surgical Controls to a romote bite are provided specific user and maintenance type information/data, displayed on a Liquid Crystal Display (LCD) window located on the front information and the Energix™ power supply. The user also has an option to have data communicated to a personal computer (PC).
      The LCD can show information about preventive maintenance type items, including:
• 1. programming of maintenance inspections
• 2. storage of operating parameters
• 3. hours of operation
• 4. bulb life data
• 5. self-diagnosis information
• 6. direct reading of parameters voltage, current, temperature
• 7. traceable management data serial number, software version number, production and service dates)

The provided text describes a 510(k) summary for a modified surgical light, the ALM PrismAlix® (PRX) Surgical Light with an upgraded Energix™ Power Supply. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria for a new, innovative medical device from first principles.

Therefore, the requested information elements related to clinical studies, ground truth establishment, expert adjudication, sample sizes, and AI performance are largely not applicable or not explicitly detailed in this type of regulatory submission.

However, I can extract the relevant information regarding acceptance criteria (in this case, conformance to recognized standards) and the "study" (testing) that demonstrates this conformance.

Here's the breakdown 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: Not specified in the document. This typically refers to the number of physical devices or components tested.
• Data Provenance: The document states "Test Data" which implies internal testing conducted by the manufacturer or a contracted testing facility. The country of origin of the data is not specified, but the submission is for a US market regulated by the FDA. The testing conducted would be considered prospective in the sense that it was done specifically to demonstrate compliance for this submission.

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

• Not Applicable. The "ground truth" for this type of device (a surgical light system) is established by its adherence to widely recognized safety and performance standards, not by expert consensus on clinical findings. The testing involves objective measurements against predefined limits outlined in the standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not Applicable. As no expert consensus or subjective assessment is involved, no adjudication method is used. Conformance is determined by objective measurements in line with the referenced standards.

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

• No. This is a hardware device (surgical light) with some integrated software for control. It is not an AI-powered diagnostic or assistive tool for human readers, so an MRMC study is not relevant or performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is not an algorithm-only device. The software present (in the Energix™ Power Supply) controls hardware components (light intensity, on/off, displays status information) and is integral to the device's function, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" in this context is the predefined requirements and limits specified within the referenced international and national standards (UL, CSA, IEC, EN). The device's performance is measured against these technical specifications.

8. The Sample Size for the Training Set

• Not Applicable. There is no mention of a training set as this device does not utilize machine learning or AI models that require training. The software is deterministic control software.

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

• Not Applicable. As there is no training set, this question is not relevant.

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