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MAQUET LUCEA LED® Surgical Light Systems are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.

MAQUET LUCEA LED® Surgical Light Systems have been developed in order to provide MAQUET EUGEAEED Surgied Lightnology. An innovative design combined with a functional shape offers an efficient product to the surgical staff. functional shape oners an cindical provide hights provide high quality illumination Designed for minor ourgory, without any compromises on the major enhancements offered by MAQUET surgical lights. The LUCEA LED® Surgical Lights are well-suited for installation in surgical suites, examining rooms, doctor's surgeries and external consultations.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LUCEA LED® Surgical Light System:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices for a surgical light system. As such, it does not present quantifiable acceptance criteria for specific performance metrics in the way a diagnostic AI device's summary might. Instead, the "acceptance criteria" are implied by conformance to various medical device standards, and the "reported device performance" is the claim of meeting these standards.

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

This document does not describe a "test set" in the context of an AI device's performance evaluation (e.g., a set of images or cases). The testing described is engineering and regulatory compliance testing for a physical medical device (a surgical light). Therefore, concepts like sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable in the way they would be for an AI algorithm.

The testing involved evaluating the physical device against the listed standards. The "data provenance" for this type of testing is typically the testing laboratory or manufacturer's internal quality assurance processes.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For a surgical light system, "ground truth" as it relates to expert consensus on medical findings is not relevant. The device's performance is objectively measured against engineering and electrical safety standards.

4. Adjudication Method

Not applicable. This is not a study requiring adjudication of expert opinions.

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

No, this document does not mention or describe an MRMC comparative effectiveness study. This type of study is typically conducted for diagnostic or AI-powered devices to assess the impact of AI on human reader performance.

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

Not applicable. The LUCEA LED® Surgical Light System is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is defined by established engineering standards, product specifications, and regulatory requirements. The device's performance is measured against these objective, quantifiable benchmarks. For example, light intensity is measured in lumens, color temperature in Kelvin, and electrical safety against specific resistance and leakage current limits.

8. The Sample Size for the Training Set

Not applicable. The LUCEA LED® Surgical Light System is a physical medical device, not an AI model that requires training data.

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

Not applicable. As described above, there is no AI training set for this device.

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