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The Trumpf surgical lights are intended to locally illuminate an operating or examination area of the patient's body with high intensity light.

Four models of the Trumpf surgical lights will be available: 301, 501, 701 and 1001. The versions differ in the diameter of the lamp housing (300 mm, 500 mm, 700 mm and 1000 mm, respectively). All lights are equipped with one or two halogen lamps and are available in either ceiling-mounted ("D") or wall-mounted ("W") configurations. The Model 301 is also available in a floor standing/mobile ("S") configuration. The lights may be mounted individually, but more typically are mounted as two- or three-unit aggregates. An optional laser pilot is available on the Models 501, 701 and 1001. The laser pilot exactly marks the center of the light field. This makes it easier for the user to focus the light field with precision even if the operating area is very small. Whenever the operating light is moved/repositioned, the laser pilot is activated. When the operating light comes to a standstill, the laser pilot continues to be in operation for another two seconds. The laser pilot can be deactivated via the control panel. The laser wavelength is 635 nm with a nominal output power of

The provided text is a 510(k) Summary of Safety & Effectiveness for the Trumpf Surgical Light. It details the device's characteristics, intended use, and its substantial equivalence to a predicate device. However, it does not include information about specific acceptance criteria or a study proving the device meets performance criteria in the way a clinical study for an AI/algorithm-driven device would.

This document describes a medical device (a surgical light) that is physically manufactured and tested against engineering standards rather than through clinical performance metrics like sensitivity, specificity, or reader agreement. Therefore, many of the requested points related to AI/algorithm performance and clinical studies are not applicable.

Here's why and what information can be extracted:

• Acceptance Criteria & Reported Performance (Table): The document refers to conformance with engineering standards, not clinical performance metrics.
• Sample Size (Test Set) & Data Provenance: Not applicable as this is a physical device tested against engineering standards.
• Number of Experts & Qualifications: Not applicable.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable.
• Standalone Performance: Not applicable.
• Type of Ground Truth: For a surgical light, "ground truth" would be established by physical measurements and adherence to specified engineering tolerances and safety standards.
• Sample Size (Training Set): Not applicable.
• Ground Truth for Training Set: Not applicable.

Here's the relevant information based on the document's content:

1. Table of Acceptance Criteria and the Reported Device Performance

Explanation for Other Points (Not Directly Applicable / Information Not Provided in the Text):

• Sample Size Used for the Test Set and the Data Provenance: This document describes a physical medical device (surgical light). The "test set" in this context refers to the manufactured units that underwent testing for compliance with engineering standards. The sample size is not specified but would typically involve testing representative units from a production batch or specific prototypes. Data provenance (country, retrospective/prospective) is not relevant for this type of device testing from the provided text.
• Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts: Not applicable. Ground truth for a surgical light's performance against engineering standards is established by objective measurements and compliance with the standards, not expert consensus in the clinical sense.
• Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set: Not applicable. Testing against engineering standards involves objective measurement and verification, not adjudication by experts for discrepancies.
• 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. This is a surgical light, not an AI or imaging diagnostic device that involves human readers.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device does not have a standalone algorithm in the typical sense of AI/diagnostic software. The "software testing" mentioned for the laser pilot and anti-drift system would refer to functional verification of those integrated electronic components, not an algorithm for clinical interpretation.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device's performance is established by the engineering standards themselves (IEC 60601-2-41, IEC 601-1/EN 60601-1) and objective measurements against the specifications outlined in those standards. This includes measures like light intensity, beam uniformity, heat output, electrical safety, and functional performance of features like the laser pilot.
• The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/machine learning model.
• How the ground truth for the training set was established: Not applicable.

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