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Aesculap's Xenon Light Source is intended for use as a high intensity light to be used with Fiberoptic cables. Applications include endoscopes, surgical headlamps, and other lighted tools that contain fiberoptic bundles. Illumination from this device is intended to be used for observation of body cavities, hollow organs and other surgical sites. Specific areas of application include arthroscopy, laparoscopy, gynecology, broncoscopy, urology, neuroendoscopy and vascular endoscopy.

The Xenon Light Source consists of a light source control unit and fiber optic cables. Technological characteristics are provided below:
Design: Light Source in stainless steel / aluminum housing
Dimensions: 305mm x 305mm x 82mm
Weight: 6.5kg
Lamp: 180W Xenon
Circuit: Transistorized
Voltage: 100 - 240V
AC Power Freq.: 50 - 60 HZ

The provided text is a 510(k) summary for the "Aesculap Xenon Light Source". It describes the device, its intended use, and states its compliance with certain performance standards. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or effectiveness.

Instead, the document focuses on:

• Substantial Equivalence: The primary "study" mentioned here is a comparison to legally marketed predicate devices (EG&G Electro-Optics, Lutex, Karl Storz, Wolf) to establish substantial equivalence in features and function. This is a regulatory pathway, not a performance study in the sense of accuracy metrics.
• Safety Standards Compliance: The document states that the device complies with recognized safety standards (IEC 60601-1, IEC 60601-1-2, UL 2601-1). This is about electrical safety and electromagnetic compatibility, not clinical performance or diagnostic accuracy.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's a breakdown of what can be inferred or explicitly stated based on the text, and where information is missing:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not applicable. No performance study involving a test set of data is described. The "test" here refers to meeting safety standards and demonstrating substantial equivalence.
• Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No ground truth establishment for a diagnostic or performance test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable.

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 MRMC comparative effectiveness study was done. This device is a light source, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a light source, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. The "ground truth" for this device's regulatory clearance is its adherence to specified safety standards and its functional similarity to existing predicate devices.

8. The sample size for the training set

• Not applicable. No training set for an algorithm is mentioned.

9. How the ground truth for the training set was established

• Not applicable.

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