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The surgical lights BERCHTOLD CHROMOPHARE® F 628 and F 528 are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.

The new BERCHTOLD CHROMOPHARE® F 628 and F 528 surgical lights are suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) in combination with reflector technology, BERCHTOLD realizes high illumination intensity with a lower heat radiation and less pattern variation compared to previous generations of BERCHTOLD products. The light features easy-to-operate swivel arms. Each light functions with an optional integrated in-light video camera and/or with upward "EndoLite" and/or with downward "GuideLite" for endoscopic procedures. The lights could be combined among each other or with other CHROMOPHARE devices, on ceiling mounted, wall mounted and floorstand configurations.

This looks like a 510(k) summary for a surgical lamp, not an AI/ML device. Therefore, many of the requested fields related to AI/ML device studies, such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment for AI models, are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not applicable. This device is a surgical lamp, and its performance was evaluated through engineering and product testing against established standards, not through a clinical test set with patient data.
• Data Provenance: Not applicable. The testing described is hardware-level performance validation against industry standards.

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

• Not applicable. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts on a dataset. For a surgical lamp, performance is assessed against technical specifications and safety standards, not expert-labeled data.

4. Adjudication Method for the Test Set:

• Not applicable. There was no 'test set' in the AI/ML sense, and thus no adjudication method for expert disagreement. Performance was evaluated against objective technical 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:

• Not applicable. This is for AI/ML devices. The CHROMOPHARE® F 628 and F 528 are surgical lamps and do not involve human readers or AI assistance in their function. Clinical testing was not required or utilized.

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

• Not applicable. This is for AI/ML algorithms. The device is a physical surgical lamp.

7. The Type of Ground Truth Used:

• Not applicable in the AI/ML context. The "ground truth" for this device's performance is adherence to the technical specifications outlined in IEC 60601-2-41:2001, IEC 60601-1, and IEC 60601-1-2. These standards define objective, measurable performance characteristics like illumination intensity, shadow reduction, heat radiation, electrical safety, and mechanical integrity.

8. The Sample Size for the Training Set:

• Not applicable. There is no training set for a surgical lamp.

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

• Not applicable. There is no training set for a surgical lamp.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The study that proves the BERCHTOLD CHROMOPHARE® F 628 and F 528 surgical lamps meet their acceptance criteria is a technical and performance testing study conducted in accordance with international standards.

• Standards Applied:

  • IEC 60601-2-41:2001: This standard specifically governs the safety and essential performance of surgical luminaires and luminaires for diagnosis. The document states that "Testing was conducted in accordance with this standard to support substantial equivalence. The F [device] has complied... all requirements of the performance standard and achieved specified desired values per the product design specifications."
  • IEC 60601-1: This is the general standard for medical electrical equipment, covering basic safety and essential performance. The devices "were subjected to testing in accordance with IEC 60601-1... for mechanical and electrical safety."
  • IEC 60601-1-2: This collateral standard addresses electromagnetic disturbances (EMC) for medical electrical equipment. The devices "were subjected to testing in accordance with... IEC 60601-1-2 for mechanical and electrical safety."

• Conclusion: The tests demonstrated that the new devices meet all the requirements of these standards, ensuring their safety and performance are equivalent to, or surpass, that of the predicate device (BERCHTOLD CHROMOPHARE® E 668, K090378). The "Performance Comparison Summary" explicitly states that the device conforms to IEC 60601-2-41:2001 and "achieved specified desired values per the product design specifications." Clinical testing was explicitly not required or utilized for this submission.

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