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The surgical light family is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold light".

The iLED surgical light mobile family is suitable for all types of surgical procedures. TruLight 5000 light heads consists of two light modules and the iLED 3 consists of three light modules. The modules contain the LEDs with their optical devices. Each LED with its optical device illuminates the complete light field. Each light module has its own control to adjust the illumination parameters. The light heads operate the same and use the same electronics and software as the ceiling mounted iLED family surgical light systems.

Here's an analysis of the provided text regarding the acceptance criteria and study for the iLED Surgical Family, Mobile device:

Important Note: The provided text is a 510(k) summary for a surgical light, not an AI/ML medical device. Therefore, many of the requested categories, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only) performance," "ground truth," and "training set sample size," are not applicable to this type of device and submission. The FDA 510(k) process for a device like a surgical light focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance testing against established standards and comparison of technical specifications.

Acceptance Criteria and Device Performance for TRUMPF iLED Surgical Family, Mobile

Since this is a conventional medical device (surgical lamp) and not an AI/ML-driven device, the "acceptance criteria" are implied by the performance characteristics demonstrated and compared to the predicate devices and general standards for surgical lights. The "study" here refers to the justification for substantial equivalence.

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 in the context of an AI/ML device where a "test set" implies specific patient data. For this surgical light, performance is demonstrated through technical specifications, testing against industry standards, and comparison to predicate devices. There isn't a "test set" of patient cases.
• Data Provenance: Not applicable in the AI/ML sense. The performance characteristics of the device were assessed through engineering design, component testing, and comparison of technical specifications, implied to be conducted by the manufacturer, TRUMPF Medizin Systeme GmbH + Co. KG, Germany.

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

• Number of Experts/Qualifications: Not applicable. Ground truth, in the AI/ML context, refers to expert labeling of data. For a surgical light, the "ground truth" of its performance is derived from physical measurements against established engineering and medical device standards. No external experts are mentioned for "ground truth labeling."

4. Adjudication Method for the Test Set

• Adjudication Method: 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

• MRMC Study: Not applicable. This device is a surgical lamp, not an AI-assisted diagnostic or therapeutic tool that enhances human reader performance.

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

• Standalone Performance: Not applicable. This is not an AI algorithm. Its performance is inherent to its physical design and functionality.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the AI/ML data labeling sense. The "ground truth" for a surgical light's performance would be objective measurements against established international and national standards for surgical illumination, such as those related to illuminance, color temperature, shadow dilution, and radiated heat, as well as verification of mechanical and electrical safety. The submission implies these standards were met, and the design is substantially equivalent to existing approved devices.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device.

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

• Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

Summary of the Study Proving Substantial Equivalence (Not "Meets Acceptance Criteria" in the AI/ML Sense):

The "study" presented in K091246 is a substantial equivalence determination based on a comparison to predicate devices, rather than a clinical trial or performance study against specific acceptance criteria for a novel AI algorithm.

• Device: iLED Surgical Family, Mobile
• Predicate Device 1: iLED (lamp heads are identical) K# 061317 (This refers to the ceiling-mounted version of the iLED surgical light family).
• Predicate Device 2: Trumpf surgical light models 301, 501, 701, and 1001 (mobile stand option was included) K# 011693.

Key Arguments for Substantial Equivalence:

1. Identical Lamp Heads: The iLED surgical light mobile family uses identical LED light heads to the previously cleared ceiling-mounted iLED surgical light system (K#061317). This implies that the core illumination technology meets established performance and safety characteristics.
2. Identical Electronics and Software: The device uses the same electronics and software as the ceiling-mounted iLED family. This suggests consistent control and performance characteristics.
3. Same Spring Arm: The mobile version uses the same spring arm as the ceiling-mounted version, indicating similar articulation and positioning capabilities.
4. Main Difference - Mounting: The primary difference is the method of mounting (to a mobile stand with a base and casters) making it mobile, a feature already present in a predicate device (K#011693).
5. No New Safety/Effectiveness Concerns: The submitter asserts, and the FDA agrees by clearning the device, that "There is no difference between the devices that raise any significant issues of safety and effectiveness."

In essence, the "study" for this device is a regulatory submission demonstrating that its design, performance characteristics, and intended use are similar enough to existing, legally marketed surgical lights that it does not raise new questions of safety or effectiveness.

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