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The StarTrol LED Lighting system is designed to provide a visible illumination of the examination /surgical field of the patient during surgical and non-surgical procedures.

The StarTrol LED Lighting System is a Class II medical device that provides an illumination field for general examination and minor surgery. The lighting system utilizes LED's for illumination and is powered from standard AC voltage sources. The head design is comprised of multiple LED's (Light Emitting Diodes). The LED head is mounted such that it can be moved and oriented by the operator to place the illumination field on the subject by means of a removable handle (sterile, single use handle covers are available). The light head is balanced with a counterweight to provide flexibility and exact placement without the drifting of the light head. Maneyverability of the light head requires minimal force by the clinician to quickly and easily place it in the desired position. The intensity of illumination is variable.

The provided text is a 510(k) summary for the StarTrol™ LED Surgical Light System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it explicitly states that no clinical data is required or was performed for this device classification submission.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training data provenance cannot be extracted from this document, as a performance study as typically understood in the context of AI/ML or diagnostic devices was not conducted.

Here's what can be gathered based on the document:

1. A 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)

• Not applicable. No test set was used for a clinical performance study. The evaluation focused on non-clinical and safety conformance to standards.

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 was established by experts for a performance test set, as no clinical performance study was conducted.

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

• Not applicable. No test set or expert adjudication was performed.

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. A MRMC comparative effectiveness study was not performed. The device is a surgical light, 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 physical surgical light, not an algorithm.

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

• The ground truth for this submission was based on compliance with recognized electrical, safety, and usability standards (UL, IEC, CSA), and comparison to the design and intended use of predicate devices. There was no "clinical ground truth" in the traditional sense.

8. The sample size for the training set

• Not applicable. The device is a physical product, not a machine learning algorithm that requires a training set. The development likely involved engineering design, testing, and validation against specifications, not algorithmic training.

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

• Not applicable. As above, there was no "training set" for an algorithm. Design and manufacturing "ground truth" would be established through engineering specifications, validated component performance, and adherence to quality system regulations like Good Manufacturing Practices.

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