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The KSEA SCB ACC Control provides remote control for overhead and surgical lights, cameras, video devices, telephones, air-conditioning and teleconference equipment in the operating room.

The Karl Storz SCB ACC Control is an interface device to provide remote control via a touch screen panel.

The provided text is a 510(k) summary for the Karl Storz SCB ACC Control, which is a remote control interface device. The document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results for the device itself.

Therefore, most of the requested information cannot be extracted from this document, as a typical performance study as requested for AI/ML devices or diagnostic tools is not present. The device described is a remote control for operating room equipment, and its safety and effectiveness are primarily supported by its functional equivalence to existing devices, not by a study with ground truth and expert consensus.

Here's what can be extracted based on the provided text, and where the information is not available:

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)

• Sample Size: Not applicable. The document does not describe a performance study with a test set of data.
• 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)

• Number of Experts: Not applicable. Ground truth establishment is not relevant for this device's regulatory submission as described.
• Qualifications of Experts: Not applicable.

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

• Not applicable. There is no test set or adjudication method described.

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 device is a remote control, not an AI/ML-driven diagnostic or assistive device that would involve human readers or MRMC studies.

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

• Not applicable. This device is not an algorithm.

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

• Not applicable. Ground truth is not a concept applied in this 510(k) submission for this type of device.

8. The sample size for the training set

• Not applicable. There is no training set mentioned, as this is not an AI/ML device.

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

• Not applicable.

Summary:

The provided document is a 510(k) summary for a remote control device (KSEA SCB ACC Control). Its regulatory pathway is based on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting a performance study with acceptance criteria, ground truth, and expert evaluations typical of AI/ML or diagnostic devices. Therefore, most of the requested information regarding performance studies, sample sizes, expert involvement, and ground truth is not applicable to this submission. The "study" referenced in the prompt (if interpreted as the documentation within the 510(k)) primarily consists of a comparison to a predicate device, asserting that "minor differences...have no effect on the performance, function or general intended use of these devices."

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