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The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope/ sinuscope is indicated for use. The 1688 Video Camera is indicated for adults and pediatric patients.

The 1688 4K Camera System with Advanced Imaging Modality is an endoscopic camera system that produces live video in the surgical field during surgical endoscopic procedures. The system is sensitive in the visible and infrared spectrum. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are attached to the camera head. The 1688 4K Camera System consists of three main components: (1) a camera control unit (CCU); (2) a camera head with an integral cable that connects to the CCU; and (3) a coupler for attaching an endoscope to the camera head.

This document, a 510(k) Summary for the Stryker 1688 4K Camera System with Advanced Imaging Modality (AIM), primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's diagnostic performance against specific clinical acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods is either not explicitly stated or not applicable in the context of this type of regulatory submission.

However, based on the provided text, I can infer and present some of the requested information related to the device's performance data that was provided in support of the substantial equivalence determination.

1. Table of Acceptance Criteria and Reported Device Performance

For regulatory purposes to demonstrate substantial equivalence, the "acceptance criteria" here relate to compliance with recognized standards and successful completion of specified tests.

2. Sample size used for the test set and the data provenance

The document does not describe a clinical "test set" in the traditional sense of a study evaluating diagnostic accuracy on patient data. The performance data provided are related to engineering and regulatory compliance testing. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission focuses on engineering and safety compliance, not clinical diagnostic accuracy assessed by experts against ground truth.

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

Not applicable. As above, there is no clinical test set requiring expert adjudication for ground truth.

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 such study is mentioned or implied in this document. The device description explicitly states it is an "endoscopic camera system that produces live video in the surgical field," which implies it is a viewing tool for human users, not an AI-assisted diagnostic device. The "Advanced Imaging Modality" refers to visible and near-infrared imaging for fluorescence and transillumination, not AI.

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

Not applicable. This device is an imaging system intended for human-in-the-loop performance, providing visual information to a surgeon. There is no mention of a standalone algorithm for automated analysis.

7. The type of ground truth used

For the engineering and regulatory compliance tests:

• Electrical Safety, EMC, Software Verification: The "ground truth" is compliance with the specifications and requirements of the cited international standards (IEC, ANSI/AAMI).
• Performance - Bench: The "ground truth" is successful operation according to internal design specifications for CCU Timing and Video Compatibility.

There is no mention of clinical ground truth (e.g., pathology, clinical outcomes) as this submission does not present a clinical performance study.

8. The sample size for the training set

Not applicable. Since there is no mention of an algorithm based on machine learning or AI that would require a "training set," this information is not provided.

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

Not applicable, as there is no training set for an AI/ML algorithm mentioned.

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