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The 1788 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope is indicated for use. The 1788 Video Camera is indicated for use in adults and pediatric patients.

The 1788 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 spectrums. 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 1788 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.

The Stryker 1788 4K Camera System with Advanced Imaging Modality (K230605) is an endoscopic camera system.

Here's an analysis of its acceptance criteria and supporting studies 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:

The document does not provide information about sample sizes for a 'test set' in the context of clinical or image-based evaluation. The performance data presented consists of engineering and software compliance testing. The data provenance is not specified beyond being generated by Stryker for its 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable as the provided documentation details engineering and software performance testing for a camera system, not the evaluation of a diagnostic or interpretive algorithm that would require expert-established ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons mentioned in point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size:

No, an MRMC comparative effectiveness study was not explicitly conducted or referenced in the provided document. The device is a camera system providing visual input, not an AI-assisted diagnostic tool that would typically be evaluated with MRMC studies to measure human reader improvement. The document explicitly states: "The 1788 4K Camera System does not require clinical studies to support the determination of substantial equivalence."

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

This information is not applicable as the device described is an endoscopic camera system, which provides visual information to a human user in a clinical setting; it is not a standalone algorithm performing a diagnostic task.

7. The Type of Ground Truth Used:

For the performance tests conducted, the "ground truth" refers to the established standards or specifications being tested against (e.g., IEC 60601-1-2:2014 for EMC, product design specifications for bench tests). It's not an expert consensus, pathology, or outcomes data in the sense of clinical decision-making.

8. The Sample Size for the Training Set:

This information is not applicable. The document describes a medical device (camera system), not an AI/ML algorithm that would typically require a training set.

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

This information is not applicable for the same reasons mentioned in point 8.

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