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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.

A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repari, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement.

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.

The provided text is a 510(k) Summary for the Stryker 1688 4K Camera System with Advanced Imaging Modality. This document primarily focuses on establishing substantial equivalence to a predicate device, as required for FDA clearance. It does not contain the kind of detailed performance study information typically associated with AI/ML device evaluations, such as specific acceptance criteria for algorithm performance, sample sizes for test sets, expert ground truth establishment, or MRMC studies.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide acceptance criteria and reported performance in the typical sense of algorithm-specific metrics (e.g., sensitivity, specificity, AUC). Instead, it lists performance testing for general device functionality, electrical safety, and electromagnetic compatibility.

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

• Sample Size for Test Set: Not specified for any AI/ML performance evaluation. The "Performance Data" section refers to engineering tests, not a clinical or image-based test set.
• Data Provenance: Not applicable, as no data set for AI/ML evaluation is described.

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

• Not applicable, as no ground truth establishment for AI/ML performance evaluation is described.

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

• 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:

• No MRMC study is mentioned. The device is an endoscopic camera system, and the document focuses on its technical specifications and safety. There is no indication of AI assistance that would involve human readers.

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

• This filing is for an endoscopic camera system. While it has an "Advanced Imaging Modality" (AIM), the document does not describe it as an AI/ML algorithm requiring standalone performance evaluation in the context of clinical decision-making. The AIM likely refers to specific imaging capabilities (e.g., near-infrared fluorescence, transillumination) rather than an interpretative AI algorithm.

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

• Not applicable.

8. The sample size for the training set:

• Not applicable, as no AI/ML training is described.

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

• Not applicable.

Summary of what is present:

The document describes the Stryker 1688 4K Camera System with Advanced Imaging Modality (AIM). It states that the device is "substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices." (K211202).

The performance data listed pertains to general device safety and functionality tests:

• Environmental RF Interference: Pass
• Electrical Safety (according to standards IEC 60601-1, IEC 60601-1-6, IEC 60601-2-18): Pass
• Electromagnetic Compatibility (according to standard IEC 60601-1-2): Pass

The "Advanced Imaging Modality" in this context refers to capabilities like "Near-infrared fluorescence" and "Near-infrared transillumination," which are imaging techniques, not necessarily an AI/ML algorithm that predicts or diagnoses. The 510(k) focuses on the camera system itself as an endoscope and accessories, not an AI diagnostic tool.

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