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1688 4K Camera System with Advanced Imaging Modality (AIM):

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 repair, 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 users of the 1688 Video Camera are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, neurosurgeons and urologists.

L11 LED Light Source with Advanced Imaging Modality (AIM) and SafeLight Cable:

Upon intravenous administration of SPY AGENTTM GREEN (indocyanine green for injection, USP), the L11 LED Light Source with AIM and SafeLightTM Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediativ patients 12 to 17 years of age, using near-infrared imaging.

Fluorescence imaging of biliary ducts with the L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.

Additionally, the L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near-infrared imaging.

Upon interstitial administration of SPY AGENT GREEN, the L11 LED Light Source with AIM and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The L11 LED Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

Precision S 4K Sinuscope:

The Precision S 4K Sinuscope is intended for use in otolaryngology and head and neck procedures, including thinology, endoscopic plastic and reconstructive surgery. The Precision S 4K Sinuscope is also intended for use in minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years ofage.

The AIM (Advanced Imaging Modality) System is an endoscopic real-time 4K visible white light and near-infrared light illumination and imaging system. The AIM (Advanced Imaging Modality) System includes the following components: (1) A Camera System for processing nearinfrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the visible light as well as near-infrared light spectrum; (3) An Endoscope for visible light and near-infrared light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and, (5) SPY AGENT 104 GREEN (indocyanine green for injection, USP) an optical imaging agent used for fluorescence imaging.

The provided document is a 510(k) premarket notification from the FDA for Stryker's AIM (Advanced Imaging Modality) System. It details the device's indications for use and a comparison to predicate and reference devices, along with performance data. However, the document does not report specific acceptance criteria for device performance or a study demonstrating the device meets those criteria from an AI/algorithm performance perspective.

The "Performance Data" section (page 9) lists several tests completed and their "Pass" results, but these relate to general medical device standards (electrical safety, EMC, laser safety, biocompatibility, cleaning, sterilization, software validation, usability, and bench performance) and animal testing for general device functionality, not specific performance metrics against acceptance criteria for an AI or advanced imaging modality's analytical accuracy or diagnostic capability.

The "Clinical Data" section states: "Published literature was provided to support a reasonable assurance of safety and effectiveness for the AIM System for use in the neurosurgery indications." This implies that existing clinical evidence, likely from non-AI-specific studies, was used to support the device's safety and effectiveness for its intended neurosurgery applications. There is no mention of a study involving AI-driven performance metrics, ground truth, or expert review for the AIM system's "Advanced Imaging Modality" in the context of diagnostic or interpretive accuracy.

Therefore, the requested information cannot be fully provided from the given text as it focuses on general device regulatory clearance rather than specific algorithm performance evaluation.

Here's a breakdown of what can be inferred or explicitly stated based on the document, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "There are no new issues of safety and/or effectiveness introduced by the AIM System". This implies that the device, including its advanced imaging modality, is considered equivalent to predicate devices in its safety and effectiveness profiles, which were previously established without explicit AI performance metrics in this submission.

Missing Information (as per the request, not present in the document):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. The document mentions "Published literature was provided to support a reasonable assurance of safety and effectiveness," but gives no specifics on the study design or data characteristics that would be relevant for an AI/algorithm performance study.
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 provided. This type of information would be crucial for an AI/algorithm performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 provided. The document does not describe an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not provided. The "Advanced Imaging Modality" is part of a system used by surgeons, suggesting a human-in-the-loop context, but no standalone algorithm performance is detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

Conclusion based on the document:

The FDA 510(k) clearance for the Stryker AIM System is based on established general medical device safety and performance standards, and a demonstration of substantial equivalence to predicate devices for its intended uses. The document does not contain specific information regarding the performance evaluation of an AI or advanced imaging algorithm against defined acceptance criteria, ground truth, or expert review, as would typically be required for a novel AI/ML-driven diagnostic or interpretive device. The "Advanced Imaging Modality" likely refers to enhanced visualization techniques (visible and near-infrared fluorescence imaging, transillumination) rather than an AI-driven analytical tool requiring specific AI performance metrics for clearance in this submission.

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