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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, sinuscopy, sinuscopy and plastic surgery whenever a laparoscope/ arthroscope is indicated for use. The 1688 Video Camera is indicated for use in adults and pediatric patients aged one month or older.
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, ENT surgeons 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 is 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 endoscope visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month or older, and visualization of at least one of the major extra-hepatic bile ducts (cystic duct common bile duct and common hepatic duct) in adults and pediatric 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. 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.
Advanced Imaging Modality (AIM) HD Autoclavable Laparoscope:
The AIM HD Autoclavable Laparoscope is intended to be used for gynecological and general procedures that clinicians deem appropriate for adults and pediatric patients aged one month or older, when the dimensions of the AIM HD Autoclavable Laparoscope are appropriate for the patient size and anatomy.

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 near-infrared 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) A Laparoscope for visible light and near-infrared light illumination and imaging; (4) SPY AGENT GREEN (indocyanine green for injection, USP) an optical imaging agent used for fluorescence imaging.

The provided text is a 510(k) summary for the Stryker AIM (Advanced Imaging Modality) System, detailing its substantial equivalence to predicate devices. While it lists indications for use, technological characteristics, and non-clinical testing performed, it does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets those criteria.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance (e.g., country, retrospective/prospective) for a test set. The clinical performance data section only mentions "Published clinical literature was provided," which is not a description of a specific study and its test set.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for a test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Information on standalone (algorithm-only) performance.
• Specific type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence through comparison of technical specifications and indications for use with predicate devices, along with standard non-clinical testing (biocompatibility, cleaning/sterilization validation) and reference to published clinical literature, rather than detailing a specific performance study against pre-defined acceptance criteria for a new AI/imaging modality.

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