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780 nm 1688 4K Camera System :

The 1688 4K Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope/ sinuscope is indicated for use. The 1688 4K Camera System is indicated for adults and pediatric patients.

A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repar, 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, 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, neurosurgeons and urologists.

780 nm L11 LED Light Source with AIM and Safelight Cable:

Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the 780 nm L11 LED Light Source with AIM and SafeLight™ Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The 780 mm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as 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 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 780 nm 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 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults 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 780 nm 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 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

The 780nm Advanced Imaging Modality (AIM) System is an endoscopic real-time 4K visible white light and near-infrared light illumination and imaging system. Near-infrared illumination is used for both fluorescence imaging using SPY AGENT TM GREEN (indocyanine green for injection, USP) and transillumination of the ureters during minimally invasive and open surgical procedures, respectively. The 780nm AIM 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 "M GREEN (indocyanine green for injection, USP) used for fluorescence imaging.

This document describes the 780 nm Advanced Imaging Modality (AIM) System (K214046) and its substantial equivalence to a predicate device (K211202). The provided text mentions various performance tests but does not detail any specific clinical study that establishes acceptance criteria for device performance related to diagnostic accuracy or clinical outcomes.

Instead, the performance data section focuses on engineering and safety standards, as well as bench and animal studies (referencing the predicate AIM system) to demonstrate the device's technical specifications and safety.

Therefore, I cannot fulfill the request for information regarding clinical acceptance criteria, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for clinical evaluation, or training set sample sizes from the given text.

However, I can extract the information that is present regarding technical performance testing:

1. Table of Acceptance Criteria and Reported Device Performance (Technical/Safety):

The document lists various tests and their results, indicating compliance with established standards or device input specifications. These are not clinical performance metrics in the traditional sense (e.g., sensitivity, specificity) but rather technical and safety assessments.

Missing Information (Not present in the provided text):

Since the document focuses on demonstrating substantial equivalence based on technical and safety testing rather than a clinical performance study measuring specific diagnostic accuracy or clinical outcomes, the following information cannot be extracted:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI vs without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical performance.
8. The sample size for the training set (as this is not an AI/ML device in the context of clinical decision support, but rather an imaging system).
9. How the ground truth for the training set was established.

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