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Upon intravenous administration of SPY AGENTTMGREEN (indocyanine green for injection, USP), the 780 nm 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 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 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 are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine consistent with its approved label, the 780 nm L11 LED Light Source with AIM and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

The 780 nm L11 LED Light Source with AIM is part of the 780 nm Advanced Imaging Modality (AIM) System. The system is an endoscopic real-time 4K visible white light and near-infrared illumination and transillumination imaging system. Near-infrared illumination is used for fluorescence imaging using indocyanine green and pafolacianine injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. The 780 nm L11 LED Light Source is a light-generating until designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination.

The provided text describes a 510(k) submission for the "780 nm L11 LED Light Source with AIM" device and mentions that the device passed several performance bench tests. However, it explicitly states:

"NOTE: The 780 nm L11 LED Light Source does not require clinical studies to support the determination of substantial equivalence."

This means that while the device underwent technical and performance testing, there wasn't a clinical study to prove the device meets clinical acceptance criteria. Therefore, most of the requested information regarding clinical acceptance criteria, sample sizes for test sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth for clinical performance is not available in the provided text.

Here's a breakdown of what can be extracted based on the input:

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

The provided document lists performance tests and indicates a "PASS" for each, suggesting these tests represent the acceptance criteria for those specific aspects. Clinical acceptance criteria are not mentioned as clinical studies were not required.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as no clinical test set was used for a study proving clinical acceptance criteria. The performance tests were bench tests.

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 applicable, as no clinical test set was used requiring expert ground truth for clinical acceptance.

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

Not applicable, as no clinical test set was used requiring adjudication.

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 applicable. The document explicitly states that clinical studies were not required. The device is a light source, not an AI-assisted diagnostic tool for "human readers."

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

This refers to an algorithm's performance. The "780 nm L11 LED Light Source with AIM" is a medical device providing illumination and imaging, not a standalone AI algorithm. While it has an "AIM" (Advanced Imaging Modality) system, the document focuses on the light source itself and its functionality for fluorescence and transillumination, not an independent algorithm for diagnostic output.

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

Not applicable, as no clinical study requiring a ground truth for diagnostic or clinical performance was conducted. The "PASS" for the bench tests indicates adherence to engineering or performance specifications.

8. The sample size for the training set

Not applicable, as no clinical training set was used for an AI algorithm.

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

Not applicable, as no clinical training set was used.

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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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