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The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in 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 1788 4K Camera System with Advanced Imaging Modality are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT/heurosurgeons and urologists.

Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 Light Source with Advanced Imaging Modality 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 L12 LED Light Source with Advanced Imaging Modality 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 L12 LED Light Source with Advanced Imaging Modality 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 L12 LED Light Source with Advanced Imaging Modality 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 L12 LED Light Source with Advanced Imaging Modality and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The L12 LED Light Source with Advanced Imaging Modality is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

Stryker's Advanced Imaging Modality (AIM) System is an endoscopic real-time 4K visible white light, near-infrared illumination and transillumination, and cyan spectral imaging system. Near-infrared illumination is used for fluorescence imaging using SPY AGENT™ GREEN (indocyanine green for injection, USP) or CYTALUX™ (pafalocianine) 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. Cyan Spectral Imaging is intended as an alternative mode of visualization that uses narrow bands for illumination during endoscopic surgery to provide greater visualization of surface structures and fine capillary patterns of the mucosal membrane.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Stryker 1788 4K Camera System with Advanced Imaging Modality and L12 LED Light Source with AIM:

A table of acceptance criteria and the reported device performance cannot be fully constructed from the provided document. The document primarily lists regulatory standards and general performance categories, indicating that the device "passed" these tests. It does not provide specific quantitative acceptance criteria or detailed reported performance values for each criterion.

However, based on the Performance Data section (page 9), we can infer the types of tests conducted and their general outcome:

Inferred Acceptance Criteria and Reported Device Performance

Here's the requested information based on the provided document:

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

   • (See table above)

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

   • The document states: "NOTE: The Advanced Imaging Modality (AIM) System does not require clinical studies to support the determination of substantial equivalence." This implies that no clinical test set (patient data) was used in the assessment for substantial equivalence. The testing described appears to be primarily bench and laboratory-based. Therefore, sample size and data provenance in the context of clinical data are not applicable based on this document.

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)

   • Since no clinical studies were performed, there's no mention of experts establishing ground truth for a clinical test set. The "Pass" results are based on compliance with engineering standards and comparisons to predicate devices in bench testing.

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

   • Not applicable. No clinical test set demanding adjudication was used.

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 comparative effectiveness study was done. The document explicitly states: "The Advanced Imaging Modality (AIM) System does not require clinical studies to support the determination of substantial equivalence." There is also no mention of AI assistance in the context of human readers for this device. The "Advanced Imaging Modality" refers to specialized illumination and visualization techniques, not AI-powered image analysis for diagnosis.

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

   • Not applicable. This device is an imaging system (camera and light source) that provides visual information to a surgeon. It is not an AI algorithm that operates standalone without human interpretation or intervention for diagnostic or therapeutic decisions.

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

   • For the performance testing, the implied "ground truth" or reference was primarily device input specifications and the performance of currently legally marketed predicate devices. For regulatory compliance, the ground truth was adherence to FDA-recognized voluntary consensus standards (e.g., IEC standards for electrical safety, usability, software, etc.).

8. The sample size for the training set

   • Not applicable. This document describes a medical imaging hardware system, not a machine learning model that requires a training set.

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

   • Not applicable. As there is no machine learning component requiring a training set, the establishment of ground truth for such a set is not mentioned.

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Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the L12 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 L12 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 L12 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 L12 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 L12 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 L12 LED Light Source with AIM and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The L12 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

The L12 LED Light Source with AIM is part of the 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 L12 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.

This document describes the Stryker L12 LED Light Source with AIM, which is an endoscopic imaging system used to provide real-time visible and near-infrared fluorescence imaging during various surgical procedures. The device received 510(k) clearance (K230754) based on substantial equivalence to predicate devices, primarily the 780 nm L11 LED Light Source with AIM (K221611).

The provided text does not contain details about acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-enabled devices involving diagnostic accuracy or similar performance metrics. This is because the L12 LED Light Source with AIM is a hardware component (a light source) that enables certain imaging modalities, rather than a diagnostic algorithm itself. As such, its performance evaluation focuses on functional aspects and safety rather than diagnostic accuracy or human reader improvement.

Here's an analysis based on the information provided, specifically highlighting why certain requested sections are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are fundamental engineering and safety standards, and the reported performance is a simple "PASS" for these tests. There are no specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) provided as would be expected for an AI/ML-driven diagnostic device.

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

Not applicable. The device is a hardware component (light source). Performance testing was conducted in a bench setting on the device itself, not on a dataset of patient images or patient data.

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

Not applicable. This information is relevant for studies evaluating human perceptual or cognitive performance, typically in conjunction with AI/ML algorithms. The provided document describes safety and functional testing for a light source.

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

Not applicable. Adjudication methods are used to establish ground truth in image datasets, often by resolving discrepancies among expert readers. This device underwent bench and software functional testing.

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. This device is not an AI/ML algorithm designed to assist human readers in image interpretation. It is a light source that enables certain imaging modalities. The document explicitly states: "The L12 LED Light Source does not require clinical studies to support the determination of substantial equivalence."

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

Not applicable. This is a hardware component, not a standalone AI algorithm.

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

Not applicable in the conventional sense for AI/ML evaluation. The "ground truth" for the tests performed was defined by engineering specifications and expected functional outputs of the light source (e.g., specific light output, proper communication, correct timing).

8. The sample size for the training set

Not applicable. This device does not use a training set as it's not an AI/ML algorithm.

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

Not applicable. As above, there is no training set for this device.

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