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Upon intravenous administration of ICG(Indocyanine green for injection) consistent with its approved label, the OPTOVISION provides real-time endoscopic visible and near-infrared fluorescence imaging. The OPTOVISION enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the OPTOVISION is intended for use with standard-of-care white light and, when indicated, intraoperative cholangioaraphy. The device is not intended for standalone use for biliary duct visualization.

Upon interstitial administration and use of ICG consistent with its approved label, the OPTOVISION is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

OPTOVISION is an endoscopic light source that enables real-time endoscopic visible and nearinfrared fluorescence imaging minimally invasive surgical procedures. Near-infrared illumination is used for fluorescence imaging using indocyanine green (ICG). This device is largely composed of a power circuit, a control circuit, and a lighting lamp (light source). A power circuit provides power to the lighting lamp and cuts off the power in an emergency, a control circuit controls the light output (intensity)/other settings of light rays, and a light source unit irradiates light directly to the Light Guide Cable (K111342) for observation of the affected area. With the configuration above, the power input from the initial power source is transmitted to the light source unit and the main body, and rays of white light and near-infrared light are directly irradiated through the Light Guide Cable to the affected area for observation. This device is designed for use in the following applications: standard endoscopic visible-light imaging and near-infrared fluorescence imaging.

The provided FDA 510(k) summary (K243591) for the "OPTOVISION Endoscopic Light Source Unit" describes the device and its comparison to a predicate device, but it does not present an acceptance criteria table or report specific device performance metrics in the way typically seen for AI/ML device studies (e.g., sensitivity, specificity, AUC).

Instead, this submission is for an endoscopic light source, and its "performance" is demonstrated through compliance with established electrical, electromagnetic, usability, photobiological safety, and software validation standards, as well as a general "Performance - Bench" test. This type of device, an endoscopic light source, does not inherently involve an AI algorithm with output metrics like those you've requested. Thus, many of the specific questions about sample sizes, expert ground truth, adjudication, MRMC studies, and standalone performance are not applicable to the information provided.

However, I can extract and present the available information in a structured format as best as possible, noting where the requested details are not present in the document.

Explanation regarding the absence of typical AI/ML study information:

The "OPTOVISION Endoscopic Light Source Unit" is classified as an "Endoscope And Accessories" (21 CFR 876.1500) with product code OWN, which refers to "Confocal Optical Imaging". This device is a light source that enables real-time endoscopic visible and near-infrared fluorescence imaging using Indocyanine green (ICG). While it uses near-infrared light for fluorescence imaging, the document does not describe it as an AI/ML device that performs diagnosis or prediction, hence the absence of metrics like sensitivity, specificity, and the related study design details. Its "performance" is primarily assessed against safety and engineering standards.

Acceptance Criteria and Device Performance (Based on available information)

Since this is an endoscopic light source, the "acceptance criteria" are compliance with relevant safety and performance standards for medical electrical equipment and usability. The "reported device performance" is the successful passing of these tests.

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable. The "performance data" describes compliance with engineering and safety standards, not a clinical study on a population of patients or data sets in the context of AI/ML.
   • Data Provenance: Not applicable. The "tests" are engineering and safety evaluations of the device itself.

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

   • Not applicable. This device is a light source, not an AI/ML algorithm requiring expert-established ground truth for its output. The "ground truth" for these tests would be the specifications and requirements of the standards themselves.

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

   • Not applicable. This type of adjudication is for disagreements in expert readings/labeling, which does not apply to compliance testing against engineering standards.

4. 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 study was done, as this device is a light source and not an AI assistant intended to improve human reader performance.

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

   • Not applicable. This is not an AI algorithm performing a standalone task. Its function is to provide illumination for human visualization.

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

   • Not applicable. The "ground truth" for the performance data are the requirements and specifications defined by the referenced international and national standards (e.g., IEC, ES standards) for medical device safety, EMC, usability, photobiological safety, and software.

7. The sample size for the training set:

   • Not applicable. The device is not an AI/ML model that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. As above, there is no AI/ML training set.

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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.

Ask a specific question about this device

Camera System: The Camera System is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. 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, Decompression fixation, Wedge resection, Lung biopsy, Pleural 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 Camera System are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

NIR FI Light Source: The NIR FI Light Source and NIR FI Light Guide are indicated for use to provide real-time endoscopic visible and nearinfrared fluorescence imaging. The NIR FI Light Source and NIR FI Light Guide enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the NIR FI Light Source and NIR FI Light Guide 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.

The individual components of the subject device, SCHOELL Y's NIR FI System, form a system to provide real-time endoscopic visible imaging (wight light imaging, WLI) and near-infrared (NIR) illumination and imaging (fluorescence imaging, FI) using indocyanine green (ICG):

• Camera System suitable for processing and recordings visible light images as well as NIR images. The Camera System consists of a Camera Control Unit (CCU) and a Camera Head for connection to a fiberoptic scope;
• . Light Source and Light Guide for use with a fiberoptic scope for emitting light within the visible spectrum as well as in the NIR spectrum to cause fluorescence;
• . Fiberoptic Laparoscope suitable for visible light and NIR light illumination and imaging;

The imaging agent (ICG) is not provided by SCHOELLY as part of the subject system.

The submitted information does not contain a study that proves the device meets the acceptance criteria in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory clearance. It describes general performance testing conducted, but not in the context of specific acceptance criteria and detailed study results as typically found in clinical trials or dedicated performance studies for AI/ML devices.

However, based on the provided text, I can extract information related to the device and the types of testing performed to support its regulatory clearance.

Here's an attempt to structure the available information, noting where specific details (like acceptance criteria, sample sizes, ground truth establishment, or expert involvement for performance scores) are not explicitly present in the provided document:

Device Name: Near-Infrared (NIR) Fluorescence Imaging (FI) System: Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance (e.g., specific sensitivity, specificity, accuracy targets). Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of evaluating a dataset for AI performance. The performance data mentioned refers to engineering and quality system validation tests. No information is provided regarding the origin (country, retrospective/prospective) of specific data sets used for validating imaging performance beyond general statements about "non-clinical performance test data."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable based on the provided text. The document does not describe a study involving expert readers establishing ground truth for a test set to assess AI performance. The focus is on the device's technical specifications and safety/effectiveness in a comparative context to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. As no human expert evaluation of a test set for AI performance is described, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC study is mentioned. The document primarily focuses on demonstrating substantial equivalence to a predicate device through technical comparisons and compliance with standards, rather than a study comparing human readers with and without AI assistance.

6. If a Standalone (Algorithm Only) Performance Study Was Done

The device described is a medical imaging system (hardware and integrated functionality for visible and NIR fluorescence imaging), not a standalone AI algorithm. Therefore, a standalone algorithm performance study as typically understood for AI/ML software is not applicable here. The "Non-Clinical Performance Testing" refers to the system as a whole.

7. The Type of Ground Truth Used

For the "Non-Clinical Performance Testing," the "ground truth" implicitly refers to the expected performance characteristics based on an existing predicate device and the design input requirements for endoscopic white light and near-infrared fluorescence imaging. The document does not specify an external "ground truth" like pathology, expert consensus on images, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. The document does not describe the development or training of an AI algorithm with a training set. The device is an imaging system, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no mention of a training set or AI algorithm training, the establishment of ground truth for such a set is not discussed.

Summary of Non-Inclusion:

The provided document is a 510(k) summary for a medical device (an imaging system) seeking clearance based on substantial equivalence. It is not a report on a clinical or performance study evaluating an AI/ML algorithm against specific performance metrics with independent test sets and expert ground truth. Therefore, many of the requested details, particularly those related to AI/ML study design (sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies), are not present in the given text. The "Performance Data" section details compliance with recognized safety, software, and reprocessing standards, and general non-clinical performance demonstrations for substantial equivalence.

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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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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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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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1688 4K Camera System with Advance Imaging Modality:

The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectorny, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural 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 surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

L11 LED Light Source with Advanced Imaging Modality:

Upon intravenous administration of SPY AGENTTM GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLightTM Cable is used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts ( cystic duct, common bile duct and common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the AIM Light Source 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 (ICG drug product), the AIM Light Source and SafeLightTM Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

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

The AIM (Advanced Imaging Modality) 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 indocyanine green (ICG) and transillumination of the ureters during minimally invasive and open surgical procedures, respectively. 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 as well as near-infrared spectrum; (3) A Laparoscope for visible light and near-infrared light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and, (5) SPY AGENT™ GREEN (indocyanine green for injection, USP) used for fluorescence imaging.

The modified AIM System (subject device) and predicate device are the same, with the exception of the 1688 4K Pendulum Camera Head and the optional Defog feature. The 1688 4K Pendulum Camera Head was cleared under K200310 and works as intended with the L11 LED Light Source that was cleared under K182160, K191046 and K192292. The optional Defog feature reduces the likelihood of fogged images common to irrigated surgical procedures.

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in the way typically found in a clinical study report for an AI/ML medical device. This document is an FDA 510(k) clearance letter and its associated summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance data for a novel algorithm's clinical efficacy.

The document discusses general "Performance Data" and "Image Quality Assessments" but states these were provided to demonstrate that the optional Defog feature works as intended and does not require clinical studies to support the determination of substantial equivalence. This implies that the performance evaluation was primarily technical and verification-based, not a multi-reader, multi-case clinical study to assess diagnostic accuracy or improvement in human performance.

Therefore, I cannot extract the level of detail requested for the acceptance criteria and the study that proves the device meets them (e.g., number of experts, adjudication method, effect size of human improvement with AI, ground truth specifics, training set size) because this information is not present in the provided 510(k) summary.

The only "acceptance criteria" explicitly mentioned are found under "Performance Data," suggesting successful completion of standard technical and quality assessments.

Here's what can be inferred from the text regarding acceptance criteria and performance, although it's very high-level:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance: Not specified. The document indicates these were "performance data" and "image quality assessments" for the "optional Defog feature," suggesting a technical evaluation rather than a clinical dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. The nature of the evaluations (technical testing of a "Defog feature" and image quality) does not typically involve expert clinical ground truth establishment in the way an AI diagnostic algorithm would.
4. Adjudication method for the test set: Not specified.
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, the document explicitly states, "The AIM (Advanced Imaging Modality) System does not require clinical studies to support the determination of substantial equivalence." This type of MRMC study is not mentioned or implied. The device's primary function is as an imaging system, not an AI-driven diagnostic aid that would directly impact human reader performance in interpreting images. The AI element, if any, is more integrated into image enhancement (like the Defog feature) rather than a separate diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned as a distinct performance metric for a standalone AI algorithm. The "Performance Data" section lists technical tests. While the "Defog feature" is an algorithm, its performance seems to have been assessed technically (image quality) rather than as a standalone diagnostic tool.
7. The type of ground truth used: For the "Performance Testing" and "Software Verification," the ground truth would be based on engineering specifications, regulatory standards (like IEC 62304), and visual assessment for "Image Quality Assessments." For a "Defog feature," "ground truth" might refer to known conditions of fogging in test environments and the system's ability to mitigate them visually. It is not clinical ground truth established by expert consensus, pathology, or outcomes data.
8. The sample size for the training set: Not applicable and not specified. The document does not describe the development or training of a machine learning model in the context of a dataset for diagnostic performance.
9. How the ground truth for the training set was established: Not applicable and not specified.

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Upon intravenous administration of SPY AGENTTM GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLightTM Cable is used with SPY AGENT GREEN to provide real-time endoscopic visible and nearinfrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the AIM Light Source and SafeLight Cable is intended for use with standardof-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 (ICG drug product), the AIM Light Source and SafeLightTM Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

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

The AIM Light Source (L10 and L11 LED Light Source) and SafeLight™ Cable are part of the AIM (Advanced Imaging Modality) System. The AIM System is an endoscopic real-time visible white light and near-infrared light illumination and imaging system. Near-infrared illumination is used for both fluorescence imaging using indocyanine green (ICG) and transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures, respectively. The AIM Light Source is a light-generating unit designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination. The SafeLight Cable transmits light from the light source to an endoscope during endoscopic procedures.

Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical performance targets for the device's diagnostic or imaging capabilities. Instead, it focuses on the device passing various design and safety standards. The "Performance - Animal" section states "Equivalent" to a legally marketed predicate device, which implies a comparative performance but doesn't quantify specific metrics.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document mentions "Performance - Animal" testing. However, it does not specify the sample size (i.e., the number of animals or cases) used for this test set.
• Data Provenance: The study mentioned is an animal study. The location or specific details of the study (e.g., country of origin, retrospective or prospective) are not provided, other than it being "in accordance with 21CFR58" (which refers to Good Laboratory Practice for nonclinical laboratory studies).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The type of animal study described generally wouldn't involve human expert readers in the same way a diagnostic imaging study would. The assessment of "equivalence" likely refers to objective measurements or observations in the animal model.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Since no information is given about human experts establishing ground truth or their interpretations, an adjudication method is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI Assistance

An MRMC comparative effectiveness study was not done. This document describes an imaging modality that assists surgeons with real-time visualization, not an AI-assisted diagnostic tool that would typically involve human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable in the context of the device described. The AIM Light Source and SafeLight Cable are imaging hardware designed to provide real-time visible and near-infrared fluorescence imaging to a human surgeon. It's not a standalone algorithm that provides an output without human interpretation. Its performance is about the quality of the image delivered for human assessment.

7. The Type of Ground Truth Used

For the "Performance - Animal" study, the ground truth would be established through direct observation and/or histological analysis in an animal model, validated against the known physiological processes of blood flow, tissue perfusion, biliary ducts, and lymphatic system activity when ICG is administered. The equivalence claim against a predicate device suggests that the ability to visualize these features was compared.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is an imaging hardware system, not a machine learning or AI algorithm that requires a separate training set. Its development would involve engineering and physical testing, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reason as point 8.

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