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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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Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight Cable are indicated for use 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.

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

The Stryker AIM LED Light Source (L10 & L11) is part of the Stryker Infrared Fluorescence (IRF) Imaging System, which is an endoscopic illumination and imaging system for real-time high definition (HD) visible light and near-infrared fluorescence imaging of indocyanine green (ICG) during minimally invasive surgery.

The Stryker Infrared Fluorescence Imaging System consists of the following main components:

• . A light source console and a light cable for outputting light within a visible light spectrum as well as near-infrared light spectrum;
• . A camera control unit for processing near-infrared and visible light images, and a coupler that is attached to the laparoscope and camera head (cleared separately);
• A laparoscope for visible light and near-infrared light illumination and imaging ● (cleared separately)
• An imaging agent kit containing ICG ●

The Stryker AIM LED Light Source uses an illuminator with a laser light source to illuminate the area of surgery. The device is used in conjunction with ICG to achieve its intended use in fluorescence angiography. The ICG is administered intravenously prior to image obtainment. A laser light is illuminated to the site of the surgery using a laparoscope. Absorption of laser light causes excitation of the ICG in the vessels resulting in emission of infrared light at a different wavelength. The camera system captures the infrared emission, processes the image and displays it on a surgical monitor.

This document describes a 510(k) premarket notification for the Stryker L10 and L11 LED Light Source with AIM (Advanced Imaging Modality). This notification primarily concerns a labeling modification allowing the use of the device with Stryker's SPY AGENT™ GREEN (Indocyanine green for injection, USP). As such, the study described focuses on demonstrating compatibility rather than proving a new performance characteristic of the device itself.

Therefore, the information typically requested regarding acceptance criteria for an AI/ML device, such as specific performance metrics, sample sizes for test/training sets, expert consensus, and MRMC studies, is not applicable to this submission. This is because the device being approved is a medical light source, not an AI/ML diagnostic or assistive device. The submission primarily relies on demonstrating substantial equivalence to previously cleared predicate devices and compatibility with a specific imaging agent.

However, I can extract the relevant information about the "study" that was conducted to support the labeling modification:

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

Since this is not an AI/ML device, there are no acceptance criteria related to algorithmic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" here implicitly refer to the demonstration of visual equivalence/compatibility.

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

• Sample size: Not specified. The document refers to "imaging studies" but does not quantify the number of images, cases, or subjects.
• Data provenance: Not specified, but given the nature of the device and testing, it would likely be laboratory-based bench testing rather than real-world clinical data. It is not indicated if it was retrospective or prospective.

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

• Not applicable as this was a visual comparison study to demonstrate compatibility, not a diagnostic accuracy study requiring expert-established ground truth. The assessment was based on "visible difference," likely by qualified personnel involved in the bench testing.

4. Adjudication method for the test set:

• Not applicable.

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 is not an AI-assisted device.

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

• Not applicable. This is a medical device (light source), not an algorithm.

7. The type of ground truth used:

• Implicitly, the "ground truth" was the expected fluorescence visualization when using a known, commercially available ICG imaging agent, against which the performance with SPY AGENT™ GREEN was compared. This is a technical (bench) demonstration of compatibility, not a clinical ground truth like pathology or outcome data.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable.

In summary, the provided document details a 510(k) submission for a medical light source that aims to modify its labeling to include compatibility with a new imaging agent. The "study" referenced is a bench test demonstrating visual equivalence of fluorescence with the new agent compared to an existing one. It is crucial to understand that the detailed criteria typically applied to AI/ML device approvals are not relevant here.

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