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The Stryker® IRF Light Source and SafeLight Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The Stryker® IRF Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visible 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 Stryker® IRF 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 Stryker® Infrared Fluorescence (IRF) Imaging System is an endoscopic illumination and imaging system for real-time high definition (HD) visible light and near-infrared dye fluorescence imaging of indocyanine green (ICG) used during minimally invasive surgery. The Stryker Infrared Fluorescence (IRF) 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. -
• -A coupler that is attached to the laparoscope and a camera head. It is optimized for nearinfrared fluorescence imaging in addition to visible light imaging.
• A laparoscope for visible light and near-infrared light illumination and imaging. -
• A Fluorescence ICG Kit containing IC-Green® drugs and Aqueous Solvents -

The Stryker system uses an illuminator with a laser light source to illuminate the area of surgery. The ICG is administered intravenously prior to image obtainment. A laser light is illuminated to the site of the surgery using a laparoscope. Upon the absorption of laser light, the ICG passing through the vessels are excited causing an infrared light to be emitted. The camera system captures the infrared emission, processes the image and displays it on a surgical display.

The provided text is a summary of the 510(k) premarket notification for the Stryker® IRF Light Source and Safelight Cable. While it details performance testing, it does not present a table of acceptance criteria or specific reported device performance metrics in a quantitative manner as typically expected for answering such a question. However, I can extract information related to the studies mentioned.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The document summarizes that the device's safety and performance were evaluated and verified in accordance with design specifications and applicable performance standards. However, it does not explicitly list specific quantitative acceptance criteria or corresponding reported device performance values in a table format. Instead, it refers to general compliance with standards and successful testing.

General Categories of Verification/Validation:

• Biocompatibility
• Sterilization Validation
• Electrical Safety and Electromagnetic Compatibility (EMC)
• Software Validation
• Bench Performance Testing
• Animal Testing (in-vivo fluorescence imaging capability)
• Clinical Literature Evaluation
• Investigator Initiated Clinical Study

Study Information

1. A table of acceptance criteria and the reported device performance
   As mentioned above, the document does not provide a specific table with quantitative acceptance criteria and reported device performance. It broadly states that the device was "evaluated and verified in accordance with design specifications and applicable performance standards" and met these.

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

   • Investigator Initiated Clinical Study:

     • Sample Size: Not specified in the provided text.
     • Data Provenance: Conducted at The Ohio State University (USA). Stated as a "non-significant risk study."
     • Retrospective/Prospective: Not explicitly stated, but "investigator initiated clinical study" usually implies a prospective design.

   • Animal Testing: Sample size not specified. Provenance not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
   The document does not provide details on the number or qualifications of experts used to establish ground truth for any of the studies mentioned (clinical or animal).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   The document does not specify any adjudication method for the test set, or for establishing ground truth in the clinical study.

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
   The document does not mention an MRMC comparative effectiveness study involving human readers and AI assistance. The device in question (Stryker® IRF Light Source and SafeLight Cable) is an imaging system, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   The device is an imaging system designed to be used by surgeons for visual assessment. It is not an "algorithm only" device. Therefore, a standalone algorithm performance test (as might be performed for an AI diagnostic algorithm) is not applicable or described. The clinical study and animal testing evaluated the system's ability to provide the intended fluorescence imaging data for human interpretation.

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

   • For the "investigator initiated clinical study" and "animal testing," the type of ground truth is not explicitly defined in the provided text. However, given the indications for use (visual assessment of vessels, blood flow, tissue perfusion, and major extra-hepatic bile ducts using near-infrared imaging), the ground truth would likely be established by:
     • Direct visual confirmation during surgery (for vessels, blood flow, tissue perfusion, and bile ducts), possibly compared to standard white light imaging or intraoperative cholangiography.
     • In animal studies, potentially histopathology or other established physiological methods to confirm perfusion or anatomical structures.
   • The document mentions fluorescence imaging of biliary ducts is "intended for use with standard of care white light and, when indicated, intraoperative cholangiography," suggesting these existing methods serve as a comparative ground truth.

8. The sample size for the training set
   The document does not mention a training set sample size. This is because the Stryker® IRF Light Source and SafeLight Cable is a hardware imaging system, not a machine learning or AI-based diagnostic algorithm that typically requires a training set.

9. How the ground truth for the training set was established
   Not applicable, as no training set for an algorithm is mentioned or implied for this device.

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