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· INFRARED 800 with FLOW 800 Option is a surgical microscope accessory intended to be used with a compatible surgical microscope in viewing and visual assessment of intraoperative blood flow in cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. Likewise, INFRARED 800 with FLOW 800 Option used during fluorescence guided surgery aids in the visual assessment of intra-operative blood flow as well as vessel patency in bypass surgical procedures in neurosurgery, plastics and reconstructive procedures and coronary artery bypass graft surgery.

· YELLOW 560 is a surgical microscope accessory intended to be used with a compatible surgical microscope in viewing and visual assessment of intraoperative blood flow in cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery.

Fluorescence accessories (YELLOW 560 and INFRARED 800 with FLOW 800 option) are an accessory to surgical microscope and are intended for viewing and visual assessment of intra-operative blood flow as well as aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. The functionality of these filters is derived from their ability to hight fluorescence emitted from tissue that has been treated with a fluorescence agent by applying appropriate wavelengths of light and utilizing selected filters. This helps a surgeon to visualize different structural body elements (such as vessels, tissue, blood flow, occlusions, aneurysms, etc.) during various intraoperative procedures. The fluorescence accessory can be activated by the user via the Graphical User Interface (GUI), foot control panel or the handgrips, for example.

For these accessories to be used with a qualified surgical microscope, the critical components of the surgical microscope need to fulfill the clinically relevant parameters for the Indications for Use of YELLOW 560 and INFRARED 800 with FLOW 800 Option.

The fluorescence accessories are embedded into the surgical microscope. The emission filter wheels are present within the head of the microscope. For filter installation into the surgical microscope, two emissions filters (one for each eyepiece) are placed into each of these filter wheel is present in front of the light source, which is installed along with the excitation filter

The provided text is a 510(k) summary for the Carl Zeiss Meditec Inc. "Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)". This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria.

The 510(k) summary primarily addresses:

• Indications for Use: The device is a surgical microscope accessory for viewing and visual assessment of intraoperative blood flow in the cerebral vascular area (e.g., assessing cerebral aneurysm, vessel branch occlusion, patency of small perforating vessels, and vessel types before/after Arteriovenous Malformation (AVM) surgery). It also aids in real-time visualization of blood flow and vessel patency in bypass surgical procedures in neurosurgery, plastics, reconstructive procedures, and coronary artery bypass graft surgery.
• Technological Characteristics: Comparison to predicate devices (YELLOW 560 (K162991) and INFRARED 800 with FLOW 800 Option (K100468)) is presented, showing substantial equivalence in application, patient population, device description, fluorescent agents used, visualization of real-time images, display, physical method, fluorescence excitation/detection, white light application, camera adaption, zoom, autofocus, autogain, control system, storage, and upgrade options. Minor differences are noted and deemed not to affect substantial equivalence.
• Non-Clinical Testing: A list of performance testing parameters for the system is provided, confirming that the "functional and system level testing showed that the system met the defined specifications."

Therefore, based on the provided text, a detailed table of acceptance criteria and a study proving the device meets those criteria (with specific performance metrics) cannot be fully constructed as requested. The document attests that the device met internal specifications through software verification and non-clinical system testing, but does not provide the specific numerical acceptance criteria or the study results themselves.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be fully provided as specific numerical acceptance criteria and reported device performance are not detailed in the provided document. The document states that "functional and system level testing showed that the system met the defined specifications" and lists the parameters tested. However, the values for these specifications and the results of the testing are not included.

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

• Sample Size: Not specified. The document mentions "non-clinical system testing" and "software verification testing" but does not provide details on the number of samples, test cases, or images used.
• Data Provenance: Not specified. This appears to be internal company testing (bench testing) rather than a study involving patient data.

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

• Not applicable/Not specified. This was a non-clinical bench and software performance testing; it does not involve expert ground truth for clinical assessment.

4. Adjudication method for the test set

• Not applicable/Not specified. As noted above, this was non-clinical bench and software performance 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

• No MRMC study was mentioned. The device is an accessory to a surgical microscope providing visualization, not an AI diagnostic tool that assists human readers in interpreting images.

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

• Not applicable. The device provides "real-time visualization" and "visual assessment," which implies human interpretation of the images/data it presents. It's an accessory, not a standalone automated diagnostic algorithm. The testing described is for the functional and system performance of the accessory.

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

• Not applicable for the non-clinical and software testing described. The "ground truth" for the performance testing would be the predefined specifications that the system components were designed to meet.

8. The sample size for the training set

• Not applicable. The description does not suggest this device uses machine learning or AI that would require a "training set" in the conventional sense for image analysis. It's a fluorescence visualization system.

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

• Not applicable, as there is no mention of a training set.

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