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The Leica FL560 is a surgical microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area.

Similar to the predicate device (Leica FL800 ULT approved under K141136), the Leica FL560 is an accessory to the Leica Microsystems (LMS) Class I 510(k) exempt surgical operating microscope (SOM). The Leica FL560 utilizes the illumination light source, supplied as standard with the SOM to produce excitation light which is filtered using an illumination filter (also referred to as the excitation filter) within the 460 - 500nm wavelength. An observation filter is introduced into the observer light path within the optics carrier of the SOM to enable visualization of the resulting fluorescence emission comprising of the green, yellow and red spectrum in a spectral band above ~510nm.

Here's a summary of the acceptance criteria and the study details for the Leica FL560, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with specific thresholds. Instead, it describes acceptance as achieving "functional equivalence" to the predicate device (Leica FL800 ULT) in various aspects. The reported performance confirms this equivalence.

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

• Bench Testing: The document states this was a "one-arm study using only the subject device FL560 on microscope platform M530 OH6". The sample size for filters is mentioned as being tested (optically, mechanically, geometrically assessed), but specific numbers are not provided. The data provenance is internal design verification testing ("in-house").
• Preclinical Testing:
  • Sample Size: "Six comparative image sets of the same cerebrovascular anatomy in either non-occluded (patent, native) or occluded (clipped) status and representative of neurosurgical procedures were visualized by both the FL560 and FL800ULT systems." This refers to the cases. The report also states "(n=18 comparative reviews, 100% confirmation)", which implies 3 observations per comparative image set (6 sets * 3 observations = 18 reviews).
  • Data Provenance: Prospective animal study conducted at the University of Mainz, Germany Institute of Neurosurgical Pathology, using a porcine model.
• Human Factors Testing:
  • Sample Size: "15 users per group were assessed via observational analysis." There were two distinct user groups (neurosurgeons, nurses/techs), so a total of 30 users.
  • Data Provenance: Prospective study conducted at the University of Utah Department of Neurosurgery, using a simulated operating room and a cerebral vascular aneurysm phantom model.

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

• Preclinical Testing: "Testing was completed at the University of Mainz, Germany Institute of Neurosurgical Pathology by neurosurgeons and veterinarians". The specific number of each is not given, but multiple experts from each specialization were involved. Their qualifications are stated as "neurosurgeons and veterinarians".
• Human Factors Testing: This study focused on usability and performance by the users themselves rather than establishing a diagnostic ground truth. The "experts" involved were the primary users: "neurosurgeons" and "nurses/techs". The number of each was 15. The study itself was designed in accordance with FDA guidance for human factors.

4. Adjudication Method for the Test Set

• Preclinical Testing: "independent scoring assessments that were predefined within the protocol." The specific adjudication method (e.g., 2+1, 3+1) is not detailed, but it implies multiple experts evaluating the images.
• Human Factors Testing: This study involved "observational analysis" with "objective pass/fail criteria pre-defined within the protocol." It doesn't describe a separate adjudication process for ground truth establishment, but rather for performance of tasks by the users.

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 studies described are not MRMC comparative effectiveness studies comparing human readers with and without AI assistance. The Leica FL560 is a surgical microscope accessory for viewing fluorescence, not an AI-powered diagnostic tool. The preclinical study was a comparative functional equivalence study between two devices (FL560 vs. FL800ULT) for blood flow visualization, and the human factors study assessed usability.

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

This information is not applicable. The Leica FL560 is a hardware accessory for a surgical microscope. It does not contain an "algorithm" as typically referred to in AI/standalone performance studies. Its performance is entirely dependent on human-in-the-loop operation, as it provides visual information to the surgeon.

7. The Type of Ground Truth Used

• Preclinical Testing: The ground truth for evaluating blood flow visualization was established by the experts (neurosurgeons and veterinarians) observing the same cerebrovascular anatomy in known "non-occluded (patent, native) or occluded (clipped) status". This can be considered expert consensus with known physiological status/surgical intervention. The comparison was between the images produced by the two devices, FL560 vs FL800ULT, in relation to the actual blood flow patterns in the porcine model.
• Human Factors Testing: The "ground truth" here related to the correct and safe operation of the device and the visibility of fluorescein. This was established by "pre-defined test cases and objective pass/fail criteria" and successful visualization in a "cerebral vascular aneurysm phantom model". This is effectively known device functionality and phantom model characteristics.

8. The Sample Size for the Training Set

This information is not applicable. The Leica FL560 is a medical device accessory, not an AI model requiring a training set.

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

This information is not applicable, as there is no AI model or training set involved.

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