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Acquiring fluorescent images for the visual assessment of circulation as a method for the evaluation of tissue perfusion and related tissue microcirculation in hands.

The Xiralite fluorescence imaging system X4 detects fluorescence signals in the defined field of view using a highly sensitive camera for signal detection and light emitting diodes (LEDs) for excitation. Fluorescence signals typically result from illumination of a specific fluorophore, the fluorescence dye indocyanine green (ICG), which is administered intravenously. Fluorescence signals are recorded at different periodical time points, thus the resulting images display an image sequence. The frame rate is between half a second and a few seconds, typically one second. The duration of the entire image acquisition is dependent on the pharmacokinetics of the administered fluorophore, with ICG typically six minutes.

The provided text describes a 510(k) premarket notification for the Xiralite Fluorescence Imaging System X4. The information focuses on demonstrating substantial equivalence to a predicate device rather than presenting formal acceptance criteria and a detailed study proving the device meets those criteria.

Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, sample sizes, and ground truth establishment is not explicitly available in the provided document.

However, based on the available information, here's a structured response.

Acceptance Criteria and Device Performance:

The document does not explicitly state quantitative acceptance criteria for the device's performance in terms of metrics like sensitivity, specificity, or accuracy. The basis for acceptance is demonstrating substantial equivalence to a predicate device, the Spy Fluorescent Imaging System (K042961, K073088). The "performance" described is largely functional and qualitative, focusing on its ability to acquire fluorescence images for visual assessment of circulation.

Study Details:

The provided document describes the basis for substantial equivalence rather than a formal, standalone clinical study with predefined acceptance criteria for AI performance. The "study" mentioned is primarily a collection of non-clinical tests and user feedback from European clinical use.

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

   • Test set sample size: Not applicable in the context of a formal performance study with a 'test set' in the AI sense.
   • Data provenance: The document references "more than 10,000 patient exams" from "more than 35 systems... in clinical use in hospitals as well as in physician offices, mainly in Germany" since 2009. This data is retrospective from real-world clinical use.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is the real-world clinical observations by healthcare professionals using the device, whose qualifications are generally described as "Health care professionals." The document does not specify a panel of experts for ground truth establishment for a test set.

3. Adjudication method for the test set: Not applicable. There was no formal adjudication process for a specific test set. The conclusion of performance and safety is based on user feedback and the absence of reported adverse events.

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 or human-in-the-loop study with AI assistance was described. The device itself is an imaging system, not an AI-powered diagnostic algorithm.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an imaging system, not an algorithm, so a standalone algorithm-only performance study is not relevant in this context. The non-clinical tests showed the functional performance of the device itself (e.g., linearity of signal, safety standards).

6. The type of ground truth used:

   • For safety and functional performance: Adherence to consensus standards (mechanical, electrical, thermal safety, EMC, biocompatibility) and linearity of signal with ICG concentration.
   • For effectiveness/intended use: User feedback from clinical operation and the absence of reported adverse events over 10,000+ patient exams over several years.

7. The sample size for the training set: Not applicable. This is not an AI-driven device requiring a training set.

8. How the ground truth for the training set was established: Not applicable.

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