(110 days)
The Leica FL800 is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area and bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery.
The Leica FL800 device is an accessory to the Leica surgical microscopes. It allows the surgical microscope to produce excitation light and resolve fluorescence light from the fluorescent agent ICG. The generated fluorescence signal depicts the distribution of the infra-red dye in the patient's blood vessels during the operation (fluorescence video angiography).
This document (K141136) is a 510(k) premarket notification for a modification to an existing device, the Leica FL800. It doesn't describe a new clinical study to establish new acceptance criteria or new performance data in the typical sense for a brand new AI device. Instead, it demonstrates the substantial equivalence of a modified version of an already cleared device to its predicates.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
Since this is a modification to an already cleared device (Leica FL800), and the manufacturer states "There will be no change to the intended use of the device nor the alteration of the device's fundamental scientific technology," there aren't new clinical performance acceptance criteria established or new performance data reported as you would expect for an initial clearance of a novel diagnostic or AI-driven device.
The "acceptance criteria" here are compliance with recognized standards for safety and electromagnetic compatibility to ensure the modification does not negatively impact the device's performance or safety.
| Acceptance Criteria (Standards Conformance) | Reported Device Performance |
|---|---|
| IEC 60601-1-2 Edition 3:2007 (EMC) | Conforms |
| IEC 60601-1 Edition 3:2005 (Electrical Safety) | Conforms |
The device's functional performance related to "viewing intra-operative blood flow in the cerebral vascular area and bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery" is considered equivalent to the predicate devices because the fundamental scientific technology and intended use have not changed. The modification is primarily a change in configuration (external to internal) for ergonomic and aesthetic reasons.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study involving a clinical test set with patient data to evaluate a new diagnostic or AI performance. The testing was for engineering standards conformance (EMC, electrical safety) on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth was established by experts from patient data, as this was not a clinical performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a clinical test set was employed.
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-driven device and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable for clinical performance. The "ground truth" for the reported conformance is adherence to the specified engineering standards.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it's not an AI/machine learning product.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a training set.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.