(264 days)
Modus IR used with the Synaptive Surgical Exoscope is indicated for fluorescence imaging in conjunction with indocyanine green to aid in the visualization of vessels (micro- and macro-vasculature) and blood flow in the cerebrovasculature before, during, and after neurosurgery, plastic, and reconstructive surgeries.
Modus IR is an accessory of the Synaptive surgical exoscope. Modus IR provides surgical staff with a means to visualize vessels and blood flow during surgical procedures that may not be visible under white light conditions. When used with the appropriate imaging agent, light output at a specific wavelength excites the imaging agent, which emits light at a specific wavelength that is detected by the optical system, thereby allowing the user to differentiate the structure that the imaging agent has concentrated in. The imaging agent is not packaged or sold as part of Modus IR. It is the responsibility of the user to source and administer the applicable imaging agent according to the excitation and observation wavelengths of Modus IR. Modus IR is selectively enabled by authorized personnel using software configuration management.
Here's a breakdown of the acceptance criteria and study information for the Modus IR device based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Acceptance/Pass Status | Reported Device Performance |
|---|---|---|
| Performance Bench Testing: | ||
| Signal-to-noise ratio (Sensitivity) | Pass | Modus IR was found to have a lower limit of detection and limit of quantification than the predicate at comparable working distances. |
| Fluorescence excitation and emissions | Pass | Although the excitation and emission wavelengths of Modus IR and the predicate device are not identical, they are considered equivalent (Modus IR: 748-802nm excitation, 820-1000nm detection; Predicate: 700-780nm excitation, 820-900nm detection). |
| Non-deformed, non-rotated, non-mirrored, and centered video image | Pass | IR images from Modus IR were found to be non-deformed, non-rotated, non-mirrored, and centered relative to the white light image, based on assessment during in-vivo animal study. |
| Spatial resolution | Pass | Modus IR was found to have a higher spatial resolution than the predicate at each working distance and zoom configuration, including at maximum zoom. |
| Photometric resolution | Pass | Photometric resolution was found to be equivalent between Modus IR and the predicate. |
| Latency to external monitor | Pass | Average latency of Modus IR was found to be lower than the predicate device. |
| In vivo Animal Study: | ||
| Functionally equivalent visualization of intraoperative blood flow and vessel architecture | 100% confirmation | In all 40 comparative evaluations by 10 neurosurgeons, intraoperative blood flow and vessel architecture visualization was found to be functionally equivalent between Modus IR and the predicate device. |
| Suitability of IR Fusion video clips for visualization of intraoperative blood flow against background anatomical structures | 100% confirmation | All IR Fusion video clips from Modus IR were found to be suitable for this purpose. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 4 comparative video sets, resulting in 40 comparative evaluations (4 video sets * 10 neurosurgeons).
- Data Provenance: Prospective, in vivo animal study using two healthy porcine models. The specific country of origin is not mentioned, but the sponsor is based in Canada.
3. Number of Experts and Qualifications for Ground Truth for the Test Set
- Number of Experts: 10 neurosurgeons.
- Qualifications of Experts: The document explicitly states "neurosurgeons," implying they are medical professionals specialized in neurosurgery, making them qualified to assess the visualization of cerebrovasculature. Their specific years of experience are not mentioned.
4. Adjudication Method for the Test Set
- The study used an assessment by 10 neurosurgeons who were blinded to which system they were evaluating. The video sets were presented in a randomized order.
- The results state "In all evaluations... was found to be functionally equivalent... (100% confirmation)." This implies a consensus or unanimous agreement among the neurosurgeons regarding the functional equivalence and suitability. It doesn't explicitly state a 2+1 or 3+1 method, but the 100% confirmation suggests that all 10 neurosurgeons agreed on the equivalence.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Yes, an MRMC-like study was done. The in vivo animal study involved multiple readers (10 neurosurgeons) assessing multiple cases (4 comparative video sets) for comparative effectiveness between the subject device and the predicate.
- Effect Size of Human Readers Improve with AI vs. without AI assistance: This information is not provided in the document. The study aimed to demonstrate functional equivalence between the new device (Modus IR) and a predicate device (INFRARED 800 with FLOW 800 option) for aiding human visualization, not to quantify the improvement of human readers with AI assistance compared to without. Modus IR is an imaging accessory, not an AI-powered diagnostic tool in the sense of AI-driven image analysis or decision support for the clinician.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone algorithm-only performance study was not explicitly mentioned or performed. The Modus IR is an imaging accessory that aids human visualization, not an algorithm that performs a task without human interpretation. Its performance is assessed in the context of aiding a human surgeon.
7. Type of Ground Truth Used
- For the in vivo animal study, the ground truth was expert consensus (10 neurosurgeons' unanimous agreement on functional equivalence and suitability of visualization).
- For the bench tests, the ground truth was based on objective measurements and comparisons against the predicate device using established metrics (e.g., limit of detection, spatial resolution measurements, qualitative assessment for image integrity).
8. Sample Size for the Training Set
- The document does not refer to or describe a training set for the Modus IR in the context of an AI/ML algorithm. Modus IR is described as an optical imaging accessory, not a software algorithm that performs diagnostic or analytical functions requiring a training set for machine learning. The software verification and validation mentioned are typically for ensuring software functions as intended, not for training a model.
9. How Ground Truth for the Training Set Was Established
- As no training set is described for an AI/ML algorithm, this information is not applicable.
§ 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.