(28 days)
For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (CABG) surgery.
The SPY Imaging System: SP2000 is currently cleared for intraoperative visual assessment of the coronary vasculature and grafts during coronary artery bypass graft (CABG) surgery. The Novadaq Technologies SPY Intra-operative Imaging System consists of 2 components: the SPY Imaging Device; and the SPY Paq®
This 510(k) pertains to a medical imaging system rather than an AI/ML device. Therefore, the typical acceptance criteria and study designs for AI/ML devices involving performance metrics like sensitivity, specificity, AUC, and multi-reader studies are not applicable in this context.
The document describes the SPY® Intra-operative Imaging System (Model SP2000), which is a fluorescent angiographic system used for intraoperative visual assessment of coronary vasculature and grafts during coronary artery bypass graft (CABG) surgery.
The FDA's decision is based on a determination of substantial equivalence to legally marketed predicate devices, not on specific performance acceptance criteria as would be typical for an AI/ML diagnostic or prognostic device.
Here's an analysis of what can be extracted from the provided text, recognizing the limitations due to the nature of the device (imaging system, not AI/ML):
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics (e.g., sensitivity, specificity thresholds) in this 510(k) summary. The primary "acceptance criterion" for clearance in this context is demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: The document does not contain specific quantifiable performance results (e.g., accuracy rates, image quality scores, comparison against a gold standard in a statistical sense). Instead, it describes:
- Intended Use: "For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (CABG) surgery."
- Functional Description: "The SPY Imaging System: SP2000 is currently cleared for intraoperative visual assessment of the coronary vasculature and grafts during coronary artery bypass graft (CABG) surgery." This indicates its functional capability rather than statistical performance.
- Substantial Equivalence: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices (K042961, K060867). This is the core "performance" assessment for this type of device submission.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided: The document does not describe a "test set" in the context of an AI/ML algorithm's evaluation with specific patient data. The substantial equivalence determination likely relied on technical specifications, design comparisons, and potentially non-clinical testing (e.g., bench testing, animal studies, or limited human clinical data typical for device safety and efficacy demonstration for systems of this type) that are not detailed here. Data provenance (country of origin, retrospective/prospective) is therefore not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable / Not provided: Since there's no defined "test set" for performance evaluation in the AI/ML sense, expert-established ground truth information is not present. The assessment relates to the system's ability to produce images suitable for a human clinician's visual assessment, rather than an AI's interpretation.
4. Adjudication Method for the Test Set:
- Not applicable / Not provided: No test set or corresponding adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No: This type of study is typically conducted for AI/ML diagnostic devices to assess how AI assistance impacts human reader performance. This device is an imaging system, not an AI diagnostic tool, so an MRMC study is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No: This concept is not applicable as the SPY system itself is an imaging tool designed for human interpretation, not an automated algorithm for standalone diagnosis.
7. The Type of Ground Truth Used:
- Not applicable / Not provided: For a medical device like an imaging system, the "ground truth" often relates to its ability to accurately visualize anatomical structures or physiological processes as confirmed by established clinical methods, but the 510(k) summary does not detail the specific studies or ground truth methodologies. The assessment focuses on the system's ability to aid a clinician in "visual assessment."
8. The Sample Size for the Training Set:
- Not applicable / Not provided: There is no "training set" in the context of AI/ML algorithm development for this device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable / Not provided: As above, no training set or associated ground truth establishment is relevant to this device submission.
In summary: The provided document is a 510(k) summary for an imaging system, not an AI/ML device. Therefore, the requested information points related to AI/ML device evaluation (like test/training sets, ground truth, expert adjudication, MRMC studies, standalone performance, and quantified acceptance criteria) are not present or applicable. The FDA clearance is based on the device's substantial equivalence to previously cleared predicate devices for its intended use as an intraoperative imaging tool.
§ 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.