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510(k) Data Aggregation
(34 days)
SPY INTRAOPERATIVE IMAGING SYSTEM
For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (CABG) surgery.
The SPY Intraoperative Imaging System: SP2000 is indicated for use for intra-operative visual assessment of the coronary vasculature and grafts during CABG surgery.
The SPY System provides the surgeon with the capability to view record and replay fluorescent images of blood vessels and bypass grafts of the A laser light source is used to illuminate the heart surface. heart. Indocyanine Green (ICG) is injected intravenously through the central venous line, bypass pump or cardioplegia line and, while coursing through the coronary arteries and grafts, the absorption of laser light causes excitation of the dye followed by emission of infrared energy. The result is a fluorescent image of the coronary vasculature. A CCD camera captures the image. These images are used to evaluate the integrity of the coronary vasculature and bypass grafts.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| In Vitro | |
| Electrical safety (IEC 60601-1, UL2601-1) | Successfully met all requirements. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Successfully met all requirements. |
| Light Emitting Laser Products (21 CFR 1040) | Successfully met all requirements. |
| Safe Use of Lasers in Health Care Facilities (ANSI Z136.3) | Successfully met all requirements. |
| American National Standard for Safe Use of Lasers (ANSI Z136.1) | Successfully met all requirements. |
| In Vivo (Safety) | |
| Exposure below ANSI MPE for skin | Exposure of 35 mW/cm² is far below MPE of 327 mW/cm². |
| No thermal damage to heart tissue | No thermal damage observed. |
| No changes to electrocardiograms | No changes to electrocardiograms during and following use. |
| No changes to arterial pressures | No changes to arterial pressures during and following use. |
| No acute or long-term cellular effects | No acute or long-term cellular effects observed. |
| No acute or long-term renal or hepatic effects | No acute or long-term renal or hepatic effects observed. |
| In Vivo (Effectiveness) | |
| Ability to acquire excellent images of entire vascular bed | Able to acquire excellent images of the entire vascular bed on each aspect of the heart. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The device's safety and effectiveness were supported by "human experience in 1485 CABG procedures." This likely refers to the number of procedures involving the device itself.
- Data Provenance: The text does not explicitly state the country of origin. It mentions the manufacturer as "Novadaq Technologies Inc." located in Mississauga, Ontario, Canada. It also states the studies were "human experience," which implies prospective observation during actual surgeries. Further details about the study design (e.g., retrospective vs. prospective) are not explicitly provided beyond 'human experience'.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The provided text does not specify the number of experts used to establish ground truth or their qualifications. The evaluation of image quality and clinical observations during the 1485 CABG procedures would have inherently involved surgeons and potentially other medical personnel, but details about an independent expert panel for ground truth establishment are not given.
4. Adjudication Method for the Test Set
The provided text does not specify an adjudication method (such as 2+1, 3+1, or none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study, and Effect Size
The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The study focuses on the device's standalone performance and safety.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study was done. The "In Vivo Testing" describes the device's performance in acquiring images and its safety parameters (e.g., exposure levels, lack of tissue damage, no impact on ECG/arterial pressures). The device itself (SPY System) performs the imaging and provides the visual assessment, and the study demonstrates its ability to do so effectively and safely.
7. Type of Ground Truth Used
The ground truth used appears to be a combination of:
- Clinical Observation/Surgical Assessment: The ability to "acquire excellent images of the entire vascular bed" and the observations regarding thermal damage, ECG changes, and arterial pressures during and following SPY use, and cellular/renal/hepatic effects, all rely on direct clinical observation and possibly standard diagnostic assessments within the context of the CABG procedures.
- Established Safety Standards: In vitro testing confirmed compliance with electrical, electromagnetic, and laser safety standards (IEC, UL, ANSI, 21 CFR).
8. Sample Size for the Training Set
The provided text does not specify a training set sample size. The device is not described as an AI/ML algorithm that requires a separate training set. Its function is to acquire and display fluorescent images, with the evaluation being done by the surgeon. The "human experience in 1485 CABG procedures" serves as the clinical data demonstrating the device's performance, but not specifically a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Since the device is not described as an AI/ML algorithm requiring a training set, the concept of establishing ground truth for a training set in this context is not applicable from the provided information.
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