(84 days)
For use in intra-operative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (CABG) surgery.
The SPYTM Intra-operative Imaging System: SP2000 is indicated for use for intraoperative visual assessment of the coronary vasculature and grafts during CABG surgery.
The SPYTM system provides the surgeon with the capability to view, record and replay fluorescent images of blood vessels and bypass grafts of the heart. A laser light source is used to illuminate the heart surface. 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.
The provided text describes the SPY™ Intra-operative Imaging System: SP2000, its intended use, and the testing performed to demonstrate its safety and effectiveness. However, it does not specify discrete acceptance criteria in a quantitative format (e.g., minimum sensitivity or specificity targets) with corresponding reported device performance metrics in a table. It instead outlines the types of testing and general conclusions on safety and effectiveness, and equivalence to predicate devices, without detailed performance data against specific, quantifiable criteria.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert involvement, and ground truth establishment cannot be fully extracted from the provided document. The document focuses more on regulatory compliance, safety, and equivalence rather than a detailed performance study with explicit acceptance criteria.
Below is an attempt to address the prompts based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define quantitative acceptance criteria for device performance (e.g., specific sensitivity, specificity, accuracy thresholds). Instead, the "Testing" section outlines general requirements and conclusions from in vitro and in vivo studies. The performance is primarily reported as meeting safety standards and achieving image quality equivalent to radiographic angiography.
| Acceptance Criteria (Inferred/General) | Reported Device Performance |
|---|---|
| In Vitro Safety & Compliance | |
| - 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 (ANSI Z136.3, ANSI Z136.1) | - Successfully met all requirements. |
| In Vivo Safety | |
| - Laser exposure below Maximum Permissible Exposure (MPE) | - Exposure: 35 mW/cm². MPE (ANSI for skin): 327 mW/cm². Exposure is far below MPE. |
| - No thermal damage to heart tissue | - Use of the SPY™ system does not cause any thermal damage to the heart tissue. |
| - No changes to ECGs or arterial pressures | - There were no changes to the electrocardiograms or arterial pressures during and following SPY™ use. |
| - No acute or long-term cellular, renal, or hepatic effects | - There were no acute or long-term cellular effects of using the SPY™ system. No acute or long-term renal or hepatic effects. |
| In Vivo Effectiveness/Performance | |
| - Image quality equivalent to radiographic angiography | - The image quality of the SPY™ system was equivalent to radiographic angiography. |
| - Ability to acquire excellent images of entire vascular bed | - The SPY™ system was able to acquire excellent images of the entire vascular bed on each aspect of the heart. |
| - (Implied) Equivalence to predicate devices for intended use | - The testing demonstrates the SPY™ Intra-operative Imaging System is safe and effective in imaging the coronary vasculature and bypass grafts intraoperatively and is equivalent to the predicate devices (Philips Integra Series 2 Systems (K984545) and Heidelberg Retinal Angiographic System (K944261), although the predicate devices are listed as angiographic X-ray and retinal imaging systems, respectively, which is somewhat incongruous with a direct comparison for cardiac imaging). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document states "human experience in 950 CABG procedures were completed to demonstrate safety and effectiveness." This indicates a substantial sample size from clinical use.
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the human experience was collected retrospectively or prospectively, but "human experience" in conjunction with demonstrating safety and effectiveness could encompass a variety of observational or trial-like data collection methods. Given the context of a 510(k) summary, it's likely a combination of clinical observations and possibly some form of prospective data collection, but this is not explicitly stated.
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)
This information is not provided in the document. The text refers to "human experience" and the "image quality... was equivalent to radiographic angiography," implying expert assessment of images. However, it does not detail how many experts were involved, their qualifications, or their role in establishing ground truth for the 950 CABG procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
- MRMC Study: An MRMC comparative effectiveness study is not mentioned. The document describes "intra-operative visual assessment" and "image quality... was equivalent to radiographic angiography," but it does not detail any study designed to compare human reader performance with and without the device, or against an AI, as the device itself is an imaging system, not an AI-assisted diagnostic tool.
- Effect Size of AI assistance: Not applicable as the device is an imaging system and not designed with AI assistance, nor is an AI component mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an imaging system (hardware and associated software for image acquisition and display), not an algorithm for standalone diagnosis. Therefore, a "standalone algorithm only" performance study is not applicable in this context. The SPY™ system is designed for "intra-operative visual assessment," implying human-in-the-loop use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document primarily relies on the following for demonstrating effectiveness:
- Equivalence to Radiographic Angiography: This suggests a comparison against an established imaging modality, likely interpreted by experts.
- Clinical Observation/Experience: "Human experience in 950 CABG procedures" implies direct clinical observation and assessment by surgeons regarding the system's ability to visualize vasculature and grafts.
- Absence of Adverse Events/Safety Measures: Lack of thermal damage, ECG/pressure changes, or cellular/organ effects were key safety "ground truths."
While expert assessment is strongly implied for "image quality" and "visual assessment," explicit details on how ground truth for vessel patency or graft integrity was formally established (e.g., through a gold standard like pathology or long-term clinical outcomes) are not detailed. It appears to be based on the established clinical utility and visual confirmation during procedures.
8. The sample size for the training set
This information is not provided. The SPY™ system is an imaging device, not an AI model that typically has a distinct training set. The "human experience" of 950 CABG procedures served as part of the validation/testing to demonstrate safety and effectiveness.
9. How the ground truth for the training set was established
Not applicable, as the device is not an AI model trained on a dataset with established ground truth in the conventional sense. The "training" for such a system would involve engineering and physical testing, not data labeling for an algorithm.
§ 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.