(98 days)
Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for Injection, USP), the SPY Elite System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY Elite System used with SPY AGENT™ GREEN is indicated for use in adult and pediatric patients one month of age and older. The SPY Elite System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries.
The SPY Elite System is an angiographic fluorescence imaging system which is used for nearinfrared fluorescence imaging during open surgery, with indocyanine green (ICG) as the imaging agent. The SPY Elite System allows surgeons to capture, review, print, and archive high-quality fluorescence images of blood flow in vessels, tissue and organ perfusion in realtime during various surgical procedures.
The SPY Elite System is comprised of an Imaging Console, CINEVAQ software and DICOM Send software. SPY Elite is intended to be used in coniunction with the SPY Elite Pack/Kit which contains ICG, sterile Water for Injection, a sterile equipment drape, instructions for use, and a drug product package insert.
The SPY Elite System, an angiographic fluorescence imaging system, has established its performance through non-clinical testing and clinical literature evaluations.
Here is a summary of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Visualization Rate (Macrovascular Blood Flow) | Across 13 studies reviewed, 12 exceeded 90% visualization rate (10 showed 100% visualization rate). |
| Visualization Rate (Microvascular Blood Flow) | Across 33 studies (2055 patients), all showed >90% visualization rate (31 studies (94%) showed 100% visualization rate). |
| Safety and Efficacy in Pediatric Patients (1 month to 21 years) | Clinical literature demonstrated effective visualization of blood flow and tissue perfusion with no identified anaphylaxis or other adverse events related to SPY fluorescence imaging with ICG in pediatric patients. The data suggested no differences in safety and efficacy between pediatric and adult patients. |
| Compliance with Safety Standards | The SPY Elite System was tested in accordance with IEC 60601-1:2012, IEC 60601-1-2:2007, and IEC 60825-1:2007. Test results showed conformance to applicable requirements. |
2. Sample Sizes Used for the Test Set and Data Provenance
The "test set" for performance evaluation appears to be composed of aggregated patient data from published clinical literature.
- Sample Size:
- Macrovascular blood flow: Data from 13 studies.
- Microvascular blood flow: Data from 33 studies involving 2055 patients.
- Data Provenance: The data is retrospective, derived from systematic summary reviews of existing clinical literature. The country of origin of this literature is not specified, but typically such reviews encompass international publications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used to establish ground truth for the test set from the clinical literature reviews, nor their specific qualifications (e.g., "radiologist with 10 years of experience"). However, the assessment of the clinical literature was conducted through "systematic summary reviews," implying a rigorous process, likely involving experts in the relevant surgical fields and medical literature analysis. The ground truth itself is derived from the reported clinical outcomes in these published studies.
4. Adjudication Method for the Test Set
The document describes "systematic summary reviews of the clinical literature" and "meta-analyses reports." This suggests a systematic approach to evaluating and synthesizing findings across multiple studies. While a specific method like "2+1" or "3+1" is not explicitly mentioned for individual case adjudication, the process of systematic review inherently involves methods to assess study quality, consistency, and synthesize results, which acts as a form of adjudication in a meta-analysis context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned comparing human readers with AI assistance versus without AI assistance. The device in question (SPY Elite System) is a fluorescence imaging system that aids surgeons in visualizing blood flow and tissue perfusion; it is not, as described here, an AI-powered diagnostic algorithm intended to work in conjunction with human readers to interpret images. Its function is to provide real-time visual information.
6. Standalone (Algorithm Only) Performance Study
The SPY Elite System is an imaging device that provides visual information in real-time. It is used "in combination with SPY AGENT™ GREEN" (Indocyanine green for Injection, USP). Its performance is inherently linked to this combination and human interpretation of the images. Therefore, a "standalone algorithm only" performance study in the typical sense of an AI model predicting outcomes without human-in-the-loop is not applicable here, as the device's purpose is to enhance human intraoperative visualization. The "visualization rate" mentioned in the performance table reflects the ability of the system to display the required information.
7. Type of Ground Truth Used
The ground truth used for performance evaluation is based on clinical outcomes and observations reported in published medical literature. Specifically, it pertains to the successful visualization of macrovascular blood flow, microvascular blood flow, and tissue perfusion during various surgical procedures, as observed and documented by clinicians in those studies. It also includes the absence of adverse events related to the imaging process.
8. Sample Size for the Training Set
The document primarily focuses on validating the device against existing clinical literature and non-clinical standards. It does not describe a "training set" in the context of an AI/machine learning model developed by the manufacturer. The device is an imaging system, and its development would typically involve engineering and optical design validations, not data-driven model training. The clinical literature reviews served as evidence for its clinical utility and safety, not for training an algorithm.
9. How the Ground Truth for the Training Set Was Established
As no "training set" for an AI algorithm is mentioned, this question is not applicable in the context of the provided information. The device is a medical imaging system, not an AI diagnostic tool that requires a training set and corresponding ground truth. Its performance validation relies on demonstrating its ability to accurately capture and display fluorescence signals as confirmed by clinicians in clinical use (as documented in literature) and its adherence to relevant safety and performance standards.
§ 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.