(104 days)
INTENDED USE: P3TTM Cardiac is intended for use with CT Angiography. P3TTM Cardiac computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration. The user will be required to confirm/change the suggested protocol before beginning an injection.
INDICATIONS FOR USE: P3T™ Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, and thoracic and abdominal aorta.
The MEDRAD Stellant CT Injector System with P3T™ Cardiac is a syringe-based fluid delivery system indicated for delivery of contrast media during computed tomography procedures. The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD Stellant CT Injector System operating software includes P3T™ Cardiac, an optional, password-enabled software accessory. The injector system, when used with P3T™ Cardiac, maintains the same intended use, same operational parameters, and same labeling (with the addition of the P3T™ Cardiac operation manual), and is used in the same manner as the injector system without the software accessory.
The P3T™ Cardiac software accessory provides the convenience of generating patientspecific contrast injection protocols, and increases the consistency of individualized injection protocols among technologists.
The provided document is a 510(k) summary for the MEDRAD Stellant CT Injector System with P3TTM Cardiac. This document describes an injector system with a software accessory (P3TTM Cardiac) that computes contrast injection protocols and scan timing for CT Angiography.
Based on the content, this is not a study of an AI/ML diagnostic or prognostic device that would have specific performance metrics like sensitivity, specificity, or AUC against a ground truth dataset. Instead, it's a submission for an imaging accessory that aids in optimizing injection protocols. The submission focuses on substantial equivalence to a predicate device (MEDRAD Stellant CT Injector System with P3TTM CardiacFlow (K072886)) rather than presenting a performance study against specific acceptance criteria for diagnostic accuracy.
Therefore, many of the requested elements for a performance study (like test set size, expert ground truth, MRMC study, standalone performance, training set details) are not applicable or not present in this type of submission, as the device's function is to generate protocols, not to interpret images or diagnose conditions.
Here's a breakdown based on the provided text, highlighting what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a table of specific quantitative "acceptance criteria" and "reported device performance" in the way one would for a diagnostic algorithm (e.g., sensitivity, specificity, accuracy thresholds). Instead, the "acceptance" for this type of device is regulatory clearance based on substantial equivalence to a predicate device. The performance is indirectly supported by the device's functionalities being comparable or expanded from the predicate, and its ability to generate injection protocols as intended.
Key "performance" aspects discussed are functional equivalence to its predicate:
| Feature | Proposed Device: Stellant CT Injector System with P3T™ Cardiac | Predicate Device: Stellant CT Injector System with P3T™ CardiacFlow (K072886) |
|---|---|---|
| Intended Use | The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. The P3T™ Cardiac software accessory computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration. | The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. The P3T™ CardiacFlow software accessory computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration. |
| Indications | P3T™ Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, and thoracic and abdominal aorta. | The P3T™ CardiacFlow software accessory is intended for use in CT angiography of cardiac structures, including coronary arteries, chambers of the heart, and thoracic and abdominal aorta during gated ECG acquisition. |
| User Interface | The P3T™ software accessory can be turned on or off by the user for any given injection. The user will be required to confirm/change the suggested protocol before beginning an injection. | The P3T™ software accessory can be turned on or off by the user for any given injection. The user will be required to confirm/change the suggested protocol before beginning an injection. |
| Functional Equivalence | (Numerous features listed in Table 1, such as Multi-Phase, Arming Modes, Protocol Storage/Recall, Hold Capability, Safety Stop Mechanism, Syringe System, Programmed Volume, Volume Remaining Readout, Fill Rate, Flow Rate, Programmable Pressure Limit, Pause, Autofill, Retract Control, Remote Start Switch, Pressure Graph, Syringe Sensing, Autoload, Auto Dock/Retract/Advance, Protocol Lock / Remote Arming, Check for Air, Scan Delay, Test Inject, Flow Profile Display, Imaging System Interface (ISI)) | All of these functionalities are listed as identical to the predicate device in Table 1. |
Summary of "Acceptance": The device was deemed "substantially equivalent" to the predicate device (K072886) by the FDA, based on the comparison of features and intended use. The extension of indications to include pulmonary vasculature and abdominal aorta (beyond gated ECG acquisition) for the P3T™ Cardiac, while maintaining the same core functionality and safety features, was accepted.
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This document does not describe a clinical performance study using a test set of patient data for a diagnostic outcome. The P3T™ Cardiac software is an accessory that computes injection protocols, not interprets images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. As there is no test set for diagnostic performance, there is no need for experts to establish ground truth in this context. The "ground truth" for the device would be the accuracy of its computed injection protocols in practice, which is generally assessed through engineering validation and clinical use rather than a formal ground-truth-labeled dataset.
4. Adjudication method for the test set:
- Not applicable / Not provided.
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:
- No. This is not a diagnostic AI device. An MRMC study is not relevant here. The device assists technologists in generating protocols, but not in image interpretation or diagnosis.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided in this context. While the P3T™ Cardiac software operates standalone to compute the protocol, it's explicitly stated that "The user will be required to confirm/change the suggested protocol before beginning an injection." This indicates a human-in-the-loop for final decision-making, which is part of its intended safe use. The submission focuses on the safety and functional equivalence of the injector system with the software rather than a standalone AI performance evaluation for diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. The "ground truth" for an injection protocol computation device would involve whether the computed protocols lead to optimal image quality and patient outcomes, which is generally assured through engineering validation, simulated environments, and clinical experience/studies (not usually detailed in a 510(k) summary focused on substantial equivalence).
8. The sample size for the training set:
- Not applicable / Not provided. The P3T™ Cardiac software computes protocols based on patient characteristics and scanner parameters using presumably pre-programmed algorithms or models, not a machine learning "training set" in the sense of image recognition or diagnostic AI.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.