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510(k) Data Aggregation
(73 days)
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 Stellant 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.
The Stellant P3T CardiacFlow software accessory 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.
MEDRAD Stellant CT Injector System operating software has been modified to include the P3T CardiacFlow accessory. P3T CardiacFlow is an optional, password-enabled accessory. The injector system, when used with P3T CardiacFlow, maintains the same intended use, same operational parameters, and same labeling (with the addition of a P3T CardiacFlow operations manual). This device is also used in the same manner as the predicate devices.
The MEDRAD Stellant CT Injector System with P3T CardiacFlow 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 has been modified to include the P3T CardiacFlow accessory. MEDRAD Stellant CT Injector System with P3T CardiacFlow maintains the same intended use, operational parameters, and labeling as the MEDRAD Stellant CT Injector System, with the addition of P3T CardiacFlow Instructions For Use. The P3T CardiacFlow accessory provides the convenience of generating patient-specific contrast injection protocols, and increases the consistency of individualized injection protocols among technologists. Stellant CT Injector System with P3T CardiacFlow is used in the same manner as the predicate device (Stellant CT Injector System without P3T CardiacFlow).
The provided document, K072886, describes the MEDRAD Stellant CT Injector System with P3T CardiacFlow software accessory. This is a premarket notification (510(k)) and primarily focuses on establishing substantial equivalence to predicate devices, rather than an independent clinical study demonstrating specific performance metrics against defined acceptance criteria. Therefore, the details requested for a clinical study proving acceptance criteria compliance are not fully available in this document.
However, based on the information provided, we can infer the acceptance criteria and some aspects of performance. The substantial equivalence argument itself serves as the "study" in this context for regulatory clearance.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the proposed device is as safe and effective as the predicate devices. The performance is reported in terms of feature comparison.
| Feature / Acceptance Criteria (Implicit) | Reported Device Performance (Proposed Device) |
|---|---|
| Intended Use Equivalence | - "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." (Same as predicate) |
| - The P3T CardiacFlow accessory is intended for CT angiography of cardiac structures (coronary arteries, chambers, thoracic/abdominal aorta) during gated ECG acquisition. | |
| Operational Parameters Equivalence | - "maintains the same intended use, same operational parameters, and same labeling (with the addition of a P3T CardiacFlow operations manual)." (Page 1) |
| - Multiphase: Up to 6 phases per P3T CardiacFlow injection (Comparable to predicate's 1-6 phases and 6 phases). | |
| - Scan Delay: 1 sec to 300 sec in 1 sec increments (Same as predicate Stellant). | |
| Safety Architecture Integrity | - "The Stellant safety architecture has not been modified nor impacted; additionally every injection protocol must be approved and locked by the practitioner. The practitioner always has the option of modifying or deleting the P3T CardiacFlow suggested protocol." (Page 1-2) |
| New Feature Functionality | - The P3T CardiacFlow software accessory computes individual contrast injection protocols and scan timing based on patient characteristics, scanner parameters, and contrast concentration. This provides "the convenience of generating patient-specific contrast injection protocols, and increases the consistency of individualized injection protocols among technologists." (Page 1) - User confirmation/change of suggested protocol is required before injection. - P3T CardiacFlow can be turned on or off (Similar to OptiBolus predicate). |
| Contraindications | - Not intended for Ungated CT angiography of Right heart, Pulmonary trunk, Pulmonary Arteries for PE studies, head/neck vessels, or peripheral angiography. (Clear delineation of scope) |
| - Not for use on patients with compromised renal or other contrast adverse related health issue. (Clear delineation of scope) | |
| Hardware Equivalence | - Dual syringe model (Compared to single/dual for predicate Stellant, and dual for OptiVantage). |
| - Color LCD, Touch screen, Remote Start Switch, Pressure Graph, Syringe Sensing, Autoload, Autodock/Retract/Advance, Protocol Lock/Remote Arming, Check for Air, Test Inject, Syringe Heat Maintainer, Flow Profile Display, Imaging System Interface (ISI) Functionality (All present and comparable to or exceeding predicate features). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a clinical study with a "test set" in the traditional sense of patient data used to evaluate AI performance. The evaluation is based on a comparison of device features, intended use, and operational parameters against existing legally marketed predicate devices. The provenance of any underlying data that informed the development of the P3T CardiacFlow algorithm (e.g., patient characteristics, scanner parameters, contrast concentration relationships) is not specified. It is likely based on engineering principles, scientific literature, and potentially in-house data/simulations rather than a distinct, prospectively collected, and adjudicated clinical "test set" for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable, as this device's regulatory review is based on substantial equivalence to existing devices and its operational safety and effectiveness, rather than a diagnostic AI algorithm requiring ground truth established by experts on a test set. The efficacy of the P3T CardiacFlow algorithm itself (meaning its ability to accurately compute protocols for optimal cardiac CT angiography) would presumably be verified through internal engineering and potentially pre-clinical or limited clinical testing, but these details are not provided in the 510(k) summary.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated in point 3.
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
Not applicable. This device is an injector system with software to assist in protocol generation, not an AI diagnostic algorithm meant to be read by human readers. Therefore, an MRMC study is not relevant to its regulatory submission in this context. The benefit of the P3T CardiacFlow is stated as "increases the consistency of individualized injection protocols among technologists" (page 1).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The P3T CardiacFlow is not a standalone algorithm that operates without human intervention. The document explicitly states: "The user will be required to confirm/change the suggested protocol before beginning an injection." and "every injection protocol must be approved and locked by the practitioner. The practitioner always has the option of modifying or deleting the P3T CardiacFlow suggested protocol." (Page 1-2). This indicates a human-in-the-loop design where the algorithm provides suggestions but requires final human approval and can be overridden.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Since this is not a diagnostic device establishing a "ground truth" for a medical condition, the concept of ground truth as typically applied to diagnostic AI is not directly applicable. For the P3T CardiacFlow software, the "ground truth" for its function would be whether the computed protocols are appropriate and effective for the intended CT angiography procedures, leading to diagnostic quality images while ensuring patient safety. This "truth" would likely be established through:
- Engineering validation: Demonstrating that the algorithm correctly applies the defined logic based on input parameters.
- Physical modeling, simulations, and phantom studies: Verifying that the proposed injection protocols achieve desired contrast enhancement profiles.
- Possibly limited clinical evaluation or literature review: Confirming that the principles underlying the algorithm lead to clinically acceptable results in practice, as informed by medical expertise in CT angiography.
However, specific details of such validation are not provided in this 510(k) summary.
8. The Sample Size for the Training Set
Not applicable. The document does not describe a machine learning model that requires a distinct "training set" of data for learning patterns, as might be the case for image recognition algorithms. The P3T CardiacFlow computes protocols based on predefined patient characteristics, scanner parameters, and contrast concentration, likely using a programmed algorithm based on scientific principles and clinical knowledge, rather than a learned model from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated in point 8.
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(76 days)
X-ray imaging of whole body - Computerized Tomography
Including:
Axial Volumetric (Helical) CT Fluoroscopy
The CKIS-004A, Injector Synchronization Option is intended to facilitate contrast enhanced CT examinations by interfacing the CT system to a contrast injection system. When employed, the CKIS-004A will allow both the CT scan and the contrast bolus to occur by activation of either the CT or the injector. The communications between the devices is based upon the CiA-425 standard.
The CKIS-004A will be added to the previously cleared TSX-101A Aquilion CT This addition requires hardware and software modifications to the system. existing device. Application of this option will facilitate contrast enhanced CT examinations by providing an interface between the CT system and the contrast injection device. This interface is based upon the protocol contained in the CIA-425 standard.
The provided document is a 510(k) summary for the Toshiba CKIS-004A Injector Synchronization Option. This device is an add-on to a CT scanner (TSX-101A Aquilion CT) that facilitates contrast-enhanced CT examinations by interfacing with a contrast injection device.
Based on the nature of the device (an injector synchronization option for a CT scanner), the document does not contain the typical acceptance criteria and a detailed study report that would be expected for a diagnostic AI/ML device. The device acts as an interface to coordinate existing medical equipment, rather than providing a diagnostic interpretation or measurement. Therefore, much of the requested information (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable or detailed in this specific submission.
However, I can extract the relevant information from the document regarding the device's characteristics and safety/effectiveness concerns.
Here's a breakdown of the information that can be extracted, and an explanation of why other requested items are not present:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, etc., which are common for diagnostic devices. Instead, the "performance" is described in terms of its intended function and compliance with standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Facilitate contrast enhanced CT examinations by interfacing CT system and injection device. | "Application of this option will facilitate contrast enhanced CT examinations by providing an interface between the CT system and the contrast injection device." |
| "This interface is based upon the protocol contained in the CIA-425 standard." | |
| "The CKIS-004A will allow both the CT scan and the contrast bolus to occur by activation of either the CT or the injector." | |
| Compliance with relevant safety and communication standards. | "This system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-32, IEC 60601-2-44. - Medical Device Safety standards and CiA -425 communications standard." |
| Substantial equivalence to predicate devices in uses and applications. | "This package is similar in uses and applications as those of the predicate devices." |
| Predicate devices: Siemens Care Contrast CT (K043807), Medrad Stellant CT Injector (K033881). | |
| Compliance with Quality System Regulations and Federal Diagnostic Equipment Standard. | "This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, that apply to this upgrade, will be met..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. As this device is an interface option and not a diagnostic algorithm, a typical "test set" in the context of image analysis or diagnostic performance is not relevant. The demonstration of performance primarily relies on compliance with technical standards and operational functionality.
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 applicable/provided. There is no "ground truth" in the diagnostic sense needed for this type of device, as it does not make diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. No adjudication method is described, as there is no diagnostic outcome being evaluated.
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
This information is not applicable/provided. This device is an injector synchronization option, not an AI/ML diagnostic aid that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device's function is to interface two existing pieces of equipment (CT scanner and injector) to facilitate a clinical procedure, not to perform a standalone diagnostic task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable/provided. As explained, the concept of "ground truth" for diagnostic performance is not relevant to this device's function. The "ground truth" for its function would be its ability to successfully communicate between the CT and injector as specified by the CiA-425 standard, which is likely verified through engineering tests and compliance rather than clinical ground truth data.
8. The sample size for the training set
This information is not applicable/provided. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. There is no ground truth for a training set in this context.
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