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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.

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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The OptiVantage DH Injector System with Enhanced Communication is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.

The OptiVantage DH Injector System with Enhanced Communication delivers radiographic contrast media and/or saline at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiVantage DH Injector System with Enhanced Communication consists of 4 main components, just like the predicate device:

• Power Head- Contains two electromechanical syringe drive systems, the syringe holding mechanisms, the main microprocessor, control electronics, control keypad for programming and initiating injection protocols, a status display, and two purge/retract manual knobs. The OptiVantage uses a drive system that is similar to existing Mallinckrodt injectors in the marketplace. It uses a motor and gearbox coupled to a ball screw. The ball screw drives a ram that attaches to the syringe plunger in order to fill or expel the contents of the syringe.
• Power Supply- The power supply converts the line voltage to the working voltage for the power head and console (approximately 24-vdc).
• Console Communicates with the Power Head to program and initiate injection protocols, displays the injection status, and displays a timer.
• Syringes The OptiVantage DH Injector System with Enhanced Communication accommodates the Syringes - The Oper rainage styles as well as a 200 ml front loading empty syringe. These Minimonrol. I 22 million place on the market and are currently used with the predicate device.

The provided text is a 510(k) summary for the OptiVantage DH Injector System with Enhanced Communication. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for a performance study.

The document is a submission to the FDA for market clearance, focusing on demonstrating that the new device is substantially equivalent to a previously cleared predicate device (K042744). The comparison table highlights features that are identical between the new device and the predicate. The "enhancement" mentioned is an additional layer of enforcement for existing safety features, rather than a new performance characteristic requiring a new clinical performance study with acceptance criteria.

Therefore, many of the requested details about performance studies, data provenance, expert ground truth, etc., are not present in this 510(k) summary document.

Here's a breakdown of what is and is not available in the provided text:

1. Table of acceptance criteria and reported device performance:

• Not available. The document does not specify quantitative acceptance criteria (e.g., specific thresholds for flow rate accuracy or pressure limits) against which a study's results would be measured. It rather lists specifications and features that are identical to the predicate device.

2. Sample size used for the test set and the data provenance:

• Not available. No performance study or test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not available. Not applicable as no performance study with ground truth establishment is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not available. Not applicable.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

• Not applicable. This device is a power injector for contrast media, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not available. No standalone performance study is mentioned. The device's performance is implicit in its specifications, which are deemed substantially equivalent to the predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not available. Not applicable.

8. The sample size for the training set:

• Not available. Not applicable as no machine learning algorithm development is described.

9. How the ground truth for the training set was established:

• Not available. Not applicable.

What can be extracted from the document related to "performance" and "criteria":

The document relies on substantial equivalence to a predicate device (OptiVantage DH Power Injection System, K042744). The "acceptance criteria" are implicitly that the new device performs identically or acceptably compared to the predicate for all relevant functions.

Reported Device Performance (based on comparison to predicate):

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