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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 CT Injector System is comprised of the same main components as the predicate device: an Injector Head, a Display Control Unit, and sterile disposables.

The provided document is a 510(k) summary for the Medrad Stellant CT Injector System. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in the manner one might find for a novel diagnostic algorithm.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and sample sizes for AI/algorithm performance are not applicable to this document as it describes a medical device (an injector system), not an artificial intelligence or machine learning diagnostic tool.

However, I can extract the information relevant to the device's comparison to its predicate and the testing conducted for its clearance.

Acceptance Criteria and Device Performance (for Substantial Equivalence)

The acceptance criteria for the Medrad Stellant CT Injector System, as presented in this 510(k) summary, are primarily focused on demonstrating substantial equivalence to its predicate device, the Medrad EnVision CT Injector System (K934086 and K993728). This means the device must share the same intended use, similar operational parameters, similar labeling, and be used in a similar manner.

The "study" in this context is the design verification and validation testing conducted as part of Medrad's Quality System, in compliance with FDA's Quality System Regulations (QSRs). The results of these tests demonstrated that the design specifications for the Stellant CT Injector System were met and that it meets applicable requirements of international standards.

Details of the "Study" (Design Verification and Validation Testing)

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

   • Not applicable (N/A). This is a hardware device (injector system). The "test set" would refer to physical units of the device and its components undergoing engineering and performance testing rather than a dataset for an algorithm. The document does not specify the number of units tested.
   • Data Provenance: The testing was conducted by Medrad Inc. as part of its internal Quality System. The country of origin of the data would therefore be the USA, where Medrad Inc. is located. It is inherently prospective with respect to the device's development and clearance.

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

   • Not applicable (N/A). "Ground truth" in this context is established by engineering specifications, international performance standards, and comparisons against the predicate device's established performance. The "experts" would be the engineering and quality control teams at Medrad, verifying that the device meets these specifications. Their qualifications would be expertise in medical device design, manufacturing, and regulatory compliance.

3. Adjudication method for the test set:

   • Not applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for human expert review of uncertain cases in diagnostic studies. For a hardware device, performance is evaluated against predefined engineering tolerances and standards. Any discrepancies would likely be resolved through further engineering analysis and re-testing until specifications are met.

4. 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 (N/A). This is not a diagnostic AI device or image reading assistance tool. Therefore, no MRMC study or AI-assistance effectiveness was performed or is relevant.

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

   • Not applicable (N/A). This device is a hardware injector system, not an algorithm. Its "standalone" performance refers to its functional operation as a medical device.

6. The type of ground truth used:

   • For a hardware device like this, the "ground truth" relates to engineering specifications, performance standards (e.g., flow rate accuracy, pressure limits, safety mechanism functionality), and comparison to the predicate device's established capabilities. It's about meeting quantifiable design outputs and demonstrating functional equivalence/improvement.

7. The sample size for the training set:

   • Not applicable (N/A). There is no "training set" in the context of an AI/ML algorithm for a hardware medical device like an injector system.

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

   • Not applicable (N/A). As there is no training set, this question is not relevant.

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The EnVision CT Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media during computed tomography applications. It is intended to be used for the specific purpose of injecting intravenous contrast medium into the human vascular system for diagnostic studies in computed tomography.

The Medrad EnVision CT Injection System is a modified version of the EnVision CT Injector (K934086). It has the same indications for use and the same intended use as the predicate device. No changes to the fundamental scientific technology were made nor are any new risks introduced by this modification. The EnVision CT Injection System is a programmable syringe-based fluid delivery system for delivery of contrast media during computed tomography procedures. Programming is achieved via a touch screen LCD display. No advanced scientific principles beyond those normally associated with electro-mechanical devices are employed.

The EnVision CT Injector is comprised of the three main components - Master Control Unit (MCU), Display Control Unit (DCU), Injector Head (HCU). The Medrad EnVision CT Injector System, like the predicate EnVision CT Injector System, uses a 125ml and 200ml Front Load Sterile Disposable Syringe. The only difference is that the modified Injector accommodates the use of an alternate 200ml contrast pre-filled syringe, and it now has an Imaging System Interface.

The provided text describes the MEDRAD EnVision CT Injection System, a powered injector for delivering contrast media during CT procedures. The document focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, comprehensive device performance data, or a controlled study design with statistical metrics that fully align with all points of the request.

However, based on the Supporting Data and Conclusion sections, we can infer some aspects related to acceptance criteria and the "study" (design verification and validation testing) performed.

Here's an attempt to extract and infer the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that "design specifications for the EnVision CT Injection System were met." While specific numerical acceptance criteria are not detailed for each functional feature, the context implies that the device's performance aligns with its stated specifications and functional characteristics. The primary acceptance criterion appears to be substantial equivalence to the predicate device and compliance with relevant standards.

• Information Display (Monochrome LCD)
• Programming Keys (Non-Dedicated, Software Determined)
• Arming Modes (Single/MultiArm)
• Multi-Phase (1-10 phases)
• Protocol Storage (50)
• Hold Capability (0-600 seconds)
• Scan Delay (0-99 seconds)
• Safety Stop Mechanism (Electrical with Software Backup)
• Syringe System (200ml, 125ml, alternate 200ml)
• Automatic Piston Retract (25 sec)
• Volume Remaining Readout (LED)
• Programmed Volume (1-125ml or 1-200ml, depending on syringe)
• Autofill (Selectable, increments 25/50ml; inactive for alternate 200ml syringe)
• Fill Rate (2-9.9 ml/sec)
• Flow Rate (0.1-9.9 ml/sec)
• Pause (1 sec - 10 min)
• KVO (Continuous or intermittent, AVG min flow rate 0.01 ml/min)
• Pressure Limit (50-300 PSI Settable)
• Remote Start Switch (Yes) | "No changes to the fundamental scientific technology were made nor are any new risks introduced by this modification."
  "Except for the change to the Syringe Sensing and the addition of the Imaging System Interface. functionality has not changed."
  The table compares features, showing current device meets or exceeds predicate. |
  | Safety and Risk Management | Design controls in compliance with FDA's Quality System Requirements; Risk analysis performed; Meets requirements of FDA's QSRs. | "design controls were applied to the development...and meet the requirements of the FDA's QSRs."
  "a risk analysis was performed, and design verification and validation testing was conducted to support the conclusion drawn by the risk analysis." |
  | Compliance with Standards | IEC 529 (IPX1); IEC 601-1, Amds 1&2; IEC 601-1-2; IEC 801-2; IEC 801-3; IEC 801-4; IEC 801-5; UL 2601-1:1994; CSA C22.2 No. 601.1-M90. | "The EnVision CT Injection System meets the applicable requirements of the following standards." (All listed standards are met). |
  | Intended Use Performance | Ability to deliver contrast media during CT applications and inject intravenous contrast medium into the human vascular system for diagnostic studies in CT. | Substantially equivalent to predicate device for its intended use, as prescribed in the User Operation Manual. |

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "design verification and validation testing" but does not specify any sample sizes for a test set. This type of regulatory submission (a 510(k) summary for a modified version of an already cleared device) typically focuses on demonstrating that changes do not introduce new risks and that the device remains substantially equivalent. It does not usually include detailed clinical study data with patient sample sizes.

Data Provenance: Not specified. Given the nature of a medical device submission, the testing would generally be conducted by the manufacturer (Medrad, Inc., based in Indianola, PA, USA) under controlled design verification and validation protocols. There's no indication of clinical data from specific countries or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The "testing" referred to appears to be engineering design verification and validation, rather than a clinical study requiring expert consensus of medical images or patient outcomes.

4. Adjudication Method for the Test Set

This information is not provided. As above, the context suggests engineering and technical compliance testing, not a study requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study would compare human reader performance with and without AI assistance, which is outside the scope of this 510(k) summary for a contrast media injector.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

This question is not applicable to the device described. The EnVision CT Injection System is a physical electro-mechanical medical device, not an algorithm or AI software for diagnostic interpretation. Its performance is evaluated through its functional specifications and compliance with standards, not as a standalone algorithmic diagnostic tool.

7. The Type of Ground Truth Used

The "ground truth" for this device's "acceptance" is its technical specifications, functional performance as per engineering tests, and adherence to established medical device standards (IEC, UL, CSA) and FDA Quality System Regulations (QSRs). There is no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic interpretation, as this is an injection system.

8. The Sample Size for the Training Set

This information is not applicable. The device is an electro-mechanical system, not a machine learning or AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

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