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The CT9000ADV is designed to inject a radiopaque contrast media into a patient's vascular system, which enhances diagnostic images obtained with computed tomography (i.e. "CT"). Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume and timing.

The CT9000ADV / OptiBolus Injection System delivers radiographic contrast media at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiBolus feature is used to enable an exponential decaying flow rate injection that will optimize the contrast usage and provide an extended period of uniform enhancement. The OptiBolus feature can be turned on or off by the user for any given injection protocol.

The major components of the system are:

1. Power Head- The CT 9000ADV / OptiBolus Powerhead is contained in a sturdy metal case. The Powerhead contains the operator interfaces for viewing injection information, controlling the fill and expel operation, starting and stopping an injections for enabled and injecting states and the interface for connection of the various syringes. The Powerhead communicates its gathered information to the Power Pack.
2. Power Pack- Contains the power supply and main microprocessor. The power supply converts the line voltage to the working voltage for the powerhead and console (approximately 24-vdc). The main processor provides a centralized control system for all system functions. The Powerhead and Console each contain a remote microprocessor that is used to control their localized functions.
3. Console- Communicates with the Power Pack to program and initiate injection protocols, displays the injection status, and displays an iniection timer. The Console provides the means for the operator to enable, disable and view an OptiBolus injection. The Console display provides a simulated display that represents the OptiBolus injection as it progresses.
4. Syringes- The CT9000ADV / OptiBolus Injection System accommodates the Mallinckrodt 125-ml pre-filled syringe styles. It is also accommodates the Liebel-Flarsheim 200-ml syringe. These syringes are commonplace on the market.

The provided text describes a Special 510(k) Summary for the CT9000ADV/OptiBolus Injection System. This document focuses on demonstrating substantial equivalence to a predicate device, the CT 8000 Digital Injection System, rather than presenting a study with acceptance criteria and device performance results in the context of diagnostic accuracy or clinical outcomes.

The "study" described herein is essentially a comparison and verification effort to ensure the new device functions similarly and safely to the predicate device, especially regarding its core function of injecting contrast media. The key difference highlighted is the "OptiBolus" feature for bolus shaping.

Here's an analysis based on the provided text, addressing your questions where possible:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative, performance-metric sense often seen in diagnostic AI/image analysis studies. Instead, the acceptance is based on demonstrating substantial equivalence to the predicate device, the CT 8000 Digital Injection System, through a comparison of features and functional specifications. The "reported device performance" is essentially that the new device meets or matches the predicate device's capabilities, with the addition of the OptiBolus feature.

Here's a table summarizing the comparison, which serves as the "performance" relative to the predicate:

The primary "new performance" of the CT9000ADV/OptiBolus is its ability to perform a "bolus shaping injection" with an exponential decaying flow rate, which the predicate device did not explicitly offer. The document implies this feature functions as designed due to the overall substantial equivalence and safety of the system.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This type of information is not applicable to this 510(k) submission. This is a submission for an injection system, not a diagnostic algorithm or AI device that processes medical images. There is no "test set" of patient data in the sense of accuracy studies for image interpretation. The "testing" would involve engineering verification and validation of the device's mechanical and software functions. The document does not provide details on the specific sample sizes used for internal engineering tests (e.g., number of injections performed, number of devices tested), nor the provenance of such test data.

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 is not applicable. As this is an injection system, not an interpretive diagnostic device, there is no "ground truth" to be established by medical experts in the context of interpreting images or diagnosing conditions. Medical experts (e.g., radiologists) use the output of such devices (enhanced CT images) for diagnosis, but their role is not to establish "ground truth" for the device's function as an injector. The "ground truth" for an injector would be its mechanical and software precision and safety, verified through engineering tests.

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

This is not applicable. There is no "test set" requiring adjudication by multiple experts in this context.

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 is not applicable. MRMC studies are used for evaluating diagnostic performance of image interpretation systems, often comparing human readers with and without AI assistance. This document describes an imaging injection system, not an AI-based diagnostic algorithm or an image analysis tool.

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

This is not applicable. This is a hardware device with software control, not an algorithm meant to perform a diagnostic task independently. Its "performance" is inherently tied to its interaction with a human operator for programming and monitoring, and its output (contrast injection) is then utilized by other diagnostic devices.

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

For an injection system, "ground truth" would relate to the precision of its mechanical and software functions (e.g., accurately delivering programmed flow rates and volumes, maintaining pressure limits). This "ground truth" is typically established through:

• Engineering specifications and tests: The device is designed and tested to meet specific mechanical, electrical, and software performance criteria.
• Calibration: Ensuring the device's sensors and actuators are accurate.
• Verification and validation testing: Demonstrating that the device performs its intended functions safely and effectively under various conditions.

The document does not detail the specific test methods or "ground truth" establishment for these engineering aspects, as that level of detail is typically found in design control and testing documents, not in a 510(k) summary. However, it implicitly relies on the fact that the predicate device (CT 8000) was proven safe and effective through such methods. The new features (specifically OptiBolus) would have undergone similar internal verification.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of machine learning for this device. The software controls the injection based on pre-programmed algorithms and user inputs, not on learned patterns from a dataset.

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

This is not applicable for the same reasons as point 8.

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