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Injector: Administration of contrast and flushing media in conjunction with computed tomography (CT) scanning of the body with an optional interface to a CT scanner
EDA: The Extravasation Detection Accessory is indicated for the detection of extravasations of contrast media during CT using a power injector.

The EmpowerCT and EmpowerCTA Injector Systems have been modified for a software change only specific to the Empower Remote Control. They have been modified to add an optional calculator for glomerular filtration rate (GFR). This optional calculator is used as an additional screening tool for the use of a CT contrast injection in conjunction with a CT scan. This calculator does not affect the safety or efficacy of the device. Nor does it affect the indications for use of the system.

The provided document describes a Special 510(k) submission for a software change to the EmpowerCT and EmpowerCTA Injector Systems, specifically adding an optional calculator for glomerular filtration rate (GFR). The core functionality of the injector systems (contrast and flushing media administration in CT scanning) remains unchanged.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a separate section for the GFR calculator. Instead, it focuses on demonstrating substantial equivalence to the predicate device, highlighting that the core injector performance metrics remain the same. The "Performance (Injector)" table compares the proposed device with the currently marketed device. Since the modification is only a software change for an optional GFR calculator, and "This calculator does not affect the safety or efficacy of the device. Nor does it affect the indications for use of the system," the implied acceptance criterion for the injector system performance is:

• The performance of the injector system (flow rate, delivery volume, maximum pressure) must be identical to the predicate widely marketed device.

For the GFR calculator itself: The document states, "This calculator does not affect the safety or efficacy of the device. Nor does it affect the indications for use of the system." This suggests that a specific clinical validation study for the GFR calculator's accuracy or impact on patient outcomes was not required for this 510(k) submission, as it's presented as an "optional calculator" that is an "additional screening tool" without affecting the device's fundamental function, safety, or efficacy. Therefore, there are no reported performance metrics for the GFR calculator and no specific acceptance criteria cited for it. The primary acceptance criterion for the overall device's performance is its equivalence to the predicate.

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

• The document describes a software modification to an existing injector system (adding a GFR calculator). It explicitly states that the modification "does not affect the safety or efficacy of the device. Nor does it affect the indications for use of the system."
• There is no mention of a clinical test set or data for the GFR calculator or the injector system itself in the provided text. The submission relies on comparative data to predicate devices and likely non-clinical (e.g., software verification and validation, electrical safety, EMC testing, etc.) testing, which is not detailed in this summary for the GFR calculator. The core injector performance described above is based on the established performance of the predicate devices.

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

• Not applicable. There is no mention of a test set requiring expert-established ground truth within this summary.

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

• Not applicable. There is no mention of a test set or adjudication process within this summary.

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 an optional GFR calculator, not an AI-assisted diagnostic imaging tool that would typically undergo an MRMC study.

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

• While the GFR calculator is an "algorithm only," the summary does not include any standalone performance study data (e.g., accuracy against a gold standard for GFR calculation) in terms of its output. The submission focuses on its nature as an "optional calculator" that does not impact the device's fundamental safety or efficacy.

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

• Not applicable. The document does not describe studies that would require establishing a ground truth of this nature. The GFR calculator would typically use standard clinical formulas, but no validation against a ground truth for its accuracy is discussed here.

8. The sample size for the training set:

• Not applicable. There is no mention of a training set, as the GFR calculator is likely based on established medical formulas, not a machine learning model trained on a dataset.

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

• Not applicable. See point 8.

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