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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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The EmpowerCTA Injector system is intended for the vascular administration of contrast and flushing media and the EmpowerCT Injector system is intended for vascular administration of contrast. Both injector systems are used in conjunction with computed tomography (CT) scanning of the body with an optional interface to a CT scanner.

The EmpowerCT and EmpowerCTA Injector Systems are currently marketed as injection systems that use one or two consumable syringe(s) to displace contrast media and flushing media (EmpowerCTA only) to the patient. A motor driven linear actuator mechanism controls displacement of the syringe piston.

The currently marketed injector systems consist of four components. These include the Injector, Remote Control, EDA and Power Supply.

Consistent with currently marketed devices, the proposed device will allow the user to administer the contrast media to the patient by specifying the following variables at the remote control.

Volume- Volume is selectable from 1 ml to 200 ml in 1 ml increments.
Flow Rate- Flow rates are selectable from 0.1 to 10 ml/sec in increments of 0.1ml/sec.
Pressure- Maximum syringe pressure is selectable from 40-300 psi in increments of 1 psi

The provided text is a 510(k) summary for a medical device (EmpowerCT/EmpowerCTA Injector System) and focuses on comparing the modified device to its predicate devices for substantial equivalence. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical trial reports or validation studies.

Here's a breakdown of what can be extracted and what is missing based on your request:

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

The document provides performance specifications for the injector systems, which can be considered acceptance criteria based on their current marketing status and regulatory approval. However, it does not explicitly present these as "acceptance criteria" against which a new study's results are being compared to prove the device meets them. Instead, it describes "Proposed Devices" and "Currently marketed devices" with identical performance specifications, indicating that the modification (connectivity) does not alter these core performance aspects.

Missing Information (Not Available in the Provided Text):

The document describes a special 510(k) submission for a device modification (adding scanner connectivity) to a previously cleared device. It establishes substantial equivalence by demonstrating that the performance characteristics of the modified device are identical to the predicate device, except for the new connectivity feature. It does not present a new study with explicit acceptance criteria and corresponding results proving the device meets those criteria for the entire device system in the context of this submission. The focus is on the impact of the modification.

Therefore, the following points cannot be answered from the provided text:

• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method
• 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
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Summary of what is present:

The document is a regulatory submission demonstrating substantial equivalence for a modification to an existing device. It highlights that the core performance parameters (flow rate, volume, pressure) remain the same as the predicate devices, and the modification is primarily related to connectivity. Therefore, it relies on the previously established performance of the predicate devices rather than presenting new studies to re-prove these fundamental aspects.

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