Search Results

The CKIS-004A, Injector Synchronization Option is intended to facilitate contrast enhanced CT examinations by interfacing the CT system to a contrast injection system. When employed, the CKIS-004A will allow both the CT scan and the contrast bolus to occur by activation of either the CT or the injector. The communications between the devices is based upon the CiA-425 standard.

Device Description

The CKIS-004A will be added to the previously cleared TSX-101A Aquilion CT This addition requires hardware and software modifications to the system. existing device. Application of this option will facilitate contrast enhanced CT examinations by providing an interface between the CT system and the contrast injection device. This interface is based upon the protocol contained in the CIA-425 standard.

AI/ML Overview

The provided document is a 510(k) summary for the Toshiba CKIS-004A Injector Synchronization Option. This device is an add-on to a CT scanner (TSX-101A Aquilion CT) that facilitates contrast-enhanced CT examinations by interfacing with a contrast injection device.

Based on the nature of the device (an injector synchronization option for a CT scanner), the document does not contain the typical acceptance criteria and a detailed study report that would be expected for a diagnostic AI/ML device. The device acts as an interface to coordinate existing medical equipment, rather than providing a diagnostic interpretation or measurement. Therefore, much of the requested information (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable or detailed in this specific submission.

However, I can extract the relevant information from the document regarding the device's characteristics and safety/effectiveness concerns.

Here's a breakdown of the information that can be extracted, and an explanation of why other requested items are not present:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, etc., which are common for diagnostic devices. Instead, the "performance" is described in terms of its intended function and compliance with standards.

Acceptance Criteria (Implied)	Reported Device Performance
Facilitate contrast enhanced CT examinations by interfacing CT system and injection device.	"Application of this option will facilitate contrast enhanced CT examinations by providing an interface between the CT system and the contrast injection device."
"This interface is based upon the protocol contained in the CIA-425 standard."
"The CKIS-004A will allow both the CT scan and the contrast bolus to occur by activation of either the CT or the injector."
Compliance with relevant safety and communication standards.	"This system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-32, IEC 60601-2-44. - Medical Device Safety standards and CiA -425 communications standard."
Substantial equivalence to predicate devices in uses and applications.	"This package is similar in uses and applications as those of the predicate devices."
Predicate devices: Siemens Care Contrast CT (K043807), Medrad Stellant CT Injector (K033881).
Compliance with Quality System Regulations and Federal Diagnostic Equipment Standard.	"This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, that apply to this upgrade, will be met..."

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

This information is not provided in the document. As this device is an interface option and not a diagnostic algorithm, a typical "test set" in the context of image analysis or diagnostic performance is not relevant. The demonstration of performance primarily relies on compliance with technical standards and operational functionality.

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 information is not applicable/provided. There is no "ground truth" in the diagnostic sense needed for this type of device, as it does not make diagnostic interpretations.

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

This information is not applicable/provided. No adjudication method is described, as there is no diagnostic outcome being evaluated.

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 information is not applicable/provided. This device is an injector synchronization option, not an AI/ML diagnostic aid that assists human readers.

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

This information is not applicable/provided. The device's function is to interface two existing pieces of equipment (CT scanner and injector) to facilitate a clinical procedure, not to perform a standalone diagnostic task.

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

This information is not applicable/provided. As explained, the concept of "ground truth" for diagnostic performance is not relevant to this device's function. The "ground truth" for its function would be its ability to successfully communicate between the CT and injector as specified by the CiA-425 standard, which is likely verified through engineering tests and compliance rather than clinical ground truth data.

8. The sample size for the training set

This information is not applicable/provided. This device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable/provided. There is no ground truth for a training set in this context.

Ask a Question

Ask a specific question about this device

Page 1 of 1