(85 days)
The Imatron EBT scanner system -- when used angiographically -- is intended to combine the capabilities of both a CT and angiography system. When used for this purpose, the system is intended to perform Electron Beam Angiography, i.e., "EBA".
More specifically, the EBT system is intended:
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- to function as a diagnostic x-ray system to produce two and three dimensional images of the heart, blood vessels, or lymphatic system from a volume of computer reconstructed cross-sectional images from x-ray transmission data from the same axial plane taken at different angles;
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- to permit radiologic visualization during or after injection of a contrast medium; and
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- to permit the transmission data from certain three dimensional images to also be presented in time-sequenced or cine fashion.
Finally, such system is intended to be used consistent with those already classified and set forth in 21 CFR Sections 892.1600 and 892.1750.
Imatron's current EBT scanner system, i.e., the CT system to be used for CT Angiography, is composed of essentially two subsystems, i.e., a CT scanner (and its associated components, parts, and accessories) and a workstation (and its associated components, parts, and accessories). Imatron's scanner operates by directing a focused beam of electrons along tungsten target rings to produce X-rays which pass through the human body at multiple angles as in conventional CT scanning systems. Such EBT scanner is capable of producing CT slices at rapid speeds since the data is produced by electronic rotation of the electron beam itself rather than the mechanical rotation of an X-ray tube as in conventional CT scanning systems. The EBT system's workstation is either directly incorporated into and physically a part of the system or is indirectly incorporated into the system via a data connection port. Such workstations are all able to receive EBT cross-sectional images (either through a direct connection or through a DICOM 3.0 or higher compatible interface) and have a cleared intended use which includes being able to produce 3 and/or 4 dimensional volume imaging (including, among other functions, volume rendering, surface rendering, maximum intensity projections, or reformatting).
The provided text does not contain detailed information about specific acceptance criteria, a study proving device performance against those criteria, or a table of acceptance criteria with reported performance. The document is a 510(k) summary for an Imatron EBT scanner system, primarily focusing on establishing substantial equivalence with existing devices for an expanded intended use (CT Angiography).
Therefore, I cannot populate all sections of your request based on the provided input. However, I can extract information relevant to the study design elements you requested where available in the document.
Here's a breakdown of what can be inferred or explicitly stated from the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document does not provide a table of acceptance criteria or specific quantitative performance metrics like sensitivity, specificity, accuracy, etc., for the device's angiographic capabilities. The submission focuses on substantial equivalence to existing CT and angiography systems, rather than presenting a performance study with pre-defined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Available. No information about a specific test set, its sample size, or data provenance is provided. The submission relies on the device being "identical to the prior Imatron Ultrafast CT scanner system" and its inherent capabilities for angiography, rather than a new clinical study.
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)
- Not Available. Since no dedicated test set or clinical study is described, there is no mention of experts used to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Available. No adjudication method is described as there is no specific test set or study.
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 Available. This submission predates widespread AI integration in medical devices and focuses on hardware capability and intended use expansion. No MRMC study or AI-assisted performance evaluation is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Available. The device described is a CT scanner system, not an algorithm. Therefore, "standalone" algorithm performance is not applicable in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available. Given the nature of the submission (510(k) for substantial equivalence of a physical device for an expanded intended use), there is no mention of a ground truth in the context of a performance study. The "truth" from the regulatory perspective here is whether the device's capabilities align with previously cleared CT and angiography systems.
8. The sample size for the training set
- Not Available. No training set is mentioned as this is a hardware device submission, not an AI/algorithm submission.
9. How the ground truth for the training set was established
- Not Available. No training set or ground truth for a training set is mentioned.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.