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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:

• 1. 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;
• 2. to permit radiologic visualization during or after injection of a contrast medium; and
• 3. 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.

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The Imatron Ultra Access Workstation is intended as an accessory to Imatron's Ultrafast Computed Tomography (CT) Scanner, a cleared device. The Ultra Access Workstation accepts data from Imatron's Ultrafast CT scanner and allows for advanced post processing of such data. Thus, as modified from the ISG Workstation, the Imatron Ultra Access Workstation is intended - as are the predicate devices - for receiving, manipulating, transmitting, storing, viewing, characterizing, comparing and enhancing high quality CT electronic images, as an aid in diagnosis, including for cardiac analysis, by a trained physician.

The Imatron Ultra Access Workstation is intended as an accessory to Imatron's Ultrafast Computed Tomography (CT) Scanner. The Ultra Access Workstation accepts data from Imatron's Ultrafast CT scanner and allows for advanced post processing of such data. The Imatron Ultra Access Workstation is intended for receiving, manipulating, transmitting, storing, viewing, characterizing, comparing and enhancing high quality CT electronic images, as an aid in diagnosis, including for cardiac analysis, by a trained physician.

The provided text describes the "Imatron Ultra Access® Workstation with Cardiac Software Extensions" and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria with detailed performance metrics. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed devices, not on proving new clinical effectiveness or diagnostic accuracy against predefined acceptance criteria.

However, based on the information provided, I can infer the "acceptance criteria" are the features and functionalities present in predicate devices, and the "study" is the substantial equivalence comparison itself.

Here's an analysis based on the document's content:

1. Table of "Acceptance Criteria" (Predicate Device Features) and Reported Device Performance

The acceptance criteria here are derived from the features present in the predicate devices. The "reported device performance" is whether the Ultra Access Device also possesses that feature.

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail a specific "test set" in the context of clinical performance evaluation (e.g., patient cases used to validate diagnostic accuracy). The "testing" mentioned ("The Ultra Access Workstation successfully passed all testing at Imatron") refers to internal verification and validation against design specifications and compliance with standards (e.g., DICOM), confirming functionality and safety aspects. It does not provide information on:

• Sample size: Not specified for any performance testing.
• Data provenance: Not specified.
• Retrospective/Prospective: Not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the 510(k) summary. The document focuses on feature comparison and substantial equivalence, not a clinical trial involving expert-derived ground truth.

4. Adjudication Method for the Test Set

Not applicable as no clinical test set with human ground truth establishment is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned or implied. The 510(k) summary is for a device accessory that enables advanced post-processing and display of CT images and does not claim to improve human reader performance through AI assistance as a primary output. The document states the workstation is intended "as an aid in diagnosis, including for cardiac analysis, by a trained physician," implying the physician remains in control.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study is explicitly described as a primary component of this 510(k) submission. The device is an "accessory" to a CT scanner and is an "Image Processing Workstation," meaning its function is to process and display images for a physician. Its performance is implicitly linked to its ability to accurately process and present the data as intended for clinical review, which is covered by compliance with standards and successful internal testing.

7. Type of Ground Truth Used

For the features described, the "ground truth" is largely conceptual compliance with existing standards (DICOM) and mirroring or enhancing functionalities found in predicate devices. For example, the ability to perform "Automatic computation of calcium score" (Item 6) implies an internal algorithm, but its accuracy isn't validated against external ground truth (e.g., pathology or long-term outcomes) in this document. The document notes that "new algorithms may yield more accurate results at higher flow states" for perfusion (Item 17), citing "attached scientific references," suggesting that the underlying algorithms might have been validated elsewhere or are derived from established scientific literature.

8. Sample Size for the Training Set

Not applicable. The document describes an image processing workstation with software features, not a machine learning model that requires a "training set" in the typical AI sense. The software's development likely involved traditional software engineering, testing, and potentially some algorithm development based on existing scientific principles or data characteristics, but not "training data" in the quantity and context usually associated with modern AI/ML.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI/ML model is mentioned.

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The intended use of the device here in question, i.e., the Imatron Ultrafast CT Scanner, remains unchanged from the intended use of prior predicate Imatron and other scanners. The Imatron Ultrafast CT Scanner is designed -- as are all similar devices -- to produce cross sectional images (i.e., thin slices) of the human anatomy. In this instance, such images are produced via helical (i.e., continuous volume or dynamic) or stationary (i.e., static) scanning. Imatron's device is -- as are some of the predicate devices -- also intended to be used for clinical situations requiring determination of specific quantitative information, such as the determination of calcium or other materials in bone, tumors, or organs.

The Imatron Ultrafast CT scanner is a scanning system which operates by directing a focused beam of electrons along tungsten target rings to produce X-rays which pass through the body at multiple angles as in conventional CT scanning systems. The Imatron Ultrafast CT 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. Currently, the Imatron Ultrafast CT scanner operating at its highest resolution mode has 864 single, contiguous X-ray detectors subtending an arc of 0.250 degrees each. The resulting 5% amplitude modulation transfer function (MTF) for high contrast objects at the center of the circle of reconstruction is 7 line pairs per centimeter (lp/cm).

The provided text describes a 510(k) submission for a design modification to the Imatron Ultrafast CT Scanner, specifically implementing a High Resolution Detector (HRD). The study focuses on demonstrating "substantial equivalence" to a predicate device rather than establishing new acceptance criteria for a novel device. Therefore, some information requested, particularly regarding acceptance criteria and separate performance metrics, is not explicitly detailed as would be for a new device submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't present a formal table of "acceptance criteria" in the sense of predefined thresholds for clinical performance metrics (e.g., sensitivity, specificity). Instead, it focuses on demonstrating that the modified device's performance, specifically its image resolution, is improved and that the device remains "substantially equivalent" to its predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 12 human subjects.
• Data Provenance: Clinical performance testing with human volunteers was conducted "on site" (likely Imatron's facility) and was prospective, following IRB overview and informed consent. The country of origin is not explicitly stated but can be inferred as the USA given the FDA submission context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. The study described is a "human volunteer testing" to show "substantial equivalence," not a diagnostic accuracy study requiring expert-derived ground truth for the device's output.

4. Adjudication Method for the Test Set

This information is not provided. As noted above, the study appears to be focused on demonstrating device functionality and equivalence, not a diagnostic accuracy study that would typically involve adjudication of device outputs against a ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission describes bench testing and human volunteer testing to demonstrate substantial equivalence of the device itself, not to evaluate reader performance with or without AI assistance. The device in question is a CT scanner, not an AI software.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The "Non-clinical Performance" section describes extensive bench testing (~61 tests including product acceptance and release criteria, and phantom testing) carried out before human testing. This represents a standalone assessment of the device's physical and technical performance. The device itself is a scanner, not an AI algorithm, so the concept of an "algorithm only" performance would refer to its technical specifications.

7. The Type of Ground Truth Used

For the bench testing and phantom testing, the "ground truth" would be established by the physical characteristics of the phantoms and the expected technical performance measurements for a CT scanner (e.g., MTF calculations). For the human volunteer testing, the "ground truth" or reference standard for comparison is the performance characteristics of the predicate device, aiming to show that the modified device performs equivalently or better in terms of image quality and safety. There is no mention of pathology, outcomes data, or expert consensus in relation to diagnostic accuracy for clinical conditions.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The Imatron Ultrafast CT Scanner is a hardware device (a CT scanner), not a machine learning or AI-based algorithm that requires a "training set" in the context of AI development.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for a hardware device.

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