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The Supria True64 System is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes. The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering. Volume datasets acquired by the Supria can be transferred to external devices via a DICOM standard interface. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.

The Supria True64 is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 64-detector technology. The system allows optimum clinical applications ranging from routine exams in response to the diversified circumstances in imaging whole body regions.

The device in question is the Supria True64 Whole-body X-ray CT System, intended for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. This 510(k) submission (K183291) focuses on comparing it to the legally marketed predicate device, Supria True64 Whole-body X-ray CT System (K171738), particularly highlighting the addition of an ECG Prospective Scan (Axial) feature.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative targets for clinical endpoints (e.g., sensitivity, specificity for a diagnostic algorithm). Instead, the acceptance criteria are implicitly defined by conformance to regulatory standards and demonstration of substantial equivalence to a predicate device, particularly regarding physical and performance characteristics and the new ECG Prospective Scan feature.

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

The document explicitly states: "Validation Testing - Clinical: None required".
This implies that no dedicated clinical test set (i.e., patient data) was used for proving the performance of the modified device (specifically the ECG Prospective Scan feature). The assessment primarily relied on bench testing and comparison to the predicate device's established performance. Therefore, there is no sample size for a clinical test set, nor specific data provenance (country of origin, retrospective/prospective) for such a set discussed.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Since no clinical testing was performed and the evaluation was based on non-clinical performance and substantial equivalence to a predicate, there were no experts used to establish ground truth for a clinical test set. The "ground truth" for the non-clinical tests would be defined by engineering specifications and physical measurements, rather than clinical expert consensus.

4. Adjudication Method for the Test Set:

Given that no clinical test set was used, there was no adjudication method applied. The evaluation was based on conformance to engineering specifications and regulatory standards in bench testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No MRMC comparative effectiveness study was done or reported. The submission explicitly states "Clinical: None required" for validation testing. Therefore, there is no reported effect size of how much human readers improve with AI vs. without AI assistance, as AI assistance is not the primary subject of this submission, nor is a reader study presented.

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

Yes, a standalone performance evaluation was conducted, in the sense that non-clinical bench tests were performed on the device itself.

• "Validation Testing - Bench" was conducted. The report states: "Based on the results of the ECG Prospective Scan Performance Testing Report contained in Verification and Validation Documentation of Section 9, Hitachi judged that Supria True64 with ECG Prospective Scan (Axial) performs to specifications."
• "ECG Prospective Scan feature was subject to performance tests, which confirmed that the X-ray was in synchronization with the ECG trigger and the acquired images. The results confirmed that images which are synchronized with ECG R-wave signal can be acquired by using ECG Prospective Scan."

These tests evaluate the intrinsic technical performance of the device's new feature, independent of a human operator's interpretation, making it akin to a standalone performance assessment for that specific function.

7. The type of ground truth used:

For the non-clinical bench testing, the ground truth was based on engineering specifications and physical validation of the device's functionality, particularly the synchronization of the X-ray with the ECG trigger and the resulting image acquisition. For the substantial equivalence argument, the ground truth was the established performance and safety of the predicate device (Supria True64 K171738) and compliance with recognized industry standards.

8. The sample size for the training set:

Not applicable. This submission describes a hardware device (CT system) and a software feature (ECG Prospective Scan) that is a modification to an existing cleared device. It is not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" for such a system would involve engineering design and calibration, not data-driven model training.

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

Not applicable. As explained above, there is no AI/ML training set in this context. The "ground truth" for developing and calibrating such a CT system and its features would be based on established physics, engineering principles, and phantom measurements to ensure accurate imaging and synchronization.

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The SCENARIA Phase 2 system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes.

The volume datasets acquired by the SCENARIA Phase 2 can be post processed by the SCENARIA Phase 2 to provide additional information. Post processing capabilities included in the SCENARIA Phase 2 software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.

Volume datasets acquired by the SCENARIA Phase 2 can be transferred to external devices via a DICOM standard interface.

The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.

The SCENARIA Phase 2 is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles.

The SCENARIA Phase 2 system consists of a Gantry, Operator's Workstation, Patient Table, high-Frequency X-ray Generator, and accessories.

The provided text describes the 510(k) summary for the SCENARIA Phase 2 Whole-body X-ray CT System. However, it does not detail specific acceptance criteria or a study that proves the device meets those criteria in the typical sense of a clinical performance study with defined metrics (e.g., sensitivity, specificity, or accuracy compared to a ground truth) and corresponding acceptance thresholds for a new device.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (SCENARIA Whole-body X-ray CT System, K101888) through performance comparisons and compliance with relevant standards.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present quantitative acceptance criteria (e.g., "sensitivity must be >X%"). Instead, the primary "acceptance criterion" is implicit: the SCENARIA Phase 2 system must be comparable to and substantially equivalent to the predicate device (SCENARIA K101888) in terms of physical, performance, and technological characteristics.

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

The document mentions "A clinical evaluation comparison was conducted," but does not provide details on the sample size (number of patients/cases) used for this clinical evaluation.
The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

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

The document does not provide any information about experts used, the number of experts, or their qualifications for establishing ground truth in the clinical evaluation. Given that it's a comparison to a predicate device, the "ground truth" implicitly refers to the predicate device's performance being the established benchmark.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method.

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

An MRMC study was not mentioned or implied. The clinical evaluation was a "comparison" with the predicate device, but its methodology is not detailed enough to suggest an MRMC study or an effect size for human readers with/without AI assistance. This device is a CT scanner, not an AI-assisted diagnostic tool, so an MRMC study in this context would be unusual.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of an algorithm is not applicable here, as the device is a CT imaging system, not an AI algorithm. The performance evaluation focuses on the imaging system's physical and image quality characteristics.

7. Type of Ground Truth Used

Based on the available text, the "ground truth" for the performance claims appears to be:

• Predicate Device Performance: The primary "ground truth" is the established performance of the legally marketed predicate device (SCENARIA K101888). The new device's performance is compared against this standard.
• Bench Test Standards: For specific technical parameters (dose profile, image noise, MTF, etc.), the ground truth would be established by physical measurements and engineering specifications, often against industry-standard phantoms or test objects.
• Compliance with International Standards: Compliance with IEC 60601 series standards serves as a ground truth for safety and general electrical/radiation performance.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable as this is a CT imaging system and not a machine learning or artificial intelligence algorithm that requires training data.

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

As no training set is relevant, this question is not applicable.

In summary: The submission for the SCENARIA Phase 2 CT system demonstrates substantial equivalence to its predicate device through a combination of clinical comparison and bench testing that evaluated physical and performance characteristics. It adheres to applicable safety and quality standards. Specific quantitative acceptance criteria for clinical performance (like sensitivity/specificity), detailed test set sizes, expert qualifications, or adjudication methods typically found in AI/CAD device submissions are not provided, as this is a medical imaging device and not an AI-powered diagnostic algorithm.

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