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This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to imaqe whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc.

The Aquilion ONE has the capability to provide volume sets of the entire These volume sets can be used to perform specialized studies, orqan. usinq indicated software/hardware, of the whole orqan by a trained and qualified physician.

FIRST 2.1 is an iterative reconstruction alqorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 is a whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. This device captures cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Toshiba CT systems. In addition, the subject device incorporates the latest iterative reconstruction technology, FIRST 2.1, intended to reduce exposure dose while maintaining and/or improving image quality.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device and discussing improvements. Explicit, quantitative acceptance criteria are not clearly defined as pass/fail thresholds in the same way they might be for a novel device with a specific performance claim. Instead, the "acceptance criteria" are implied by showing the new device performs "substantially equivalent to or demonstrates an improvement" over the predicate device, particularly in terms of image quality and dose reduction.

• Diagnostic quality images for head, chest, abdomen/pelvis, extremity, and cardiac exams.
• Superior LCD performance with FIRST. |
  | Dose Reduction | Demonstrate dose reduction while maintaining/improving image quality. | - Dose reduction claim with a range of 59.2% to 82.4% supported.
• 49.2% noise reduction demonstrated with FIRST.
• Low Contrast Detectability (LCD) comparability at full dose (FBP) and reduced dose (FIRST 2.1) using a non-inferiority analysis with a model observer approach. |
  | suRE Subtraction Angio | Improved visibility of contrast enhancement over predicate device. | - Visual assessment by doctors and clinical case examples determined "the visualization of contrast enhancement, especially blood vessels, are improved when compared to the predicate device." |
  | suRE Subtraction Iodine Mapping | Functions as intended to assess contrast enhancement and provide additional information for abdominal organs. | - Visual assessment of clinical case examples determined "provides additional information for the assessment of abdominal organs, differential enhancement mapping images are useful visualization tools and CE Boost images provide improved CNR." |

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

• Test Set Sample Size:
  • Image Quality Metrics (Phantoms): Not explicitly stated, as it uses phantoms for objective measurements.
  • Quantitative Dose Reduction/Spatial Resolution Evaluations: Not explicitly stated, as it uses phantoms and a model observer approach to simulate human perception.
  • suRE Subtraction Angio & Iodine Mapping (Clinical Evaluation): Refers to "clinical case examples" but does not specify the number of cases.
  • Diagnostic Image Quality: "Representative diagnostic images" were obtained, but the number is not specified.
• Data Provenance: Not specified in terms of country of origin. The studies are described as "bench testing" (phantoms), "model observer studies," and "clinical evaluation/case examples," implying a mix of objective measurements and human review of images. It does not state whether the clinical evaluations were retrospective or prospective, though "clinical case examples" often implies retrospective.

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

• Quantitative Dose Reduction/Spatial Resolution Evaluations (LCD): "A model observer approach which incorporates some aspects of human vision was used." This is not human expert ground truth but an algorithm mimicking human perception.
• suRE Subtraction Angio & Iodine Mapping: "Visual assessment scoring method by doctors" (Angio) and "visual assessment scoring method of clinical case examples" (Iodine Mapping). The number of doctors/experts is not specified. Their qualifications are broadly stated as "doctors" for Angio and not specified beyond "visual assessment" for Iodine Mapping.
• Diagnostic Image Quality: "Representative diagnostic images, reviewed by an American Board Certified Radiologist." The number of radiologists is not specified (could be one or more). The qualification is "American Board Certified Radiologist."

4. Adjudication Method for the Test Set

• Not explicitly stated for the qualitative assessments. For the "visual assessment scoring method by doctors," it's not clear if there was a consensus process (e.g., 2+1, 3+1), or if individual assessments were aggregated.
• For the dose reduction and image quality metrics using phantoms, adjudication is not applicable as it involves objective measurements or a model observer.

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

• No, an MRMC comparative effectiveness study involving human readers comparing AI-assisted vs. non-AI-assisted performance was not explicitly described.
• The document describes comparisons between images reconstructed with FIRST 2.1 (iterative reconstruction, the "AI" component) and Filtered Back Projection (FBP, the older method) in terms of objective metrics and model observer studies for dose reduction/spatial resolution.
• For the suRE Subtraction features, it mentions "visual assessment scoring method by doctors" comparing the new features to the predicate device, but this is not framed as a rigorous MRMC study comparing human performance with and without the AI (FIRST 2.1) or the suRE features' assistance. It focuses on the features providing improved image visibility or additional information.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, a standalone performance assessment was conducted.
• The "Image Quality Evaluation" and "Quantitative Dose Reduction/Spatial Resolution Evaluations" sections primarily describe the standalone performance of the FIRST 2.1 algorithm. This includes:
  • CT image quality metrics (spatial resolution, noise, CNR, etc.) performed using phantoms.
  • The dose reduction and noise reduction claims were established by comparing FIRST 2.1 to FBP using phantom data and a model observer approach, which is an algorithmic assessment of image quality.
  • PUREViSION Optics (LCD and Noise Improvement) was evaluated via model observer studies using phantoms.

7. Type of Ground Truth Used

• Phantom Data: For image quality metrics, dose reduction, and noise reduction evaluations (e.g., spatial resolution, CT number accuracy, low contrast detectability). This is an objective, physical standard.
• Model Observer Approach: Used for low contrast detectability in the dose reduction studies. This is an algorithmic simulation of human perception, not human expert consensus or clinical outcomes.
• Expert Visual Assessment/Clinical Case Examples: For suRE Subtraction Angio and Iodine Mapping, and for overall diagnostic image quality. This relies on medical expertise but is qualitative and subject to inter-observer variability if not rigorously adjudicated.

8. Sample Size for the Training Set

• The document does not provide any information regarding the training set sample size for the FIRST 2.1 iterative reconstruction algorithm. This information is typically proprietary to the manufacturer and not usually included in 510(k) summaries unless specifically relevant to a new and unprecedented AI claim.

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

• Since the training set sample size is not provided, how its ground truth was established is also not described in this document. Iterative reconstruction algorithms like FIRST 2.1 are developed by optimizing parameters based on phantom data, simulated noise models, and sometimes a large dataset of patient images with associated image quality metrics, but the specifics are not detailed here.

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