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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 image 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 organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.

Aquilion ONE (TSX-305A/3) V7.3 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aquilion ONE (TSX-305A/3) V7.3:

1. Table of Acceptance Criteria and Reported Device Performance:

The document is a 510(k) summary for a premarket notification for a Computed Tomography X-ray System. It is not a clinical study report with specific acceptance criteria directly tied to a diagnostic performance metric (like sensitivity or specificity) of a disease-detecting AI algorithm. Instead, it demonstrates substantial equivalence to a predicate device, focusing on technical specifications and image quality for general diagnostic use.

Therefore, the "acceptance criteria" here relate to demonstrating that the new device performs acceptably for its intended use and is equivalent to the predicate. The "performance" is primarily a comparison of technical specifications and image quality metrics against the predicate.

• View rate: Maximum 2910 views/s (same)
• Detector: 896 channels x 320 rows (same)
• Pitch factor: Range 0.555 to 1.575 / 0.555 to 1.5 (very similar)
• FOV: 240/320/500mm / 180/240/320/400/500mm (subject has slightly reduced range, but still within typical diagnostic needs)
• Metal artifact reduction: SEMAR (Volume, Helical, ECG gated) / SEMAR (Volume, Helical) (subject has added ECG gated capability)
• Gantry opening size: 780 mm (same)
• All previously cleared software options are listed as "no change" in functionality, with some having "workflow improvements" (e.g., Lung Volume Analysis, surESubtraction Lung, MyoPerfusion, Dual Energy System Package, 4D Airways Analysis) which are enhancements rather than regressions.

Differences (addressed through testing or not raising new concerns):

• Gantry Rotation Speed: 0.35s (Optional max 0.275s) for subject vs. 0.275s (Standard or optional) for predicate. This indicates a minor hardware difference, likely addressed by showing image quality is maintained.
• Wedge filter types: Two types for subject vs. Three for predicate. This is a minor design change.
• X-ray tube voltage/current: Max 72kW (Optional Max 90kW) for subject vs. Max 90kW (for one model) or Max 72kW (for others) for predicate. Comparable.
• Image reconstruction time: Up to 80 images/s for subject vs. Up to 50 images/s for predicate. Improvement in subject device.
• Helical reconstruction method: 20 rows or more: TCOT+ for subject vs. 16 rows or more: TCOT+ for predicate. Improvement in subject device (more rows).
• Patient Couch Type and related dimensions/weights: Various configurations/differences between subject and predicate models, indicating design variations but within expected functional range.
• Gantry tilt angle: ±30° for subject vs. ±22° for predicate. Improvement in subject device.
• Minimum area for installation: Smaller for subject (27m² vs 37.2m²). Improvement in subject device.
• Area finder: Optional for subject vs. NA for predicate. New feature on subject device. |
  | Image Quality | Image quality metrics (spatial resolution, CT number magnitude/uniformity, noise properties, low contrast detectability/CNR performance) should meet established specifications and be comparable to the predicate device. Images obtained should be of diagnostic quality. | CT image quality metrics performed using phantoms demonstrated that the subject device is substantially equivalent to the predicate device with regard to: spatial resolution, CT number magnitude/uniformity, noise properties, and low contrast detectability/CNR performance. Representative diagnostic images (head, chest, abdomen/pelvis, extremity, cardiac) were also reviewed and demonstrated diagnostic quality. |
  | Safety and Standards Compliance | The device must be designed and manufactured under Quality System Regulations (21 CFR 820, ISO 13485) and conform to applicable performance standards for ionizing radiation-emitting products (21 CFR, Subchapter J, Part 1020). It must also comply with various IEC, NEMA, and other relevant standards. | The device is designed and manufactured under QSR and ISO 13485. It conforms to applicable performance standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020] and numerous international standards including IEC60601-1 series, IEC60601-2 series, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18, NEMA XR-25 and NEMA XR-26. |
  | Software Validation | Software documentation must comply with FDA guidance for a Moderate Level of Concern, and validation testing should be successfully completed. | Software Documentation for a Moderate Level of Concern was included. Successful completion of software validation is cited in the conclusion. |
  | Risk Management | Risk analysis should be conducted. | Risk analysis was conducted. |

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

• Test Set Description: The "test set" for this submission primarily consists of:
  • Phantoms: Used for evaluating CT image quality metrics (spatial resolution, CT number, noise, low contrast detectability). The number and specific types of phantoms are not explicitly stated but are typically standard phantoms used in CT performance testing.
  • Representative Diagnostic Images: Clinical images covering various body regions (head, chest, abdomen/pelvis, extremity, cardiac). The number of cases/patients is not specified.
• Data Provenance: The document does not explicitly state the country of origin for the diagnostic images. Given Toshiba Medical Systems Corporation is based in Japan and Toshiba America Medical Systems, Inc. is in the US, the data could originate from either region or a combination. The document also does not specify if the data was retrospective or prospective. However, for a 510(k) clearance based on substantial equivalence, particularly for a hardware/software update to a CT scanner, diagnostic images are often retrospectively collected or acquired as part of internal validation.

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

• Number of Experts: One (1) expert is explicitly mentioned.
• Qualifications of Experts: An "American Board Certified Radiologist." No specific years of experience are stated. This expert reviewed the representative diagnostic images to confirm diagnostic quality.

4. Adjudication Method for the Test Set:

• The document describes a single American Board Certified Radiologist reviewing images to confirm diagnostic quality. This indicates no formal adjudication method involving multiple readers (like 2+1 or 3+1) was used for this specific part of the evaluation. The assessment of image quality from phantoms would not typically involve expert adjudication.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document is for a general-purpose CT scanner system, not an AI-specific diagnostic tool that assists human readers. Therefore, there is no mention of an effect size for human reader improvement with or without AI assistance.

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

• No, a standalone performance study in the context of an AI algorithm was not done. The Aquilion ONE (TSX-305A/3) V7.3 is a complete CT system where the "algorithm" refers to the image reconstruction and processing capabilities, which are inherent to the device's function. The study validates the overall system's ability to produce diagnostic images, not a separate AI algorithm's diagnostic accuracy. The performance is assessed on the system output.

7. The Type of Ground Truth Used:

• For the phantom studies, the "ground truth" is typically known physical properties of the phantoms (e.g., known dimensions, densities, contrast levels).
• For the representative diagnostic images, the "ground truth" for confirming "diagnostic quality" is based on the expert opinion/consensus of an American Board Certified Radiologist. This is a form of expert consensus, albeit from a single expert in this stated context. There is no mention of pathology or outcomes data being used as ground truth for this submission.

8. The Sample Size for the Training Set:

• The document does not specify a separate "training set" sample size. This submission is for a medical imaging device (CT scanner) rather than a deep learning AI algorithm that undergoes distinct training. The underlying algorithms for image reconstruction and processing (e.g., TCOT+, SEMAR) are developed and refined through engineering and iterative testing, but not typically in the same "training set" paradigm as AI for diagnostic interpretation. The software validation is mentioned, which refers to standard software development lifecycle testing.

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

• As a "training set" in the context of AI development is not explicitly mentioned as relevant to this submission, the establishment of ground truth for a training set is not applicable/described. The "ground truth" during the development of a CT scanner's image reconstruction algorithms would typically involve engineering specifications, physical models, and potentially early clinical data used for empirical tuning and validation, but not a formally labeled training set in the AI sense.

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This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.

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

The Aquilion LB, TSX-201A/3, v6.0 is a 40-row CT System that is intended to acquire and display cross-sectional volumes of the whole body, including the head. This system is based upon the technology and materials of previously marketed Toshiba CT systems.

Here's an analysis of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Study Details for Aquilion LB, TSX-201A/3, V6.0

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) summary for the Toshiba Aquilion LB, TSX-201A/3, V6.0, primarily focuses on demonstrating substantial equivalence to a predicate device rather than establishing novel performance claims against specific, quantitative acceptance criteria. Therefore, the "acceptance criteria" here are implicitly tied to maintaining or improving upon the performance of the predicate device and meeting general safety and image quality standards for CT systems.

- Spatial resolution 
- CT number 
- Contrast-to-noise ratio 
- Uniformity performance                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |

| Diagnostic Image Quality (Clinical) | - Representative diagnostic images (brain, chest, abdomen, peripheral exams) obtained using the subject device and reviewed by an American Board Certified Radiologist demonstrated that the device produces images of diagnostic quality and performs as intended. |
| Lung Volume Analysis Software Functionality | - Integration testing was conducted to verify that this application functions as intended on the Aquilion LB system. (Note: The algorithm itself was previously cleared and demonstrated accurate volume calculations using an electronic phantom, LungMan Phantom, and chest image datasets). |
| Safety and Regulatory Compliance | - Device designed and manufactured under Quality System Regulations (21 CFR § 820) and ISO 13485 Standards.

• Conforms to applicable parts of various IEC standards (e.g., IEC60601-1, IEC60601-2-44, etc.), NEMA standards (PS 3.1-3.18, XR-25, XR-26).
• Complies with all applicable requirements of radiation safety performance standards (21 CFR §1010 and §1020).
• Risk analysis and verification/validation testing conducted through bench testing demonstrates that the requirements for modifications have been met.
• Software Documentation for a Moderate Level of Concern per FDA guidance.
• Testing in accordance with applicable IEC standards. |

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

Due to the nature of this 510(k) submission, which is for a modification of an existing CT system, the "test set" primarily refers to data used for phantom studies and representative clinical images rather than a large-scale clinical study with a specific patient sample size.

• Sample Size for Test Set:
  • Phantom Studies: Not explicitly quantified, but performed using "phantoms" for image quality metrics.
  • Clinical Images: "Representative diagnostic images" were obtained. The exact number of patients or images is not specified.
  • Lung Volume Analysis: Previously demonstrated using an "electronic phantom, LungMan Phantom and image data sets of the chest." The number of image datasets is not specified for this prior clearance.
• Data Provenance: Not explicitly stated (e.g., country of origin). The document describes typical verification and validation activities for a medical device manufacturer. Given Toshiba Medical Systems Corporation is based in Japan and Toshiba America Medical Systems, Inc. is in the US, the testing could have occurred in either or both regions. The studies appear to be retrospective in the sense that they are conducted for verification and validation purposes after device modification, not as a prospective clinical trial.

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

• Clinical Image Review: "Representative diagnostic images, reviewed by an American Board Certified Radiologist."

  • Number of Experts: One ("an American Board Certified Radiologist").
  • Qualifications: American Board Certified Radiologist. No specific years of experience are mentioned.

• Phantom Studies and Detector Performance: Ground truth for these technical assessments is typically established by physical measurements and engineering specifications, not human experts.

• Lung Volume Analysis: The ground truth for the software's accuracy was previously established, at the time of K133715 clearance, using physical (LungMan Phantom) and electronic phantoms, for which the true volumes are known, and image datasets of the chest. The role of experts in establishing ground truth for these past tests isn't detailed in this document, but typically involves engineers/physicists for phantom assessments.

4. Adjudication Method for the Test Set

• Clinical Image Review: For the "representative diagnostic images," only one radiologist is mentioned as reviewing them. Therefore, an explicit adjudication method (like 2+1 or 3+1) involving multiple experts is not described for this specific part of the submission. The review likely served as a qualitative confirmation of diagnostic quality.
• Other Testing: Adjudication methods are not applicable to phantom studies or technical performance measurements.

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

• No, an MRMC comparative effectiveness study was not done according to this document. The submission focuses on demonstrating substantial equivalence of a modified device and its inherent performance, not on comparing human reader performance with and without AI assistance. The Lung Volume Analysis software is described as a post-processing application, but its impact on human reader effectiveness is not quantified in this submission.

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

• Yes, for certain aspects.
  • Detector Performance and Image Quality Metrics (Phantoms): These are inherently standalone, algorithm-only, or device-only performance assessments. The device (Aquilion LB) is characterized directly.
  • Lung Volume Analysis: For the algorithm itself, its accuracy in volume calculations (part of its previous clearance, K133715) was demonstrated using an "electronic phantom, LungMan Phantom and image data sets of the chest," implying a standalone assessment of the algorithm's output against known values or established methods. The current submission only verified its integration and proper functioning on the Aquilion LB system.

7. The Type of Ground Truth Used

• Technical Specifications/Physical Measurements: For detector performance, spatial resolution, CT number, contrast-to-noise ratio, and uniformity. This ground truth is based on known physical properties of phantoms and calibrated measurement systems.
• Expert Consensus/Opinion (for Clinical Images): For the "representative diagnostic images," the "American Board Certified Radiologist" provided the ground truth (or confirmation) of diagnostic quality. This is an expert opinion-based assessment.
• Known Values (for Lung Volume Analysis): For the Lung Volume Analysis software, the ground truth was derived from known volumes in electronic and physical phantoms ("LungMan Phantom"). For "image data sets of the chest," the ground truth for actual volumes would likely have been established through a highly reliable method, possibly manual expert tracing on high-resolution images or comparison with other gold-standard volumetric methods (though not explicitly stated in this document).

8. The Sample Size for the Training Set

• The document does not provide information regarding a "training set" or its sample size. This is expected as the submission is for a modification to a cleared CT system, not for a de novo AI algorithm that requires extensive training data. The improvements and validations described pertain to hardware changes (new detector) and software integration, not to the development or retraining of a machine learning model.

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

• As no training set is mentioned or implied, this question is not applicable based on the provided document.

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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 image 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 organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.

The Aquilion ONE Vision, TSX-301C/3 and 301C/4, v6.00 are 320-row CT Systems and the TSX-301C/5, v6.00 is a 160-row CT system consisting of the same gantry, couch and console used for data processing and display. These devices capture cross sectional volume data sets used to perform specialized studies, using indicated software, by a trained and qualified physician. These systems are based upon the technology and materials of previously marketed Toshiba CT systems.

The provided 510(k) summary focuses on demonstrating substantial equivalence of a modified CT system (Aquilion ONE Vision, TSX-301C/3, 301C/4 and 301C/5, v6.00) to its predicate device. This submission is for a hardware and associated software modification to an existing CT scanner, not a new AI/CADe device. Therefore, many of the typical acceptance criteria and study elements pertinent to AI systems that you requested are not directly applicable or explicitly detailed in this document.

However, I can extract the information that is present and explain why some of your requested details might not be found in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device modification, the "acceptance criteria" are generally related to demonstrating that the modified device performs at least as well as the predicate device in terms of image quality and safety, and continues to meet relevant standards. The performance is assessed through various tests, primarily utilizing phantoms and review by an expert.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: The document mentions "representative diagnostic images" but does not specify a numerical sample size for the clinical image review. This type of submission often relies on a qualitative assessment of a small, representative set of images rather than a large statistical study.
• Data Provenance: Not explicitly stated (e.g., country of origin). Since it's a Toshiba America Medical Systems submission, the testing would likely have occurred in the US or Japan. The assessment of diagnostic images by an "American Board Certified Radiologist" suggests at least some of the data review, if not acquisition, was US-based.
• Retrospective or Prospective: Not specified. Given the nature of a device modification test, it could involve prospective acquisition of new images for evaluation, or retrospective review of images acquired with the modified device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: "an American Board Certified Radiologist" (singular).
• Qualifications: "American Board Certified Radiologist." The duration of experience is not specified.

4. Adjudication method for the test set

• Adjudication Method: Not applicable or specified. With only one radiologist reviewing, there is no inter-reader discrepancy to adjudicate.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a CT scanner itself, not an AI/CADe accessory intended to assist human readers in image interpretation. Therefore, assessing human reader improvement with/without "AI assistance" is not relevant to this submission.

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

• Standalone Performance: Not applicable. This is a conventional CT imaging system, not an algorithm being evaluated for standalone performance. The "softwar" mentioned refers to control software and image processing pathways within the CT system, not an independent AI diagnostic algorithm.

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

• Type of Ground Truth: For the image quality assessment, the "ground truth" was the qualitative judgment of an "American Board Certified Radiologist" that the images were of "diagnostic quality" and that the device "performs as intended." For the phantom studies, the ground truth is against known physical properties and measurements within the phantoms, assessed by quantitative metrics (spatial resolution, CT number, CNR, noise, uniformity).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/not provided. This submission is for a hardware and control software modification to a CT scanner. The concept of a "training set" in the context of machine learning (AI) does not apply here. The system's performance is based on engineered design and physical principles, not on being trained on a dataset of images with ground truth labels.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no "training set" in the AI sense for this device. The system's operational parameters and calibration are established through design specifications, factory calibration, and quality control processes.

In summary: This 510(k) submission is for a modification to a general-purpose CT imaging system. The performance evaluation focuses on demonstrating that the modified hardware and software maintain or improve the fundamental imaging capabilities and safety profiles compared to the predicate device, primarily through phantom testing and qualitative clinical image review by a radiologist. It does not involve the a-typical AI/CADe specific study designs and ground truth methodologies you would expect for an AI-powered diagnostic tool.

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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 image 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 organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.

The Aquillion ONE Vision TSX-301C/1 and TSX-301C/Z, v6.00 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. These systems are based upon the technology and materials of previously marketed Toshiba CT systems.

The provided text describes a 510(k) summary for the Aquilion ONE Vision CT scanner (K132222) and its modifications. However, it does not contain information about specific acceptance criteria or a study proving the device meets them with performance metrics related to diagnostic accuracy, sensitivity, or specificity.

The document states that the submission includes "summary tables detailing the risk analysis and verification/validation testing conducted through bench testing which demonstrates that the requirements for the modifications made to the system have been met." It also mentions "successful completion of software validation" and compliance with various IEC, NEMA, and CFR standards.

This kind of 510(k) submission, particularly a "Special 510(k)" for modifications to a cleared device, often focuses on demonstrating that the changes do not adversely affect safety and effectiveness, and that the device still meets the performance specifications of the predicate device. It typically doesn't involve new clinical performance studies to establish acceptance criteria for diagnostic accuracy metrics in the same way a de novo device or a device with new clinical claims might.

Therefore, many of the requested categories related to clinical performance studies (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance) cannot be extracted from this document as such studies are not described.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document refers to "requirements for the modifications" and "applicable standards" but does not define specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) or report device performance against such metrics. The changes are primarily technical (OS change, image quality improvements, dose reduction availability, addition of previously cleared software).

2. Sample size used for the test set and the data provenance

Not available in the provided text. The document mentions "bench testing" and "software validation" but does not specify a test set of patient data or its characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not available in the provided text.

4. Adjudication method for the test set

Not available in the provided text.

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 applicable/Not mentioned. The device is a CT scanner, and the modifications are largely technical and do not appear to involve AI-assisted reading or a direct comparison of human reader performance with and without AI.

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

Not applicable/Not mentioned. The device is a CT scanner, not a standalone algorithm.

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

Not available in the provided text.

8. The sample size for the training set

Not applicable/Not mentioned. There is no mention of a training set for an algorithm in this document. The "training" for a CT scanner typically refers to system calibration and quality control, not machine learning model training.

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

Not applicable/Not mentioned.

Summary of what the document DOES state regarding testing and safety:

• The device is designed and manufactured under Quality System Regulations (21 CFR § 820) and ISO 13485 Standards.
• It conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020].
• It complies with various IEC and NEMA standards (IEC60601-1 series, IEC60601-2-x series, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18, NEMA XR-25, NEMA XR-26).
• A "Special 510(k) submission includes summary tables detailing the risk analysis and verification/validation testing conducted through bench testing which demonstrates that the requirements for the modifications made to the system have been met."
• "Software Documentation for a Moderate Level of Concern" was included.
• "Testing of the modified system was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems."
• Conclusion: "Based upon bench testing, successful completion of software validation, application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use."

In essence, the document confirms that the modified CT scanner underwent rigorous engineering and software validation according to established industry standards and regulatory requirements, demonstrating that the modifications did not compromise the device's safety or effectiveness compared to the predicate device. However, it does not provide specific clinical performance metrics or studies as might be expected for an AI-powered diagnostic device.

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This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.

The Aquilion PRIME has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

The Aquilion PRIME TSX-303A/2, v5.00 is an 80-row CT System and the TSX-303A/6, v5.00 is a 40-row CT system that is intended to produce axial scans of the whole body to include the head. These systems are based upon the technology and materials of previously marketed Toshiba CT systems.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Toshiba Aquilion PRIME CT system (K130645):

The submission K130645 is for a modification of an already cleared device (Aquilion Prime CT System, K120710). As such, the purpose of the submission is to demonstrate that the modified device is substantially equivalent to the predicate device and that the modifications do not adversely affect its safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of distinct "acceptance criteria" against which a device's performance is strictly measured in a pass/fail manner with specific quantitative thresholds. Instead, it describes a comparative evaluation against a predicate device and relies on an image quality metrics study using phantoms to show substantial equivalence.

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

• Sample Size: Not explicitly stated in terms of patient cases. The testing mentioned is an "image quality metrics study, utilizing phantoms." Phantoms are standardized test objects, not patient data.
• Data Provenance: Not applicable as patient data was not used for this specific substantial equivalence claim. The testing involved phantoms.

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

• Number of Experts/Qualifications: Not applicable. Ground truth for phantom-based image quality metrics is established by physical measurements and computed reference values within the phantom, not by expert interpretation.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The "image quality metrics study, utilizing phantoms" involves objective measurements (e.g., spatial resolution, CT number, CNR, noise properties) comparing the modified device to the predicate, rather than human interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

• MRMC Study: No, an MRMC comparative effectiveness study was not performed or mentioned in this submission. This is not a study assessing human reader performance with or without AI assistance. It's a technical modification to a CT scanner.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

• Standalone Performance: Not applicable in the context of an algorithm's diagnostic performance. This submission is about a CT hardware and software system, not a diagnostic AI algorithm that operates standalone. The image quality metrics study is a technical performance assessment of the system.

7. The Type of Ground Truth Used:

• Ground Truth: For the "image quality metrics study, utilizing phantoms," the ground truth is established by the known physical properties of the phantoms and the expected scientific principles of CT imaging. This allows for objective quantification of spatial resolution, CT number accuracy, contrast-to-noise ratio, and noise properties.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This document describes a modification to an existing CT system and its validation through phantom studies and adherence to standards. It does not refer to the development of a machine learning algorithm that would require a distinct "training set" of data.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set for a machine learning algorithm.

Summary of the Study:

The primary study mentioned to demonstrate that the device meets implied acceptance criteria is an "image quality metrics study, utilizing phantoms." This study compared the modified Aquilion PRIME CT system to its predicate device (TSX-302A/2, Aquilion Prime CT System) to demonstrate substantial equivalence in key image quality parameters.

Key Findings: The study validated that the subject device is substantially equivalent to the predicate device with regard to:

• Spatial resolution
• CT number
• Contrast-to-noise ratio (CNR)
• Noise properties

This type of technical study, along with bench testing, software validation, risk management, and compliance with applicable standards (IEC, NEMA, FDA), was considered sufficient by the manufacturer and the FDA to conclude that the modified device is safe and effective and substantially equivalent to the predicate.

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