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The HiRise is intended to be used for 3-D imaging of the upper and the lower extremities and pelvis of adult and pediatric patients weighing from 40 to 450 lbs.
The device is to be operated in a professional healthcare environment by qualified health care professionals only.

The HiRise is a Cone Beam Computed Tomography Imaging Device that acquires 360-degree rotational projection sequences which are reconstructed into 3D volumetric images of the examined anatomical region. The device uses a gantry assembly, which is comprised of an X- ray source, image detector, and a motorized gantry. The gantry facilitates the acquisition of a full X-ray projection sequence by the acquisition software. For non-weight bearing scans of the lower extremity, a patient positioner accessory allows the patient to sit into a position where he/she can comfortably place his/her anatomy into the imaging bore.
The gantry assembly is mounted on vertical actuators and can travel vertically to capture weight-bearing anatomy at various heights ranging from the feet to the pelvis regions. The HiRise provides total vertical travel of 37 inches to accommodate patients of various sizes. Images produced by the HiRise can be sent electronically to a DICOM complaint image viewing software.

Here's a breakdown of the acceptance criteria and study details for the HiRise device, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

• New tube voltage range
• New tube current range
• New scan times
• New max exposure times
• New imaging volumes
• Changes in protocol resolution
• Updated body parts imaged (removal of humerus, forearm protocol configurations)
• New scanner weight
• New power requirements
• New scatter numbers.
  This indicates the device met this criterion. |
  | Internal Verification (X-Ray Circuitry) | Passes all internal verification with no anomalies causing increased risk. | All applicable test plans passed with no anomalies increasing risk. This indicates the device met this criterion. |
  | Third-Party Testing (Safety & Compliance) | Passing all third-party testing to all applicable requirements. | Completed 3rd party testing with no outstanding failures for IEC 60601-1 and all applicable collateral and particular standards (specifically 60601-1-2, 60601-1-3, and 60601-2-44). This indicates the device met this criterion. |
  | Increased Weight | (No specific numerical criterion, implied that negligible increase is acceptable) | Weight changed to 900 lbs (from 850 lbs for scanner). Acknowledged as negligible increase (approx. 50 pounds). Labeling updated. This indicates the change was handled and deemed acceptable. |
  | Minor Material Changes (Biocompatibility) | Biocompatibility assessed in alignment with 10993 and do not impact the safety of the device. | Biocompatibility assessed in alignment with 10993 and do not impact the safety of the device. This indicates the device met this criterion. |

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

The document does not specify the sample size used for the test set.

The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective based on the nature of "clinical review of images," implying existing images were evaluated rather than prospectively acquired data specifically for this study. The context suggests it was an internal validation of changes to an existing device (HiRise V2 compared to HiRise V1).

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

"fellowship-trained MSK radiologist."

The document states one fellowship-trained MSK radiologist was used. The specific number of years of experience is not provided, but "fellowship-trained" indicates advanced specialization in Musculoskeletal Radiology.

4. Adjudication Method

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). Since only one radiologist
is mentioned for the clinical review, it implies no formal multi-reader adjudication was performed for establishing the ground truth of the test set. The single expert's opinion served as the validation.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. The validation involved a single radiologist reviewing images from the device's new protocols, focused on demonstrating diagnostic quality rather than comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was implied through the "Internal Verification in alignment with all internal testing of previous HiRise" and "Completed 3rd party testing," which would assess the device's technical and imaging output characteristics independently of human interpretation.
However, the clinical acceptability for diagnostic quality was evaluated by the radiologist, which is human-in-the-loop, but the core technical performance before that step is standalone. The document does not describe an AI/algorithm where a standalone AI performance would be distinct from the device's imaging capabilities. This device is a CT X-ray system, not primarily an AI diagnostic algorithm.

7. Type of Ground Truth Used

The ground truth for assessing image quality and diagnostic acceptability was expert consensus from a single fellowship-trained MSK radiologist. The radiologist determined if the images were "clinically acceptable and adequate diagnostic quality."

8. Sample Size for the Training Set

The document does not provide information on a training set sample size. Since this submission is for changes to an existing CT X-ray system (HiRise V2) and its imaging protocols, and not for a new AI/Machine Learning algorithm, the concept of a "training set" in the context of AI development is not directly applicable here. The device's performance relies on its hardware and reconstruction algorithms, which are validated through technical performance standards and clinical review, not typically "trained" on data in the same way an AI model would be.

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

As noted in point 8, the concept of a training set is not directly applicable in the context of this device's submission as described. Therefore, there is no information on how ground truth for a training set was established.

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The HiRise is intended to be used for 3-D imaging of the upper extremities and pelvis of adult and pediatric patients weighing from 40 to 450 lbs.

The device is to be operated in a professional healthcare environment by qualified health care professionals only.

The HiRise is a Cone Beam Computed Tomography Imaging Device that acquires 360-degree rotational projection sequences which are reconstructed into 3D volumetric images of the examined anatomical region. The device uses a gantry assembly, which is comprised of an X- ray source, image detector, and a motorized gantry. The gantry facilitates the acquisition of a full X-ray projection sequence by the acquisition software. For non-weight bearing scans of the lower extremity, a patient positioner accessory allows the patient to sit into a position where he/she can comfortably place his/her anatomy into the imaging bore.

The gantry assembly is mounted on vertical actuators and can travel vertically to capture weight-bearing anatomy at various heights ranging from the feet to the pelvis regions. The HiRise provides total vertical travel of 37 inches to accommodate patients of various sizes. Images produced by the HiRise can be sent electronically to a DICOM complaint image viewing software.

The provided text describes the HiRise, a Cone Beam Computed Tomography (CBCT) X-ray system, and states that it has been determined substantially equivalent to its predicate device, the CurveBeam LineUP.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HiRise device are primarily established through its demonstrated substantial equivalence to the predicate device, the CurveBeam LineUP. The reported device performance is presented in the context of this comparison and in studies confirming diagnostic quality and safety.

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

The document does not specify a distinct "test set" in terms of patient cases for a statistical performance study comparing the HiRise to a ground truth or predicate quantitatively. Instead, it relies on two primary methods:

• Phantom Scans: "image quality phantoms were scanned in the HiRise and evaluated by a medical physicist." The sample size of phantoms is not specified.
• Clinical Image Review: "datasets of the humerus, elbow, forearm, hand, wrist, pelvis/hip, femur, knee, shin (lower leg or tib/fib) and foot/ankle were reviewed by a board-certified radiologist and found to be of diagnostic quality." The number of patient cases (datasets) reviewed is not specified.
  The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective). However, the "clinical review of images" suggests actual patient data, likely retrospective.

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

• Number of experts: At least one board-certified radiologist.
• Qualifications: "board-certified radiologist." Specific years of experience are not mentioned.
• Additionally, a "medical physicist" evaluated image quality phantoms.

4. Adjudication method

The adjudication method for the clinical image review is not explicitly described. It states that "a board-certified radiologist... found [images] to be of diagnostic quality." This implies a single expert's assessment without mentioning a consensus process or multiple readers.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not conducted or described. The HiRise device is a Computed Tomography X-Ray System, which directly acquires images, and the provided documentation focuses on its imaging performance versus a predicate device, not on AI-assisted interpretation.

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

Yes, an assessment of the device's standalone performance was done. The "performance testing by a medical physicist" and "clinical review of images by a radiologist" evaluating the HiRise images themselves indicate a standalone assessment of the device's output quality. There's no mention of a human-in-the-loop component being evaluated for the device's image acquisition functionality.

7. The type of ground truth used

The ground truth for evaluating the HiRise's performance was established through:

• Expert Consensus/Opinion: For clinical images, it was the "diagnostic quality" determined by a "board-certified radiologist."
• Bench Testing/Phantom Standards: For image quality phantoms, evaluation by a "medical physicist" against established image quality requirements, and verification of "optimal X-Ray tube voltage" and "increased tube current" through bench testing. Additionally, "Detector performance testing" verified image quality met requirements.

8. The sample size for the training set

The document describes the HiRise as an imaging device (hardware and associated software for image acquisition and reconstruction), not a machine learning or AI algorithm in the context of image interpretation. Therefore, there is no "training set" for an AI model mentioned in this submission. The "training set" concept is not applicable here as the device's functionality doesn't appear to be based on a trained AI for image analysis.

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

As there is no "training set" for an AI model mentioned, this question is not applicable based on the provided text.

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