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510(k) Data Aggregation
(198 days)
Multitom Rax is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients.
The True2scale Body Scan functionality (i.e., slot-scanning-based acquisition and reconstruction technique) of the Multitom Rax is intended to be used for the genetrically accurate (in scanning direction) 2-D representation of the spine, the lower limbs or the full body which may be used for the assessment of body axes and skeletal alignment. The True2scale Body Scan is not intended to be used for interventional purposes.
The Real3D functionality (i.e., cone-beam CT acquisition and reconstruction technique) of the Multitom Rax is intended to be used for 3-D bone imaging of the head, the upper and lower extremities as well as the lumbar spine. Real3D is not intended for imaging of the torso of patients with a Body Mass Index (BMI) exceeding 30 kg/m².
Multitom Rax is not for mammography examinations.
Multitom Rax is a stationary X-ray system for radiography and fluoroscopy. Multitom Rax consists of a floor mounted patient table (option) and ceiling suspended X-ray tube, and a ceiling suspended Solid State X-ray Imager (SSXI). Together with an X-ray generator and a digital imaging system, Multitom Rax provides comprehensive image acquisition modes to support radiographic and fluoroscopic imaging procedures.
With the True2scale Body Scan technology, Multitom Rax performs a continuous scan that moves along the patient's vertical axis with a highly collimated radiation beam along a line trajectory using the system's two telescopic arms. The projections, which are acquired during the scanning process, form the basis for a reconstruction to obtain a 2D representation of the scanned object.
With the Real3D technology, Multitom Rax performs a continuous, circular scan around the patient using the system's two telescopic arms. The projections, which are acquired during the scanning process, form the basis for a reconstruction to obtain a 3D representation of the scanned object.
The Siemens Multitom Rax device's Real3D functionality (cone-beam CT) was evaluated by comparing its technological characteristics and performance to a legally marketed predicate device (Multitom Rax with True2scale Body Scan Option) and a reference device (CurveBeam LineUP).
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" in a separate section with numerical targets for each performance metric. Instead, the comparison to the reference device (CurveBeam LineUP) serves as the benchmark to demonstrate performance is at least equivalent or better, especially for the newly added CBCT functionality. The acceptance criteria can be inferred from the comparison table where the subject device's performance is listed against the reference device.
| Feature | Reference Device (CurveBeam LineUP) Performance | Subject Device (Multitom Rax Real3D) Performance | Comment / Implied Acceptance |
|---|---|---|---|
| kVp | 100 - 120 | 60 - 130 | Better for Multitom Rax Real3D (Wider range of kVp, implying flexibility and potentially better image quality for diverse patient types and body regions). |
| Voxel size | 0.3 mm | 0.2 mm - 0.5 mm (depending on chosen reconstruction kernel) | Better for Multitom Rax Real3D (Ability to achieve smaller voxel size, indicating higher spatial resolution). |
| Slice spacing | 0.3 mm | 0.2 mm - 0.5 mm (depending on chosen reconstruction kernel) | Better for Multitom Rax Real3D (Ability to achieve smaller slice spacing). |
| FOV (diameter, height) | Regular: 20 cm x 20 cm (d, h) | ||
| Extended: 35 cm x 20 cm (d, h) | Real 3D Hi-Res: 15 cm x 15 cm (d, h) | ||
| Real3D: 23 cm x 23 cm (d, h) | Not directly comparable, but Multitom Rax Real3D has a larger regular FOV. Extended FOV not available for Multitom Rax, but its regular FOV is larger than the reference's regular FOV. This indicates suitability for diverse anatomical regions. | ||
| Scan time* | 23s or 26s | Real3D Hi-Res: 14s | |
| Real3D: 12s or 16s (depending on anatomy) | Better for Multitom Rax Real3D and Real3D Hi-Res (Shorter scan times, reducing patient motion artifacts and patient dose). | ||
| High-contrast resolution (10% MTF) | 12 lp/cm | Real 3D Hi-Res: up to 25 lp/cm (very sharp kernel) | |
| Real 3D: up to 15 lp/cm (sharp kernel) | Better for Multitom Rax Real3D (Significantly higher line pairs per centimeter, indicating superior ability to resolve fine details). | ||
| Low-contrast detectability | n/a | 20 HU @ 4 mm (smooth kernel) | |
| 10 HU @ 8 mm (smooth kernel) | Not reported for CurveBeam LineUP. Justification for adequacy: Intended use is high-contrast bone imaging, so low-contrast detectability is not as critical as for hemorrhage detection. The reported values are therefore considered acceptable for the intended use. | ||
| Slice Sensitivity Profile / z-axis point spread function | Not directly reported (isotropic voxels assumed) | 0.42 mm ± 0.1 mm (Real3D) | |
| 0.31 mm ± 0.1 mm (Real 3D Hi-Res) | Not reported for CurveBeam LineUP. Justification for adequacy: Isotropic resolution for Multitom Rax Real3D is stated, implying consistent resolution in all directions, which is a desirable characteristic. | ||
| Image noise | n/a | Smooth: 20 ± 15 HU | |
| Medium: 60 ± 40 HU | |||
| Sharp: 100 ± 60 HU | |||
| Very sharp: 300 ± 150 HU | Not reported for CurveBeam LineUP. Justification for adequacy: Noise depends on dose, object, and reconstruction kernel, making direct comparison difficult. The reported values are considered acceptable for the intended diagnostic quality of high-contrast bone imaging. | ||
| Uniformity (in-plane) |
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(22 days)
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.
| Feature / Criteria (Derived from comparison to Predicate) | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (HiRise) |
|---|---|---|
| Indications for Use | 3-D imaging of foot, knee, hand, elbow. | Expands to 3-D imaging of the upper extremities and pelvis of adult and pediatric patients weighing from 40 to 450 lbs. |
| Performance: 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. | ||
| Patient Weight Range | 50 lbs to 400 lbs | Expands to 40 lbs to 450 lbs. |
| Performance: The increased weight range has been tested and verified by third-party 60601-1 testing. | ||
| Scan Axis | Horizontal and vertical | Horizontal and vertical |
| Performance: Image sequences captured utilizing the gantry in vertical scanning mode were included in the datasets sent to the board-certified radiologist and found to be of diagnostic quality. | ||
| Tube Voltage (CT scans) | 100-120 kVp | 100-130 kVp. |
| Performance: Bench testing determined optimal X-Ray tube voltage for each anatomy and patient size. Higher kVp was determined to be required to clinically image the new anatomy (hips and pelvis). | ||
| Tube Current | 5 mA | 5.5 or 6.5 mA. |
| Performance: Increased tube current was required to provide diagnostic quality image sequences in the new anatomy (hips and pelvis). | ||
| Scan Time (CT) | 21 sec | 26 sec. |
| Performance: HiRise is slightly slower to allow for greater exposure time required for the denser anatomy. Image quality performance was verified with Bench Testing. | ||
| Image Detector | CMOS flat panel | Amorphous Silicon flat panel. |
| Performance: Detector performance testing verified image quality met requirements. Performance testing demonstrated that the image quality of the amorphous silicon flat panel is statistically equivalent to that of the predicate. | ||
| 3D Imaging Volume | 20cm (high) x 35 cm (diameter) | Large FOV: 8" (20cm) height x 16" (40cm) diameter; Medium FOV: 8" (20cm) height x 10" (25cm) diameter. |
| Performance: Image sequences captured utilizing both volumes were included in the datasets sent to the board-certified radiologist and found to be of diagnostic quality. | ||
| Typical Resolution | 0.3 mm voxel | LFOV: 0.3mm, MFOV: 0.25mm. |
| Performance: Image sequences captured utilizing both volumes, and subsequent resolutions, were included in the datasets sent to the board-certified radiologist and found to be of diagnostic quality. | ||
| Image Quality (Overall) | Diagnostic quality (Implied by predicate) | Performance: Image quality phantoms were scanned in the HiRise and evaluated by a medical physicist. The scans were reviewed by a radiologist and found to be of diagnostic quality. Clinical review of images by a radiologist indicated that HiRise is safe and effective when used as labeled. |
| Safety and Effectiveness | Compliance with regulations and standards | Performance: Complies with applicable FDA and international standards pertaining to electrical, mechanical, software, EMC, and radiation safety of medical devices (e.g., AAMI ES60601-1, IEC 60601-1-3, IEC 62366, IEC 62304, IEC 60601-2-44, IEC 60601-1-2, IEC 61223-3-5, NEMA PS 3.1-3.20, IEC 60825-1). |
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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