(218 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 patients. The Multitom Rax is not for mammography examinations.
The True2scale Body Scan functionality (ie., slot-scanning-based acquisition and reconstruction technique) of the Multitom Rax is intended to be used for the generation of a geometrically 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 feature is not intended to be used for interventional purposes.
The Multitom Rax is a stationary X-ray system for radiography and fluoroscopy. The Multitom Rax consists of a floor mounted patient table (option) and ceiling suspended Xray tube and a ceiling suspended Solid State X-ray Imager (SSXI). Together with an X-ray generator and a digital imaging system, the Multitom Rax provides comprehensive image acquisition modes to support radiographic and fluoroscopic imaging procedures. X-ray tube and SSXI suspension movements are synchronized to provide rotation around a center. Series imaging acquired during the rotation are provided to 3D post-processing workstations.
With the new True2scale Body Scan technology, the 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.
The provided text describes the acceptance criteria and a study to prove the device, Multitom Rax with True2scale Body Scan Option, meets those criteria. However, it does not contain a typical "acceptance criteria table" with numerical metrics and their corresponding performance. Instead, it focuses on the equivalence to a predicate device and clinical image quality.
Here's an attempt to extract and synthesize the information based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Inferred from Study Purpose) | Reported Device Performance (Summary of Findings) |
|---|---|
| Acceptable clinical image quality to allow detection and evaluation of vertebral alignment in each projection plane. | All ten (10) anonymized clinical image sets were found to be of acceptable clinical image quality by expert, board-certified radiologists. |
Study Details:
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A table of acceptance criteria and the reported device performance: See table above. The document emphasizes the new True2scale Body Scan technology's ability to provide "geometrically 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 primary "acceptance criteria" for the clinical evaluation, therefore, was the subjective assessment of image quality for enabling this assessment.
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Sample size used for the test set and the data provenance:
- Sample Size: Ten (10) anonymized clinical image sets.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states "anonymized clinical image sets."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated, but referred to as "expert, board-certified radiologists" (plural).
- Qualifications: "expert, board-certified radiologists." No detail on years of experience is provided.
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Adjudication method for the test set: Not explicitly detailed. The statement "all image sets were found to be of acceptable clinical image quality" suggests a consensus or majority opinion, but the specific adjudication method (e.g., 2+1, 3+1) is not provided.
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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:
- No, an MRMC comparative effectiveness study was not performed as described. The clinical evaluation was focused on the image quality of the new technology itself, without comparing human readers with and without AI assistance. The True2scale Body Scan is described as a "slot-scanning-based acquisition and reconstruction technique" for generating images, not an AI-assisted diagnostic tool for interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The study was effectively a standalone performance assessment of the image generation capability of the True2scale Body Scan technology. The focus was on the machine's output (image quality) rather than a diagnostic algorithm's performance. The "human experts" were evaluating the output of the device itself.
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The type of ground truth used:
- Expert Consensus/Subjective Assessment: The ground truth for the clinical image evaluation was established through the subjective assessment of "expert, board-certified radiologists" who determined if the images were of "acceptable clinical image quality" for vertebral alignment detection and evaluation. It's not based on pathology or outcomes data.
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The sample size for the training set:
- The document does not mention a training set or machine learning model training in the context of the True2scale Body Scan clinical evaluation. The "software VF11 design was completed in accordance with Siemens Quality Management System Design Controls and verification and validation testing were successfully conducted" but it does not specify if this included a machine learning component requiring a training set. The True2scale Body Scan is described as an "acquisition and reconstruction technique," suggesting image processing rather than AI-driven interpretation.
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How the ground truth for the training set was established:
- Not applicable, as no training set for a machine learning model is mentioned in the context of this premarket submission.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.