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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.

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

The document mentions an "image quality evaluation of 21 anonymized clinical and phantom data sets."

• Sample size: 21 data sets (comprising clinical and phantom data).
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). It simply mentions "anonymized clinical and phantom data sets."

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

The image quality evaluation was conducted by "expert US board-certified radiologists."

• Number of experts: Not explicitly stated, but implies a group of experts plural.
• Qualifications of experts: US board-certified radiologists. No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). It states the image quality evaluation was conducted by experts "showing that presented 3D images are of sufficient diagnostic quality to assess osseous structures including fractures and bone angles." This suggests a consensus or individual assessment against diagnostic quality, rather than a specific algorithmic adjudication.

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

No, the document does not describe an MRMC comparative effectiveness study that assesses how much human readers improve with AI vs. without AI assistance. The study described is an image quality evaluation by radiologists, not a comparative effectiveness study involving AI assistance.

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

Yes, standalone performance was evaluated through the non-clinical tests and the comparison of technological characteristics against a reference device. These tests assessed the intrinsic image quality metrics (high-contrast resolution, low-contrast detectability, CT number accuracy, uniformity, image noise, etc.) of the Real3D functionality without human intervention in the diagnostic process.

7. The Type of Ground Truth Used

For the non-clinical performance metrics (e.g., resolution, uniformity, CT number accuracy), the ground truth is established through phantom data and standardized measurement techniques. For the "clinical" aspects of the 21 data sets, the ground truth for diagnostic quality assessment was the expert consensus/opinion of US board-certified radiologists who determined if the images were of "sufficient diagnostic quality to assess osseous structures including fractures and bone angles."

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. The descriptions focus on the validation and verification of software and the performance evaluation of the Real3D functionality.

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

As the document does not provide information on the training set, the method for establishing its ground truth is also not provided.

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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

Study Details:

1. 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.

2. 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."

3. 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.

4. 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.

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:

   • 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.

6. 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.

7. 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.

8. 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.

9. 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.

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The Multitom Rax is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations.

The Multitom Rax is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal. thoracic and lung exposures as well as examination of the urogenital tract. The unit may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiography, digital angiography and digital subtraction angiography (DSA).

The Multitom Rax may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.

The Multitom Rax is not for mammography examinations.

The Multitom Rax is a stationary X-ray system for radiography and fluoroscopy. The Multitom Rax consists of a floor mounted patient table 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 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.

The provided text is a 510(k) summary for the Siemens Multitom Rax, an X-ray imaging system. The submission focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria in a standalone clinical study. Therefore, much of the requested information regarding acceptance criteria, study design parameters (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), and comparative effectiveness studies (MRMC, standalone algorithm performance) is not explicitly detailed in this document.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not present a table with specific quantitative acceptance criteria or device performance metrics in the format of a clinical study. Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The submission does not describe a clinical test set with human subjects to evaluate performance against specific acceptance criteria. The "tests" mentioned are primarily non-clinical verification and validation activities and compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set with ground truth established by experts is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set with adjudication is described.

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

No MRMC comparative effectiveness study was done. The device described is an X-ray imaging system, not an AI-powered diagnostic algorithm for image interpretation.

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

Not applicable. This is an X-ray imaging system, not a standalone AI algorithm.

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

Not applicable. No clinical ground truth is described. The "ground truth" in this context refers to the successful verification against engineering specifications and compliance with safety standards for the device's components and functionality.

8. The sample size for the training set

Not applicable. This is an X-ray imaging system undergoing a 510(k) submission based on substantial equivalence, not an AI model requiring a training set.

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

Not applicable, as there is no training set for an AI model.

Summary of the Study and Evidence Presented for Device Acceptance (Substantial Equivalence):

The Siemens Multitom Rax obtained a 510(k) clearance based on demonstrating substantial equivalence to two predicate devices:

• Primary predicate: AXIOM Luminos dRF (K062623)
• Secondary predicate: AXIOM Aristos FX Plus (K061054)

The "study" that proves the device meets the acceptance criteria (substantial equivalence) is a combination of non-clinical verification and validation testing and compliance with recognized standards.

Here's the evidence presented:

• Indications for Use: The Multitom Rax has identical indications for use as the Primary predicate AXIOM Luminos dRF (K062623).
• Technological Characteristics:
  • The Multitom Rax uses the same X-ray generator, X-ray tube, solid state X-ray imager (SSXI), digital imaging system, and image processing software as the Primary predicate AXIOM Luminos dRF.
  • The system control (in-room or remote) is the same fashion as the Primary predicate AXIOM Luminos dRF.
  • The mechanical design concept is the same as the Secondary predicate AXIOM Aristos FX Plus.
  • Changes implemented involve enhanced movement flexibility of suspension arms, increased number of predefined automatic positions, optimized software algorithm for faster movement, and a more sophisticated collision software. These features were also available in the secondary predicate to some extent (e.g., automatic positioning).
  • The automatic exposure control processes data from 5 dose measurement fields instead of 3 (compared to predicate devices).
  • Increased number of organ programs, including additional pediatric applications.
• Non-Clinical Test Data:
  • Design completed in accordance with Siemens Quality Management System Design Controls and Engineering.
  • Verification and Validation testing were successfully conducted.
  • Tests demonstrated the device is safe and effective, performs comparably to predicate devices, and is substantially equivalent.
  • Tests included verification/validation testing to internal functional specifications (including software).
  • Since the Multitom Rax uses the same SSXI as the Primary predicate and X-ray geometry and techniques are the same, clinical image comparisons involving SSXI were not conducted.
  • Compliance documentation for software (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) was provided, including results of verification/validation tests for software requirements and risk hazards.
• Performance Standards Compliance:
  • Confirmed compliance with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment.
  • Complies with relevant voluntary safety standards for Electrical Safety and Electromagnetic Compatibility testing, specifically numerous IEC standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 62366, ISO 14971, IEC 62304, IEC 60601-2-28, IEC 60601-2-54, IEC 61910-1, NEMA PS 3.1 - 3.20, IEC 60825-1, ISO 10993-1, IEC 60601-2-43).
• Conclusion: The verification/validation activities confirmed that device requirements were fulfilled, system functionality is consistent with user needs and intended uses, and the device performs as designed without raising new questions regarding safety or effectiveness, thus supporting a determination of substantial equivalence.

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