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Luminos Agile Max 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 gastrointestinal examinations 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, venography, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). The system may be used on pediatric, adult and bariatric patients.

Luminos Agile Max is not for mammography examinations.

Luminos dRF Max 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 gastrointestinal examinations 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, venography, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). The system may be used on pediatric, adult and bariatric patients.

Luminos dRF Max is not for mammography examinations.

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 gastrointestinal examinations 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, venography, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). The system may be used on pediatric, adult and bariatric patients

Multitom Rax is not for mammography examinations.

Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological therapeutic applications such as examinations and small interventions of the urogenital tract. The table supports endourological and minimal invasive surgery in urology as there are transurethral interventions (e.g. ureterorenoscopy (URS), double stent placement, cystoscopy. transurethral resection of bladder tumors (TURB), transurethral resection of the prostate (TURP)), percutaneous urological procedures (e.g. percutaneous nephrostomy (PCN), percutaneous nephrolitholapaxy (PCNL)), urological X-ray diagnosis (e.g. survey imaging of the kidney, ureter, and bladder (KUB), intravenous pyelogram (IVP), retrograde pyelography), micturition cystourethrogram (MCU), videourodynamics, laparoscopic procedures and minor open urological interventions. The system may be used on pediatric, adult and bariatric patients.

Uroskop Omnia Max is not for mammography examinations.

All four radiology imaging devices are stationary X-ray systems for radiography and fluoroscopy. They use the same X-ray generator, the same X-ray tube and similar collimators. They also share the same imaging and system control device: The Fluorospot Compact. The reason for this submission is the upgrade of all systems to the software VF10. This new software will bring the following new features to the devices: IEC 4th for EMC, Windows 10, Cybersecurity package, Pediatric package, Use hospital IT (e.g. RIS) on modality, 16 fps mode for 3D (Multitom Rax only), SSXI update. The image processing algorithms (Diamond View Plus) will be used for exposures without grid and fluoroscopy image processing algorithms will be enhanced and called "Clearview". Also the name suffix "Max" is being established as an addition to the product name of Luminos Agile, Luminos dRF and Uroskop Omnia.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Siemens Medical Solutions X-ray systems:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a pass/fail quantifiable manner, but rather presents a comparison demonstrating that the updated devices (with VF10 software) are "substantially equivalent" to their predicate devices. The performance metrics revolve around various technical specifications, particularly for the detectors and compliance with regulatory standards.

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

The document explicitly states: "For the subject of this premarket submission, Siemens did not do an evaluation of the clinical image quality as x-ray technology; geometry and SSXI changes are minor."

This indicates there was no dedicated clinical test set in terms of patient images. The evaluation primarily relied on non-clinical performance data, engineering verification and validation testing, and compliance with standards. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable.

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

As there was no clinical evaluation with a dedicated test set evaluated by experts, this information is not applicable. The ground truth for the non-clinical performance data (e.g., DQE, MTF) would be derived from physical measurements and calibrated test equipment, not expert human assessment.

4. Adjudication Method for the Test Set

Since there was no clinical test set requiring human interpretation, an adjudication method is not applicable.

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

No MRMC comparative effectiveness study was done. The submission explicitly states "Siemens did not do an evaluation of the clinical image quality." Therefore, no effect size of human readers improving with AI vs. without AI assistance can be reported. The device is an X-ray imaging system, not an AI-based diagnostic tool for interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

No standalone performance study of an algorithm was done in the context of image interpretation or diagnostic accuracy. The "software update VF10" relates to the operating system, cybersecurity, feature enhancements, and control of the imaging hardware, not a new diagnostic algorithm that would operate in a standalone manner. The performance data presented (DQE, MTF) are intrinsic characteristics of the imaging detectors themselves, measured objectively, and not an "algorithm-only" performance in a diagnostic sense.

7. Type of Ground Truth Used

For the non-clinical performance evaluation, the ground truth was based on:

• Physical measurements and industry standards: For detector performance metrics like DQE and MTF. These are objectively measured using specified test conditions and equipment.
• Compliance with regulatory and consensus standards: For safety, electromagnetic compatibility, software life cycle, and radiation control.
• Engineering verification and validation: To confirm software requirements are met and system functionality aligns with user needs.

There was no "expert consensus, pathology, or outcomes data" used as ground truth for a clinical efficacy study.

8. Sample Size for the Training Set

The document primarily describes a software upgrade and associated hardware (detector) changes for existing X-ray systems. It does not refer to a machine learning or AI algorithm that would require a "training set" of data. Therefore, the sample size for a training set is not applicable.

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

Since there was no training set for a machine learning algorithm, this information is not applicable.

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