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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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The UROSKOP Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimal invasive urology/surgery). The system, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including:

• Querying and retrieving patient history information and/or previous diagnosis and images from other modalities.
• X-ray examinations of the urogenital and area (e.g. cystoscopy, kidney, bladder, ureter, urethra) including KUB, IVP, vasovesiculography, reflux-cystogram, cystourethrogram, and michuration cystourethrogram combined with uroflow measurements.
• Ultrasound examinations (in conjunction with a stand-alone ultrasound system) of the kidney, bladder, prostate, scrotum.
• endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement, penile implant placement, transvirethral resection of prostate or bladder, alternative treatment of the BPH, brachytherapy, as well as gynecological pacedures requiring radiological support).
• percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy)
• laparoscopy (e.g. cholecystectomy, nephrectomy, lymph node dissection, abdominal testis. detection/correction, varicocele).
• application of fistula (kidney/bladder)
• simple procedures (e.g. urethra, testis, phimosis)
• intracorporeal shock wave lithotripsy
• uroflow/urodynamics
• pediatric radiological and therapeutic applications.

UROSKOP Omnia is a radiographic and fluoroscopy examination table with the X-ray tube over the table and the detector underneath the patient table. The table top can be moved longitudinally and laterally as well as vertically. This system is a modified version of the UROSKOP U04 (marketed as UROSKOP Access). The modification features a solid state image detector with the Fluoros of Compact in place of the Image Intensifier and CCD camera for image recording and processing. The table design remains unchanged while the new imaging chain is based on the AXIOM Luminos dRF described in premarket notification K. 062623 which received FDA Cleanance on August 22. 2007.

This 510(k) summary for the UROSKOP Omnia does not include specific acceptance criteria or a detailed study proving the device meets those criteria. The submission focuses on demonstrating substantial equivalence to predicate devices (UROSKOP U04 and AXIOM Luminos dRF) by highlighting similarities in intended use, design, and components, particularly the imaging chain modification from an image intensifier to a flat panel detector.

Therefore, many of the requested details about acceptance criteria, performance metrics, sample sizes, expert qualifications, and ground truth establishment are not provided in the given document.

Here's an attempt to answer the questions based on the available information:

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

   • Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., resolution, contrast, dose). The acceptance is implicitly based on meeting the same performance and safety standards as the predicate devices, particularly the AXIOM Luminos dRF regarding its imaging chain.
   • Reported Device Performance: Not quantified. The submission states that the UROSKOP Omnia uses the same flat detector (Pixium 5100) and digital imaging system (Fluorospot Compact) as the AXIOM Luminos dRF, implying that its imaging performance should be comparable to the cleared predicate device.

   Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
   Comparable imaging quality and safety to predicate devices (UROSKOP U04 and AXIOM Luminos dRF).	Uses identical flat detector (Pixium 5100) and digital imaging system (Fluorospot Compact) as the AXIOM Luminos dRF, which was previously cleared (K062623).
   Compliance with general safety and effectiveness concerns, including appropriate warnings, error handling, and adherence to industry practices.	Instructions for use provided, visual/audible warnings incorporated, continuous system monitoring with error blocking, operators are healthcare professionals, adherence to recognized industry practices, and final performance testing.

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

   • No specific test set or data from a clinical or phantom study is described in this 510(k) summary to establish direct performance for the UROSKOP Omnia itself. The assessment relies on substantial equivalence to predicate devices. Therefore, sample size and data provenance are not applicable in the context of a new performance study for this specific device.

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

   • Not applicable. No new test set requiring expert ground truth establishment for this device is mentioned.

4. Adjudication method for the test set

   • Not applicable.

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

   • Not applicable. This device is an X-ray system, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

   • Not applicable. This is not an AI algorithm.

7. The type of ground truth used

   • Not applicable, as no new performance study generating ground truth is described. The "ground truth" for the device's clearance is its demonstrated equivalence to legally marketed predicate devices, which would have undergone their own testing and validation procedures.

8. The sample size for the training set

   • Not applicable. This device is not an AI algorithm requiring a training set.

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

   • Not applicable.

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