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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 Luminos Agile is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations.

Luminos Agile may be used for emergency treatment on an outpatient basis, as well as for bedside examinations.

Luminos Agile is a floor-mounted universal fluoroscopic x-ray diagnostic system (R/F system), that was developed for tableside examinations in combination with an Explorator. The modification is to replace the Image Intensifier / TV Camera with a solid state detector (flat panel/digital imager). The Explorator houses the flat panel solid state detector.

This modified AXIOM SIRESKOP SD will be marketed under the trade name Luminos Agile. The modification does not affect the intended use of the device nor does it alter its fundamental scientific technology.

Luminos Agile may be configured as a single tube system, with an under table tube or a dual tube system which features an additional 3D overhead tube crane, that can be moved longitudinally and laterally as well as vertically. The dual x-ray tube configuration provides a quick change between under table and over table exposure modes. The under table tube is used for fluoroscopy and radiographic exposures taken with the Digital Imaging System. The over table tube is suspended from an overhead tube support for exposures with a table Bucky or Bucky wall stand, either with film cassettes or solid state detector. The digital images produced by the solid state detector are recorded and displayed by the Fluorospot COMPACT digital imaging system. The table design remains unchanged while the new imaging chain is based on the AXIOM Luminos dRF described in premarket notification K062623 which received FDA Clearance on August 22. 2007.

The provided text describes the Siemens Luminos Agile, a floor-mounted universal fluoroscopic x-ray diagnostic system. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and study methodologies (MRMC, standalone, training set details) is not available in the provided text. The document is primarily a regulatory submission to establish equivalence for market clearance.

Here's a breakdown of the information that can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The acceptance criteria for a 510(k) submission generally revolve around demonstrating "substantial equivalence" to a legally marketed predicate device in terms of intended use, technology, and safety/effectiveness. This does not involve setting specific performance thresholds (e.g., sensitivity, specificity) for a new clinical study.
• Reported Device Performance: Not provided in terms of quantitative clinical performance metrics (e.g., diagnostic accuracy, image quality scores). The document states that the modification (replacing an Image Intensifier/TV Camera with a solid state detector) "does not affect the intended use of the device nor does it alter its fundamental scientific technology." It also mentions that "the Luminos Agile is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed," and that Siemens adheres to industry practices to minimize hazards. This is general safety and functionality assurance rather than quantifiable performance for acceptance.

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

• Not Applicable/Not Provided. The document is a 510(k) submission asserting substantial equivalence. It does not describe a new clinical study with a "test set" in the context of diagnostic performance. The testing mentioned (final performance testing) refers to engineering/system validation, not a clinical trial with patient data for performance evaluation.

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/Not Provided. As there is no described clinical test set for diagnostic performance, there is no mention of experts establishing ground truth for such a set.

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

• Not Applicable/Not Provided. See point 3.

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. This document describes an X-ray system, not an AI-powered diagnostic algorithm. An MRMC study would not be relevant in this context.

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

• No. This is a hardware system, not a standalone algorithm.

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

• Not Applicable/Not Provided. No clinical ground truth is described as having been established for testing diagnostic performance in this document. The ground truth for regulatory clearance in a 510(k) is typically the established safety and effectiveness of the existing predicate device(s).

8. The sample size for the training set

• Not Applicable/Not Provided. This is a hardware system, not a machine learning algorithm that requires a training set.

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

• Not Applicable/Not Provided. See point 8.

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