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The MULTIX Impact system is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The MULTIX Impact system is not meant for mammography.

The MULTIX Impact uses digital detectors for generating diagnostic images by converting x-rays into image signals. The MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

The MULTIX Impact Radiography X-ray system is a modular system of X-ray components (floor-mounted X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless detectors) similar to the predicate the Multix Fusion Max. This 510(k) submission describes modifications to the predicate device the Multix Fusion Max cleared via K162971. The following modifications have been made to the cleared predicate device and the new system will be branded the MULTIX Impact:

1. A new 43x35cm Wireless detector, 3543DR 1.
2. A new X-ray tube and a new generator
3. An optional 40 line grid with grid suppression algorithm
4. Wireless Remote Control Console
5. An optional All-in-one PC containing touch screen function
6. An optional positioning assistance camera
7. Upgrade software to VA10
8. Upgrade operator system from Windows XP to Windows 10

The Siemens MULTIX Impact X-ray system is a modification of the predicate device, the Multix Fusion Max (K162971). The submission focuses on demonstrating substantial equivalence rather than presenting an effectiveness study for a new clinical claim. Therefore, the information provided primarily concerns performance testing to confirm that the modifications do not negatively impact safety or effectiveness.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission demonstrating substantial equivalence to a predicate device for an X-ray system, the acceptance criteria are generally focused on demonstrating that various component modifications do not degrade performance below the predicate's established levels, and that the device meets relevant safety and performance standards. Formal "acceptance criteria" for a specific clinical task are not explicitly stated for the device as a whole in the way they would be for a diagnostic AI algorithm. Instead, the comparison is to the predicate and established standards.

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

The document describes modifications to an existing X-ray system and its components. The "test set" here refers to the actual physical device and its components undergoing verification and validation testing, rather than a dataset of medical images for a diagnostic algorithm.

• Sample Size for Test Set: Not applicable in the context of a dataset of cases. The testing was performed on the MULTIX Impact system itself and its components.
• Data Provenance: Not applicable in the clinical data sense. The testing is described as "Non-clinical tests... during product development" and "testing for verification and validation." This implies internal testing by the manufacturer.

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

Not applicable. This is not a study requiring expert clinical read-outs for ground truth. The "ground truth" for this submission is adherence to technical specifications, performance standards (like DQE, MTF), and safety requirements, which are evaluated by engineering and quality control processes.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of clinical image adjudication for ground truth establishment. Technical performance and safety are verified through engineering tests.

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 study was performed or is mentioned. This submission is for an X-ray system, not an AI-powered diagnostic device, and it focuses on demonstrating substantial equivalence of modified hardware and software components, not on comparative effectiveness with human readers.

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

Not applicable. The device is an X-ray system, which is inherently used with human operators. There is no "algorithm only" performance claim. The software modifications are part of the overall X-ray system's functionality.

7. The Type of Ground Truth Used

The "ground truth" for this submission relates to:

• Technical Specifications: Ensuring components meet their specified performance parameters (e.g., DQE, MTF for the detector, power output for the generator).
• Compliance with Standards: Verification that the device adheres to recognized national and international standards (IEC, ISO, NEMA).
• Safety and Effectiveness: Demonstration that modifications do not introduce new safety risks or degrade the overall effectiveness of the predicate device, as evaluated through risk analysis and functional testing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set of data.

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

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

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