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The Multix Select DR is a digital system used for making X-ray exposures of the head, spinal column, abdomen, thorax (lungs), internal organs and extremities with/without using conventional film/screen and CR -systems, and may be used on pediatric, adult and bariatric patients. The Multix Select DR system is not meant for mammography.

Multix Select DR is a product sharing same image system platform with Siemens' Multix Fusion x-ray system cleared under Premarket Notification K121513 on 08/10/2012, but target to low end DR market segment. The Multix Select DR system consists of radiologic table, x-ray generator, x-ray tube, flat panel detector (mobile (wired)), imaging system and Bucky-wall stand. The Multix Select DR offers the following system configurations: A digital radiography system with a mobile (wired) flat panel detector. The key components are a Patient Table and a Bucky wall stand which are available in different configurations. The x-ray tube is a Single Tank Tube Assembly and mounted in a column integrated on the patient table. A manual movement of the x-ray tube is available.

The provided document does not describe a study to prove acceptance criteria for a new device's performance in the way typically found for AI/ML devices. Instead, this is a 510(k) premarket notification for a traditional medical device (an X-ray system), where "acceptance criteria" primarily refer to conformance with established safety and performance standards rather than clinical performance metrics like sensitivity or specificity for an AI algorithm.

The document argues for substantial equivalence to a predicate device (Multix Fusion K121513) based on similar indications for use and technological characteristics. The "performance testing" described is focused on compliance with regulatory standards for electrical safety, mechanical safety, EMC, radiation performance, software lifecycle, and quality systems.

Therefore, many of the requested fields (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study results) are not applicable or not provided in this context.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

• Same Indications for Use
• Same or similar comparable components (X-ray tube, collimator, table, X-ray Generator, Bucky wall stand, Digital Imaging system, Flat panel detector) | The Multix Select DR is presented as substantially equivalent to the Multix Fusion (K121513).
  Differences in Generator (55kW vs 55/65/80kW), X-ray Tube (OPTIPHOS 135/30/55R vs OPTITOP 150/40/80HC-100), Collimator (Manual vs Manual or automatic), Table (Floating vs Lifting & Floating), Bucky wall stand (Manual vertical movable, Non-tiltable tray vs Manual vertical movable, tiltable tray), and Flat Panel Detector (DRZ+ Gadox a-Si vs Cesium iodide CsI a-Si) are stated not to affect safety or effectiveness, supported by verification, validation, and risk management. |
  | Voluntary Standards Conformance (General) | - IEC 60601-1: General Requirements for Safety (1988, Amend 1,2)
• IEC 60601-1-1: Safety requirements for medical electrical systems (2000)
• IEC 60601-1-2: Electromagnetic Compatibility (Ed 2:2001, Amend 1:2004)
• IEC 60601-1-3: Radiation protection for diagnostic X-ray equipment (First Ed. 1994-07 & Ed. 2.0 2008-01)
• IEC 60601-1-4: Programmable electrical medical systems, edition 1.1 (2000)
• ISO 14971: Application of risk management to medical devices (2007)
• IEC 62304 Ed. 1.0: Medical device software - Software life cycle processes
• ISO 10993-1: Biological evaluation of medical devices (2009)
• IEC 60601-1-6: Usability (2004) | Siemens "certify to conformance" and "hereby certifies that the subject device the Multix Select DR will be in Clemono neroby ooking recognized consensus standards" for all listed voluntary standards. Performance data is provided in Original 510k submission Appendix G (not included in the extract). |
  | Voluntary Standards Conformance (Radiology) | - IEC 60601-2-7: Safety of high-voltage generators of diagnostic X-ray generators (1998)
• IEC 60601-2-28: Safety of X-ray source assemblies and X-ray tube assemblies (2010)
• IEC 60601-2-32: Safety of associated equipment of X-ray equipment (1994)
• NEMA PS 3.1-3.20 (2011): Digital Imaging and Communications in Medicine (DICOM)
• IEC 60601-2-54: Basic safety and essential performance of X-ray equipment for radiography and radioscopy (Edition 1.0) | Siemens "certify to conformance" and "hereby certifies that the subject device the Multix Select DR will be in Clemono neroby ooking recognized consensus standards" for all listed voluntary standards. |
  | Federal X-ray Performance Standards (21 CFR)| - 21 CFR 1020.30: Manufacturer's Responsibility, Identification, Information to assemblers/users, Warning label, Leakage Radiation, Radiation from components, Beam Quality, Aluminum equivalent
• 21 CFR 1020.31: Control and indication of technique factors, Reproducibility, Linearity, Field limitation and alignment (mobile, portable, stationary), Field indication and alignment (stationary), Beam-on indicators | Siemens "certifies that the subject device the Multix Select DR will meet the applicable requirements of the FDA Performance Standards for lonizing Radiation application for diagnostic X-Ray systems and their major components." |

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

• Not applicable/Not provided. The submission focuses on substantial equivalence through component comparison and conformance to engineering/safety standards, not clinical performance testing with a "test set" of patient data for image interpretation.

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

• Not applicable/Not provided. Ground truth establishment by experts for image interpretation is not mentioned as part of this 510(k) submission.

4. Adjudication method for the test set:

• Not applicable/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:

• Not applicable. This device is an X-ray system, not an AI/ML diagnostic algorithm designed to assist human readers.

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 in the context of clinical performance of an AI model. For the safety and performance testing, the "ground truth" would be the established specifications and requirements of the various IEC, ISO, and 21 CFR standards.

8. The sample size for the training set:

• Not applicable. This is not an AI algorithm that requires a training set of data.

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

• Not applicable.

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