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The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatic patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications. Exposure may be taken with the Patient's sitting, standing, or in the prone/ supine position.

The DigiX FDX System is not meant for mammography.

The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.

The DigiX FDX system is a diagnostic X-Ray system intended for general purpose radiographic imaging of the human body. It is not intended for mammographic imaqing.

The DigiX FDX system is comprised of a combination of devices that include a ceiling mounted X-Ray tube suspension, vertical Bucky stand, fixed or mobile patient Bucky table, X-Ray generator, X-Ray tube, beam limiting device, and a solid-state image receptor.

The DigiX FDX systems are not intended to be operated with any other cleared devices, or to be integrated with other software/hardware devices via direct or indirect connections.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on demonstrating substantial equivalence to predicate devices rather than defining specific quantitative performance metrics as "acceptance criteria" for a new AI/software feature in the way clinical performance studies usually do. Instead, the "acceptance criteria" are implied to be that the modifications do not negatively impact safety or effectiveness, and that the device performs comparably to the predicate devices and meets relevant safety standards.

For the new features explicitly mentioned (Automatic Stitching and Dual Energy Subtraction), the document states they add functionality without affecting patient safety or effectiveness. For the other components, the criteria are often "Same" or "Similar functionality with same imaging results" or "doesn't affect the safety or effectiveness."

To represent this in a table, we'll extract performance comparisons from the "Functional and Specification Differences" table (Table 4) and the "Justification for Differences" (Table 5).

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

The document states:

• "Non-clinical testing included verification and validation testing, image evaluation, testing, and safety testing."
• "Performance testing included functional testing of all motions of the system(s) with respect to the design specifications. Image performance testing was conducted and results included in the submission."
• "Clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system."

The document does NOT specify a sample size for any test set (clinical or otherwise) in terms of patient data or images used for validation of the radiographic system itself, nor does it mention data provenance (country of origin, retrospective/prospective). It primarily relies on hardware and software equivalence, and compliance with industry standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The document explicitly states "Clinical testing is not applicable." Therefore, there was no clinical study conducted that would necessitate expert readers to establish ground truth for a test set. The evaluation focuses on technical performance and equivalence to predicate devices.

4. Adjudication Method for the Test Set

Not applicable. As no clinical test set requiring expert adjudication was performed, no adjudication method is mentioned.

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

No MRMC comparative effectiveness study was done. The document states "Clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system." Therefore, there is no information on how much human readers improve with or without AI assistance. The new software features (Automatic Stitching, Dual Energy Subtraction) are presented as additional functionalities that don't affect safety or effectiveness, not as AI-assisted diagnostic tools requiring a comparative effectiveness study.

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

Not applicable. The device is a radiographic system, not an AI algorithm intended for standalone diagnostic performance. While it includes new software features (Automatic Stitching, Dual Energy Subtraction), these are integrated functionalities of the imaging system and not described as standalone diagnostic algorithms requiring independent performance evaluation without human interaction.

7. Type of Ground Truth Used

The "ground truth" for the evaluation is primarily based on:

• Compliance with technical specifications and design requirements: Functional testing, image performance testing.
• Adherence to safety and performance standards: IEC 60601 series, EN ISO 14971, IEC 62366-1, IEC 62304, 21 CFR 1020.30, 21 CFR 1020.31.
• Substantial equivalence to predicate devices: Demonstration that the new device has the same intended use, fundamental technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
• Software documentation assessment: For the software components, including the new features, documentation was provided for a "Moderate Level of Concern" software as per FDA guidance.

No clinical ground truth (e.g., expert consensus, pathology, outcomes data) was used or required given the nature of this submission.

8. Sample Size for the Training Set

Not applicable. The document describes an X-ray imaging system, not an AI/ML device that requires a training set of data. The new software features (Automatic Stitching, Dual Energy Subtraction) are described as functionalities, not adaptive algorithms that learn from data.

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

Not applicable. As there was no training set, there was no ground truth to establish for it.

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Multix Fusion Max system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion Max 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 Fusion Max system is not meant for mammography.

Multix Fusion Max uses a mobile (wired), or a fixed (integrated) or wireless digital detector for generating diagnostic images by converting x-rays into image signals. The Multix Fusion Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

The Multix Fusion Max Radiography X-ray system is a modular system of x-ray components (ceiling suspension with x-ray tube, bucky wall stand, bucky table, x-ray generator, portable wireless and integrated detectors) which is the same as the predicate device, the Multix Fusion Max (K162971). The portable wireless and integrated detectors used with Multix Fusion Max are imported from the cleared predicate device, Multix Fusion Max (K162971). There are no new imaging detectors added to the subject x-ray system. The Multix Fusion Max software is being used unchanged from the reference device, Ysio Max (K181279). This 510(k) submission describes modifications to the predicate device, the Multix Fusion Max, cleared via K162971.

The purpose of this submission is for the following modifications to Multix Fusion Max:

• Updated operating system from Windows 7 to Windows 10 and software version upgrade from VE21 to VF10
• New cybersecurity features
• Additional pediatric exposure technique factors
• A new 80-line grid with a 15:1 ratio
• The image processing algorithms (DiamondView MAX) will be used for exposures without grid
• The Multix Fusion Max with VF10 has been tested according to the currently recognized voluntary standards.

The provided document is a 510(k) summary for the Multix Fusion Max X-ray system. It describes modifications to an existing device (Multix Fusion Max, K162971) and claims substantial equivalence to that predicate device. The changes include an updated operating system (Windows 7 to Windows 10), software version upgrade, new cybersecurity features, additional pediatric exposure technique factors, and a new 80-line grid.

Crucially, this document does not contain information about a study that proves the device meets specific performance acceptance criteria for diagnostic accuracy, sensitivity, or specificity, especially not in the context of an AI-assisted diagnostic device or a multi-reader, multi-case study. The performance testing mentioned is primarily "non-clinical performance testing" for device functionality, safety (electrical, mechanical, radiation), and software verification/validation, rather than clinical performance for diagnostic effectiveness. The document states:

• "Non-clinical tests were conducted for the Multix Fusion Max during product development. The modifications described in this Premarket Notification are supported with verification and validation testing."
• "The testing results indicate that all the software specifications have met the acceptance criteria. Verification and validation testing was found acceptable to support the claim of substantial equivalence."
• "The non-clinical test data demonstrate that the Multix Fusion Max device performance is comparable to the predicate device that is currently marketed for the same intended use."

The entire premise of the 510(k) submission for this device is to demonstrate substantial equivalence to a previously cleared device, not to prove new or improved clinical effectiveness through a diagnostic performance study. The device is a radiographic system for generating images, not an AI or CAD system that provides diagnostic interpretations or assists human readers in making diagnoses.

Therefore, many of the requested details about acceptance criteria for diagnostic performance, sample size for test sets (in a clinical sense), ground truth establishment, expert readers, MRMC studies, or standalone AI performance do not apply to the information presented in this 510(k) summary.

However, I can extract information related to what was studied to support the 510(k) clearance based on substantial equivalence.

Here's the closest answer based on the provided text, highlighting what is (and isn't) present:

Acceptance Criteria and Study for Multix Fusion Max (K191418)

The provided 510(k) summary for the Multix Fusion Max (K191418) focuses on demonstrating substantial equivalence to a predicate device (Multix Fusion Max, K162971) following modifications primarily related to software (operating system upgrade, cybersecurity), and minor hardware changes (new grid, expanded pediatric technique factors). The "study" described is a series of non-clinical verification and validation tests rather than a clinical diagnostic performance study. As such, many of the requested criteria related to AI or diagnostic accuracy studies are not applicable to the content of this document.

1. Table of Acceptance Criteria and Reported Device Performance

General acceptance criteria are related to safety, functionality, and compliance with standards. The document does not provide specific quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) for a clinical study of images, as this was not a submission for an AI/CAD device.

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

• Sample Size: Not applicable in the context of a clinical test set of patient images for diagnostic accuracy. The testing performed was non-clinical verification and validation of system functionality and safety.
• Data Provenance: Not applicable for a clinical test set. The document refers to its manufacturing sites in Shanghai, China, and Forchheim, Germany, and the applicant is Siemens Medical Solutions USA, Inc. The testing described is intrinsic to the device's engineering and software.

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

• This is not applicable as the submission describes non-clinical engineering and software validation, not a diagnostic performance study where human experts establish ground truth for image interpretation.

4. Adjudication Method for the Test Set

• Not applicable for the type of non-clinical testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC study was not done or described in this 510(k) summary. This device is a basic X-ray system, not an AI or CAD system designed to assist human readers in diagnosis.

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

• Not applicable. This device is an X-ray imaging system, not an AI algorithm intended for standalone diagnostic interpretation.

7. The Type of Ground Truth Used

• Not applicable in the context of diagnostic image interpretation. For functional testing, "ground truth" would be established through engineering specifications, direct measurement, and known physical principles.

8. The Sample Size for the Training Set

• Not applicable. This document describes a conventional X-ray system, not a machine learning or AI algorithm that requires a training set of data.

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

• Not applicable, as no training set for an AI/ML algorithm is described.

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