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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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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 pediatic, adult and bariatic 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) same as the predicate the Multix Fusion. This 510(k) submission describes modifications to the predicate device the Multix Fusion cleared via K142049.

The provided text is a 510(k) summary for the Siemens Multix Fusion Max X-ray system. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to demonstrating substantial equivalence, not typically a clinical performance study with specific metrics like sensitivity or specificity for an AI-powered diagnostic device.

This document describes the device as a radiographic system with various hardware and software modifications compared to its predicate. The "acceptance criteria" here are primarily about demonstrating that the new modifications do not introduce new safety concerns and that the device performs functionally similarly to its predicates.

Here's an analysis of the provided information, framed within your request, but acknowledging the nature of a 510(k) for a general radiography system rather than an AI diagnostic algorithm:

1. Table of Acceptance Criteria (as implied by a 510(k) for an X-ray system) and Reported Device Performance

For an X-ray system like the Multix Fusion Max, "acceptance criteria" are defined by its substantial equivalence to predicate devices, focusing on technical specifications, safety, and operational performance. The "performance" is the demonstration that these are met or that differences are not significant and do not raise new safety/effectiveness questions.

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

This is an X-ray system submission, not a study of an AI-powered diagnostic device. Therefore, there isn't a "test set" in the sense of a dataset of patient images for an AI algorithm. The testing described is primarily non-clinical, focusing on system function, image quality a phantom/test environment, and safety standards compliance.

• Sample Size: Not applicable in the context of clinical "test set" for an AI algorithm. Non-clinical tests were conducted at the product development stage, but specific "sample sizes" of components or tests are not detailed.
• Data Provenance: Not applicable. The "data" are internal testing results, not patient data from a specific country or collected retrospectively/prospectively.

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

Not applicable. There is no mention of expert readers or ground truth establishment in this type of 510(k) submission for a general X-ray system. The performance demonstration is based on technical specifications and engineering tests.

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 is not an AI-powered diagnostic device, and no MRMC study is mentioned or required for this type of submission.

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

Not applicable. This is an X-ray imaging system, not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of clinical ground truth. The "ground truth" for this device's performance demonstration relies on engineering specifications, adherence to international standards (e.g., IEC, ISO), and performance metrics like DQE and MTF measured in a controlled environment, not clinical outcomes or expert labels.

8. The Sample Size for the Training Set

Not applicable. This is an X-ray system, not an AI algorithm requiring a "training set."

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

Not applicable.

In summary, the provided document
describes a 510(k) premarket notification for a conventional X-ray system, not an AI-powered diagnostic device. Therefore, the questions related to AI algorithm development, clinical datasets, expert ground truth, and reader studies are not addressed and are not applicable to this type of device submission. The acceptance criteria are based on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and compliance with recognized standards.

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The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion 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 system is not ment for mammography. The Multix Fusion uses a mobile (wired), or fixed (integrated) or wreless digital detector for generating diagnostic images signals. The Multix Fusion is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

Siemens Medical Solutions USA, Inc. intends to market a Radiography X-ray system the Multix Fusion VA30 and VA40. This 510(k) submission describes several modifications to the previously cleared predicate devices the Multix Fusion K121513 and the YSIO Max Radiography X-ray system K133259. The following Modifications are made to the cleared predicate devices and developed into the Subject Device the Multix Fusion VA 30 and VA40:

1). A new 43x43cm fixed detector, Pixium 4343RG manufactured by Trixell; 2). A new 43x36cm wireless detector, Paxscan 4336W manufactured by Varian. 3). A new 43x43cm fixed detector, Pixium 4343RC manufactured by Trixell. 4) Slight change in the Indication for Use Statement as compared to the secondary predicate Ysio Max K133259). 5). Bucky Wall Stand (BWS) changed from manual to motor driven movement. 6). Radiographic Grid change from movable 50-line grid to stationary 80-line grid. 7). A remote control console to control BWS motorized movement, center align, collimator size and collimator light and 8). An optional Multix DR-Upgrade with wireless detector (Varian Paxscan 4336W) for the predicate the Multix Fusion, K121513 is also available within Multix Fusion VA40.

The Multix Fusion VA30 and VA40 Radiography X-ray system is designed as 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 the Multix Fusion K121513.

This FDA document is a 510(k) summary for the Siemens Multix Fusion VA30 and VA40 X-ray system. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or reporting performance as one would for a novel AI device with specific performance metrics.

Therefore, the requested information cannot be fully provided from the given document as it does not contain the level of detail regarding acceptance criteria, specific device performance numbers, sample sizes for test sets, expert qualifications, or details about comparative effectiveness studies typically found in submissions for AI/ML devices.

However, based on the provided text, here's what can be extracted and inferred:

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

The document does not provide a table with specific quantitative acceptance criteria or numerical performance metrics (e.g., sensitivity, specificity, AUC) for the Multix Fusion VA30 and VA40. The evaluation is based on demonstrating that modifications do not affect the intended use and that the device conforms to various performance standards and safety regulations.

The "acceptance criteria" are implied by adherence to:

• Performance standards: IEC 60601-1 (various editions), IEC 62366, ISO 14971, IEC 62304, PS 3.1 - 3.20 (DICOM), IEC 60601-1-6, ISO 10993-1.
• Safety and Effectiveness: Demonstrated through verification and validation testing, risk analysis, and conformance to EMC/electrical safety standards.
• Substantial Equivalence: The core acceptance is that the device is "substantially equivalent" to predicate devices (Multix Fusion K121513 and YSIO Max K133259) in terms of intended use, design, material, functionality, technology, and energy source, and that it does not introduce new safety risks.

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

The document primarily discusses non-clinical performance testing (verification and validation testing, integration and functional tests, risk analysis). It explicitly states: "Clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system." Therefore, there is no mention of a test set with human patient data or its provenance for evaluating the device's diagnostic performance for the new modifications.

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, as clinical testing with a human-read test set for diagnostic performance was not performed or deemed necessary for this 510(k) submission.

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

Not applicable, as clinical testing with a human-read test set for diagnostic performance was not performed or deemed necessary.

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 such study was conducted or reported. This device is a stationary X-ray system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical X-ray system, not a standalone algorithm. Its performance is evaluated based on its technical specifications, conformance to standards, and safety.

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

For the non-clinical and verification/validation testing mentioned, the "ground truth" would be established by engineering specifications, calibration standards, and adherence to recognized industry and regulatory standards (e.g., verifying radiation output against expected values, confirming software functionality as per design documents, ensuring electrical safety within limits). There is no patient-level ground truth in the context of diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device is an X-ray system. The modifications are related to physical components (detectors, Bucky stand, grid, etc.) and associated software for controlling the system, not a machine learning algorithm trained on a dataset.

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

Not applicable.

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The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Multix Fusion system is not meant for mammography.

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

The Multix Fusion is a modification of Siemens' Ysio X-ray system cleared under Premarket Notification K081722 on 08/22/2008. The Multix Fusion offers the following system configurations:

• An analog radiography system or; .
• A digital radiography system with a mobile (wired) and/or a portable . (wireless) flat panel detector or;
• An optional Multix DR-Upgrade for the analog version of the Multix Fusion . and other tables within the Multix and Vertix analog family.

This modification does not affect the general intended use of the device nor does it alter its fundamental scientific technology.

The Multix Fusion system consists of a radiologic table, x-ray generator, x-ray tube, flat panel detector (wired or wireless) and Bucky-wall stand. It will be marketed as an analog system, a digital radiographic system with a mobile (wired) and/or portable (wireless) flat panel detector or an optional Multix DR- Upgrade for the analog version of the Multix Fusion and other tables within the Multix and Vertix analog family.

The key components are a patient table, a ceiling mounted support and a Bucky wall stand which are available in different configurations. A semi-motorized movement in the ceiling-mounted X-ray tube is available. The optional Multix DR-Upgrade for the analog version of the Multix Fusion consists of a mobile (wired) and/or portable (wireless) flat panel detector and an imaging system. Components used to upgrade (Multix DR-Upgrade) the analog version of the Multix Fusion and other tables within the Multix and Vertix analog family are the same or similar components cleared in the Ysio 510(k) K0817227 on August 22, 2008.

The Multix Fusion may be combined into different configurations to provide specialized customer requirements.

Similar to the cleared Ysio stationary x-ray system, the Multix Fusion and the Mutix DR-Upgrade have the same or similar comparable components. The subject device the Multix Fusion does not affect the indication for use nor the intended use of the device nor does it alter its fundamental scientific technology.

The provided text is a 510(k) summary for the Multix Fusion X-ray System. It describes the device, its intended use, and its substantial equivalence to a predicate device (Ysio).

However, the document does not contain information about formal acceptance criteria for device performance, a study to prove those criteria are met, specific performance metrics, sample sizes for test/training sets, data provenance, expert qualifications, ground truth establishment, or any MRMC (Multi-Reader Multi-Case) study results.

The document states:

• "Non-clinical testing was conducted for the Multix Fusion during product development. This includes verification and validation testing as well as phantom testing. The risk analysis was combation and risk controls implemented to mitigate identified hazards. The testing results supports that all the software specificating have met the acceptance criteria." (Page 3, Section 9)
• "Testing for verification and validation of the device was found acceptable to support the claims of substantial eqivalence." (Page 3, Section 9)

Therefore, based on the provided text, I cannot complete the requested tables and information because the details of the acceptance criteria, the study design, specific performance metrics, and data characteristics are not included.

Here's an explanation of why each requested point cannot be fulfilled:

1. Table of acceptance criteria and reported device performance: The document generally states that "software specifications have met the acceptance criteria" and "testing...was found acceptable to support the claims of substantial equivalence," but it does not specify what those criteria are or what the actual performance values were.
2. Sample size used for the test set and data provenance: No information on test sets, their size, or data provenance (e.g., country of origin, retrospective/prospective) is provided. The testing mentioned refers to "phantom testing" and "verification and validation," which are typically done internally and not necessarily on patient data as part of a formal clinical reader study for performance claims.
3. Number of experts used to establish ground truth and qualifications: No information about experts or ground truth establishment is given.
4. Adjudication method: Not mentioned.
5. MRMC comparative effectiveness study: The document does not mention any MRMC study or any comparison of human readers with vs. without AI assistance. This device is a diagnostic imaging system, not an AI-based interpretation tool.
6. Standalone (algorithm only) performance: Not mentioned. The device itself is an X-ray system, not a standalone AI algorithm.
7. Type of ground truth used: Not mentioned.
8. Sample size for training set: No information on training sets is provided, as this is a traditional medical device, not an AI model requiring a training set in that context.
9. How ground truth for training set was established: Not applicable based on the available information.

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