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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 bariatric 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 imaging.

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.

The provided FDA 510(k) summary for the DigiX FDX device details its substantial equivalence to predicate devices, particularly focusing on technical and functional similarities rather than a standalone performance study with specific acceptance criteria related to diagnostic accuracy. Therefore, the response will focus on the details available within the document regarding non-clinical testing and conformity to standards, as a direct "acceptance criteria vs. reported performance" table for diagnostic metrics is not present.

Here's a breakdown of the requested information based on the provided text:

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

The document does not present specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity for a particular condition) and a corresponding reported device performance with numerical results. Instead, the acceptance criteria are framed in terms of:

• Conformity to recognized standards: The device must comply with various IEC and ISO standards related to electrical safety, electromagnetic compatibility, radiation protection, software life cycle, usability, and risk management.
• Meeting design requirements: Non-clinical verification testing ensures the device's functions and image performance meet its design specifications.
• Substantial equivalence: The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to the predicate devices (DigiX FDX K192541 and Siemens Ysio K081722) without raising new questions of safety or effectiveness.

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

The document explicitly states: "No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed device. Hence, clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system. Bench testing was performed to assess the device safety and effectiveness."

Therefore, there was no "test set" in the sense of patient images or clinical data used for this 510(k) submission to prove diagnostic performance. The testing was non-clinical (bench testing, verification, and validation) and focused on engineering criteria, safety, and functionality.

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

Not applicable, as no clinical test set requiring expert ground truth was used for this submission.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication was used for this submission.

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. The DigiX FDX is an X-ray imaging system, not an AI-assisted diagnostic device for image interpretation. Its changes primarily involve hardware components (new detectors) and software GUI updates.

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

Not applicable. This device is an X-ray system, not a standalone diagnostic algorithm.

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

Not applicable in the context of diagnostic ground truth. For the non-clinical testing performed, the "ground truth" would be established by engineering specifications, recognized standards, and established testing methodologies for hardware and software functionality and safety.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set for diagnostic classification.

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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