(81 days)
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:
- 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.
- 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.
- Number of experts used to establish ground truth and qualifications: No information about experts or ground truth establishment is given.
- Adjudication method: Not mentioned.
- 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.
- Standalone (algorithm only) performance: Not mentioned. The device itself is an X-ray system, not a standalone AI algorithm.
- Type of ground truth used: Not mentioned.
- 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.
- How ground truth for training set was established: Not applicable based on the available information.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.