(55 days)
MULTIX Impact C is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact C 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. MULTIX Impact C is not intended for mammography.
MULTIX Impact C uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact C is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
The MULTIX Impact C 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, and portable wireless and fixed detectors) based on the predicate device, the MULTIX Impact (K193089). The detectors for the subject device, MULTIX Impact C, are the same as the detectors of the predicate device. The following modifications have been made to the predicate device:
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- New ceiling suspension with motorized tube tilting support for ortho function and new ceiling suspension with manual tube tilting
- Modified automatic collimator 2.
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- New Bucky Wall Stand
- Upgraded software version from VA11 to VA20 to support hardware modifications 4.
- Modified patient table న్.
- Modified touch user interface (TUI) 6.
- Modified wireless remote-control console (WRCC) with new control design 7.
The new system will be branded as the MULTIX Impact C.
The provided text is a 510(k) summary for a medical device called MULTIX Impact C, which is a radiographic X-ray system. It describes the device, its intended use, and claims substantial equivalence to a predicate device (MULTIX Impact K193089).
However, the document focuses on demonstrating substantial equivalence through comparisons of technical characteristics and adherence to standards for the device itself (X-ray system), rather than providing details about an AI algorithm's performance or a clinical study that would involve acceptance criteria for such an algorithm. The MULTIX Impact C is designed to generate diagnostic images, but there is no mention of an AI component or software that interprets images or assists human readers in a diagnostic capacity.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and AI performance cannot be extracted from this document, as it describes a hardware-focused X-ray system rather than an AI-driven image analysis tool.
Here's a breakdown based on the information available in the provided text:
1. A table of acceptance criteria and the reported device performance
No acceptance criteria and reported device performance directly related to an AI algorithm's diagnostic output (e.g., sensitivity, specificity, AUC) are provided. The tests described are non-clinical performance and safety tests for the X-ray system hardware and associated software.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no AI-specific test set or data provenance is mentioned. The testing described is for the X-ray system's hardware and software functionality, not for AI diagnostic performance.
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 no ground truth for an AI diagnostic algorithm's performance is established or discussed. The document mentions "operators are healthcare professionals familiar with and responsible for the x-ray examinations to be performed," but this refers to the users of the X-ray system, not experts establishing ground truth for AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no AI-specific test set or adjudication method is mentioned.
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 document describes an X-ray imaging system, not an AI-assisted diagnostic tool that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a radiographic X-ray system; there is no standalone algorithm performance described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth for an AI diagnostic algorithm is not discussed. The "ground truth" for the device's performance would be its conformity to engineering specifications and safety standards, as demonstrated by non-clinical testing.
8. The sample size for the training set
Not applicable, as there is no mention of an AI model or a training set. The software mentioned (VA20) is an upgraded version to support hardware modifications and new control features, not an AI for image analysis.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of an AI model or a training set.
Summary of what is described regarding the device's "acceptance criteria" and testing:
The document indicates that the device (MULTIX Impact C X-ray system) meets its "acceptance criteria" through:
- Non-clinical performance testing: "Non-clinical tests were conducted for the MULTIX Impact C during product development. The modifications described in this Premarket Notification are supported with verification and validation testing."
- Adherence to Standards: The device conforms to numerous international and national standards, including:
- ES60601-1:2005/(R)2012 and A1:2012 (Medical electrical equipment – General requirements for basic safety and essential performance)
- IEC 60601-1-3:2008+A1:2013 (Medical electrical equipment – General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment)
- IEC 60601-1-2:2014 (Medical electrical equipment – General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests)
- IEC 62366-1:2015 (Medical devices – Application of usability engineering to medical devices)
- ISO 14971:2007 (Medical devices – Application of risk management to medical devices)
- IEC 60601-1-6:2013 (Medical electrical equipment – General requirements for basic safety and essential performance – Collateral Standard: Usability)
- IEC 62304:2015 (Medical device software – Software life cycle processes)
- IEC 60601-2-28:2017 (Medical electrical equipment – Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis)
- IEC 60601-2-54:2018 (Medical electrical equipment – Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy)
- NEMA PS 3.1-3.20 (2016) (DICOM standards)
- ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process)
- Software Documentation and Testing: "Software Documentation for a Moderate Level of Concern software... The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted on the MULTIX Impact C during product development." All software specifications "met the acceptance criteria."
- Risk Analysis: "The risk analysis was completed and risk controls were implemented to mitigate identified hazards. The test results support that all the software specifications have met the acceptance criteria."
- Substantial Equivalence: The primary "acceptance criterion" for clearance appears to be demonstrating substantial equivalence to a predicate device (MULTIX Impact K193089), which is achieved by showing similar indications for use, mechanical design, and that "non-clinical test data demonstrate that the MULTIX Impact C device performance is comparable to the predicate device."
In summary, the provided text is for the regulatory submission of an X-ray machine. It details the device's features, compliance with general safety and performance standards for X-ray equipment, and its similarity to a predicate device. It does not describe an AI diagnostic algorithm or a clinical study for such an algorithm's performance.
§ 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.