(55 days)
MULTIX Impact is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact 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 is not intended for mammography.
MULTIX Impact uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
The MULTIX Impact (VA20) Radiography X-ray system is a modular system of x-ray components (floor-mounted x-ray tube, bucky wall stand, bucky table, x-ray generator, portable wireless and fixed detectors) based on the predicate device, the MULTIX Impact (K193089). The detectors for the subject device, MULTIX Impact (VA20), are the same as the detectors of the predicate device. The following modifications have been made to the predicate device:
- Modified tube stand (motorized) to support Ortho Function 1.
- Modified automatic collimator 2.
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- New bucky wall stand
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- Upgraded software version from VA11 to VA20 to support hardware modifications
- Modified patient table న్.
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- Modified touch user interface (TUI)
- Modified wireless remote control console (WRCC) with new control design 7.
The modified system will be branded as the MULTIX Impact.
The provided text is a 510(k) summary for the Siemens MULTIX Impact X-ray system. It details modifications made to a previously cleared predicate device (MULTIX Impact K193089). This document does not include information about specific acceptance criteria or the study that proves the device meets those criteria in the typical sense of a clinical performance study with defined metrics like sensitivity, specificity, or reader performance.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. The "acceptance criteria" here are primarily conformity to recognized standards and successful completion of non-clinical verification and validation testing, ensuring the modified device performs as intended and introduces no new safety risks.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by 510(k) Submission) | Reported Device Performance (Summary from Submission) |
|---|---|
| Conformance to international and national standards (e.g., IEC 60601 series, ISO 14971, NEMA PS 3.1-3.20) | "MULTIX Impact (VA20) conforms to the following standards: ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012; IEC 60601-1-3:2013; IEC 60601-1-2:2014; IEC 62366-1:2015; ISO 14971:2007; IEC 60601-1-6:2013; IEC 62304:2015; IEC 60601-2-28:2017; IEC 60601-2-54:2018; NEMA PS 3.1-3.20 (2016) and ISO 10993-1:2009." "All test results are a pass and support our claim of device safety and effectiveness." |
| Functional performance of modified components (e.g., tube stand, collimator, Bucky wall stand, software) | "Verification and validation testing have been successfully completed and test results show that the subject device, MULTIX Impact (VA20) with all its components, is substantially equivalent to the predicate device." "Non-clinical tests (integration and functional) were conducted on the MULTIX Impact (VA20) during product development." "The test results support that all the software specifications have met the acceptance criteria." |
| Software safety and effectiveness (Moderate Level of Concern) | "Software Documentation for a Moderate Level of Concern software... is also included... The performance data demonstrates continued conformance with special controls for medical devices containing software." "The risk analysis was completed, and risk controls were implemented to mitigate identified hazards." |
| Equivalence to predicate device in terms of indications for use, design, material, functionality, technology, and energy source. | "The MULTIX Impact (VA20) is substantially equivalent to the predicate device... The subject device is within the same classification regulation, has the same indications for use, and the same mechanical design as the predicate device." "The subject device uses the same or similar components cleared in the MULTIX Impact..." "The non-clinical test data demonstrate that the MULTIX Impact (VA20) device performance is comparable to the predicate device..." |
| Absence of new potential safety risks | "In summary, Siemens concludes that the MULTIX Impact (VA20) does not introduce any new potential 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)
This document describes a premarket notification for a modification to an existing X-ray system. The testing mentioned is primarily non-clinical verification and validation testing of hardware and software components against engineering specifications and regulatory standards. There is no mention of a "test set" in the context of clinical image data or patient studies from specific countries or whether they were retrospective/prospective. The assessment focuses on the performance of the system as a medical device, not a diagnostic algorithm.
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 this is a 510(k) submission for an X-ray system, the "ground truth" (in the sense of expert-labeled medical images for an AI algorithm) is not relevant to the type of testing performed. The documentation focuses on engineering and regulatory compliance, not diagnostic accuracy of an AI component.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "test set" with expert adjudication is mentioned in the context of this 510(k) 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
No. This 510(k) pertains to an X-ray imaging system itself, not an AI-powered diagnostic aide. Therefore, an MRMC study and effects on human reader performance are not described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document does not describe an AI algorithm or its standalone performance. The device is an X-ray system, which requires human operators.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The ground truth concept, as it relates to expert-labeled medical data for AI algorithms, is not part of this submission for an X-ray system itself. The "ground truth" for the engineering tests would be the design specifications and expected functional behavior of the components.
8. The sample size for the training set
Not applicable. This document does not describe an AI algorithm that undergoes training.
9. How the ground truth for the training set was established
Not applicable. This document does not describe an AI algorithm or its training process.
§ 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.