(27 days)
MULTIX Impact E is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact E enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and obese patients. Exposures may be taken with the patient sitting, standing, or in the prone position. MULTIX Impact E uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact E is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. MULTIX Impact E is not intended for mammography.
The MULTIX Impact E 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 detector) based on the predicate device, the MULTIX Impact E (VB10) (K220919). The following modifications have been made to the predicate device: 1) A new elevating table (option) 2) Upgraded software version to VB20 to support hardware modifications. The modified system will be branded as the MULTIX Impact E.
Please note, this document pertains to the MULTIX Impact E, which is a stationary X-ray system, and not an AI-powered diagnostic device. The submission focuses on demonstrating substantial equivalence to a predicate device, highlighting hardware modifications and software upgrades to support these changes. Therefore, the questions related to AI device performance, such as MRMC studies, ground truth establishment for AI, and training/test set sample sizes, are not applicable to this specific submission.
The acceptance criteria and performance are based on general safety and effectiveness of X-ray systems, primarily through compliance with recognized standards and non-clinical testing.
Here's a breakdown based on the provided document, addressing the applicable points:
Acceptance Criteria and Device Performance for MULTIX Impact E (X-Ray System)
1. A table of acceptance criteria and the reported device performance
The document does not present explicit "acceptance criteria" in a quantitative performance table for a diagnostic outcome (like sensitivity/specificity for a disease). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through meeting regulatory standards, functional performance of components, and safety considerations. The performance is reported in terms of comparison to the predicate device for various attributes.
Here's an inferred "acceptance criteria" based on the document's structure, which is "Substantially Equivalent to Predicate Device (MULTIX Impact E VB10, K220919) and Reference Device (MULTIX Impact VA21, K213700) with no new safety risks":
| Attribute | Acceptance Criteria (Equivalent/No Negative Impact) | Reported Device Performance (Subject Device: MULTIX Impact E) |
|---|---|---|
| Indications for Use | Same as predicate device. | Same: Radiographic system for whole body (skull, chest, abdomen, extremities) for pediatric, adult, obese patients. |
| Detector | Same as predicate device. | Same: Wireless detector Mars1717VS. |
| Tube Stand (TS) | Integrated fully manual TS: Same as predicate. Independent fully manual TS: Movement range increase has no impact on safety/effectiveness. | Integrated fully manual TS: Same functionality. Independent fully manual TS: Movement range 33 |
| X-ray Tube | Same as predicate device. | Same: RAY-12S_3 tube (170KJ (230kHU), 54KW input, 50/60 Hz anode freq). |
| Collimator | Same as predicate device. | Same: Manual collimator with blade position and Cu filter status feedback. |
| Generator | Same as predicate device. | Same: 50KW and 40KW high frequency X-ray generators. |
| Automatic Exposure Control (AEC) | Same as predicate device. | Same: 3 fields AEC chamber with analog interface. |
| Patient Table | Fixed table: Same as predicate. Elevating table: Increases clinical flexibility/versatility with no impact on safety/effectiveness. | Fixed table: Same with integrated rail. Elevating table (option): New, with independent rail mounting tube stand. Verified no impact on safety/effectiveness. |
| Human Machine Interface (HMI) | Tube-side control module (TCM): Same as predicate. Touch User Interface (TUI): Software update to support independent rail has no impact on safety/effectiveness. | TCM: Same functions (SID display, tube angle display, release brakes). TUI: Added Rotation Vertical Axis (RVA) button in software for independent rail support. Verified no impact on safety/effectiveness. |
| UI on Imaging System | Same as predicate device. | Same: Siemens UI concept. |
| Software Version | Updated to support hardware mods with no impact on safety/effectiveness. | VB20 (Predicate: VB10) - Updated to support hardware modifications. Verified no impact on safety/effectiveness. |
| Technical Specifications (Elevating Table vs. Reference) | Motorized elevating table: Function reduced for lower cost/low-end market with no impact on safety/effectiveness. Tracking: No tracking between tube stand and bucky (vs. auto-tracking on reference) with no impact on safety/effectiveness. Max weight capacity: Same. Emergency stop: Same. | Motorized elevating table (manual bucky movement vs. motorized on reference). Adjustable height: 52-96 cm (vs. 51.5-90 cm on reference). No tracking between tube stand and bucky. High weight capacity: 300 kg. With Emergency stop. Verified no impact on safety/effectiveness. |
| Safety and Effectiveness | Device operates safely and effectively, no new safety risks. | Risk management via hazard analysis and controls. Compliance with electrical, mechanical, and radiation safety standards. |
| Software Documentation | Conforms to FDA's Content of Premarket Submissions for Device Software Functions Guidance (basic level). | Software documentation submitted and shown to conform to basic documentation level, demonstrating continued conformance with special controls for medical devices containing software. |
| Non-clinical Testing | Compliance with relevant industry standards. | Complied with ANSI AAMI ES60601-1, IEC 60601-1-2, 60601-1-3, 60601-2-28, 60601-2-54, 60601-1-6, IEC 62366-1, ISO 14971, IEC 62304, IEC TR 60601-4-2, NEMA PS 3.1-3.20 (DICOM), ISO EN ISO 10993-1. |
| Verification & Validation | Testing demonstrates intended performance and supports substantial equivalence claim. | Non-clinical tests (integration and functional) successful. Risk analysis complete, controls implemented. Test results support all software specifications met acceptance criteria. Verification and validation found acceptable. |
2. Sample sized 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 (510(k)) for a conventional X-ray system, not an AI/ML-driven device. The "test set" here refers to non-clinical verification and validation testing of the device hardware and software against engineering specifications and regulatory standards.
- Sample Size: Not applicable in the context of patient imaging data for an AI algorithm. The testing involves system-level and component-level verification, functional tests, and safety tests performed on representative units of the device. The document does not specify a "sample size" of devices tested, but rather indicates that such testing was "successfully completed."
- Data Provenance: Not applicable in the context of patient data. The "data" comes from engineering tests and measurements on the device itself, not from clinical images.
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. Ground truth as typically defined for medical image analysis (e.g., diagnosis of disease) is not established for this type of device submission. The "ground truth" for the performance of an X-ray system revolves around its physical characteristics, image quality parameters, and safety compliance, which are measured and evaluated by engineers and quality assurance personnel against established technical specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth for image interpretation. This submission is based on engineering and manufacturing verification and validation, not clinical image interpretation.
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 device, and no MRMC study was performed 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 not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by engineering specifications, compliance with recognized industry standards (e.g., IEC, ISO, NEMA for X-ray systems), and adherence to manufacturing quality controls. This is demonstrated through physical measurements, electrical tests, safety circuit validation, software functionality tests, and image quality measurements, rather than clinical outcomes or diagnostic interpretations.
8. The sample size for the training set
Not applicable. This document does not describe an AI/ML device with a training set.
9. How the ground truth for the training set was established
Not applicable. This document does not describe an AI/ML device with a training set.
§ 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.