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510(k) Data Aggregation
(56 days)
Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)
Intended for use by a qualified/trained doctor or technician on adult subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
The Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) is comprised of a High Voltage Generator with a maximum power output of 63kW, the Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60C, MobileApex 60H) can meet different exposure needs for varying positions and body mass. With the Digital Radiography System's (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) state-of-the-art design and powerful 63kW generator coupled with the Digital Detector (CareView 1500Cwe, CareView 750Cw, Mars1717X, Mars1417X, Luna 1012X) and Digital Radiography Operator Console, users can obtain clear images quickly and easily.
Based on the provided text, the device in question is a Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H). The acceptance criteria and the study proving the device meets these criteria are focused on demonstrating substantial equivalence to a predicate device, the MX40 Mobile Digital X-ray System (K181874), rather than proving a specific, quantitative performance metric for a clinical application (like detection of a disease).
The documentation primarily discusses non-clinical performance tests related to electrical safety, electromagnetic compatibility, radiation protection, software validation, and usability. There is no mention of a clinical study to assess diagnostic performance (e.g., accuracy in detecting specific conditions).
Therefore, the following information is extracted and where information is not provided in the text, it is explicitly stated as "Not provided in the text."
Acceptance Criteria and Device Performance for Digital Radiography System
The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness, primarily through compliance with recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on substantial equivalence) | Reported Device Performance (based on non-clinical testing) |
|---|---|
| 1. Similar Intended Use: Intended for diagnostic radiographic exposures of various body parts on adult subjects (skull, spinal column, chest, abdomen, extremities). Not for mammography. | Device confirmed to have the "similar intended use" as the predicate. |
| 2. Similar Technological Characteristics: (e.g., Mobile X-ray System, Manual Operation, Radiology Panel, Class II, 21 CFR 892.1720 Regulation, IZL/MQB Product Code, operates on battery/line, 100-240V, uses specific X-ray tubes, specific imaging panels (already cleared), Windows OS, DICOM, Wi-Fi). | The comparison table (Section 8) explicitly states that the "Proposed Device has the similar intended use, similar technological characteristics as the predicate device." Key specifications are provided and compared to the predicate, with minor differences acknowledged (e.g., generator power level is 63 kW for proposed vs. 50 kW for predicate, but this is not identified as raising new safety/effectiveness issues). |
| 3. Safety and Effectiveness: Compliance with relevant international and FDA standards for medical electrical equipment, radiation protection, software life cycle, usability, and diagnostic X-ray systems. | The device has been tested and found compliant with:IEC 60601-1 (General requirements for basic safety and essential performance)IEC 60601-1-2 (Electromagnetic disturbances)IEC 60601-1-3 (Radiation protection in diagnostic X-ray equipment)IEC 60601-2-54 (Particular requirements for X-ray equipment for radiography and radioscopy)IEC 62304 (Medical device software - Software life cycle processes)IEC 62366-1 (Usability engineering)21 CFR 1020.30 (Diagnostic X-Ray systems)21 CFR 1020.31 (Radiographic equipment)All non-clinical testing results indicate the device is "as safe and effective as the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable/Not provided. The summary describes non-clinical engineering and performance testing against standards, not a clinical test set with patient data for diagnostic performance.
- Data provenance: Not applicable/Not provided. The testing described is type testing and verification against standards, not clinical data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. Ground truth in a diagnostic sense (e.g., for disease detection) was not established as part of this submission's described testing, which is focused on technical performance and safety.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No clinical test set requiring adjudication of ground truth is described.
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. An MRMC study was not done. This device is a mobile X-ray system, not an AI-powered diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device (X-ray system), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for diagnostic performance. For the described non-clinical performance tests (e.g., electrical safety, radiation output), the "ground truth" is defined by the requirements and specifications of the relevant international and FDA performance standards (e.g., IEC 60601 series, 21 CFR 1020.30/31).
8. The sample size for the training set
- Not applicable/Not provided. This document describes a traditional medical device (X-ray system) and its non-clinical testing, not an AI/ML product that would require a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. (See point 8).
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