(90 days)
The Radiography 7000 M is intended for diagnostic procedures on both adult and pediatric patients who are unable to be transferred to the stationary X-ray system. It enables radiographic imaging of various body parts, including the skull, chest, spine, shoulders, pelvis, extremities, abdomen, and other body regions. The system allows for applications in different positions, such as sitting, standing, and lying in either a prone or supine position. However, it should be noted that the system is not suitable for mammography applications.
The Radiography 7000 M digital mobile will be a new motorized mobile x-ray system that will employ integrated wireless flat panel detectors of two different sizes (large and small) to obtain digital images in mobile environments; the system will also be able to utilize CR or traditional film cassettes in a back-up scenario. The system will primarily use wireless technology for image acquisition and the transmission of images to archive systems like PACS, as well as for the retrieval of patient and exam information from the radiology information system (RIS) or hospital information system (HIS). The system is available in the following configurations: with 20 kW X-ray generator, with 40 kW X-ray generator. The Radiography 7000 M system is an integrated system consisting of the following subsystems: Base Unit (Sedecal Mobile X-ray system SM-IV, cleared under K232185 August 21, 2023), SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories, Eleva WorkSpot 43.0.
The provided text describes the acceptance criteria and the study conducted for the Philips Radiography 7000 M, a mobile X-ray system. The document is a 510(k) summary of safety and effectiveness, and primarily demonstrates substantial equivalence to a predicate device.
Here's an analysis based on the provided information, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a detailed table of specific quantitative acceptance criteria alongside corresponding quantitative device performance metrics for features like image quality (e.g., resolution, SNR) beyond stating compliance with general standards. Instead, it provides a summary that all tests passed, indicating that the device met its acceptance criteria. This is common in 510(k) summaries where detailed test reports are typically provided separately to the FDA.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| System Verification Testing | Conformance to system requirements | Pass |
| Software Verification Testing | Conformance to software requirements | Pass |
| Risk Control | Meeting defined risk control measures | Pass |
| Cybersecurity | Compliance with cybersecurity requirements (e.g., asset ID, risk assessment, mitigation) | Pass |
| Image Quality | Compliance with 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices' and image quality test results showing no adverse impact from changes. | Image quality testing performed and compliant. No adverse impact from changes. MTF and DQE values are similar to the predicate device. |
| Electrical Safety & Performance | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-2-28, IEC 62220-1-3 | All relevant IEC standards passed. |
| Usability | Compliance with IEC 60601-1-6, IEC 62366-1 | All relevant IEC standards passed. |
| Software Life Cycle | Compliance with IEC 62304, Guidance for Content of Premarket Submissions for Device Software Functions | All relevant standards and guidance passed. |
| Wireless Technology | Compliance with Guidance for Radio Frequency Wireless Technology in Medical Devices, FCC Rules and Regulations CFR 47, Part 15, Subpart B | All relevant guidance and rules passed. |
| Pediatric Information | Compliance with Guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications | All relevant guidance passed. |
| Biological Evaluation | Compliance with ISO 10993-1 | All relevant ISO standards passed. |
| Risk Management | Compliance with ISO 14971 | All relevant ISO standards passed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set sample size" in terms of patient data or clinical images. The testing conducted is primarily non-clinical performance testing and bench testing for compliance with various recognized standards (e.g., electrical safety, software validation, cybersecurity). The data provenance is implied to be from laboratory settings during these non-clinical tests. There is no mention of patient data being used for validating the device's performance in this specific 510(k) submission.
"There is no clinical data submitted in this 510(k) Premarket notification."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical data or clinical "test set" was used (as stated in point 2), there is no information about experts establishing ground truth for such a set. The document focuses on showing substantial equivalence through engineering and regulatory compliance, not clinical performance evaluation with human readers.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring ground truth adjudication is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
No MRMC study was done, nor is AI assistance a stated feature of this specific device's submission. The device is a mobile X-ray system, not an AI-powered diagnostic tool. The submission focuses on the safety and effectiveness of the hardware and integrated software for image acquisition, primarily demonstrating equivalence to a predicate device.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a medical device for X-ray imaging, inherently involving a human operator (technologist or physician) to acquire and interpret images. There's no "algorithm only" performance reported in the context of an AI-driven diagnostic algorithm.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" is established by the specified requirements and standards themselves. For example, for electrical safety, the ground truth is adherence to the voltage limits defined in IEC 60601-1. For image quality, it's compliance with established metrics and guidelines from guidance documents. There is no ground truth based on expert consensus, pathology, or outcomes data mentioned, as no clinical study data was submitted.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/ML device requiring a training set, the concept of a training set sample size does not apply here. The device's functionality is based on established physics and engineering principles, not statistical learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model for this device.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.