(25 days)
The Definium AMX 700 X-Ray Unit is indicated for use in generating radiographic images of human anatomy. It is intended for general-purpose diagnostic procedures. It is capable of generating radiographic images on film or digitally. This device is not intended for mammographic applications.
The GE Definium AMX 700 is a mobile x-ray system that enables the capture of radiographic images via a tethered digital detector or traditional film cassettes.
The GE Definium AMX 700 is a mobile X-ray system. The information provided outlines its substantial equivalence to a predicate device rather than a study involving specific acceptance criteria for a new clinical performance claim. Therefore, much of the requested information regarding clinical studies, ground truth establishment, expert adjudication, and sample sizes is not applicable in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety | Conforms with applicable medical device safety standards. |
| Radiation Safety | Conforms with applicable medical device safety standards. |
| Substantial Equivalence to GE AMX-4+ Mobile X-ray System | Utilizes similar technology and materials, comparable in key safety and effectiveness features, same basic design and construction, similar weight and power requirements, same intended uses. |
| Quality System Compliance | Design and development processes conform with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. |
| Intended Use | Indicated for use in generating radiographic images of human anatomy for general-purpose diagnostic procedures (not mammographic applications). Capable of generating radiographic images on film or digitally. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. No clinical test set involving patient data was required for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No clinical test set requiring expert-established ground truth was part of this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set requiring adjudication was part of this 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:
- Not Applicable. This submission is for a conventional mobile X-ray system, not an AI-powered device. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No clinical ground truth was established for this submission as it relied on substantial equivalence. The "ground truth" for the device's acceptability was its conformance to safety standards and its functional equivalence to a legally marketed predicate device.
8. The sample size for the training set:
- Not Applicable. This is a hardware device, not a machine learning model, so there is no training set in the context of AI. If "training set" refers to engineering testing or design validation, the document does not specify sample sizes for those internal processes.
9. How the ground truth for the training set was established:
- Not Applicable. As above, there is no "training set" in the context of AI. For engineering and design validation, conformance to specifications and industry standards would be the "ground truth." The document states "The design and development processes of the manufacturer conform with 21 CFR 820, ISO 9001 and ISO 13485 quality systems," which implies internal validation against established criteria.
Summary of the Study (as described in the document):
The "studies" summarized are focused on electrical and radiation safety, confirming the device's conformance with applicable medical device safety standards. No clinical tests were required because the product is considered a combination of two already cleared devices for the US market (via 21 CFR Part 807). The substance of the submission revolves around demonstrating substantial equivalence to the predicate GE AMX-4+ Mobile X-ray System, meaning the new device has the same intended uses and fundamental scientific technology, and comparable safety and effectiveness features.
§ 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.