(39 days)
The Mobilett XP and Mobilett XPhybrid are radiographic systems designed for use in wards, intensive care and premature-birth wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.
The Mobilett XP and Mobilett XP hybrid x-ray systems are microprocessor controlled mobile x-ray systems developed for routine bedside radiographic procedures in intensive care, emergency, central X-ray, and pediatric departments, as well as operating rooms.
This 510(k) submission (K033238) for the Mobilett XP and Mobilett XPHybrid describes a mobile x-ray system. The information provided does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.
Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in terms of performance metrics (e.g., accuracy, sensitivity, specificity). | The device is described as "microprocessor controlled mobile x-ray systems developed for routine bedside radiographic procedures." |
| Substantial equivalence to predicate device Siemens Mobilett Plus/Mobilett Plus HP (K932106). | The submission aims to demonstrate substantial equivalence to the predicate device. The FDA's letter confirms a finding of substantial equivalence. |
| Compliance with general controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling, prohibitions against misbranding and adulteration). | The FDA's letter states that the applicant "must comply with all the Act's requirements." |
| Intended Use: For use in wards, intensive care and premature-birth wards, pediatric and emergency departments, operating theatres, and central X-ray departments. | The reported intended use aligns with this criterion. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The submission does not describe a clinical performance study with a test set. The basis for clearance is substantial equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method 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. This submission is for an x-ray system, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This submission describes an x-ray system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. There is no mention of ground truth in the context of a performance study. "Substantial equivalence" to a legally marketed predicate device is the basis for clearance, implying that the predicate's established performance and safety serve as the benchmark.
8. The sample size for the training set:
- Not Applicable. As this is an x-ray system and not an AI/machine learning device, there is no concept of a "training set" in the context of this submission. Device design and validation would likely rely on engineering tests, compliance with standards, and comparison to the predicate.
9. How the ground truth for the training set was established:
- Not Applicable. (See point 8)
§ 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.