(76 days)
The Mobilett Mira is a radiographic system 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 Mira is a mobile X-ray system with a solid state detector. The system is designed to provide X-ray imaging for healthcare professionals. Cable less operation and motor-driven movements are supported with build in rechargeable batteries. The mobile generator is positioned at bedside and the X-ray system is directed to the anatomical area to be imaged. The image detector is placed perpendicular to the central beam behind the anatomical area of interest. The system features a collimator with a light field that mimics the x-ray field to limit the field of exposure to the area to be imaged. Exposure may be released via remote control. The image data acquired by the detector are sent wireless to the mobile unit.
The Mobilett Mira is a modification of the Mobilett XP originally cleared under Premarket Notification K033238 on 11/14/2003. The modification consists of a rotatable suspension arm, a solid state image detector, digital image acquisition system and a 35KW generator. This modified Mobilett XP will be marketed under the trade name Mobilett Mira. The modification does not affect the intended use of the device nor does it alter its fundamental scientific technology.
Here's an analysis of the provided text regarding acceptance criteria and the study proving device performance:
Unfortunately, the provided text for the Siemens Mobilett Mira 510(k) submission does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria.
The document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than presenting a detailed performance study with acceptance criteria.
Therefore, many of your requested items cannot be directly extracted from this document. However, I can infer some general aspects based on the nature of a 510(k) submission for an X-ray system.
Here's a breakdown of what can and cannot be answered based on the provided text:
Acceptance Criteria and Device Performance (Based on available information)
Since a formal performance study with explicit acceptance criteria is not detailed, the "acceptance criteria" for a 510(k) of this nature primarily revolve around demonstrating that the modified device (Mobilett Mira) is as safe and effective as the predicate device (Mobilett XP / XP hybrid) and other similar cleared components (Ysio solid-state detector).
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from 510(k) context) | Reported Device Performance (Inferred from 510(k) claims) |
|---|---|
| Safety: Device operates without undue electrical, mechanical, and radiation hazards. | * "Several safety features including visual and audible warnings are incorporated into the system design." |
| * "Mobilett Mira is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed." | |
| * "Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing." | |
| Effectiveness: Device performs its intended functions for X-ray imaging, providing images of diagnostic quality. | * "Designed to provide X-ray imaging for healthcare professionals." |
| * "The solid state imaging detector replaces the conventional cassette with film/screen combination." (Implies equivalent or improved imaging capability) | |
| Intended Use: Device maintains the same intended use as the predicate device. | * "The Mobilett Mira is intended for the same indications for use as the predicate Mobilett XP / XP hybrid." |
| Technological Characteristics: Modifications (rotatable suspension arm, solid-state detector, digital acquisition, 35KW generator) do not negatively impact safety or effectiveness and are either cleared in predicate devices or minor modifications to existing components. | * "These modifications are 510(k) cleared in the mentioned predicate devices." |
| * "Several of the components used in the Mobilett Mira are either commercially available with current Siemens systems or include minor modifications to existing components." | |
| Substantial Equivalence: Device is equivalent to predicate devices regarding indications for use, fundamental scientific technology, and performance. | * "The modification does not affect the intended use of the device nor does it alter its fundamental scientific technology." |
| * "It is Siemens opinion, that the Mobilett Mira is substantially equivalent to the Mobilett XP." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. A 510(k) for a hardware modification like this typically relies on engineering testing, compliance with standards, and comparison to existing cleared devices rather than a clinical "test set" of patient data in the way an AI algorithm might. The document doesn't mention any specific patient data test set.
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 / Not provided. Since no specific patient data test set is described, there's no mention of experts establishing ground truth for such a set. Engineering and safety testing would involve qualified engineers and technicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. There is no described test set of patient data requiring adjudication.
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, a MRMC study was not done, and is not applicable. This device is a mobile X-ray system, not an AI-powered diagnostic tool. The submission is for a hardware modification, not a software algorithm that assists human readers.
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 in the context of patient data. For hardware modifications, "ground truth" would relate to engineering specifications, performance measurements against established standards (e.g., radiation output, image quality metrics like spatial resolution, contrast-to-noise ratio), and compliance with safety regulations. These would be assessed through bench testing and verification/validation activities, not typically through clinical "ground truth" patient data in a 510(k) for such a device.
8. The sample size for the training set
- Not applicable. This device is hardware; it does not involve a training set for an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. This device is hardware; it does not involve a training set for an AI algorithm.
§ 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.