(26 days)
The Siremobil Iso-C 3D with the 3D Navigation Interface option is intended to be used whenever the surgeon benefits from intraoperatively generated 3D information of high contrast objects and anatomical structures (e.g. bones and joints). The Siremobil Iso-C 3D with the 3D Navigation Interface option is designed as a 3D imaging device for conditions such as complex bone or joint fractures of the upper and lower extremities (including knee, foot, elbow, hand), and the spine.
The 3D-navigation interface is hardware and software interface between the Siremobil Iso-C 3D and commercially available 3td party navigation systems. The software calculates the navigation matrix required by the external navigation system for the navigation in 3D-image data sets. The matrix is transferred to the navigation system in the DICOM-header of the 3D image data sets.
The provided text does not contain specific acceptance criteria, a detailed study description, or performance metrics for the 3D Navigation Interface for Siremobil Iso-C 3D. The document is a 510(k) summary, which focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with acceptance criteria.
Therefore, I cannot populate the table or answer the questions with the requested information from the provided text.
Here is an explanation for each point:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided 510(k) summary. K973598 mentions that clinical data will be submitted, but it is not included in the supplied text.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): This information is not present in the provided 510(k) summary.
- 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): This information is not present in the provided 510(k) summary.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not present in the provided 510(k) summary.
- 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: This information is not present in the provided 510(k) summary. This device is an interface for navigation systems, not an AI or diagnostic interpretation tool, so an MRMC study in this context would be unlikely.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is not present in the provided 510(k) summary.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): This information is not present in the provided 510(k) summary.
- The sample size for the training set: This information is not present in the provided 510(k) summary.
- How the ground truth for the training set was established: This information is not present in the provided 510(k) summary.
§ 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.