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The Siremobil Iso-C 3D is intended to be used whenever the surgeon benefits from intraoperatively generated 3D information of high contrast objects (bones and joints). The Siremobil Iso-C 3D focuses on complex bone or joint fractures of the upper and lower extremities (including knee, foot, elbow, hand), and the entire spine.

The Siremobil Iso-C 3D with extended Indications for Use is based on Siemens isocentric mobile C-arm, marketed as Siremobil Iso-C 3D. The extended Indications for Use to include the entire spine for the Siremobil Iso-C 3D contains no new hardware or software

The Siremobil Iso-C 3D 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 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 entire spine.

The Siremobil Iso-C 3D is an isocentric mobile x-ray C-ram which consists of a high frequency generator, X-ray tube assembly, image intensifier, TV camera, film cassette attachment, Laser light localizers, electronics cabinet and a monitor trolley which consists of the digital memory device, image monitor(s), and user interface. The 3D Imaging option allows the reconstruction of two-dimensional images acquired with a mobile isocentric C-arm device into a three-dimensional image format.

The provided text is a 510(k) Summary for the Siemens Siremobil Iso-C 3D Mobile X-Ray System, seeking an extended indication for use to include the entire spine. This document does not contain a detailed study demonstrating device performance against specific acceptance criteria.

Instead, it relies on demonstrating substantial equivalence to previously cleared devices. The key information provided in this document is about the device's intended use and its equivalence to predicates, not a performance study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer many of the detailed questions about a performance study, as such a study is not described here.

Here's what can be extracted based on the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Cannot be provided from this document. The 510(k) submission is for substantial equivalence to predicates, not a de novo performance study against explicit acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Cannot be provided from this document. No test set or data provenance details are mentioned as no performance study is described.

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):

• Cannot be provided from this document. No test set or ground truth establishment details are mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Cannot be provided from this document. No 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:

• Cannot be provided from this document. No MRMC study is described. The device is a 3D imaging system, not an AI-assisted diagnostic tool in the sense of improving human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Cannot be provided from this document. No standalone performance study for an algorithm is described. The device is an imaging system providing 3D information to a surgeon.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Cannot be provided from this document. No ground truth type is mentioned as no performance study is detailed.

8. The sample size for the training set:

• Cannot be provided from this document. The document describes a medical imaging device, not a machine learning algorithm that requires a training set in the conventional sense.

9. How the ground truth for the training set was established:

• Cannot be provided from this document. Not applicable as per point 8.

In summary: The provided 510(k) summary focuses on demonstrating that the Siremobil Iso-C 3D with its extended indications is substantially equivalent to existing, legally marketed devices, rather than presenting a de novo study with explicit acceptance criteria and performance data. The FDA clearance is based on this substantial equivalence argument.

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