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The GE Healthcare Navigation and Visualization System [InstaTrak® 3500 Plus System or FluoroTrak™ 9800 Plus System] together with the Axcess™ Bone Pin, is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotaxic surgery and which provides a reference to rigid structures such as sinus, skull, long bone or vertebra visible on medical images such as CT, MR or x-ray,

The Axcess™ Bone Pin is to be used where rigid fixation of a tracking device to bone is required.

The GE Healthcare Navigation and Visualization System [InstaTrak® 3500 Plus System or FluoroTrak™ 9800 Plus System] together with the Axcess™ Bone Pin. The Axcess™ Bone Pin is one example of the Axcess™ Bone Pin.

The provided text is a 510(k) premarket notification for a medical device (GE Healthcare InstaTrak® 3500 Plus/FluoroTrak™ 9800 Plus System with Axcess™ Bone Pin). This document focuses on demonstrating substantial equivalence to predicate devices and describes the intended use and classification of the device.

It does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot provide the requested table or answer the specific questions about the study and its results based on the given input. The document is primarily a regulatory submission for market clearance, not a report of a performance study.

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The AMX5 and AMX5D are indicated for use in generating radiographic images of human anatomy in all general purpose X-ray diagnostic procedures. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, pediatrics, orthopedics, and clinics.

The AMX5 is a power driven mobile unit including an X-ray generator, X-ray tube, and beam limiting device, along with control electronics for the drive mechanism, and embedded software. The AMX5D is the same as the AMX5 but is used in conjunction with a portable digital X-ray detector.

The provided 510(k) summary for the AMX5 and AMX5D Mobile X-ray Systems states that "Clinical Tests: None required." These devices are considered substantially equivalent to the predicate device (AMX4 Plus Mobile X-ray system, K021016) based on comparable technological characteristics, safety, and effectiveness. Therefore, the information requested regarding acceptance criteria and studies to prove meeting them, in the typical sense of a new technology demonstrating diagnostic performance, is not applicable in this case.

Instead, the submission focuses on demonstrating equivalence through:

• Safety Standards: The devices were "evaluated for electrical, mechanical, and radiation safety, and conforms with applicable medical device safety standards." Compliance was verified through independent evaluation with factory surveillance.
• Intended Use and Technology Comparison: The AMX5 and AMX5D have the "same intended uses; incorporate the same technology; and use similar design, construction, materials, and features as the legally marketed AMX 4 Plus Mobile X-ray system."

Since no clinical studies were deemed necessary, there is no information available within the provided text for the following:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. Multi reader multi case (MRMC) comparative effectiveness study
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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