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The InstaTrak 3000 System 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 stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, cranial, a long bone or vertebra, visible on medical images such as CT, MR, or Xray.

The InstaTrak 3000 System is an image guidance system indicated for use during sinus, skull base, cranial and axial skeletal procedures. The InstaTrak 3000 with FluoroTrak is similar to the InstaTrak 3000 System cleared under K983529. The changes to the system include software enhancements and the addition of a calibration fixture. Using the InstaTrak 3000, the surgeon can readily identify the immediate location and position of the surgical instrument during the indicated procedure. The InstaTrak 3000 assists the surgeon in avoiding critical nerves and other anatomical structures. The InstaTrak 3000 offers multiple modes of operation that includes sinus, skull base, cranial, axial skeletal, to the user based on the indications the user desires. Software is available to the user for using any one, two, or all three of the operational modes. A selection of the operational modes is made by the user prior to the procedure depending needs of the user. The original InstaTrak 3000 System allows the user to view the reconstructed 2D images of the patient's anatomy in response to the mouse or the tracked surgical instrument. Alignment of the patient and images is accomplished through the registration process. In all types of surgery the goal is the same, to indicate to the surgeon based on the pre-operative medical images, where the position of a tracked surgical tool is with regard to the patient's anatomy. The InstaTrak 3000 with FluoroTrak is based on the same hardware and software used in the original InstaTrak System and provides all of the above features. It utilizes the same clinically proven electromagnetic tracking technology as its predecessor.

Here's an analysis of the provided text regarding the acceptance criteria and study for the InstaTrak 3000 System with FluoroTrak Module:

Unfortunately, the provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt. The document is a 510(k) summary for premarket notification, which focuses on establishing substantial equivalence to predicate devices rather than providing a full performance study report with quantitative acceptance criteria and detailed statistical results.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states "within the specification" but does not explicitly list the quantitative acceptance criteria (e.g., specific accuracy thresholds in millimeters) for location, surgical instrument position, or any other performance metric.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Testing was performed using the new component of the InstaTrak 3000 with FluoroTrak to determine if the new component affected device accuracy."

Missing Information:

• Sample Size: The number of tests, cases, or subjects used for this testing is not mentioned.
• Data Provenance: There is no information about whether the data was prospective or retrospective, or the country of origin.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Missing Information: The document does not describe the methodology for establishing ground truth for the performance testing, nor does it mention the involvement or qualifications of any experts for this purpose.

4. Adjudication Method for the Test Set

Missing Information: No adjudication method (e.g., 2+1, 3+1, none) is mentioned as part of the performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or implied in this document. This device is an image-guided surgical system, not an AI diagnostic tool that assists human readers in interpreting images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

The performance testing described focuses on the device (InstaTrak 3000 with FluoroTrak module) and its accuracy when using a new component. It is implied to be a standalone performance evaluation of the system, not specifically an algorithm-only study in the context of AI. The core function of the device is image guidance for a surgeon, so human-in-the-loop

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