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The Excella® Navigation Instruments are intended to be used during the preparation and placement of Excella II®, Excella 3® & Excella MIS® screws during spinal surgery to assist the surgeon in locating anatomical structures in either open or percutaneous spinal procedures. The Excella Navigation Instruments are specifically designed for use with the Medtronic® StealthStation® System S8 and associated tracking arrays, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra can be identified relative to an acquired image (CT, MR, 2D/3D fluoroscopic image reconstruction) and/or an image-based model of the anatomy.

The Innovasis® Excella® Navigation Instruments used for the preparation and insertion of Excella III , Excella 3° & Excella MIS® screws, in either open or percutaneous procedures. These instruments are with the Medtronic® StealthStation® System or as standalone, unnavigated instruments.

The FDA document concerns the Excella Navigation Instruments and its 510(k) premarket notification (K223511), which determined the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does NOT describe a study that proves the device meets specific acceptance criteria based on metrics like sensitivity, specificity, accuracy, or any performance related to an AI/algorithm-driven diagnostic or assistive system.

Instead, the document details engineering and functional testing for a stereotaxic instrument (navigation instruments for spinal surgery). The acceptance criteria and "study" described are focused on the physical and functional performance of the navigation instruments themselves, not on an algorithm's diagnostic or predictive capabilities and their impact on human reader performance.

Therefore, I cannot fulfill the request as it pertains to an AI/algorithm-driven device performance study, because the provided document does not contain that information. The device in question is a physical instrument for navigation during surgery, and the "tests" described are for its mechanical and operational accuracy and compatibility.

Summary of Available Information (related to engineering/functional testing, not AI performance):

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria (High-Level)	Reported Device Performance
   Positional Accuracy	All measurements were within specifications and comparable to the predicate product (ASTM F2554-18)
   Navigated Instrument Accuracy	Confirmed
   Navigation System Functionality	Confirmed under expected use conditions
   CAD Model Accuracy	Verified that CAD models are accurately reflected in the application software
   Implant/Instrument Mating	Verified that instruments can be assembled with appropriate devices according to intended use
   Spine Tools Package Functionality	Verified that the Spine Tools package has met the required interface needs of the spine application software

2. Sample size used for the test set and data provenance:
   This information is not provided in the document. The testing described (e.g., positional accuracy, simulated use) would likely involve a sample of the instruments themselves, but the exact number or data provenance (e.g., specific images or patient data) is not detailed.

3. Number of experts used to establish ground truth and qualifications:
   This information is not provided. The testing appears to be engineering-focused (e.g., comparing measurements to specifications or CAD models), not dependent on human expert interpretation of medical images.

4. Adjudication method for the test set:
   This information is not applicable/provided. The testing appears to be quantitative measurements and functional checks, not requiring adjudication of human interpretations.

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study, effect size:
   No MRMC study was done or reported. The device is a navigation instrument, not an AI model assisting image interpretation, so such a study would not be the primary means of validation for this type of device.

6. Stand-alone (algorithm-only) performance:
   Not applicable. The device is a physical instrument, not a standalone algorithm. While it needs to interface with a navigation system (Medtronic StealthStation S8), the performance described is for the instrument itself.

7. Type of ground truth used:
   The "ground truth" for these tests appears to be engineering specifications, CAD model data, and predefined functional requirements. For positional accuracy, it would be the true physical position as measured by a highly accurate reference system.

8. Sample size for the training set:
   Not applicable. This is a hardware device undergoing functional and performance testing, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:
   Not applicable. See point 8.

In conclusion, the provided FDA document details the regulatory clearance for a medical instrument based on engineering and functional performance tests tied to physical accuracy and compatibility, not an AI-driven device requiring clinical performance metrics like sensitivity, specificity, or human reader studies.

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