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The Kalitec Navigated Instrument System is indicated for use during the preparation and placement of screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Kalitec Navigated Instruments System reusable instruments are specifically designed for use with the Medtronic Navigation StealthStation System which are 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 a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. Use of the Kalitec Navigated Instruments is limited to use only with Kalitec pedicle screw systems.

The Kalitec Navigated Instrument System is comprised of nonsterile, reusable instruments, including probes, taps, and drivers that can be operated manually. These instruments are designed to function with the Medtronic StealthStation® S8(v2.0.1-7) System, in combination with the Medtronic NavLock™ tracker and Medtronic SureTrak®Il clamps and arrays to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of Kalitec polyaxial screws.

Here's a breakdown of the acceptance criteria and study information for the Kalitec Navigated Instrument System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "side-by-side testing," but does not specify the sample size for the test set (i.e., how many instruments were tested or how many measurements were taken).

The data provenance is not explicitly stated beyond being part of a non-clinical test conducted by Kalitec Direct, LLC. It is a retrospective study as it's a submission for a 510(k) premarket notification.

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

Not applicable. This study appears to be a technical performance validation against a standard (ASTM F2554) and a predicate device, rather than an evaluation requiring expert clinical interpretation to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. As this was a technical performance validation, there would not typically be an adjudication method in the sense of resolving discrepancies between expert opinions. The performance was measured against the ASTM standard and the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study described is a non-clinical performance validation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence. The study focuses on the "dimensional accuracy" of the "Kalitec Navigated Instrument System" in conjunction with the Medtronic StealthStation® System. This is a technical performance assessment of the device itself, rather than an evaluation of human performance with or without the device. While a human surgeon would ultimately use the instruments, the test described is about the instrument's accuracy, not a surgeon's performance using it.

7. The Type of Ground Truth Used

The "ground truth" for the test set was:

• Dimensional accuracy as defined by ASTM F2554. This is a recognized standard for evaluating dimensional accuracy.
• Performance of the legally marketed predicate device (Medtronic® StealthStation® system and predicate device). The Kalitec system's performance was compared to this established benchmark.

8. The Sample Size for the Training Set

Not applicable. This device is a navigated instrument system, not an AI/ML algorithm that requires a training set in the typical sense. The device's functionality is based on its mechanical design and interaction with the navigation system, not on learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

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