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The Curiteva Navigation System is intended to be used during the preparation and placement of Curiteva screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Curiteva Navigation System is specifically designed for use with the Medtronic StealthStation® System, 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 vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Curiteva Navigation System instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System S7 v2.1.0 and S8 v1.2.0 (1.2.0-20) to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of Curiteva screws.

The Curiteva Navigation System includes awls, probes, taps, drills, and drivers. The Curiteva Navigation System instruments are to be used with the Curiteva Pedicle Screw System or the Curiteva Sacroiliac Joint Fusion System, as specified.

All instruments are made of stainless steel per ASTM F899. The Curiteva Navigation System instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic StealthStation Navigation System hardware and software.

This FDA 510(k) summary (K223200) describes a device that is an accessory to a navigation system, not a standalone AI/software device. Therefore, many of the typical acceptance criteria and study details for AI/ML-driven medical devices (like MRMC studies, training set details, or ground truth establishment by experts for algorithmic performance) are not applicable to this submission.

The Curiteva Navigation System consists of physical surgical instruments (awls, probes, taps, drills, and drivers) intended for use with an existing, cleared navigation system (Medtronic StealthStation). The performance evaluation focuses on the physical accuracy and compatibility of these instruments, not on an AI algorithm's diagnostic or predictive capabilities.

Based on the provided document, here's an analysis of the acceptance criteria and performance study:

Understanding the Device and its Evaluation

Device Category: Orthopedic Stereotaxic Instrument (accessory to a Computer Assisted Surgical System).
Purpose: To assist surgeons in precisely locating anatomical structures during spinal surgery when used with a Medtronic StealthStation Navigation System.
Nature of Device: Reusable surgical instruments (physical, non-AI).

Acceptance Criteria and Performance Study Summary

Given the nature of the device as surgical instruments, the "acceptance criteria" here refer to testing that demonstrates the instruments' physical accuracy and suitability for their intended use when integrated with the specified predicate navigation system.

1. Table of Acceptance Criteria and Reported Device Performance

The results of this non-clinical testing show that the performance of the Curiteva Navigation System is sufficient for its intended use. This implies that the positional accuracy, as measured by the standard, met predefined acceptance thresholds (though specific numerical thresholds and results are not provided in this summary). |
| Dimensional Comparison to Predicate Devices | Dimensional comparisons were made between the subject and predicate devices.

While specific results are not detailed, this testing would ensure that the new instruments are dimensionally compatible and comparable to existing cleared instruments used with similar navigation systems, without introducing new safety or performance concerns. The conclusion of substantial equivalence implies these comparisons were favorable. |
| Material Compatibility/Safety | All instruments are made of stainless steel per ASTM F899. This ensures the material meets established standards for medical devices, contributing to patient safety (e.g., biocompatibility, corrosion resistance, durability for sterilization). |
| Compatibility with Medtronic StealthStation | The instruments are designed for use only with Medtronic StealthStation® Navigation System S7 v2.1.0 and S8 v1.2.0 (1.2.0-20) hardware and software. The testing would validate this compatibility. The summary implicitly concludes successful compatibility as it deems the device suitable for its intended use with this system. |
| Compatibility with Curiteva Implant Systems | The instruments are to be used with the Curiteva Pedicle Screw System or the Curiteva Sacroiliac Joint Fusion System. This implies testing or design validation to ensure proper fit and function with these specific implant systems during surgical procedures. |
| Substantial Equivalence to Predicate Device | Conclusion: "The overall technology characteristics and mechanical performance data lead to the conclusion that the Curiteva Navigation System is substantially equivalent to the predicate device [Medtronic Navigated Instruments (K161210)]." This is the overarching acceptance criterion for 510(k) clearance, relying on all the above performance demonstrations. |

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

• Sample Size: The document does not specify a specific "sample size" in terms of patient data. For the positional accuracy testing (ASTM F2554-18), the sample would be the physical instruments themselves or specific test fixtures designed to simulate use. The standard typically involves repetitive measurements to establish accuracy and precision. No human patient test set is described, as this is laboratory testing of the instruments.
• Data Provenance: The testing is non-clinical (i.e., laboratory-based, bench testing). No patient data (e.g., from specific countries, retrospective/prospective studies) is mentioned, as it is not relevant for this type of device and performance evaluation.

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

• Not Applicable. For this type of mechanical/physical device accessory, "ground truth" is established by a standardized measurement method (e.g., a calibrated measurement system validating positional accuracy against a known reference). Experts (e.g., radiologists) are not involved in establishing this specific type of "ground truth." The ground truth for positional accuracy is derived from metrology principles and measurement standards.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies involving interpretation of medical images or patient outcomes, especially with AI algorithms. This device's testing is purely technical/mechanical.

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

• No. An MRMC study is relevant for AI or diagnostic devices where human readers' performance (with or without AI assistance) is being evaluated. This is a set of physical surgical instruments, not an AI algorithm.

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

• No. This device is a set of physical instruments, not a software algorithm, so "standalone" algorithm performance is not applicable. Its performance is always "human-in-the-loop" in the ultimate clinical use (surgeon using the instrument). The ASTM F2554-18 test can be considered a "standalone" test of the physical instruments' accuracy when used with the specified navigation system, but it's measuring physical precision, not an algorithm's output.

7. The Type of Ground Truth Used

• The "ground truth" for the performance evaluation of these physical instruments is based on quantifiable, objective measurements derived from engineering and metrology standards. Specifically, for positional accuracy, it's defined by the reference measurements and tolerances within the ASTM F2554-18 standard. It is not based on expert consensus, pathology, or clinical outcomes data in this context.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no training set for an algorithm.

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

• Not Applicable. There is no training set mentioned or implied for this device.

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