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The DYNAMIS™ SI Screw System is indicated for sacroiliac joint fusion for:

· Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroillitis.

· Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients

undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The DYNAMIS™ SI Screw System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

The DYNAMIS™ SI Screw System consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. Implants are constructed from medical grade titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The implants are fully threaded with a lag design. To accommodate varying patient anatomy, the DYNAMIS™ SI Screw Implants are available in multiple diameters and length offerings. The DYNAMIS™ SI Screw Implants consist of a cannulated central threaded body. The implants allow for packing of autograft and allograft materials. Using the designated instrument system, two or more implants should be inserted across the SI Joint to apply a compressive force across the joint and to provide stabilization and fusion. The DYNAMIS™ SI Screw implants are single use devices that are provided sterile.

This FDA 510(k) summary for the DYNAMIS™ SI Screw System does not describe an AI/ML device or a study involving human readers. Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, adjudication methods, and MRMC studies is not applicable.

The document primarily focuses on establishing substantial equivalence for a physical medical device (a sacrioiliac joint screw system) through mechanical performance testing against established ASTM standards and comparison to predicate devices.

However, I can extract the following relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states the device "demonstrate[s] that the DYNAMIS™ SI Screw System is substantially equivalent to the predicate devices" for all tests, implying its performance met or exceeded the performance of the predicate devices based on these mechanical tests. Specific numerical acceptance criteria and performance values are not provided in this summary.

The following numbered points are not applicable or cannot be extracted from the provided text as the document pertains to a physical medical device clearance, not an AI/ML software device performance study:

2. Sample sizes used for the test set and the data provenance: Not applicable. This is not a study assessing AI/ML model performance on a dataset of patient data. The "test set" refers to the physical screws undergoing mechanical testing. While not specified, these would be a sample of the manufactured screws.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML validation (e.g., expert labels on medical images) is not relevant here. The ground truth for mechanical testing is established by the specified ASTM standards and the physical properties of the materials and design.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human adjudication is involved in assessing mechanical test results against established ASTM standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is not about an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of typical AI/ML ground truth. For this device, the "ground truth" for performance is defined by the objective mechanical testing standards (ASTM F3574, ASTM F543) and comparison to the predicate devices.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device that requires a training set or associated ground truth.

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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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