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The Stryker Navigation System, when used with the SpineMap® 3D software application, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery.

The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a rigid anatomical structure such as the pelvis or spine can be identified.

The system assists in the positioning of instruments for procedures on the pelvis and spine, including:

Screw Placement in the spine, ilium, or pelvis

The OrthoLock Anchoring System is intended to be used as an accessory to the Stryker Orthopedic, Trauma, and Spine Navigation Systems. It is a manual instrument intended to be used in surgery to anchor a patient tracker.

The OrthoLock Anchoring System may be used as part of the Stryker Orthopedic, Trauma, and Spine Navigation Systems, which are indicated for any medical condition in which the use computer assisted surgery may be appropriate. The System can be used for intraoperative guidance where a regid anatomical structure can be identified.

The nGenius Spine Clamp is intended to be used as an accessory to the Stryker Spine Navigation System. The nGenius Spine Clamp is a manual instrument and intended to be used in spine surgery to attach a patient tracker to lumbar or thoracic spinous processes.

The nGenius Spine Clamp may be used as part of the Stryker Spine Navigation, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

The Navigated Drill Guide Set is intended to be used as an accessory to the Stryker Spine Navigation System. The Navigated Drill Guide Set consists of manual instruments that are intended to be used in spine surgery by providing guidance during drilling.

The Navigated Drill Guide Set may be used as part of the Stryker System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

The Navigated Xia 3 Awl Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.

The Navigated Xia 3 Awl Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

The Navigated Xia 3 Awl Taps are intended for use with the Rotation Adaptor and associated trackers to facilitate the placement of screws of the Stryker Spine Xia 3, Xia 4.5, MANTIS Redux, and ES2 Spinal Fixation Systems using the Stryker Spine Navigation System.

The Navigated Xia 3 Serrato Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.

The Navigated Xia 3 Serrato Taps may be used as part of the Stryker System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

The Navigated Xia 3 Serrato Taps are intended for exclusive use with the Rotational Navigation Adapter and associated trackers to facilitate the placement of the Stryker Spine Xia 3 System - Serrato using the Stryker Spine Navigation System.

Device Description

The Stryker Navigation System with the SpineMap® 3D 3.1 software application is intended for use as an image guided surgery system to enable open or percutaneous computer assisted spinal surgery. It assists the surgeon in positioning of instrumentation during spinal surgeries. The system provides intraoperative guidance to the surgeon using wireless optical tracking technology and displaying the position of navigated surgical instruments relative to medical images such as CT images.

The Stryker Navigation System with SpineMap 3D 3.1 software is comprised of a platform, SpineMap 3D software, navigated instruments (e.g. patient/instrument trackers, pointers), and accessories. The system uses wireless optical tracking technology to display the intraoperative location of navigated surgical instruments relative to medical images, such as a CT image. The platform consists of a computer, camera, monitor and IO (input/output) Tablet. The SpineMap 3D 3.1 software is dedicated for spinal procedures as defined in the Indications for Use. Required navigated instruments include instruments such as a patient tracker, an instrument tracker, and pointers. An instrument battery also required when a battery powered navigated instrument or calibration device is used.

The SpineMap 3D 3.1 software application is a required part of the Stryker Navigation System. It is installed by a Stryker representative on the platform. The SpineMap 3D 3.1 software application is used on a platform and interfaces with Stryker navigated instruments and accessories. It is compatible with the Nav3i Platform family, which includes the NAV3i, NAV3, and NavSuite3.

SpineMap 3D 3.1 is an interactive software application that provides the functions necessary to conduct the indicated spinal procedures. The software application implements methods for planning, patient registration, and instrument navigation. It also guides the user through the preoperative and intraoperative workflow process.

The SpineMap 3D 3.1 Software Application provides new features including improved patient registration with non-Hounsfield calibrated imaging devices, updated screw database that includes new Stryker Spine spinal implant screws, an updated Coordinate Engine to improve the visibility of the nGenius Universal Tracker when used on the Rotational Navigation Adapter, implements an Automatic Intraoperative Mask (AIM) Registration fallback workflow to allow the surgeon to identify LEDs when the automatic LED detection for AIM registration fails due to poor image quality or when using non-Hounsfield calibrated systems, implements a new indirect vector calibration workflow to calibrate the new Navigated Drill Guides, and implements new cybersecurity measures.

The nGenius Spine Clamps are manual surgical instruments that are intended to be used in spine surgery to attach a patient tracker to the lumbar or thoracic spinous processes to enable surgical navigation. They are intended to be accessories to the Stryker Spine Navigation System. The nGenius Spine Clamps are available in two different sizes (i.e., short and long). They can be used in open or percutaneous procedures. The nGenius Spine Clamps are compatible with the nGenius Universal Tracker and the Spine Tracker.

The OrthoLock is a manual surgical instrument intended to be used to anchor a patient tracker. It is an anchoring system that is used to anchor a patient tracker during computer assisted orthopedic, trauma, and spinal surgeries. It can be used with the Stryker Orthopedic, Trauma, and Spine Navigation Systems.

The OrthoLock anchoring system is intended to be used with the Stryker Navigation Pins and OrthoLock Ex-Pins. It can be tightened or loosened with the screwdriver or Universal Joint Screwdriver.

The OrthoLock Indications for Use are being updated as part of this Traditional 510(k) to allow them to be used during spinal surgical procedures.

The Navigated Drill Guide Set consists of short and long Navigated Drill Guides, short and long Navigated Drill Guide Calibrators, short and long Navigated Drill Bits, a Navigated Drill Bit Stop, and a Navigated Drill Guide Set Container (class 1 exempt). The instruments of the Navigated Drill Guide Set are intended to be used with the Stryker Navigation System with the SpineMap 3D 3.1 software application.

The Navigated Drill Guides are manual instruments that are intended to provide guidance during drilling. They can be used in open or percutaneous procedures. The Navigated Drill Guides can be used as accessories to the Stryker Spine Navigation System. The Navigated Drill Guides can be navigated using the nGenius Universal Tracker as an instrument tracker.

The Navigated Drill Guides are available in two sizes (i.e., short and long). The Navigated Short Drill Guide is intended for use with the Navigated Short Drill Bits and in spine surgical procedures on the cervical, thoracic, and lumbar spine. The Long Navigated Drill Guide is intended for use with the Long Navigated Drill Bits and in spine surgical procedures on the cervical, thoracic and lumbar spine.

The Navigated Drill Guides can be calibrated using the Navigated Drill Guide Calibrators. Calibration of the Navigated Drill Guides has been incorporated into the SpineMap 3D 3.1 software application workflow. The Navigated Drill Guides can also be calibrated using the Vector Calibration Device (VCD) or the Point Calibration Device (PCD).

The Navigated Drill Guide Calibrators are manual instruments that are intended to be used to calibrate the Navigated Drill Guides when used with the SpineMap 3D 3.1 software in combination with the Point Calibration Device or Vector Calibration Device. The Navigated Drill Guide Calibrators come in short and long lengths and are intended to be used with the corresponding Navigated Drill Guide. They are not intended to be used for calibrating the Navigated Drill Guides when they are not being used with Navigation.

The Navigated Drill Guide Calibrator cannot be navigated.

The Navigated Drill Bits are manual instruments that are intended to drill holes of a specified diameter. They drill non-threaded holes. They are designed for use with the Navigated Drill Bit Stop. While the design is based on the Xia CT Drill Bits, they are not designed to be used exclusively with any Stryker Spine Implant System.

The short and long Navigated Drill bits come in a variety of sizes. They must be used with a handle and are designed to be used with Stryker Spine's Short Quick Release Handle (class 1, exempt) and Quick Release Handles (class 1, exempt) which have previously been released to market as Class 1, exempt devices.

The Navigated Drill Bits are single-use only. They will be provided non-sterile, but will need to be sterilized prior to use.

The Navigated Drill Bits cannot be navigated and can be used during non-navigated spine surgical procedures.

The Navigated Drill Bit Stop is a manual instrument that is intended for use with the short and long Navigated Drill Bits. The Navigated Drill Bit Stop allows the drilling depth of the Navigated Drill Bits to be controlled by pre-setting the drill depth. The Navigated Drill Bit Stop cannot be navigated.

The Navigated Xia 3 Awl Taps are manual surgical instruments intended to facilitate placement of Stryker Spine implants. They are a combination of an awl and a tap. The Awl Taps have an awl tip that includes a range of tap diameter sizes with thread designs that are only compatible with bone screws from Stryker Spine's Xia 3, Xia 4.5 (not including Xia Bone CT), ES2, MANTIS, and MANTIS Redux implant systems.

The Navigated Xia 3 Awl Taps are intended as accessories to the Stryker Spine Navigation System. The Awl Taps are designed for use with the Rotational Navigation Adaptor when used for navigated spinal procedures. The Navigated Xia 3 Awl Taps can be used with the Navigated Xia 3 Round Ratchet Handle, Navigated Xia 3 Ratchet T-Handle, and the Navigated Mantis Short Ratchet T-Handle, which have previously received market clearance via letter to file for both navigated and non-navigated spine surgical procedures.

The Serrato Navigated Taps are manual surgical instruments intended to facilitate placement of Stryker Spine's Xia 3 - Serrato screw implants. They have a dual-lead thread geometry and come in a variety of diameter sizes. The thread profile is designed to match that of the Serrato screw implants which is critical in achieving a rigid bone fixation. The Xia 3 Serrato Navigated Taps have a color-anodized titanium ring that corresponds to a specific diameter size for each tap.

The Navigated Xia 3 Serrato Taps are intended as accessories to the Stryker Spine Navigation System. They are designed for use with the Rotational Navigation Adaptor when being used for navigated spinal procedures. The Navigated Xia 3 Serrato Taps are designed to be used with a Modular Handle (Class 1, exempt) if used for non-navigated surgical procedures.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Stryker Navigation System with SpineMap 3D software application and its accessories, based on the provided FDA 510(k) document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Target Performance)	Reported Device Performance
Mean accuracy of 2 mm for positional displacement and 2° for trajectory angle displacement within the working space.	Mean Positional Displacement: 1.07 mm
Mean Trajectory Angle Displacement: 0.61 degrees
95th percentile of the point displacement ≤ 3 mm and ≤ 3° for angular axis displacement within the registration zone.	The document provides 99th percentile, which is stricter:
99th Percentile Positional Displacement: 2.70 mm
99th Percentile Trajectory Angle Displacement: 1.07 degrees
Effectiveness of all risk controls determined in the device risk analysis.	Verified and all requirements met. No new issues of safety or effectiveness were raised.
Compliance with design specifications for all components.	Verified and all requirements met. No new issues of safety or effectiveness were raised.
Software verification and validation (IEC 62304 and FDA guidance on general principles of software validation).	All requirements met. No new issues of safety or effectiveness were raised.
Biocompatibility of all patient contact materials (ISO 10993-1:2009 and FDA draft guidance on the use of ISO 10993-1).	Verified. No new issues of safety or effectiveness were raised.
Electrical Safety (ANSI/AAMI ES60601-1:2005/ (R)2012, AND C1:2009 AND A2:2010(R)2012).	Conformance verified.
Electromagnetic Compatibility (IEC 60601-1-2: 2007 +AC: 2010, CISPR 11 Group 1, Class B, and compatibility with RFID).	Conformance verified and additional testing for RFID compatibility confirmed.
Functionality of devices after simulated shipping conditions.	Verified. No new issues of safety or effectiveness were raised.
Sterility assurance level (SAL) of 10-6 or greater after processing for reusable devices (steam sterilization).	All requirements met. No new issues of safety or effectiveness were raised.
User needs and intended use requirements (validated with intended users in cadaver labs or simulated use tests).	All requirements met and no new issues of safety or effectiveness were raised.

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set in numerical terms (e.g., number of cadavers, number of subjects). However, it mentions that the "subject devices were validated with intended users in cadaver labs or simulated use tests." This indicates that the testing was conducted in a laboratory or simulated environment, likely using anatomical models or cadavers.

The data provenance is retrospective/simulated/laboratory-based, as "No clinical testing was performed" (page 20). The country of origin of the data is not specified, but the applicant, Stryker Leibinger GmbH & Co. KG, is located in Freiburg, Germany.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. It mentions validation "with intended users," implying surgeons or similar medical professionals, but lacks detail.

4. Adjudication Method

The document does not specify any adjudication method for the test set results (e.g., 2+1, 3+1, none).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document states that "No clinical testing was performed" (page 20), which would typically be a prerequisite for such a study involving human readers. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.

6. Standalone (Algorithm Only) Performance

The main accuracy claims (positional and angular displacement) are presented as standalone performance metrics for the navigation system itself, specifically "tracking in the workspace" and "within the registration zone," without direct human intervention as part of the measured accuracy. The system's performance is inherently about the algorithm's ability to accurately track instruments.

7. Type of Ground Truth Used

The ground truth for the accuracy measurements was established using physical measurements related to positional and angular displacement within a controlled environment (working space/registration zone). This would typically involve highly precise measurement devices to establish the true position/angle against which the system's output is compared. For user needs and intended use, the ground truth would be the satisfaction of requirements/successful completion of tasks in simulated environments or cadaver labs.

8. Sample Size for the Training Set

The document does not provide a sample size for a training set. This is a navigation system and associated instruments, not a machine learning model that typically undergoes a distinct training phase with a labeled dataset for image recognition or similar tasks. The "software verification and validation testing" (page 19) would involve testing against predefined specifications and requirements, rather than training data in the AI sense.

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

As there isn't a traditional "training set" in the context of an AI/ML model for this device, the concept of establishing ground truth for a training set does not apply directly. The software development process would involve various stages of testing and validation against defined functional and performance requirements, but not typically a labeled training dataset like in machine learning.

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