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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.

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.

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

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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The Stryker KWIC Needle is a manual surgical instrument intended to be used in spine surgery to facilitate placement of guidewires. The device may also be used to aspirate autologous blood or bone marrow by use of a syringe. The blood or bone marrow may be combined with bone graft or bone void filler.

The Stryker KWIC Needle may be used as part of a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The KWIC Needle is indicated for use in spinal surgical procedures in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure, such as the skull or vertebra, can be identified relative to medical images.

The Stryker KWIC (K-wire Insertion Cannulated) Needle is a manually operated needle that is used to assist in the placement of guidewires (e.g. K-wires) and/or the aspiration of autologous blood or bone marrow for orthopedic surgery. The Stryker KWIC Needle is designed to interface with already-cleared Stryker navigation systems.

This device is to be manually calibrated and used with Stryker navigation systems. This device is intended to be used in spine applications to perform general manual functions within the orthopedic environment including the placement of guidewires (e.g. K-wires) or to draw bone marrow. Guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.

Here's an analysis of the acceptance criteria and study information for the Stryker KWIC Needle based on the provided 510(k) summary:

This device is a manual surgical instrument and not a software-driven AI device. Therefore, many of the typical questions for AI devices regarding statistical metrics, ground truth, expert adjudication, MRMC studies, and standalone performance are not applicable. The performance data focuses on demonstrating mechanical and functional equivalence to predicate devices, as is common for physical medical instruments.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated with a numerical value. The study refers to "simulated cadaveric testing." It does not specify the number of cadavers or individual tests performed.
• Data Provenance: Not explicitly stated. Given the nature of a 510(k) submission for a physical device, the testing would have been conducted internally by the manufacturer or a contracted lab. The location (e.g., country of origin) of the cadaveric testing is not provided. The testing is retrospective in the sense that it's performed as part of the device development and submission process, not as a real-world, prospective clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. For a manual surgical instrument, the "ground truth" is typically established by the physical verification of its function (e.g., did the guidewire pass, did the system recognize the instrument). There is no mention of human experts interpreting data or images to establish ground truth in the way one would for an AI diagnostic device. The performance is assessed by direct observation of the device's mechanical and functional capabilities.

4. Adjudication method for the test set:

• Not Applicable. There is no mention of an adjudication process, as the performance tests are functional and objective (e.g., the needle either works with the navigation system or it doesn't; the guidewire either can be placed or it cannot).

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:

• No. This is a manual surgical instrument, not an AI or imaging device that involves human readers interpreting diagnostic results. Therefore, an MRMC study is not relevant or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• No. This device is a physical instrument, not an algorithm. Its performance is always tied to human use (manual operation) and, in some cases, integration with other systems (Stryker Navigation System), which themselves are tools for human surgical guidance.

7. The type of ground truth used:

• For the functional testing (guidewire placement, navigation system compatibility): The ground truth is established by direct observation and successful completion of the intended physical function in a simulated environment (cadaveric testing).
• For the aspiration function: The ground truth is derived from demonstrated capability of the predicate device paired with material/constructive equivalence of the current device.

8. The sample size for the training set:

• Not Applicable. This is not an AI or machine learning device that requires a training set.

9. How the ground truth for the training set was established:

• Not Applicable. As there is no training set mentioned or implied for this physical device.

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The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement, teeth and other related tissue in a variety of surgical procedures, including but not limited to Dental, ENT, Neuro and Endoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.

The device description of the Stryker System includes drills, shavers, shields, guards, motors, attachments, saws, wire drivers, collets, console, irrigation pump, cords, footswitch, handswitch, clips, tubing, cutting accessories, and sterilization cases. The scope of this modification is limited to the console of the system.

This document is a 510(k) summary for the Stryker Consolidated Operating Room Equipment (CORE) System. It describes the device, its intended use, and states that it is substantially equivalent to previously cleared devices.

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. This type of information is typically found in performance testing sections of a 510(k) submission, which evaluates quantifiable metrics like accuracy, precision, or other performance characteristics of the device.

The provided document is limited to:

• Device identification: Trade Name, Common Name, Classification Names, Equivalent predicate devices, Device Description, Intended Use, Technological Comparison.
• Regulatory correspondence: A letter from the FDA confirming substantial equivalence and outlining general controls.
• Indications for Use Statement: Detailing the surgical procedures and materials the device is intended for.

Therefore, I cannot provide the requested information:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

The document focuses on demonstrating substantial equivalence to predicate devices, implying that its safety and effectiveness are established by comparison to existing, legally marketed devices with similar technological characteristics and intended uses, rather than through a new, standalone performance study with detailed acceptance criteria as one might see for novel AI/software devices.

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The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement and other bone related tissue in a variety of surgical procedures, including but not limited to ENT. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.

The device description of the Stryker System includes drills, shavers, shields, guards, motors, attachments, saws, wire drivers, collets, console, irrigation pump, cords, footswitch, handswitch, clips, tubing, cutting accessories, and sterilization cases. The scope of this modification is limited to the console of the system.

This is a 510(k) premarket notification for the Stryker Consolidated Operating Room Equipment (CORE) System, specifically the console. It doesn't contain information about AI/ML models or clinical studies to establish performance metrics as would typically be found for AI-driven diagnostic devices. This submission is for a traditional medical device (a surgical console) and demonstrates substantial equivalence to previously cleared devices. Therefore, many of the requested categories related to AI/ML performance and studies are not applicable.

Here's an analysis of the provided text based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices. This is achieved by showing that the new device has similar intended use and technological characteristics, and does not raise new questions of safety or effectiveness. The document itself is the comparison table demonstrating this equivalence.

2. Sample size used for the test set and the data provenance

Not applicable. This is not an AI/ML device that uses a test set of data for performance evaluation. The "test" for this device is demonstrating substantial equivalence through a comparative analysis of its design and technical specifications against predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no "ground truth" establishment from experts for a test set in a 510(k) submission for a non-AI surgical console. The "ground truth" here is the established safety and effectiveness of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no test set or adjudication process for performance evaluation in this 510(k) submission.

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 is not an AI-assisted device, and no MRMC studies were conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a hardware device (surgical console) and does not deploy an algorithm for standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. As described above, the "ground truth" concept is not directly applicable in the context of this traditional medical device 510(k) submission. The basis for approval is the demonstrated substantial equivalence to established predicate devices whose safety and effectiveness have already been determined.

8. The sample size for the training set

Not applicable. There is no AI/ML model for which a training set would be used.

9. How the ground truth for the training set was established

Not applicable. There is no AI/ML model or training set.

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