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The Q Guidance System, when used with the Spine Guidance 5.2 Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients.

The system is indicated for any surgical procedure on the spine 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 such as the skull, pelvis or spine can be identified.

The system assists in the positioning of instruments for procedures on the pelvis and spine, including:
· Screw and Needle Placement in the spine or pelvis
· Bone resection in the spine

The Mako Spine System is intended to be used as an accessory to the Stryker Spine Guidance System. It is intended to be used to facilitate preparation and placement of screws of Stryker Spine implants in the non-cervical spine in adult and pediatric (adolescent) patients.

The Mako Spine System is intended to be used as part of the Stryker Spine Guidance System, which is indicated for any surgical procedure on the spine 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 such as the spine or pelvis can be identified.

The Stryker System 8 Dual Trigger Rotary Battery Powered Heavy Duty System is intended for use in the drilling, reaming, and decorticating of bone and other bone related tissue in a variety of surgical procedures. They are also usable in the placement of screws, wires, pins, and other fixation devices.

The Stryker System 8 Dual Trigger Rotary Battery Powered Heavy Duty System, when used in conjunction with Stryker Spine Guidance Software, is intended to be used to facilitate preparation and placement of screws of Stryker Spine implant systems in adult and pediatric (adolescent) patients.

The Spine Guidance System is a computer-assisted stereotaxic, image-guided, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery on the spine and pelvis. It assists the surgeon in precisely positioning manual and powered instruments and locating patient anatomy during spinal surgery. The system is comprised of the Spine Guidance 5.2 Software, Q Guidance System (computer platform), Mako Spine System, navigated accessories/ instruments (e.g., patient/ instrument trackers, pointers), and various system components (e.g., trackers, calibration instruments, etc.).

The system provides intraoperative guidance to the surgeon using passive and active wireless optical tracking technologies as well as haptic trajectory guidance to facilitate pedicle preparation and screw placement using Mako Spine System.

The Spine Guidance 5.2 Software displays the intraoperative location of navigated surgical instruments relative to imported patient medical images via wireless optical tracking technology. The software provides the functions to perform the indicated navigated spine surgical procedures. The software guides the user through the necessary preoperative and intraoperative steps required to set-up and perform the navigated spine surgical procedures.

The Mako Spine System is an accessory to the subject Spine Guidance 5.2 (SG5.2) Software and extends the functionality of the SG5.2 Software to provide trajectory guidance to align the End Effector tube with a pre-planned screw trajectory to facilitate preparation and placement of screws in the non-cervical spine. The Mako Spine System includes a Mako 3.5 Robotic arm, new dedicated instrumentations (i.e. Spine Pedicle End Effector, Spine Pedicle Registration Tool, Pedicle Instruments, etc.), and previously cleared compatible instruments (i.e. Vizadisc, Rio System Quick Connect Base Array, End Effector Tracker Array, Calibration End-Effector, etc.). Mako 3.5 Robotic Arm is connected to the existing Q Guidance System (K233542) via Mako ethernet cable.

The System 8 Dual Trigger Rotary Handpiece is used in the drilling, reaming, and decorticating of bone and other bone related tissue in a variety of surgical procedures. It is also used in the placement of screws, wires, pins, and other fixation devices. The handpiece, when used with a compatible instrument tracker, can be used with the Spine Guidance 5.2 Software to facilitate preparation and placement of screws using Stryker Spine implant systems.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics. Instead, the document is an FDA 510(k) clearance letter for the Stryker Q Guidance System, Mako Spine System, and System 8 Rotary Handpiece.

A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with specific statistical acceptance criteria as would be found in a clinical trial or a robust standalone AI performance study.

The document mentions "non-clinical performance testing" which includes:

• Software testing as required by IEC 623304 and FDA Guidance on General Principles of Software Validation.
• System accuracy verification per ASTM F2554.
• Full system cadaver validation.
• Biocompatibility verification according to ISO 10993-1:2018.
• Sterilization validation of reusable devices per ISO 17665-1.
• Shelf-life validated per ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1980-21.
• Electrical Safety and Electromagnetic Compatibility verification to IEC 60601-1 and IEC 60601-1-2.

However, it does not provide details on:

1. A table of acceptance criteria and reported device performance. While "System accuracy verification per ASTM F2554" is mentioned, the specific metrics, thresholds, and results are not provided.
2. Sample size, data provenance, number of experts, adjudication methods for any test set, or details of any MRMC study. The document states "No clinical testing was required to support this submission," which means there would be no human reader study or corresponding ground truth establishment on a clinical test set as described in your prompt.
3. Standalone (algorithm-only) performance results, as this device is a guidance system, not a diagnostic AI algorithm.
4. Type of ground truth used in the context of an AI performance study, as such a study was not required or detailed.
5. Sample size for the training set or how ground truth was established for it. This information pertains to AI model development, which is not the focus of this 510(k) submission document.

In summary, based on the provided text, it is not possible to answer your questions regarding acceptance criteria, performance data, test set details, ground truth establishment, or AI-specific study methodologies, because the document is a 510(k) clearance that explicitly states "No clinical testing was required to support this submission" and focuses on demonstrating substantial equivalence through non-clinical performance and other regulatory compliance tests.

The document does describe the Indications for Use for the Q Guidance System and Mako Spine System, which outlines the intended purpose and patient population. It also provides a Summary of Technological Characteristics comparing the subject devices to predicate devices. However, this is for demonstration of substantial equivalence, not a detailed performance study with quantifiable acceptance criteria and results as typically seen for AI/ML devices.

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Ortho Guidance Precision Knee Software:
The Stryker guidance systems, with the Ortho Guidance Precision Knee Software, are intended as a planning and intraoperative quidance system to enable open computer-assisted surgerv. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.

Ortho Guidance Express Knee Software:
The Stryker quidance systems, with the Ortho Guidance Express Knee Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.

Ortho Guidance Versatile Hip Software:
The Stryker guidance systems, with the Ortho Guidance Versatile Hip Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery.

The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified.

The systems are indicated for conditions of the hip joint in which the use of computer-assisted surgery may be appropriate.

The system is indicated for the following surgical procedures:

• Total Hip Arthroplasty (THA)

• Precisely positioning instruments, implants, and bony tissue during orthopaedic hip surgery

• Revisions

Q Guidance System:
The Q Guidance System is intended as an aid for precisely locating anatomical structures in open or percutaneous computer assisted surgery. When used with the Ortho Guidance Precision Knee, Express Knee, or Versatile Hip Software, the Q Guidance System is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the femur, tibia, or long bone can be identified.

The system is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. It allows for the localization of surgical instruments, and visualization of their position relative to patient specific anatomical landmark information, assisting the surgeon in performing the intervention at a high level of precision. The system uses active optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model. The computed model is based on an intraoperative anatomy survey of the pelvis and/or leg.

Here's a breakdown of the acceptance criteria and the study information for the Stryker Q Guidance System and its associated software, based on the provided document:

Acceptance Criteria and Device Performance

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The Stryker Q Guidance System, with the Cranial Guidance Software, 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 can be identified. The system assists in the positioning of instruments for cranial procedures, including: Cranial biopsies Craniotomies Craniectomies Resection of tumors and other lesions Skull base procedures Transnasal neurosurgical procedures Transsphenoidal pituitary surgery Craniofacial procedures Skull reconstruction procedures Orbital cavity reconstruction procedures General ventricular catheter and shunt placement Pediatric ventricular catheter and shunt placement

The Q Guidance System is intended as an aid for precisely locating anatomical structures in 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 and where reference to a rigid anatomical structure such as the skull, vertebra, or long bone can be identified.

The Stryker CranialMask Tracker is intended to be used as an accessory to the CranialMap and the Cranial Guidance software applications. It is intended to be placed on the patient's facial skin and used in combination with preoperative and intraoperative imaging devices to enable automatic patient registration for open or percutaneous computer-assisted surgery. The Stryker CranialMask Tracker can be used as a noninvasive patient tracker to support open or percutaneous cranial neurosurgical procedures.

The Stryker EM Stylet is indicated for use as an accessory to the Stryker Q Guidance System when used with the Cranial Guidance Software and electromagnetic navigation. It is indicated for use in locating anatomical structures during navigated cranial procedures. The system is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The system 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 the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. The EM Stylet is indicated for use in the following procedures: General ventricular catheter and shunt placement Pediatric ventricular catheter and shunt placement

The Stryker Navigated Biopsy Needle is intended to be used as an accessory to the Stryker Q Guidance System when used with the Cranial Guidance Software. It is a side cutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula for use in the stereotaxic biopsy of cranial tissue. The Stryker Navigated Biopsy Needle may be used as part of the Stryker Cranial Guidance 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 Q Guidance System with Cranial Guidance Software is a computer-assisted stereotaxic, image-guided, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precisely positioning instruments and locating patient anatomy during cranial surgery. The Q Guidance System with Cranial Guidance Software system is comprised of a computer platform. Cranial Guidance Software, navigated instruments (e.g., patient/ instrument trackers, pointers), and various system components. The system provides intraoperative guidance to the surgeon using electromagnetic, passive and active wireless optical tracking technologies. The computer platform consists of a computer, camera, electromagnetic field generator and box to plug in electromagnetic instruments, big touchscreen monitor, and a small touchscreen monitor. The Cranial Guidance Software is dedicated to cranial surgical procedures as defined in the indications for use. Required navigated instruments include instruments such as a patient tracker, an instrument tracker, pointers, suction tubes, seekers, etc. An instrument battery is required when a battery powered instrument or calibration device is used. The Cranial Guidance Software displays the intraoperative location of navigated surgical instruments relative to imported patient medical images via electromagnetic or wireless optical tracking technology. The software provides the functions to perform the indicated navigated cranial surgical procedures. The software guides the user through the necessary preoperative and intraoperative steps required to set-up and perform the navigated cranial surgical procedures. The Q Guidance System was initially cleared in premarket notification K220593. The only change to this device from its initial clearance is the addition of the electromagnetic tracking technology and the integration of the Zeiss Microscope using the Zeiss Microscope Tracker. The Cranial Guidance Software includes the following system components described below.

Here's a breakdown of the acceptance criteria and study information for the Stryker Q Guidance System with Cranial Guidance Software, EM Stylet, and Navigated Biopsy Needle, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document explicitly states the system's design goal for accuracy is a mean of 2mm positional and 2° angular displacement. The reported performance includes a 99% Confidence Interval (Upper) which exceeds the 2mm/2° stated design goal in some instances (e.g., Optical Nav Positional Displacement 2.65mm, Optical Nav Trajectory Angle Displacement 2.93°, EM Nav Positional Displacement 2.57mm, EM Nav Trajectory Angle Displacement 2.82°). However, the document concludes that "All requirements were met and no new issues of safety or effectiveness were raised," implying these results were considered acceptable within the overall context of the safety and performance evaluation.

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

• Accuracy Testing:
  • Pediatric patients: Non-clinical accuracy testing was performed using pediatric models made based on a neonate image set. The exact number of models is not specified.
  • Adult patients: Accuracy testing was performed via a Simulated Use study with cadavers. The exact number of cadavers is not specified.
• Intended Use/User Needs Validation: Conducted in "cadaver labs or simulated use tests." The exact number of participants or cases is not specified.
• Data Provenance: The document does not explicitly state the country of origin for the datasets used in testing (pediatric models, cadavers). The testing seems to be prospective (i.e., designed as part of the validation process) rather than retrospective clinical data.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth specifically for the accuracy testing of the device (i.e., for the positional and angular displacement measurements). The "Intended Use/User Needs" validation involved "intended users," but their specific number or qualifications (e.g., years of experience as surgeons) are not detailed.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth for the performance metrics. The accuracy measurements appear to be objective, engineering-style measurements against a known reference. For the "Intended Use/User Needs" validation, it simply states that all requirements were met, implying a qualitative assessment by the "intended users."

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. The 510(k) summary explicitly states: "No clinical testing was performed." Therefore, no MRMC comparative effectiveness study was conducted, and no effect size on human reader improvement with AI assistance is reported.

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

The primary performance data reported (positional and angular displacement accuracy) are standalone algorithm/device accuracy metrics, as they quantify the device's ability to precisely locate structures and guide instruments in a controlled testing environment (using pediatric models and cadavers), independent of a human surgeon's subjective interpretation or decision-making beyond the act of using the device. This testing is focused on the device's intrinsic measurement capabilities.

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

For the accuracy measurements (positional and angular displacement), the ground truth would be based on precisely measured, known physical locations or trajectories within the test setup (pediatric models or cadavers). This is an engineering- or physics-based ground truth, where the "true" position or angle is established by highly accurate measurement systems or a known fiducial reference.

8. The sample size for the training set

The document does not provide any information about a training set size. This 510(k) summary describes a navigation system and its accessories, not a machine learning or AI algorithm that typically requires a separate training set. While the "Cranial Guidance Software" is mentioned, the performance evaluation focuses on the accuracy of the navigation system components rather than a pattern recognition or diagnostic AI.

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

Since no information on a training set or its size is provided, the method for establishing its ground truth is also not described. As noted above, the device's evaluation is primarily based on the accuracy of its navigation capabilities, which rely on precise physical measurements rather than annotated data for training.

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Ortho Guidance Precision Knee Software:

The Stryker Ortho Q Guidance System, with the Ortho Guidance Precision Knee Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system is indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.

Ortho Guidance Express Knee Software:

TThe Stryker Ortho Q Guidance System, with the Ortho Guidance Express Knee Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system is indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.

Ortho Guidance Versatile Hip Software:

The Stryker Ortho Q Guidance System, with the Ortho Guidance Versatile Hip Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure, such as but not limited to the pelvis or femur, can be identified. The system is indicated for conditions of the hip joint in which the use of computer-assisted surgery may be appropriate. The system is indicated for the following surgical procedures:

• Total hip arthroplasty (THA)

• Precisely positioning instruments, implants, and bony tissue during orthopaedic hip surgery

• Revisions

Ortho Q Guidance System:

The Stryker Ortho Q Guidance System is intended as an aid for precisely locating anatomical structures in open computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the skull, vertebra, or long bone can be identified.

The purpose of this Traditional 510(k) submission is to seek clearance for 3 new software applications and 1 new guidance system. The applications have been created for functionality on the new guidance system in scope of this submission. The subject devices in scope of this submission are outlined in Table 6-1 with the predicate information in Table 6-2. The devices in scope of this submission, Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, and the Ortho Q Guidance System work within an ecosystem with a host of other existing smart devices and accessories that will be demonstrated to be compatible with the subject devices but are not in scope of this submission.

The Ortho Guidance Precision Knee Software used with Stryker Ortho Q Guidance System is referred as Ortho Guidance Precision Knee System. The Ortho Guidance Express Knee Software used with Stryker Ortho Q Guidance System is referred as Ortho Guidance Express Knee System. The Ortho Guidance Versatile Hip Software used with Stryker Ortho Q Guidance System is referred as Ortho Guidance Versatile Hip System.

The system is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. It allows for the localization of surgical instruments, and visualization of their position relative to patient specific anatomical landmark information, assisting the surgeon in performing the intervention at a high level of precision. The system uses active optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model. The computed model is based on an intraoperative anatomy survey of the pelvis and/or leg.

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The Stryker Q Guidance System, when used with the Spine Guidance software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients.
The system is indicated for any surgical procedure on the spine 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 such as the spine, pelvis or skull can be identified.
The system assists in the positioning of instruments for procedures on the spine and pelvis, including:

• Screw Placement in the spine or pelvis

The Q Guidance System is intended as an aid for precisely locating anatomical structures in 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 and where reference to a rigid anatomical structure such as the skull, vertebra, or long bone can be identified.

The Stryker Q Guidance System with Spine Guidance 4.0 Software system is a computer-assisted stereotaxic, image-guided, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precisely positioning instruments and locating patient anatomy during spinal surgery.
The Q Guidance System with Spine Guidance 4.0 Software system is comprised of a computer platform, Spine Guidance Software, navigated accessories/ instruments (e.g., patient/ instrument trackers, pointers), and various system components (i.e. Calibration Body, Registration Pointer, etc.). The system provides intraoperative guidance to the surgeon using passive and active wireless optical tracking technologies. The computer platform consists of a computer, camera, big touchscreen monitor, and a small touchscreen monitor.
The Spine Guidance 4.0 Software is dedicated to spine surgical procedures as defined in the indications for use. Required navigated instruments include a patient tracker, an instrument tracker, pointers, etc. An instrument battery is required when a battery powered instrument or calibration device is used.
The Spine Guidance 4.0 Software displays the intraoperative location of navigated surgical instruments relative to imported patient medical images via wireless optical tracking technology. The software provides the functions to perform the indicated navigated spine surgical procedures. The software guides the user through the necessary preoperative and intraoperative steps required to set-up and perform the navigated spine surgical procedures.

Here's a breakdown of the acceptance criteria and the study details for the Spine Guidance Software and Q Guidance System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for the accuracy test. It mentions that the system was validated "in cadaver labs or simulated use tests," implying a test set. This suggests a retrospective or simulated prospective setting, as it's not a live clinical trial. The country of origin of this data is not specified in the provided text.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the context of the accuracy testing. It only mentions validation with "intended users."

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was performed."

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

The primary performance data provided (positional and angular displacement accuracy) appears to be a standalone (algorithm only) performance evaluation, measuring the system's inherent ability to track and guide without the variable of direct human interpretation influencing the core accuracy metric. The "Intended Use/User Needs" validation involved "intended users in cadaver labs or simulated use tests," which likely involved human interaction with the device, but the core accuracy metrics are stated as system capabilities.

7. The Type of Ground Truth Used

For the accuracy criteria (positional and angular displacement), the ground truth would likely be established by highly precise measurement tools and methods (e.g., coordinate measuring machines, optical tracking systems with higher precision than the device itself, or physical phantoms with known dimensions) rather than direct expert consensus on an image. For the "Intended Use/User Needs" validation, the ground truth would be based on the successful performance of the intended surgical tasks as evaluated by the "intended users" in the simulated environments.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set.

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

The document does not provide information on how the ground truth for any potential training set was established. Given that this is a surgical navigation system, rather than an AI/ML diagnostic algorithm relying on image interpretation, the concept of a "training set" in the traditional sense for diagnostic AI may not directly apply. The system is calibrated and validated against known physical parameters and simulation standards, rather than being "trained" on a dataset of labeled medical images to learn patterns.

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