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.

Device Description

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.

AI/ML Overview

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:

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.
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.
Standalone (algorithm-only) performance results, as this device is a guidance system, not a diagnostic AI algorithm.
Type of ground truth used in the context of an AI performance study, as such a study was not required or detailed.
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.

Summary

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August 27, 2024

Stryker Leibinger GmbH & Co. KG Dipan Lad Senior Staff Regulatory Affairs Specialist Bötzinger Straße 41 Freiburg Baden-Wurttembe, D-79111 Germany

Re: K241517

Trade/Device Name: Q Guidance System; Mako Spine System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 29, 2024 Received: May 29, 2024

Dear Dipan Lad:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali -S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative. Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K241517

Device Name

Q Guidance System Mako Spine System

Indications for Use (Describe)

Q Guidance System

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

Mako Spine System

System 8 Rotary Handpiece

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K241517

510(k) SUMMARY

Sponsor Information o

Sponsor:	Stryker Leibinger GmbH & Co. KGBötzinger Straße 4179111 Freiburg, Germany
Contact Person:	Dipan LadSenior Staff Regulatory Affairs SpecialistStryker Spine2 Pearl Ct.Allendale, NJ 07401 USAEmail: dipan.lad@stryker.com
Alternate Contact:	Kirsten ReinholdSenior Manager, NPD Regulatory AffairsStryker Spine2 Pearl Ct.Allendale, NJ 07401 USAPhone: (201) 831-5903Email: kirsten.reinhold@stryker.com
Date Prepared:	May 29, 2024

Subject Device Information o

Subject (Modified) Device Information
Trade/ Proprietary Name	Q Guidance SystemMako Spine System
Common Name	Stereotaxic Instruments
Classification	Class II
Classification Product Code	OLO
Classification Name	Orthopedic Stereotaxic Instrument
Classification Regulation	21 CFR 882.4560
Review Panel	Orthopedic

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0 Predicate Devices

The following are the legally marketed predicate devices to which substantial equivalence is O claimed:
- Spine Guidance Software (version 5.1) - K241171
- Mako Total Knee Application - K241011
- 트 System 8 Rotary Handpiece - Class I Exempt (Product Code: HWE)
Legally marketed reference device used to support substantial equivalence in terms of using O robotic arm in spine procedure for trajectory guidance:
- Mazor X - K203005

o Device Description

Spine Guidance 5.2 Software O

Mako Spine System O

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, O 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.

System 8 Rotary Handpiece O

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0 Intended Use/ Indications for Use

Spine Guidance 5.2 Software O

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

0 Screw and Needle Placement in the spine or pelvis
Bone resection in the spine ●

Mako Spine System O

o System 8 Rotarv Handpiece

O Summary of Technological Characteristics

A comparison of the technological characteristics of the subject devices included in the scope of this Traditional 510(k) is included below.

The technological comparison between the subject device (Spine Guidance 5.2 Software) O and the predicate device (Spine Guidance 5.1 Software):

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	Table 6-2: Technological Comparison between Spine Guidance 5.2 Software (Subject Device) and the
Predicate Device

Item	Subject Device:Spine Guidance 5.2 Software	Predicate Device:Spine Guidance 5.1 Software (K241171)
Indicationsfor Use	The Q Guidance System, when used with theSpine Guidance Software, is intended as aplanning and intraoperative guidance system toenable open or percutaneous computer assistedsurgery in adult and pediatric (adolescent) patients.The system is indicated for any surgical procedureon the spine in which the use of computer assistedplanning and surgery may be appropriate. Thesystem can be used for intraoperative guidancewhere a reference to a rigid anatomical structuresuch as the skull, pelvis or spine can be identified.The system assists in the positioning ofinstruments for procedures on the pelvis and spine,including:• Screw and Needle Placement in the spineor pelvis• Bone resection in the spine	The Q Guidance System, when used with theSpine Guidance Software, is intended as aplanning and intraoperative guidance system toenable open or percutaneous computer assistedsurgery in adult and pediatric (adolescent) patients.The system is indicated for any surgical procedureon the spine in which the use of computer assistedplanning and surgery may be appropriate. Thesystem can be used for intraoperative guidancewhere a reference to a rigid anatomical structuresuch as the skull, pelvis or spine can be identified.The system assists in the positioning ofinstruments for procedures on the pelvis and spine,including:• Screw and Needle Placement in the spineor pelvis• Bone resection in the spine
Main SystemComponents	• Q Guidance System• Mako Spine System• Various reusable and single use instruments foruse with the SG5.2 Software	• Q Guidance System• Various reusable and single use instruments foruse with the SG5.1 Software
Modes ofOperation	• Mako 3.5 Robotic Arm pre-surgery check• Patient preparation• System set-up• Image import• Planning• Patient registration• Mako 3.5 Robotic Arm setup• Navigation including haptic trajectory guidance	• Patient preparation• System set-up• Image import• Planning• Patient registration• Navigation
OperatingPrinciple	• The software is installed on the computer that ispart of the platform• Images are imported in DICOM format• The software displays the images and planneditems with navigational information on amonitor	• The software is installed on the computer that ispart of the platform• Images are imported in DICOM format• The software displays the images and planneditems with navigational information on amonitor
PlanningFeatures	• Screws (including Screw PlacementSuggestion)• Measurements• Segmentations (Manual and automatic)• Local correlation (merge regions)• Planes• Smart Zones	• Screws (including Screw PlacementSuggestion)• Measurements• Segmentations (Manual and automatic)• Local correlation (merge regions)• Planes• Smart Zones
	Subject Device:	Predicate Device:
Item	Mako Spine System	Mako Total Knee Application (K241011)
Indicationsfor Use	The MAKO System is intended to be used as anaccessory to the Stryker Spine Guidance System. It isintended to be used to facilitate preparation andplacement of screws of Stryker Spine implants in thenon-cervical spine in adult and pediatric (adolescent)patients.The MAKO System is intended to be used as part ofthe Stryker Spine Guidance System, which isindicated for any surgical procedure on the spine inwhich the use of computer assisted planning andsurgery may be appropriate. The system can be usedfor intraoperative guidance where a reference to arigid anatomical structure such as the spine or pelviscan be identified.	The Mako System is indicated for use in surgical kneeand hip procedures in which the use of stereotacticsurgery may be appropriate, and where reference torigid anatomical bony structures can be identifiedrelative to a CT based model of the anatomy. Theseprocedures include:• Total Knee Arthroplasty
Majorcomponents	• Q Guidance System• Mako 3.5 Robotic Arm• Spine Pedicle End Effector (trajectory guidancetube)	• Q Guidance System• Mako 3.5 Robotic Arm• Mako Integrated Cutting System (MICS endeffector)
Tools/accessories	• Non-sterile and sterile instruments.• Disposable sterile drape on device.	• Non-sterile and sterile instruments.• Disposable sterile drape on device.
Principle ofoperation	• Preoperative images• Mako 3.5 Robotic Arm pre-surgery check• Patient Preparation• System Set-up• Image Import (or intraoperative imaging)• Planning• Patient Registration• Mako 3.5 Robotic Arm setup• Navigation including haptic trajectory guidance	• Preoperative images• Preoperative surgical planning andinterpretive/intraoperative navigation• Mako 3.5 Robotic Arm pre-surgery check• Patient preparation• System set-up• Image import• Patient registration• Surgical planning• Stereotactic/haptic boundaries during bonepreparation and implant placement

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o The technological comparison between the subject device (Mako Spine System) and the predicate device (Mako Total Knee Application):

Table 6-3: Technological Comparison between the Mako Spine System (Subject Device) and the Predicate Device

Technological Comparison between the System 8 Rotary Handpiece and the predicate O device

There have been no changes to the intended use, design, materials, fundamental scientific technology, or cleaning/ sterilization processes. The only update is to the indications for use for the handpiece reflecting its use as an accessory with Spine Guidance 5.2 Software.

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o Summary of Non-Clinical Testing

The subject devices (Spine Guidance 5.2 Software and Mako Spine System) have been evaluated through the following non-clinical performance testing. The results of the evaluation tests demonstrate that the subject devices successfully meet the requirements of their intended use, and the subject devices demonstrate substantial equivalent to the cited predicate devices.

Software testing as required by IEC 62304 and FDA Guidance on General Principles of Software O Validation, January 11, 2002.
System accuracy verification per ASTM F2554. O
Full system cadaver validation O
Biocompatibility verification according to ISO 10993-1:2018 and the FDA Guidance Use of O International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, September 2023.
Sterilization validation of the reusable devices per ISO 17665-1 and the FDA Guidance O Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (March 2015).
Shelf-life validated per the following standards: ISO 11607-1:2019, ISO 11607-2:2019, ASTM O F1980-21.
Electrical Safety and Electromagnetic Compatibility verification to IEC 60601-1:2005, IEC O 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 and IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020.

Summary of Clinical Testing 0

No clinical testing was required to support this submission.

o Conclusion

The subject devices, Spine Guidance 5.2 Software, Mako Spine System, and System 8 Rotary Handpiece, perform as intended and are substantially equivalent to the cited predicate devices with regard to intended use, indications for use, design, principles of operation, technology, materials, and performance. No new issues of safety or effectiveness have been raised. The performance testing supports a determination of Substantial Equivalence.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).