The GYDER® Hip Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopaedic surgical procedures. The GYDER® Hip Navigation System facilitates the accurate positioning of the acetabular cup only during Anterior Hip Arthroplasty approaches with the patients in supine position.

The GYDER® Hip Navigation System is intended to be used only during Anterior Hip Arthroplasty approaches with the patients in supine position, with acetabular cups that are uncemented and allow for post-impaction measurement and confirmatory measurement.

Device Description

The GYDER® Hip System is a computer controlled non-invasive surgical tool to aid navigation during Total Hip Arthroplasty via the Anterior Approach. The system includes both reusable and consumable components, designed to work together to assist the surgeon in positioning the acetabular cup in the intended orientation during primary or revision Total Hip Arthroplasty.

AI/ML Overview

The provided text is a 510(k) Summary for the GYDER® Hip System. It details the device's substantial equivalence to a predicate device and includes information on performance testing. However, it does not contain the specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format requested, particularly for an AI/ML-based device evaluation with expert consensus ground truth.

The excerpt discusses non-clinical testing which includes "System accuracy testing by bench testing for angle measurement accuracy including using ASTM F2554-18" and "Simulated use testing in cadaver with advising surgeons to validate the system meets requirements for user needs and usability in a simulated use environment." This indicates performance validation, but not in the context of an AI/ML model's diagnostic or assistive performance against expert consensus.

Therefore, I cannot provide all the requested information for an AI/ML model study based on this document. I will fill in what can be inferred or explicitly stated regarding performance testing of this stereotaxic instrument, and note where the information for an AI/ML study is not available from the provided text.

Acceptance Criteria and Device Performance (Based on available information for a Navigation System, not AI/ML directly)

Acceptance Criteria Category	Specific Criteria/Metric	Reported Device Performance
Angle Measurement Accuracy (Bench Testing)	ASTM F2554-18 compliance for angle measurement accuracy	Device meets ASTM F2554-18 for angle measurement accuracy.
System Functionality & Reliability (Software)	Integrity of code, functionality, reliability	Verified and validated for various use sequences.
System Hardware Performance	Meets functional requirements	Verified and validated to meet functional requirements.
Usability (Simulated Use Testing)	Meets requirements for user needs and usability	Validated in simulated use environment with advising surgeons.
Biocompatibility	ISO 10993-1 (2018) compliance	Assessment states compliance.
Cleaning, Sterilization, Shipping Validation	Validation of specified processes	Validated.

Since this is a stereotaxic instrument, not an AI/ML diagnostic or assistive device that would typically rely on a test set of data interpreted by experts for ground truth, many of the requested fields are not applicable or not provided in the context of this 510(k) summary. I will indicate this where appropriate.

Study Details (based on information pertinent to a surgical navigation system):

Sample sized used for the test set and the data provenance:
- Test Set Sample Size: The document mentions "Simulated use testing in cadaver" and "bench testing." It does not specify the number of cadavers or the number of tests performed for quantifiable test set size.
- Data Provenance: Cadaver studies. The country of origin for the cadaver data is not specified. The studies appear to be prospective, as they are "simulated use testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For this type of device (surgical navigation), "ground truth" is typically established through direct physical measurements on the cadaver (e.g., using a goniometer or an established gold-standard measurement tool) rather than expert consensus on image interpretation.
- The document mentions "advising surgeons" for usability validation in cadaver studies, but not for establishing a ground truth in the sense of diagnostic interpretation. Their qualifications are not specified beyond being "surgeons."
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable in the context of this device's performance testing (which involves physical measurements/usability rather than expert interpretation of data).
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 MRMC study was done, as this is not an AI/ML diagnostic or assistive device for "human readers." It's a surgical navigation system providing real-time guidance. The comparison is against the predicate device's performance, not human reader improvement with AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- "System accuracy testing by bench testing for angle measurement accuracy including using ASTM F2554-18" can be considered a standalone performance test for the algorithm's output accuracy against a physical standard. The results indicate it meets the standard.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the accuracy testing, the ground truth would be the physical geometric standard defined by ASTM F2554-18 and actual measurements on the bench, or the defined anatomical axes in cadaver studies using validated measurement techniques. It is not expert consensus for image interpretation.
The sample size for the training set:
- Not applicable. This is a navigation system and the document does not indicate the use of machine learning models requiring large training datasets with curated ground truth labels in the same way an AI/ML diagnostic device would. Software verification and validation (listed under "Non-Clinical Testing") would cover traditional software development and testing, not AI model training.
How the ground truth for the training set was established:
- Not applicable, as no AI model training set is mentioned or implied.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.

January 29, 2025

Gyder Surgical Pty Ltd. % David Rutledge Consultant Global Strategic Solutions, LLC 1631 Mercy Street Mountain View, California 94041

Re: K243387

Trade/Device Name: GYDER® Hip System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 26, 2024 Received: October 31, 2024

Dear David Rutledge:

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"

{1}------------------------------------------------

(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).

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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

{2}------------------------------------------------

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

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K243387

Device Name GYDER® Hip System

Indications for Use (Describe)

Indications For Use

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

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

K243387 510(k) Summary

Applicant Information: Gyder Surgical Pty Ltd 30 – 32 Compark Circuit, Mulgrave, Victoria, 3170, Australia Contact Person: Sujit Dike Title: Chief Executive Officer Phone: +1 484-886-7331 Email: sujit@gydersurgical.com

Primary Correspondent, Authorized Consultant and 510(k) Submitter: David R. Rutledge Global Strategic Solutions, LLC 1631 Mercy Street, Mountain View, CA 94041, United States Phone: +1 630-846-0350 Email: David.Rutledge@GlobalStrategicSolutions.com

Device Name: GYDER® Hip System Common Name: Stereotaxic Instrument Regulation name: Orthopedic Stereotaxic Instrument Classification: Class II Product Code: OLO Submission Type: Traditional 510(k), New Device Regulation Number: 21 CFR 882.4560 Predicate Device: OrthAlign Plus System (K130387)

Indications For Use

Intended Use

{5}------------------------------------------------

Device Description

Substantial Equivalence

The GYDER® Hip Navigation System is substantially equivalent to the OrthAlign Plus System predicate device in the Hipalign configuration based on the analysis of Clinical, and Biological characteristics and performance data that includes bench and cadaver based tests.

Comparison between GYDER® Hip System and the Predicate Device

Attribute	Subject Device:GYDER® Hip Navigation System	Predicate DeviceOrthAlign Plus® in the HipAlign®configuration	ComparisonDifferences/Similarities

510(k) Number	New application	K130387 [3]Orthalign Plus® in the HipAlign®configuration for Total HipArthroplasty (THA).	N/A
FDA Regulation	882.4560	882.4560	EQUIVALENT.
Product Code	OLO: Orthopedic Stereotaxic Instrument	OLO: Orthopedic StereotaxicInstrument	EQUIVALENT.
Product Classification	Class II	Class II	EQUIVALENT.
Use	Prescription Use/ Rx Only	Prescription Use/ Rx Only	EQUIVALENT.
Intended User	Primary user: Orthopedic SurgeonSecondary user: Surgical Assistant / Nurse	Primary user: Orthopedic SurgeonSecondary user: Surgical Assistant /Nurse	EQUIVALENT.
Use Environment	Hospital / Operating Theatre	Hospital / Operating Theatre	EQUIVALENT
Patient Population	Patients undergoing Total HipArthroplasty:• Anterior Approach with patient supine.	Patients undergoing Total HipArthroplasty.• Anterior Approach with patientsupine• Posterior Approach with patientlateral decubitus.	EQUIVALENT forAnteriorApproach.GYDER® HipNavigationSystem does notsupport PosteriorApproach.
Attribute	Subject Device:GYDER® Hip Navigation System	Predicate DeviceOrthAlign Plus® in the HipAlign®configuration	ComparisonDifferences/Similarities
Indications for Use	The GYDER® Hip Navigation System is acomputer-controlled system intended toassist the surgeon in determiningreference alignment axes in relation toanatomical structures during stereotacticorthopedic surgical procedures. TheGYDER® Hip Navigation System facilitatesthe accurate positioning of the acetabularcup relative to the alignment axes.Example orthopedic surgical proceduresinclude:• Total Hip Arthroplasty: AnteriorThe GYDER® Hip Navigation System forsupine patient registration is indicated foruse:• In Hip Arthroplasty surgical procedures;• with acetabular cups that areuncemented and allow for post-impaction measurement andconfirmatory measurement.	The HipAlign® System is acomputer-controlled systemintended to assist the surgeon indetermining reference alignmentaxes in relation to anatomical andinstrumentation structures duringstereotactic orthopedic surgicalprocedures. The HipAlign® Systemfacilitates the accurate positioningof implants, relative to thealignment axes.Example orthopedic surgicalprocedures include but are notlimited to:• Total Hip Arthroplasty:Anterior/Posterior	EQUIVALENT forAnteriorApproach.GYDER® HipNavigationSystem does notsupport PosteriorApproach.
Operating Conditions	Specified storage and operatingconditions for surgical environments• Hospital use, normal ambientconditions of temperature, and lighting• Within the sterile field of an operatingtheatre• Temperature: 16 to 24°C• Humidity: 20 to 60% RH (non-condensing)• Pressure: 70 kPa to 106 kPa	Specified storage and operatingconditions for surgicalenvironments• Hospital use, normal ambientconditions of temperature, andlighting• Within the sterile field of anoperating theatre• Temperature: 15 to 25°C• Humidity: 10 to 70% RH (non-condensing)• Pressure: 70 kPa to 106 kPa	EQUIVALENT
Storage andTransportationConditions	Specified storage conditions for typicaltransport environments:• Temperature: -30 to 60°C• Humidity: 15 to 90% RH (non-condensing)• Pressure: 50 kPa to 106 kPa	Specified storage conditions fortypical transport environments:• Temperature: -30 to 60°C• Humidity: 10 to 95% RH (non-condensing)• Pressure: 60 kPa to 101 kPa	EQUIVALENT
SystemCharacteristics	Computer-assisted navigation system	Computer-assisted navigationsystem	EQUIVALENT
Control Mechanism	Electronics attached to movableinstruments, placed in specific proceduralpositions, on or in contact with bonyanatomy, for recording sensor data.	Electronics attached to movableinstruments, placed in specificprocedural positions, on or incontact with bony anatomy, forrecording sensor data.	EQUIVALENT
Attribute	Subject Device:GYDER® Hip Navigation System	Predicate DeviceOrthAlign Plus® in the HipAlign®configuration	ComparisonDifferences/Similarities

OperatingPrinciple/Registrationof Anatomy	Patient registration referencing AnteriorPelvic Plane landmarks using a non-invasive mechanical device. Sensors areattached to moveable instruments placedin specified procedural positions, on or incontact with bony anatomy, for recordingdata. Measurements to confirm the finalimplant angles after implantation hasbeen completed.	Patient registration referencingAnterior Pelvic Plane landmarksusing invasive pins. Sensors areattached to moveable instrumentsplaced in specified proceduralpositions, on or in contact withbony anatomy, for recording data.Measurements to confirm the finalimplant angles after implantationhas been completed.	SIMILAR
Measurement andNavigation	• Computer derived values.• Inertial Measurement Unit (IMUcontaining Accelerometer and rategyroscope) measurement oforientation of instrument.	• Computer derived values.• Inertial Measurement Unit (IMUcontaining Accelerometer andrate gyroscope) measurement oforientation of instrument.	EQUIVALENT
Main Components	Sensors and Software:• Navigation Unit (reusable computer)• Navigation and measurement softwareSingle-Use items:• Clam Shell (navigation unit sterileenclosure)• ASIS Markers• APP RulerRe-usable Instrument sets:• Orthopaedic Brace and Impactor Set• Impactor (as manufactured by MacSurgical)	Sensors and Software:• Navigation Unit (reusablecomputer unit)• Navigation and measurementsoftwareSingle -Use items• Single-use sensorRe-usable Instrument sets:• Pelvic Pins and instrument set• Impactor	EQUIVALENT.
User interface	Integrated Graphical User Interface. Thedevice uses algorithms to convert sensoroutputs into spatial coordinates,providing graphical and numericalrepresentations of the instrumentsrelative to patient anatomy on the NUscreen.	Integrated Graphical User Interface.The device utilizes algorithms toconvert sensor outputs into spatialcoordinates, providing graphicaland numerical representation ofinstruments relative to patientanatomy on the computer screen.	EQUIVALENT.
Sterility (incl.method)	• Navigation Unit protected by sterileClam Shell and is not exposed tobiological contaminants.• Clam Shell and ASIS Markers: EOsterilization.• Orthopaedic Brace, Impactor Bracket,Impactor: Steam/autoclavesterilization.	• Navigation Unit: EO sterilization.• Instruments: autoclavesterilization	EQUIVALENT
Energy Sources	• Navigation Unit:• DC battery power• Other components are passive	• Navigation unit and referencesensor:• DC battery power	EQUIVALENT.
Attribute	Subject Device:GYDER® Hip Navigation System	Predicate DeviceOrthAlign Plus® in the HipAlign®configuration	ComparisonDifferences/Similarities

		• Other components are passive
Analytical Studies	• Cadaver study performed.	• Cadaver study performed.	EQUIVALENT.

Table 1. Comparison of Subject Device to Predicate Device

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

Performance Data

Device performance testing confirms that the GYDER® Hip Navigation System can be used according to its intended use. The GYDER® Hip Navigation System has been verified and validated according to Gyder Surgical procedures for product design and development. Performance testing addressed the functionality and surgical procedure workflows/steps as defined in the GYDER® Hip System Instructions for Use and demonstrates that the GYDER® Hip System is as safe, as effective, and performs as well as the predicate device [OrthAlign Plus® System (K130387)].

Non-Clinical Testing

Testing included:

• Software verification and validation to ensure the integrity of the code and functionality and reliability of the software in various use sequences.

System hardware verification/validation testing to ensure the device meets their functional requirements.
Instrumentation cleaning, sterilization and shipping validations for the specified processes.
· System components biocompatibility assessment per ISO 10993-1 (2018).
System accuracy testing by bench testing for angle measurement accuracy including using ASTM F2554-18.
· System usability testing for formative and summative testing.
Simulated use testing in cadaver with advising surgeons to validate the system meets requirements for user needs and usability in a simulated use environment.

This testing regime demonstrates that the subject device is as safe and performs as well as the predicate device.

Clinical Testing

No clinical trial required. Simulated use testing on cadavers performed

Conclusion

The GYDER® Hip System is substantially equivalent to the predicate device OrthAlign Plus® System (K130387). Testing against the FDA consensus performance standard (ASTM F2554-18) and clinical

{9}------------------------------------------------

validation using cadaver models has demonstrated that the GYDER® Hip System is as safe and as effective as the predicate device.

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).