The Waypoint GPS™ is indicated for use during pedicle screw pilot hole drilling to provide visual feedback to the surgeon of changes in color to the tissue at the tip of the probe that may indicate contact with soft tissues and possible vertebral cortex perforation. The Waypoint GPS™ is indicated for use in both open and percutaneous (MIS) procedures.

Device Description

The Waypoint GPS™ is comprised of a single use, disposable device and a software application that is downloaded onto the provided tablet. The system is intended to surgeons during pilot hole drilling for pedicle screw placement. Waypoint GPS™ probe is single use disposable and consists of a handle containing electronics and a stainless-steel shaft with distal LED and fiber optics for visualizing the tissues immediately in contact with the distal end of the probe. The device produces visual signals to indicate changes in color associated with possible verforation. It uses light to provide visual alerts to indicate a change in anatomical structure to prevent placement in soft tissues or vertebral cortex perforation.

AI/ML Overview

The Waypoint Guided Pedicle System (GPS) is indicated for use during pedicle screw pilot hole drilling to provide visual feedback to the surgeon of changes in color to the tissue at the tip of the probe that may indicate contact with soft tissues and possible vertebral cortex perforation.

Here's an analysis of the acceptance criteria and the study results:

1. Table of Acceptance Criteria and Reported Device Performance

Although explicit "acceptance criteria" values (e.g., minimum accuracy percentage) are not provided in a single, clear table within the document, we can infer the criteria from the "Test Method Summary" and "Results" columns, especially for the GLP Animal Study which directly compares performance.

Acceptance Criteria (Inferred)	Reported Device Performance
Biocompatibility: Device materials are non-cytotoxic, non-sensitizing, non-irritating, non-toxic, and non-pyrogenic.	Passed. Non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic.
Insertion Force: Device can complete a minimum of 15 insertions into Sawbones at a specified depth without mechanical failure.	Passed. Each shaft was able to successfully complete 15x insertions without mechanical failure.
Torque on the shaft (endurance): Device can withstand 15x torque cycles on the shaft without mechanical failure while inserted in Sawbones.	Passed. Each shaft was able to successfully withstand 15x torque on a shaft cycle without mechanical failure.
Torque to failure: Device shaft can withstand a target torque without failure.	Passed. Each shaft was able to successfully withstand the target torque.
Simulated Use Testing: Device can successfully complete pairing with tablet, color calibration, color testing, and battery monitoring after endurance testing. Users can perform procedure and interpret results.	Passed. Each device successfully completed all procedure steps. Users can perform the device procedure and correctly interpret the device output.
Visualization and Color: Device output (RGB values and color change) reliably reflects contact with different colored materials.	Passed. Each device successfully completed the test cycle and displayed correct colors and RGB values.
Electrical Safety and EMC: Device complies with IEC 60601-1 and IEC 60601-1-2 standards.	Passed.
Software Verification and Validation: Software complies with FDA guidance for medical device software (moderate level of concern).	Passed.
Sterilization Validation: Sterilization process achieves sterility.	Passed.
Distribution and Aging: Device maintains performance (insertion force, torque, simulated use, visualization, color) after climactic conditioning, accelerated aging, and package performance testing. Sterile barrier is maintained.	Passed. Performance tests were successful on both unaged and aged devices. Sterile barrier was maintained.
GLP Animal Study (Non-Inferiority): The subject device (Waypoint GPS System) is non-inferior to the predicate PediGuard device in correctly identifying tip location (cortical bone, cancellous bone, breach). Users can adequately interpret results.	Passed. Users correctly identified GPS device tip location in 100% of procedures. Users successfully distinguished between cortical bone, cancellous bone, and a breach by the change in color and RGB values. Users correctly identified PediGuard tip location in 95% of procedures. Demonstrated with statistical significance (0.050) that the subject device is non-inferior to the predicate.

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

GLP Animal Study: The study involved multiple users performing pilot hole procedures in ovine lumbar vertebrae. The exact number of individual procedures or specific animal count is not given, but it states "The total number GPS procedures (including transverse processes) demonstrated the device performs as intended and users adequately interpret results with 95/95." This implies a total of 95 GPS procedures were evaluated.
- Provenance: This was an in vivo animal study using ovine (sheep) lumbar vertebrae. The geographical origin of the animals or the study site is not explicitly stated. It is a prospective study design for the animal study component.

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

GLP Animal Study: "Fluoroscopic CT was used to verify pilot hole depth, GPS, and PediGuard results." This indicates that imaging (Fluoroscopic CT) served as the primary, objective ground truth. It is not explicitly stated how many experts (e.g., radiologists) interpreted these CT scans or their qualifications. However, in such studies, interpretation of CT by qualified personnel (likely veterinarians or radiologists with expertise in animal anatomy) would be standard.
Cadaver Study: The document mentions "a cadaver," implying human cadavers were used for a portion of the simulated use testing. Again, the number and qualifications of experts establishing ground truth (likely anatomical dissection for confirmation) are not specified.

4. Adjudication Method for the Test Set

GLP Animal Study: The primary ground truth was established by Fluoroscopic CT. The interpretation of this CT data (which would inherently involve expert adjudication if there were ambiguities, though not explicitly detailed) served as the objective measure. The device's output (color description for GPS, auditory for PediGuard) was then compared against this objective ground truth. It doesn't describe a specific adjudication method like "2+1" for human reader discrepancies, as the ground truth was derived from imaging.

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

Yes, a comparative study was done for the GLP Animal Study. It was a side-by-side comparison of the Waypoint GPS device and the predicate PediGuard device involving "multiple users" (readers).
Effect Size of Human Readers' Improvement with AI vs. without AI Assistance: This specific metric (improvement of human readers with AI assistance) is not directly provided or applicable in the requested format.
- The study compares two devices: Waypoint GPS (subject device) which provides visual feedback (color changes) and PediGuard (predicate device) which provides auditory feedback (change in cadence and pitch). Both are "assistance" devices.
- The study aims to show non-inferiority of the GPS device to the PediGuard device, not necessarily the improvement of human readers with either device compared to without any device.
- However, the results show:
  - Users correctly identified GPS device tip location in 100% of procedures.
  - Users correctly identified PediGuard tip location in 95% of procedures.
- This demonstrates that with the assistance of the GPS device, users were able to correctly identify tip location more consistently (100%) than with the predicate PediGuard device (95%) in the animal model. The study concludes statistical non-inferiority (p=0.050).

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, a standalone study was not performed or described. The Waypoint GPS device is designed to provide "visual feedback to the surgeon" and its performance is evaluated in the context of "user interpretation" of its outputs. The "human-in-the-loop" is an integral part of its intended use and evaluation.

7. Type of Ground Truth Used

GLP Animal Study: Fluoroscopic CT scans were used to objectively verify pilot hole depth and location, establishing the ground truth for bone anatomy and breach detection.
Cadaver Study: Likely anatomical dissection or expert visualization for the human cadaver component, though not explicitly detailed.

8. Sample Size for the Training Set

Not Applicable / Not Provided. The document describes a medical device, not an AI/ML algorithm that undergoes a distinct training phase with a specific dataset. The "device" in this context refers to the physical instrument and its integrated electronics/software, which are likely designed and calibrated based on engineering principles and preclinical testing, rather than "training" on a dataset like a machine learning model.

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

Not Applicable / Not Provided. As explained above, there isn't a "training set" in the common AI/ML sense for this device. The principles of operation (spectral reflectance for color changes) are built into the device design rather than learned from labeled data.

Summary

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May 12, 2023

Waypoint Orthopedics, Inc. Tiffini Wittwer Regulatory Affairs 300 Applebrooke Drive Malvern, Pennsylvania 19355

Re: K222106

Trade/Device Name: Waypoint Guided Pedicle System (GPS) Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: QWP Dated: April 7, 2023 Received: April 12, 2023

Dear Tiffini Wittwer:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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, Patrick Antkowiak -S Patrick Antkowiak

Acting Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222106

Device Name Waypoint Guided Pedicle System (GPS)™

Indications for Use (Describe)

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)

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510(k) Summary - K222106

SUBMITTER: I.

	Company	Waypoint Orthopedics, Inc.
		300 Applebrooke Drive
		Malvern, PA 19355
	Contact Person:	Tiffini Wittwer
		Regulatory Affairs Consultant
		Phone: 707.799.6732
		E-mail: twittwer@mededge.io
	Date Prepared:	April 7, 2023
	II. DEVICE
	Trade Name:	Waypoint Guided Pedicle System (GPS)™
	Common Name:	Nerve Stimulator
	Classification Name:	Neurosurgical Nerve Stimulator / Locator (21 CFR 874.1820)
	Regulatory Class:	II
	Product Code:	OWP
Item	Waypoint GuidedPedicle System™(Subject Device)	SpineGuardPediGuard With DSGConnect Technology(Predicate Device)	Comment
510(k)	K222106	K201454
Class	II	II	Same
Product Code	QWP	PDQ, ETN	Primary product code is the same
Indicationsfor Use (IFU)	The Waypoint GPS™ isindicated for use duringpedicle screw pilot holedrilling to provide visualfeedback to the surgeon ofchanges in color to the tissueat the tip of the probe that mayindicate contact with softtissues and possible vertebralcortex perforation. TheWaypoint GPS™ is indicatedfor use in both open andpercutaneous (MIS)procedures.	The PediGuard is indicated foruse during pedicle screw pilothole drilling to providefeedback to the surgeon viavisual and audible alerts thatindicate a change in impedanceat the tip of the probe and mayindicate contact of the tip withsoft tissues and possiblevertebral cortex perforation.The PediGuard system isindicated for use in both openand percutaneous (MIS)surgical approaches to thespine. PediGuard is alsoindicated for use withfluoroscopic guidance inpercutaneous (MIS) surgicalapproaches to the spine.The PediGuard also isspecifically indicated for use inintraoperativeelectromyographic ("EMG")surveillance to assist in thelocation and evaluation ofspinal nerves during surgery ofthe spine, by administration oflow voltage electrical energy totissues and nerves duringsurgery of the spine, and EMGmonitoring of muscle groupsassociated with those nerves.	Subject device has a narrowerindication for use that thepredicate (does not includefluoroscopic guidance or EMGsurveillance). Description ofoutput (color versusimpedance) does not changethe indication for use. Uservalidation testing demonstratesthis difference does not raisenew questions of safety ofeffectiveness.
Item	Waypoint GuidedPedicle System™(Subject Device)	SpineGuardPediGuard With DSGConnect Technology(Predicate Device)	Comment
Output	Visual	Visual and Auditory	User validation testing of thesubject device and side-by-sideanimal testing of the subjectdevice and predicate devicedemonstrates this differencedoes not raise new questions ofsafety of effectiveness.
Connection	Software application on tabletallows for visualization	Software application on tabletallows for visualization	Same
Principles ofoperation	Shaft serves as bone awl andprovides visual feedbackindicating if device hasperforated vertebral cortex	Shaft serves as bone awl andnerve locator by providingvisual and auditory feedbackindicating if device hasperforated vertebral cortex	Pre-clinical performance testing ofthe subject device, and side-by-sideanimal testing of the subject deviceand predicate device demonstratesthat this difference does not raisenew questions of safety oreffectiveness.
TechnicalPrinciples ofOperation	Spectral reflectance: the electro-optical property of a material toreflect light. Photons of a specificwavelength are reflected back to asensor. These wavelengths appearon the display tablet as the colorinformation for the respectivetissue type.● Cortical bone has lowestabsorbance => morephotons reflect back tosensor => lighter color● Cancellous bone has higherabsorbance of green / blue& reflects red => red todark displayed● Cortical breach (void) =>highest absorbance => lackof light reflected back tosensor => dark or blackcolor	Electrical conductivity: theproperty of a material to allowcurrent flow. Electricalconductance between twoelectrodes is measured ascurrent. Current is monitoredin feedback circuitry thatgenerates an output frequencyin an audible range.● Cortical bone has lowconductivity => lowercurrent => low, slow signal● Cancellous bone hascomparatively mediumconductivity => mediumsignal● Periosteum and blood havehigh conductivity(indicates cortical breach)=> larger measurement toconvert => higher pitched,faster sound	Pre-clinical animal testing,including side-by-side testing of thesubject device and the predicatedevice demonstrate that thetechnical difference does not raisenew questions of safety oreffectiveness.
Handle Shape	Gearshift Knob-Handle	Gearshift T-Handle	Same
Components	Single piece, Stainless Steel Shaft,plastic handle	Single piece, Stainless Steel Shaft,plastic handle, ceramic insulatoror modular with removable handle	Same external components.Performance bench testingdemonstrates differences ininternal components do not raisenew questions of safety ofeffectiveness.
Item	Waypoint GuidedPedicle System™(Subject Device)	SpineGuardPediGuard With DSGConnect Technology		Comment
		(Predicate Device)
Shaft / boneawl material	17-4PH Stainless Steel	Inner electrode: 316L StainlessSteel (ASTM F138) Outerelectrode and/or shaft: 304Stainless Steel (ASTM F899),316L Stainless Steel and/or 17-4PH (ASTM F899)	Biocompatibility testing andperformance testing of the subjectdevice demonstrates materialdifferences do not raisenew questions of safety ofeffectiveness.
SafetyFeatures	Device cannot be turned off untilbattery exhausted. Prevents reuseof device.	Device cannot be turned off untilbattery exhausted. Prevents reuseof device.	Same
InternallyPowered	Lithium-Ion BatteryChemistry: Li/MnO2Max output current: 3.0mA	Lithium-Ion BatteryChemistry: Li/MnO2Max output current: 5.5mA	Same battery type; run time ofsubject device is lower thanpredicate. Electrical safety andperformance testing demonstratesdifference does notraise new questions of safety ofeffectiveness.
Sterility	Sterile	Sterile	Same
Single Use orReusable	Single use	Single use	Same
Distal ShaftShape	Straight, cannulated	Curved or straight; or straight(cannulated) with removable innerstarter stylet (optional) andsensory needle	Same as 1 predicate model
Dimensions	Shaft Length: 200mmDiameter of cutting edge: 4.0mm	Shaft Lengths: 120mm & 160mmOuter Diameters: 4.0mm - 5.5mm	OD is within predicate range.Performance and cadaver testing ofthe subject device demonstratesdifference does not raise newquestions of safety of effectiveness.
Circuit Board	Capacitors, Resistors and Diodes- Firmware (programmable chip)on circuit board	Capacitors, Resistors and Diodes- Firmware (programmable chip)on circuit board	Same
AnatomicalSite	Spine	Spine	Same
Where used	Within a sterile field in anoperating room	Within a sterile field in anoperating room	Same

III. PREDICATE DEVICE(S)

The subject device is equivalent to the following devices:

K201454 DSG Connect Technology

IV. DEVICE DESCRIPTION:

v. INDICATION FOR USE

VI. SUBSTANTIAL EQUIVALENCE

The subject Waypoint GPS™ system is similar to the predicate in several ways. Both devices provide real- time feedback to the surgeon during the preparation of the pedicle screw pilot holes, alerting the tip of the sensor senses a change in the surrounding tissues. The subject and predicate devices have the same

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intended use and use environment with similar indication for use and user interface. Both the subject device and predicate are provided as sterile, battery operated, hand-held probes comprised of similar materials. Performance testing has demonstrated that the primary technical difference (use of electrical impedance verses spectral reflectance) raises no new issues of safety and effectiveness. Thus, the subject Waypoint GPS is substantially equivalent to the predicate PediGuard.

Table 1: Substantial Equivalence Review

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VII. PERFORMANCE DATA

Table 2 below lists all of the testing that has been performed on the Waypoint GPS System.

Table 2: Performance Test Summary

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Test	Test Method Summary	Results
BiocompatibilityTestingCytotoxicity Sensitization IntracutaneousReactivity Acute SystemicToxicity Material MediatedPyrogenicity	FDA Guidance “Use of International StandardISO 10993, 'Biological Evaluation of MedicalDevices Part 1: Evaluation and Testing andISO 10993-1, Biological Evaluation of medicalDevices Part 1: Evaluation and Testing within arisk management process.(ISO 10993-5, ISO 10993-10, 10993-11)	Passed. Non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic.This test is relevant in determiningsubstantial equivalence because itdemonstrates any material differencesbetween the subject device and the predicatedo not raise new questions of safety.
Insertion Force	Device shafts and finished devices were testedto demonstrate that it can complete a minimumof 15 insertions into Sawbones at a specifieddepth without mechanical failure similar to astandard bone awl.	Passed. Each shaft was able to successfullycomplete 15x insertions without mechanicalfailure. This test is relevant in determiningsubstantial equivalence because itdemonstrates the subject device can createmultiple pilot holes during one clinicalprocedure and perform as a bone awl.
Torque on the shaft	Device shafts and finished devices weresubjected to 15x torque on the shaft cycles.This was done to demonstrate that the devicecan ultimately function as a standard bone awl.Testing was performed with the tip of the shaftbeing at a specified depth in Sawbones and atorsion machine was used to apply force. Eachdevice was tested repeatedly 15 times.	Passed. Each shaft was able to successfullywithstand 15x torque on a shaft cycle withoutmechanical failure. This test is relevant indetermining substantial equivalence becauseit demonstrates the subject device canreliably create multiple pilot holes duringone clinical procedure and perform as a boneawl.
Torque on the shaft	Torque to failure testing was performed ondevice shafts. This testing was performed byholding both ends of the device using vices andthen rotating the proximal end using a torsionmachine.	Passed. Each shaft was able to successfullywithstand the target torque. This test isrelevant in determining substantialequivalence because it demonstrates thesubject device shaft can reliably be used increating multiple pilot holes during oneclinical procedure as a bone awl.
Simulated Use Testing	Complete devices were tested for pairing ofdevice with tablet, color calibration, colortesting, and battery monitoring. Each devicewas tested 2 times before and after beingsubjected to Insertion Force and Torque on theshaft.	Passed. Each device was able to successfullycomplete each of the procedure stepsrequired for intended use. This test isrelevant to determining substantialequivalence because it demonstrates that theWayPoint GPS System (device and tablet)reliably performs as intended under worstcase conditions. The reliability of the devicecommunication and pairing to the tabletsupports substantial equivalence of theproposed device to the predicate device withtablet communication feature.
Visualization and color	Complete devices were tested for visualizationand color. This testing included monitoring thetablet screen to see if RGB value and the colorchanged as probe contacts with different colorsand recording RGB values for each color cardused.	Passed. Each device was able to successfullycomplete the test cycle and display correctcolors and RGB values. This test is relevantin determining substantial equivalencebecause it demonstrates the device output(change in color) is reliably achieved, similarto the change in sound of the predicatedevice
Test	Test Method Summary	Results
Electrical Safety andelectromagneticcompatibility (EMC)	Testing was conducted in compliance with theIEC 60601-1 standard for safety and IEC60601-1-2 standard for EMC.	Passed. This test is relevant in determiningsubstantial equivalence because the subjectdevice and predicate device both containelectrical components in their the devicedesign.
Software Verificationand Validation Testing	Testing was conducted as recommended byFDA's "Guidance for the Content of PremarketSubmissions for Software Contained inMedical Devices." For moderate level ofconcern software	Passed. This test is relevant in determiningsubstantial equivalence because the subjectdevice and predicate device both containsoftware in the device design.
Sterilization Validation	Testing was conducted in accordance with ISO11135-1:2014 - Sterilization of HealthcareProducts – Ethylene Oxide: Requirements fordevelopment, validation, and routine control ofa sterilization process for medical devices. TheOverkill test method was used.	Passed. This test is relevant in determiningsubstantial equivalence because the subjectdevice and predicate device are bothterminally sterilized products.
Distribution and Aging	Devices and the package system were subjectedto climactic conditioning, accelerated aging,and package performance testing as outlined inASTM D4169-22 using Distribution Cycle 13.Individual pouches were then subjected togross leak detection (bubble) per ASTMF2096-11, and seal strength (peel) testing perASTM F88/F88M-21.	Passed. Insertion force, torque, simulateduse, visualization, and color testing were allperformed on unaged and aged devicesdemonstrating sterile barrier packaging anddevice performance reliability over time.This test is relevant in determiningsubstantial equivalence because both devicesare terminally sterilized and required toreliably perform as intended through statedexpiration date.
Cadaver study	Multiple users performed device set up,calibration, pilot hole creation, andinterpretation of tablet display results per theInstructions for use. Each user performed theprocedure in a modified sawbone that includeddifferent colors, and a cadaver.	Passed. This test is relevant to determiningsubstantial equivalence because itdemonstrates users can perform the deviceprocedure and correctly interpret the deviceoutput in the same procedure and intendeduse and the predicate.
GLP Animal Study	In vivo performance testing. Multiple usersperformed pilot hole procedures in ovinelumbar vertebrae using the GPS device and thepredicate PediGuard device. Each pilot holewas planned for a specific depth (cortical bone,cancellous bone, or breach of cortical bone).Fluoroscopic CT was used to verify pilot holedepth, GPS, and PediGuard results. Additionalprocedures were performed in the transverseprocesses using GPS with direct visualizationconfirmation. Users reported the device tiplocation for both the subject device (colordescription) and predicate device (auditorydescription) locations. Data output was alsorecorded for each device procedure. The side-by-side comparison data was powered to>90%.	Passed. Users correctly identified GPSdevice tip location in all procedures (100%).Users successfully distinguished betweencortical bone, cancellous bone, and a breachby the change in color and change in red,green, blue (RGB) values displayed on thetable.Users correctly identified PediGuard tiplocation in most procedures (95%). Userswere able to distinguish between corticalbone, cancellous bond, and breach by thechange in cadence and pitch the predicatedevice emitted.The results demonstrated with statisticalsignificance (0.050) that the subject device(WayPoint GPS System) is non-inferior tothe predicate PediGuard device.The total number GPS procedures (includingtransverse processes) demonstrated thedevice performs as intended and usersadequately interpret results with 95/95.
Test	Test Method Summary	Results
GLP Animal Study(continued)		This study is relevant in determining thesubstantial equivalence of the subject devicebecause it provides in vivo objectiveevidence that the technical differencesbetween the subject device and the predicatedo not affect the intended use. Further theside-by-side in vivo testing demonstrates thatuser interpretation of the subject device isequivalent to the predicate device.

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CONCLUSIONS VIII.

Waypoint Orthopedics considers the Guided Pedicle System™ (GPS) to be substantially equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in intended use, indication for use, anatomical sites, principles of operation, and materials. As confirmed through bench testing the Waypoint GPS™ is as safe and effective for its intended purpose as the predicate device.

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.