Caduceus S is intended as an intraoperative gudance system to enable minimally invasive surgery. Intraoperatively registered surgical Instruments are tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data.

Caduceus S enables image-guide navigation of medical image data, which can either be acquired preoperatively CT or intraoperatively C-arm by an appropriate image acquisition system.

Caduceus S offers pedicle screw implant size planning and navigation on rigid bone structures with intraoperatively registered surgical Instruments.

Caduceus S is indicated for L5~T6 spine surgery where reference to a rigid anatomical structure can be identified relative to the acquired patient imagery (CT or C-arm).

The headset (Surglasses) of the Caduceus S system is an optional heads up display that projects the 2D stereotaxic screens of the system's display.

Device Description

Caduceus S surgical navigation system is an image guidance system, which is composed of Navi Tracker, Surglasses, other hardware (Navigation Cart with an arm, Touch Screen, Router, Control System, Connection System), disposable tools (Disposable Passive Sphere, Straight Guide Pin, Navi Clamp Kit, Instrument Adapter Type A&B, Calibration Plate, Registration Kit, Correction Tool), reusable tools (Calibration Board, Instrument Holder), and Spine Navigation Software. Caduceus S is an optical tracking and guiding system for spine surgery. It can track the marks on the surgical instruments and patient's anatomical structure with marks, and register with the preoperative or intraoperative images of the patients. During the surgery, it can be displayed on the Touch Screen and the head mounted display Surglasses to provide the navigation for the surgical instruments.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the Caduceus S device meets them, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The core performance validation for this device, a surgical navigation system, relates to its accuracy in positioning and trajectory. The summary explicitly states:

Acceptance Criteria	Reported Device Performance
System Level Accuracy
Mean positional error ≤ 2.0 mm	CT Mode: Mean positional error = 1.91 mm (99% UBL* = 2.07 mm) C-arm Mode: Mean positional error = 1.80 mm (99% UBL* = 2.06 mm)
Mean trajectory error ≤ 2°	CT Mode: Mean angular error = 1.59° (99% UBL* = 1.71°) C-arm Mode: Mean angular error = 1.65° (99% UBL* = 1.80°)
Performance on head mounted display: FOV, resolution, luminance, transmission, distortion, contrast ratio, latency	The testing of device intended performance is successful, and all requirements are met. (Specific numerical values for these metrics are not provided in this summary but were likely documented in the full submission).

*UBL = Upper Bound Limit (This indicates the upper limit of the confidence interval for the measured error, providing a statistical guarantee.)

Study Details

The primary study mentioned for evaluating device performance is a "System's accuracy" and "Performance and Usability of device intended use" study, which involved both phantom and cadaver studies.

Sample Size and Data Provenance:
- Test Set Sample Size: The exact number of pedicle screws positioned or cases in the cadaver study is not explicitly stated as a number of subjects/specimens, but it mentions pedicle screws were positioned in L5-T6 spine. The testing was conducted in both "phantom and cadaver studies."
- Data Provenance: The document does not specify the country of origin for the cadaver data. It states the studies were non-clinical. The studies were retrospective in the sense that they were pre-market validation studies using pre-existing materials (phantoms, cadavers) to simulate real-world conditions.
Number of Experts and Qualifications for Ground Truth:
- The document does not specify the number of experts used to establish the ground truth or their specific qualifications. It mentions that the positional error was derived from the "post-op scan" and its virtual tip as recorded by the Caduceus S system. This suggests the ground truth was established by comparing system output to a precise post-procedure imaging measurement.
Adjudication Method:
- The document does not describe an adjudication method involving multiple human readers for the test set. The ground truth appears to be based on direct measurement from post-operative imaging.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical test data was used to support the decision of substantial equivalence." This means no study was performed comparing human readers with and without AI assistance to measure improvement. The device is purely an intraoperative guidance system, and its validation focuses on its technical accuracy rather than interpretive diagnostic performance.
Standalone Performance Study:
- Yes, a standalone study was performed. The described "System's accuracy" assessment is a standalone evaluation of the algorithm's output (positional and angular error) against the established ground truth (derived from post-op scans). This is algorithm-only performance without a human-in-the-loop directly influencing the measured accuracy metrics.
Type of Ground Truth Used:
- The ground truth was established by measurements obtained from post-operative imaging (post-op scan). Specifically, for positional error, it was the difference between the actual screw tip position derived from the post-op scan and the system's recorded virtual tip. For trajectory error, it was the difference between the screw orientation and its recorded virtual trajectory. This closely aligns with "outcomes data" or highly precise "imaging-based comparison."
Training Set Sample Size:
- The document does not specify the sample size used for the training set. This is a common omission in 510(k) summaries, as the focus is on the validation of the final device, not the development process.
Ground Truth Establishment for Training Set:
- The document does not provide details on how ground truth was established for any training set. Given the nature of a 510(k) submission and the device (a surgical navigation system rather than a diagnostic AI), details on training data are typically less prominent in the publicly available summary unless directly relevant to a novel AI methodology requiring extensive clinical data for training. The performance validation relies on the non-clinical bench and cadaver studies.

Summary

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December 16, 2022

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Taiwan Main Orthopaedic Biotechnology Co., Ltd. Min-Liang Wang, CEO 1F., No. 46, Keya Rd., Daya Dist. Taichung City, 42881 Tw

Re: K220554

Trade/Device Name: Caduceus S Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 30, 2022 Received: November 30, 2022

Dear Min-Liang Wang:

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 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

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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 (QS) 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 medical devices and radiation-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.

Jesse Muir -S

For; 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

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Indications for Use

510(k) Number (if known)

K220554

Device Name Caduceus S

Indications for Use (Describe)

Caduceus S enables image-guide navigation of medical image data, which can either be acquired preoperatively CT or intraoperatively C-arm by an appropriate image acquisition system.

Caduceus S offers pedicle screw implant size planning and navigation on rigid bone structures with intraoperatively registered surgical Instruments.

Caduceus S is indicated for L5~T6 spine surgery where reference to a rigid anatomical structure can be identified relative to the acquired patient imagery (CT or C-arm).

The headset (Surglasses) of the Caduceus S system is an optional heads up display that projects the 2D stereotaxic screens of the system's display.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Traditional 510(k) Summary

K220554 510(k) SUMMARY

5.1	Type of Submission:	Traditional
5.2	Date of Summary:	February 25, 2022
5.3	Submitter:	Taiwan Main Orthopaedic Biotechnology Co., Ltd.
	Address:	1F., No. 46, Keya Rd., Daya Dist., Taichung City 428, Taiwan(R.O.C.)
	Phone:	+886-4-3707-3159
	Fax:	+886-4-2565-3330
	Contact:	Jacky Fan (Regulatory Affair)

5.4 Identification of the Device:

Proprietary/Trade name:	Caduceus S
Classification Product Code:	OLO
Regulation Number:	882.4560
Regulation Description:	Stereotaxic instrument
Review Panel:	Orthopedic
Device Class:	II
Basis for the Submission:	New Device

ર્ રંડ Identificationof the Predicate Device:

Predicate Device Name:	Spine & Trauma Navigation
Submitter:	Brainlab AG
Classification Product Code:	OLO
Regulation number:	882.4560
Device Class:	II
510(k) Number:	K183605

5.6 Identificationof the Reference Device:

Reference Device Name:	xvision Spine system (XVS)
Submitter:	Augmedics Ltd.
Classification Product Code:	OLO

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Regulation number:	882.4560
Device Class:	II
510(k) Number:	K190929

5.7 Indications for Use

Caduceus S is intended as an intraoperative guidance system to enable minimally invasive surgery. Intraoperatively registered surgical Instruments are tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data.

Caduceus S enables image-guide navigation of medical image data, which can either be acquired preoperatively CT or intraoperatively C-arm by an appropriate image acquisition system.

Caduceus S offers pedicle screw implant size planning and navigation on rigid bone structures with intraoperatively registered surgical Instruments.

Caduceus S is indicated for L5~T6 spine surgery where reference to a rigid anatomical structure can be identified relative to the acquired patient imagery (CT or C-arm).

The headset (Surglasses) of the Caduceus S system is an optional heads up display that projects the 2D stereotaxic screens of the system's display.

5.8 Device Description

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Traditional 510(k) Summary

5.9 Substantial Equivalence Determination

Equivalence, same and difference among the subject, predicate and reference devices are cited as below.

Item	Subject Device	Predicate Device	Reference Device	Substantial EquivalenceDetermination
Proprietary Name	Caduceus S	Spine & Trauma Navigation	xvision Spine system (XVS)
510(k) No.		K183605	K190929
Indications forUse	Caduceus S is intended as anintraoperative guidance system toenable minimally invasive surgery.Intraoperatively registered surgicalInstruments are tracked by a passivemarker sensor system to virtualcomputer image space on a patient'spreoperative or intraoperative 2D or 3Dimage data.Caduceus S enables image-guidenavigation of medical image data,which can either be acquiredpreoperatively CT or intraoperativelyC-arm by an appropriate imageacquisition system.Caduceus S offers pedicle screwimplant size planning and navigationon rigid bone structures with	Spine & Trauma 3D is intended as anintraoperative image-guidedlocalization system to enableminimally invasive surgery. It links afreehand probe, tracked by a passivemarker sensor system to virtualcomputer image space on a patient'spreoperative or Intraoperative 2D or3D image data.Spine & Trauma 3D enables computer-assisted navigation of medical imagedata, which can either be acquiredpreoperatively or inter-operatively byan appropriate image acquisitionsystem.The software offers screw implant sizeplanning and navigation on rigidbone structures with precalibrated and	The xvision Spine System, withxvision Spine System Software, isintended as an aid for preciselylocating anatomical structures ineither open or percutaneous spineprocedures. Their use is indicatedfor any medical condition in whichthe use of stereotactic surgery maybe appropriate, and wherereference to a rigid anatomicalstructure, such as the spine, can beidentified relative to CT imageryof the anatomy. This can include thespinal implant procedures, such asPosterior Pedicle Screw Placementin the thoracic and sacro-lumbarregion.The Headset of the xvision Spine	EquivalentBoth the subject andpredicate devices are anintraoperative image-guidedlocalization system to enableminimally invasive surgeryand the subject device isfocus on spine surgery.Both the subject andreference devices display theimage by a headset and ascreen.Although there are sometechnical differences amongthese devices, the subjectdevice is tested and
	intraoperativelyregistered surgical	additional	individually-calibrated System displays 2D stereotaxic	validated so that the
	Instruments.	surgical tools. The system is indicated	screens and a virtual anatomy	difference does not raise
	Caduceus S is indicated for L5~T6 for any medical condition in which the		screen. The stereotaxic screen is	new issues of SE.
	spine surgery where reference to a rigid	use of stereotactic surgery may be	indicated for correlating the
	anatomical structure can be identified	appropriate and where a reference to a	tracked instrument location to the
	relative to the acquired patient imagery	rigid anatomical structure, such as the	registered patient imagery. The
	(CT or C-arm).	skull, the pelvis, a long bone or	virtual screen is indicated for
	The headset (Surglasses) of the	vertebra can be identified relative to	displaying the virtual instrument
	Caduceus S system is an optional heads	the acquired image (CT, MR, 2D	location in relation to the virtual
	up display that projects the 2D	fluoroscopic image or 3D fluoroscopic	anatomy to assist in percutaneous
	stereotaxic screens of the system's	image reconstruction) and/or an image	visualization and trajectory
	display.	data based model of the anatomy.	planning.
			The virtual display should not be
			relied upon solely for absolute
			positional information and should
			always be used in conjunction with
			the displayed stereotaxic
			information.
Type of Use	Prescription Use	Prescription Use	Prescription Use	Same
Use Environment	Operating Room	Operating Room	Operating Room	Same
	• Platform including cart, computer,monitor and tracking cameras	• Platform including cart, computer,monitor and tracking cameras	• Headset with near eyesee-through display	Equivalent
Main Component	• Headset with near eye see-through	• Software application	• tracking camera	subject device iscomposed of headset as the
	displayNavi trackerSoftware applicationReflective markers - SpheresInstrument universal adaptors	Reflective markers - SpheresAccessories (Instrument adaptors,referencing system)	Software applicationReflective markers - FlatInstrument universal adaptorsReference point	reference device does, andthe rest components aresimilar with that of thepredicate device.Although the maincomponent is slightlydifferent among thesedevices, the subject device is
	Patient PreparationSystem Set-up	Patient PreparationSystem Set-up	Patient PreparationSystem Set-up	tested and validated so thatthe difference does not raisenew issues of SE.Equivalent
Modes ofOperation	Intraoperative scanScan ImportPlanningPatient RegistrationNavigation	Intraoperative scanScan ImportPlanningPatient RegistrationNavigation	Intraoperative scanScan ImportPatient RegistrationNavigation	The modes of operation arethe same between subjectand predicate devices.
LocalizationTechnology	Optical	Optical	Optical	Same
Optical Tracker	Two infrared cameras, positioned 1.3 ~2 m away from tracked objects	Two infrared cameras, positioned 2 ~3 m away from tracked objects	Single infrared camera, positioned0.5m above tracked objects	EquivalentThe number of trackingcameras is the same betweensubject and predicate

				devices.Although the positioningdistance is slightly differentamong these devices, thesubject device is tested andvalidated so that thedifference does not raisenew issues of SE.
Tracking ofRotational Motion	6 degrees of freedom (DOF)	6 degrees of freedom (DOF)	6 degrees of freedom (DOF)	Same
				Equivalent
	Triangulation	Triangulation	Perspective N-point	The tracking algorithm is the
				same between subject and
				predicate devices, and it is
TrackingAlgorithm				compared on the headsetbetween subject andreference devices.
				The difference does not raisenew issues of SE.
System AccuracyRequirement	System Level Accuracy with a meanpositional error of 2.0 mm and meantrajectory error of 2°	System Level Accuracy with a meanpositional error of 2.0 mm and meantrajectory error of 2°	System Level Accuracy with amean positional error of 2.0 mmand mean trajectory error of 2°	Same
Imaging Modality	X-Ray Based Imaging	X-Ray Based Imaging	X-Ray Based Imaging	Same
Item	Subject Device	Predicate Device	Reference Device	Substantial EquivalenceDetermination
Proprietary Name	Caduceus S	Spine & Trauma Navigation	xvision Spine system (XVS)
510(k) No.		K183605	K190929
Display Features	2D images: axial and sagittal3D modelTrajectoriesTrajectory guidanceInstrument's tip view3D transparent3D OFF (only 2D)3D follow instrument movement	Look Sideways 3DAnatomic OrthogonalTrajectory 1 and 2Trajectory GuidanceLook AheadProbe's EyeAP and LateralSynthetic AP and LateralMaximum IntensityProjectionVideo Input	2D images: axial and sagittal3D modelTrajectoriesTrajectory guidanceInstrument's tip view3D transparent3D OFF (only 2D)3D follow instrument movement	EquivalentThe display features are thesame between subject andreference devices.
Software Interface(GUI)	Black and gray style with proceduretask overview in a menu. Softwarecontrols for images, instrument andplanned trajectory management arecontained in a left side bar.	Black and gray style with proceduretask overview in left menu option andnext/back task flow at bottom of thescreen. Software controls for images,planning and instrument managementare contained in a right side bar.	Black and blue style withprocedure task overview in a menuand next/back task flow. Softwarecontrols for images, instrument andplanned trajectorymanagement.	EquivalentAlthough the design ofsoftware interface is slightlydifferent among thesedevices, the subject device istested and validated so thatthe difference does not raisenew issues of SE.
Display and	Augmented Reality using near eye	Data displayed on a monitor	Augmented Reality using near eye	Equivalent
OpticsTechnology	see-through display; data displayed on patient's anatomy.		see-through display; data displayed on patient's anatomy.	The display technology is the same between subject and reference devices.
Frame rate ofdisplayed images	60 fps	(not revealed)	60 fps	EquivalentThe frame rate is the same between subject and reference devices.
Headset powersource	Li-ion rechargeable battery	(no headset)	Li-ion rechargeable battery	EquivalentThe frame rate is the same between subject and reference devices.
Communicationbetween Scannerand platform/computer	CD 、DVD 、USBDCIOM Import	Network ConnectivityCD 、DVD 、USBDCIOM ImportDCIOM Export	USB & LAN connectivity usingDICOM	EquivalentAlthough the communication way between scanner and computer is slightly different among these devices, the subject device is tested and validated so that the difference does not raise new issues of SE.
Communicationbetween Headsetand computer	Wireless, encrypted	(no headset)	Wireless, encrypted	EquivalentThe communication way between headset and
Caduceus S		Traditional 510(k) Summary
Applications	C-arm Imaging SystemCT Imaging System	(not revealed)	O-arm Imaging SystemZiehm Vision FD Vario 3DC-Arm and RFD 3D SiemensCIOS SPinAiro system by Brainlab	computer is the samebetween subject andreference devices.EquivalentAlthough the application isslightly different amongthese devices, the subjectdevice is tested andvalidated so that thedifference does not raisenew issues of SE.

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Traditional 510(k) Summary

Taiwan Main Orthopaedic Biotechnology Co., Ltd.

5.10 Similarity and Difference

The Caduceus S has been compared with predicate device "Spine & Trauma Navigation" and reference device "xvision Spine system". The subject device has same intended use, principle of operation and similar technological characteristics as the predicate and reference devices. The subject device has undergone safety and the results complied with the test requests.

Although there are some different specifications between these devices, the performance test has been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device. Therefore, the difference among the subject, predicate and reference devices did not raise of substantial equivalence. The subject device is substantially equivalent to the predicate and reference devices in intended use, design and performance claims.

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5.11 Summary of Non-clinical Testing

A series of safety and performance tests were conducted on the subject device, Caduceus S.

Test	Conclusion	Main Reference
General designrequirements and riskanalysis	Verification of general design requirements is successful,and risk control measures are effective and mitigate theassociated risks.	ISO 14971
Sterilization Validationfor EO sterile surgicalinstruments	The testing of device safety for sterilization as well asvalidation is successful, and all requirements are met.	ISO 11135;ISO 10993-7;ISO 11737-1;ISO 11737-2
Reliability Testfor electrical hardware	The testing of general device function in criticalenvironment is successful, and all requirements are met.	N/A
Shelf Life Test for EOsterile surgical instruments	The testing of device safety for shelf life of sterilepackage is successful, and all requirements are met.	ASTM F1980;ASTM F1886 / F1886M;ASTM F1140 / F1140M;ASTM F1929;ASTM F88 / F88M
Biocompatibility Testsfor surgical instruments	The testing of device safety for biocompatibility issuccessful, and all requirements are met.	ISO 10993-1 and thesubsequent standards;FDA Guidance for Use ofInternational Standard ISO10993-1.
Software Validation	The testing of software validation is successful, includingunit and integration tests, and all requirements are met.	IEC 62304;FDA Guidance for the Contentof Premarket Submissions forSoftware Contained in MedicalDevices
Cybersecurity Evaluation	The evaluation of device demonstrates the positivecybersecurity under the expected using environment, andall requirements are met.	FDA Guidance for the Contentof Premarket Submissions forManagement of Cybersecurity inMedical Devices
Test	Conclusion	Main Reference
ElectromagneticCompatibility andElectrical Safety Testsfor electrical hardware	The testing of device EMC & Electrical safety issuccessful, and all requirements are met.	IEC / EN 60601-1;IEC / EN 60601-1-2;FDA Guidance for Informationto Support a Claim ofElectromagnetic Compatibility(EMC) of Electrically-PoweredMedical Devices.
Wireless CoexistenceEvaluation	The evaluation of device demonstrates the positivewireless coexistence under the expected usingenvironment, and all requirements are met.	AAMI TIR 69;ANSI IEEE C63.27;FDA Guidance for RadioFrequency Wireless Technologyin Medical Devices.
Performance on the headmounted display	The testing of device intended performance issuccessful, and all requirements are met.	Field of View(FOV),resolution,luminance, transmission,distortion, contrast ratio,latency
System's accuracy	The System Level Accuracy was also validated in acadaver study, in which pedicle screws were positionedpercutaneously in L5~T6 spine, using the Navi ClampKit as the rigid reference point.	IEC 63145-20-20;ASTM F2554;IEC 62366-1;
Performance and Usabilityof device intended use	The positional error was calculated as the differencebetween the actual screw tip position, derived from thepost-op scan, and its virtual tip, as recorded by theCaduceus S system. The trajectory error was calculatedas the difference between the screw orientation and itsrecorded virtual trajectory.An overall mean positional error of 1.91mm (99%UBL= $2.07$ mm) and angular error of 1.59 (99%UBL= $1.71$ ) was measured under CT mode and overallmean positional error of 1.80mm (99%UBL= $2.06$ mm) and angular error of 1.65 (99%UBL= $1.80$ ) was measured under C-arm mode.Thus, the system has demonstrated performance in 3Dpositional accuracy with a mean error statistically	FDA Guidance for ApplyingHuman Factors and UsabilityEngineering to Medical Devices.

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Taiwan Main Orthopaedic Biotechnology Co., Ltd.	Traditional 510(k) Summary
Caduceus Ssignificantly lower than 3mm and in trajectory angleaccuracy with a mean error statistically significantlylower than 3 degrees, both in phantom and cadaverstudies.

All the test results demonstrate Caduceus S meets the requirements of its pre-defined acceptance criteria and intended use, and performs as safely and effectively as predicate and reference devices.

5.12 Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

5.13 Conclusion

After comparing the devices and analyzing non-clinical safety & performance testing data, it can be concluded that the Caduceus S is substantially equivalent to the predicate and reference devices.

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).