The X-Guide(R) Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and intra-operative surgical phase of dental implantation procedures.

The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.

The device is intended for use for partially edentulous adult and geriatric patients who require dental implants as part of their treatment plan.

Device Description

The X-Guide® Surgical Navigation System is an electro-ontical device designed to aid dental procedures by providing the surgeon with accurate surgical tool placement and guidance with respect to a surgical plan built upon Computed Tomographic (CT scan) data.

The system provides the surgeon with a three visual aid to indicate dental drill location in space, with 6 degrees of freedom (X, Y, Z, Pitch, Yaw, and Roll) and an accuracy (RMS) of < 1 mm. This helps to improve the Oral Surgeon drilling precision within a patient oral cavity. Since the system is still working in the freehand mode, meaning he/she is always in control of the surgery.

The implant process occurs in two stages is the preplanning of the surgical implantation procedure. The dental surgeon plans the surgical procedure in the Implant Planning Software. XOS®. A virtual implant is aligned to the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Once an implant has been optimally positioned, the X-Guide® Surgical Navigation System in preparation for implant surgery.

In Stage 2 the system provides accurate quidance of the dental surgical instruments according to the pre-operative plan. As the dental surgeon moves the surgical instrument around the patient anatomy, 2D barcode tracking patterns on the Hand Piece Tracker and the Patient Tracker are detected by visible light cameras in a stereo configuration and processed by data processing hardware to precisely and continuously track the motion of the surgically-relevant portion of the patient.

The relative motion of the dental handpiece and the patient anatomy, captured by the tracking hardware, is combined with patient-specific calibration data. This enables a 3D graphical representation of the handpieced in precise location and orientation relative to a 3D depiction of the implant target, along with depictions of the patient anatomy, and other features defined in the surgical plan. This provides continuous visual feedback that enables the dental surgeon to maneuver the dental handpiece into precise alignment.

Several patient-specific calibrations underpin the quidance system. Hand Piece calibration is performed to determine the geometric relationship between the Hand Piece Tracker and the tip of the surgical instrument.

AI/ML Overview

The provided document is a 510(k) premarket notification for the X-Guide® Surgical Navigation System. It primarily focuses on demonstrating substantial equivalence to a predicate device (IGI-System™ by DENX Advanced Dental Systems Ltd. K023424) rather than presenting a detailed clinical study report with specific acceptance criteria and a comprehensive study design for device performance.

Therefore, many of the requested details about acceptance criteria, study design for proving performance, and expert involvement are not explicitly stated in the provided text as one would find in a dedicated clinical study report. The document describes aspects of verification and validation, including software testing and general clinical testing for accuracy and usability, but not a full-fledged MRMC or standalone performance study as might be conducted for an AI-driven diagnostic device.

Here's an attempt to extract and infer the information based on the provided text, while noting the limitations:

1. Table of Acceptance Criteria & Reported Device Performance:

The primary performance criterion mentioned consistently is navigation accuracy.

Acceptance Criteria (Inferred from Predicate and claims)	Reported Device Performance
Overall System Accuracy (RMS)	< 1 mm
No new Usability issues or risks identified	"No new Usability issues or risks have been identified"
No adverse events or complications identified or reported	"no adverse events or complications have been identified or reported" within 7 months of testing involving over 150 patients.

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

Clinical Testing Sample Size: "Over 150 patients participated in the study."
Data Provenance: The document states that "Clinical testing was conducted by Board Certified Oral Surgeons and testing was conducted at their facilities." This implies the data is likely prospective from clinical use in the US (given the FDA submission).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Number of Experts: Not explicitly stated. The testing was conducted by "Board Certified Oral Surgeons."
Qualifications of Experts: "Board Certified Oral Surgeons." The document does not specify their years of experience but board certification implies a high level of expertise in their field.

4. Adjudication Method for the Test Set:

Adjudication Method: Not specified or described. The document mentions that the system provides "continuous visual feedback that enables the dental surgeon to maneuver the dental handpiece into precise alignment" and "If significant deviation between the plan and the system performance occur, the system will alert the user." This suggests real-time feedback and alerts as part of the system's operation, but not a separate adjudication process for a test set in the traditional sense of a diagnostic study.

5. MRMC Comparative Effectiveness Study:

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or described in the provided text. The device is a surgical navigation system, providing real-time guidance, not primarily a diagnostic imaging interpretation tool typically assessed with MRMC studies. The document states it is "a supporting additional information to the decision-making process during the surgical procedure. It is by no means intended to replace the surgeon's judgment."

6. Standalone Performance (Algorithm Only):

Standalone Performance: Not explicitly detailed as a separate study. The "Overall System Accuracy (RMS) of < 1 mm" is a performance metric, likely derived from technical and potentially simulated clinical testing, but the document doesn't isolate the "algorithm only" performance from the integrated system functioning with human interaction. The device is fundamentally a navigation system with a human in the loop.

7. Type of Ground Truth Used:

Type of Ground Truth: The ground truth for surgical navigation systems like this is typically established by comparing the navigated instrument's actual position and orientation to the pre-planned CT-based surgical plan. The root mean square (RMS) accuracy of < 1 mm is a measure against this planned (and presumably verified) target. The text mentions "CT scan data" and "virtual implant is aligned to the desired location in the CT scan." This suggests the surgical plan derived from CT data serves as the target or "ground truth" for the navigation's accuracy validation.

8. Sample Size for the Training Set:

Training Set Sample Size: Not applicable or not specified. This document describes a medical device, not an AI model that undergoes a machine learning training phase with a dedicated dataset. The software undergoes "Software Verification and Validation Testing," which is a standard engineering process, not a machine learning training process.

9. How Ground Truth for Training Set Was Established:

Ground Truth for Training Set: Not applicable, as there's no mention of a machine learning training set or associated ground truth establishment for such a purpose. The accuracy and performance claims are based on engineering validation and usability/clinical observation.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 8, 2015

X-Nav Technologies, LLC. Mr. Fred Cowdery Director- Regulatory Affairs 1555 Bustard Road, Suite 75 Lansdale, PA 19446

Re: K150222

Trade/Device Name: X-Guide® Surgical Navigation System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: PLV Dated: September 14, 2015 Received: September 15, 2015

Dear Mr. Cowdery:

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. 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang-S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150222

Device Name

X-Guide(R) Surgical Navigation System

Indications for Use (Describe)

The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.

The device is intended for use for partially edentulous adult and geriatric patients who require dental implants as part of their treatment plan.

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 (As required by Section 807.92)

Date Prepared:	October 8, 2015
Applicant:	X-NAV Technologies, LLC1555 Bustard Road, Suite 75Lansdale, PA. 19446
Contact Person:	Fred CowderyDirector – Regulatory Affairs and Quality AssurancePh 267-436.0414Email: fred.cowdery@x-navtech.com
Device Trade/Proprietary Name:	X-Guide® Surgical Navigation System,Model P007839
Device Name: Common / Usual:	Surgical Navigation System
Classification Name:	21 CFR 872.4120 (Bone Cutting Instrument and Accessories)
Regulatory Class:	II
Product Code:	PLV (Dental Stereotaxic Instrument)
Predicate Device(s):	IGI-System™ by DENX Advanced Dental Systems Ltd. (K023424)

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Device Description:

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Likewise. Patient Tracker calibration is performed to determine the geometric relationship between the scan coordinates of the patient anatomy. There are separate procedures for Patient Tracker calibration, depending on whether the X-Clip or the E-Clip is used.

For toothed patients (partially edentulous), an X-Clip®, which contains embedded radiodense spheres, is attached to patient teeth prior to CT image acquisition. The location of the X-Clip® establishes a link between the CT coordinate system and the patient's surgical anatomy. Immediately prior to surgery, the Pattached, and a separate calibration determines the relationship between the Patient Tracker. This device remains on the patient teeth for the duration of surgery.

For edentulous (toothless) patients, the surgeon drills several narrow holes in the CT scan. Nothing is implanted. After the CT scan and surgical plan are completed, including the step of locating and marking the holes in the CT image, an E-Clip" is attached to the patient just prior to surgery. This device is necessary to attach tracking patterns to facilitate the navigation and tracking process, and is calibrated to the patient anatomy and CT by probing each of the fiducial holes and correlating these locations to the locations marked in the plan.

During execution of the surgical procedure, the X-Guide® Surgical Navigation System correlates between the surgical plan and the surgeon's actual performance. If significant deviation between the plan and the system performance occur, the system will alert the user.

The X-Guide® Surgical Navigation System is a supporting additional information to the decision-making process during the surgical procedure. It is by no means intended to replace the surgeon's judgment. The final decisions as to the exact location and depth of the surgery are the sole responsibility of the surgeon can at any time during the surgical procedure modify the planned implant positions. Under no circumstances does the device relieve the or her ultimate clinical responsibility.

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Image /page/6/Picture/0 description: The image shows the logo for X-NAV Technologies. The logo features a stylized "X" made of horizontal bars in shades of blue, green, and gray. To the right of the "X" is the word "NAV" in large, bold, dark blue letters, and below the "X-NAV" is the word "TECHNOLOGIES" in smaller, light gray letters.

Indications for Use:

The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.

The device is intended for use for partially edentulous adult and geriatric patients who need dental implants as part of their treatment plan.

Comparison of Technological Characteristics:

The X-Guide® Surgical Navigation System shares clinical, technological, and performance features with a similar FDA cleared tracking device - The Denx Ltd. IGI-System™ (K023424).

Both systems provide accurate guidal tools and implantable devices through the use of computer aided navigation. This guidance is achieved through the use of optical tracking of the surgical tools.

Neither device is intended to replace human assessment, but to provide objective information relating and alignment of the surgical tools or implantable devices in reference to the patient anatomy.

Additionally, the X-Guide' Surgical Navigation System and the predicate device share several other significant features:

Both devices have the same Intended Use. ●
Both devices provides animated indicators to show the real time location of the surgical tool relative to the patient . anatomy, showing the tool in the patient CT in real time.
Both devices employ stereo computer vision tracking techniques. .
Both devices reduce risk of damage to adjacent anatomical structures.
Both devices share identical specified environments of use. ●
Both devices provide Planning Software allowing for placement of implant, target surgical site, and guidance to the ● implant site.
Both devices provide sub-millimeter navigation accuracy. ●
Both devices use CT Scans for registration of the patient tracking attachment, for use in planning the desired ● implant location, and as a reference to determine the exact positioning of the surgical tools during the surgical procedure.

There are many similarities between the X-Guide® Surgical Navigation System™, however there are also some differences, mostly relating to technology and performance.

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While the X-Guide® Surgical Navigation System™ both use stereo cameras to gather tracking information, the two systems have a fundamental difference in the tracking mediums and methods used. The IGI-System™ utilizes Infrared LEDs, operating at approximately 1050 nm, configured in an Emitter Collector configuration for tracking whereas the X-Guide® System utilizes a pattern illuminated by an LED array for tracking purposes.

Furthermore, the X-Guide® Surgical Navigation System's feature points are based on contrast saddle-points, whose detected locations are more stable under pertations in lighting, partial obscuration) than the roughly circular intensity pattern produced by an Infrared LED, resulting in higher theoretical accuracy in surgical environments.

The X-Guide® Surgical Navigation System™ both have provisions for patient and stereo camera alignment within the tracking volume. Since the lG-System™ cameras can only detect in the infrared spectrum, not allowing for video feedback to aide in the positioning process, lasers are necessary. In the X-Guide® system stereo cameras are positioned visually utilizing video feedback from the stereo cameras.

The X-Guide® Surgical Navigation System™ both attach the Applied Part to the patient. The X-Guide® System Applied part is a Type B whereas the IGI System Applied Part is Type BF. The difference in applied part rating extends from the IGI-System™ applied part being both conductive and utilizing electrical energy on the component. The applied part utilized by the X-Guide® Surgical Navigation System is nonconductive and does not utilize electrical energy, providing a lower risk of electrical shock to the patient in the event of a single fault.

Several times during a surqical procedure it is common for the surgical instrument. (Dental Hand Piece) to exit and enter a "havigation zone", which is essentially the surgical region. Typically, the reason to ext is to change drill bit types and lengths. When the surgical instrument is entering the "havigation zone", the X-Guide" Surgical Navigation System requires the doctor to touch the "Go Button". This action will automatically trigger the calculation of the drill bit length prior to resuming surgery.

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Image /page/8/Picture/0 description: The image shows the logo for X-NAV Technologies. The logo features a stylized "X" made of green, blue, and gray angled bars. The words "-NAV" are in large, bold, dark blue letters, and the word "TECHNOLOGIES" is in smaller, light gray letters below.

Comparison of Technological Characteristics:

	N/A	K023424
Use Specifications	X-Guide®	IGI-System™	Justification ofDifferences
Indications for Use	The X-Guide® Surgical Navigation System is acomputerized navigational system intendedto provide assistance in both the preoperativeplanning phase and the intra-operativesurgical phase of dental implantationprocedures.The system provides software topreoperatively plan dental surgicalprocedures and provides navigationalguidance of the surgical instruments.The device is intended for use for partiallyedentulous and edentulous adult andgeriatric patients who need dental implantsas part of their treatment plan.	The Image-Guided Implantation (IGI)System is a computerized navigationalsystem intended to provide assistance inboth the planning (pre-operative) and thesurgical (intra-operative) phases of dentalimplantation procedure. The systemprovides accurate navigational guidance ofsurgical instruments, with regard to the pre-operative planning in dental implantationprocedure.The device is intended for use for partiallyor fully endentulous patients who needdental implants as part of their treatmentplan.	There is nodifference betweenthe products inIntended Use.The X-Guide®Surgical NavigationSystem specifies atarget population,whereas theIGI-System™ doesnot.
Use Environment	Clinical Setting, Doctors Office	Clinical Setting, Doctors Office	No Difference
	N/A	K023424
Technology / PerformanceCharacteristics	X-Guide®	IGI-System™	Justification of Differences
Operating Temperature	10 - 35 deg C	Not specified	Both systems are intended for use in similarclinical environments.
Operating Relative Humidity	30% - 90% non-condensing	Not Specified	Both systems are intended for use in similarclinical environments.
Altitude	500 hPa-1060hPa	500 hPa - 1060 hPA	No Difference
Transport Temperature	-20 - +60 deg C	0 - 40 deg C	The X-Guide® can withstand a wider range ofstorage / transport temperature withoutcompromising system integrity
Transport Humidity	10% - 95% non-condensing	10% - 80% non-condensing	The X-Guide® can withstand a higher level ofhumidity during transport without compromisingsystem integrity.
Optical Radiation	LED, Risk Group 1 (minimalrisk) per IEC 62471-1	Laser, Class II (<1mW) perIEC 60825-1, 620-690nm	No Difference in Risk Level
Tracking Technology	Stereo Cameras / LEDs /Pattern	Stereo Cameras /Infrared LEDs	X-Guide® Surgical Navigation System uses passiveelements on the patient for tracking purposeswhereas the IGI-System™ uses active elements(containing electrical energy) attached to thepatient for tracking purposes.
Calibration Frequency	Prior to each surgery	Factory Calibrated andauthorized servicepersonnel.	No Difference
Overall System Accuracy (RMS)	<1mm	<1 mm	No Difference
Alarms	Audible, Visual	Audible, Visual	No Difference
Monitor	LCD-TFT	LCD-TFT	No Difference
Communications Interface	Ethernet	Ethernet	No Difference
Software	Navigational Guidance andImplant Planning	Navigational Guidance andImplant Planning	No Difference
	N/A	K023424
Technology / PerformanceCharacteristics	X-Guide®	IGI-System™	Justification of Differences
Dimensions	Height: 64.653 in (1642.19 mm)Width: 21.011 in (533.67mm)	Unavailable	Both systems are intended for use in similarclinical environments and are classified as mobileper IEC / EN 60601-1definition.
Mounting Configuration	Mobile Cart	Mobile Cart	No Difference
Weight	130lbs. (58.97 kg)	Unavailable	Both systems are classified as Mobile, per IEC / EN60601-1definition. Differences in weight that mayexist do not affect either devices efficacy orintended use.
Safety Features	X-Guide®	IGI-System™	Justification of Differences
Electrical Safety	IEC 60601-1:2005 3rd EditionAAMI ES60601-1:2005+A1:2009 +A2:2010EN 60601-1:2006	EN60601-1:1990 +A1:1992+A2: 1995; +A13IEC 601-1:1998 +A1:1991+A2:1995 +CorrigendumEN60601-1-1:1993+A1:1995IEC60601-1-4:1996	The X-Guide® system has been certified to morerecent editions of the Electrical Safety Standards,which have a heavier influence of ISO 14971 RiskManagement. EN60601-1-1 and IEC 60601-1-4have been merged into the 3rd edition of EN60601-1:2006 and IEC60601-1:2005. Therefore bothsystem were evaluated to the same standards.While both standards provide guidance forsymbolic labeling of medical devices, ISO 15223-1:2012 is an FDA recognized standard.While both standards provide guidance forevaluating risk in medical devices, ISO 14971:2012is an FDA recognized standard.
	ISO15223-1:2012	EN980:1996 +A1:1999
	BS EN ISO 14971:2012	EN1441:1997
	Electromagnetic Compatibility	IEC 60601-1-2:2007 3rd Edition	EN 60601-1-2:1993IEC 601-2:1993
Biocompatibility	Yes (ISO 10993-1, -5, -10, -11, -12)	not specified	Do not anticipate any significant difference in thischaracteristic since both systems are intended foruse in similar clinical environments.
Sterilization	Steam	Steam	No Difference
Disinfectant (High-Level)	3% Glutaraldehyde solution	3% Glutaraldehyde solution	No Difference

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Safety Features	X-GuideR	IGI-System™	Justification of Differences
Ingress Protection	IP2X	Not Specified in IFU orProduct Labeling	Do not anticipate any significant difference in thischaracteristic since both systems are intended foruse in similar clinical environments.

	N/A	K023424
Energy	X-Guide®	IGI-System™	Justification of Differences
Mains Voltage, Frequency	100 - 127VAC / 200 - 240VAC ;50 / 60 Hz	100VAC /120VAC / 230VAC50 / 60 Hz	No significant difference – Both systems areconfigurable to operate over the same voltage andfrequency ranges.
Input Power (VA )	1500VA	260VA	The X-Guide® system Computer utilizes highperformance video cards for data processing andcontains and LED Lighting Module which accountsfor most of the system power.
Fusing Type / Rating	Circuit Breaker: 100-127VAC, 10A	Fuse: Qty 2 @ 6A/100-120VAC	Both components perform the same function. Thedifference between the components is that aCircuit Breaker can be manually reset whereas afuse requires replacement.
Degree of ProtectionAgainst Electrical Shock	Applied Part Type B	Applied Part Type BF	The X-Guide® applied part (X-Clip) which attachesto the patient for tracking patient motion is madeof a non-conductive material and does not deliverelectrical energy. Since the IGI-System™ appliedpart contains electrical energy, it is classified in ahigher risk category (, Type BF ) for protectionagainst electrical shock,
Type of Protection AgainstElectrical Shock	Class I	Class I	No Differences
Mode of Operation	Continuous	Continuous	No Differences

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Image /page/12/Picture/0 description: The image shows the logo for X-NAV Technologies. The X in X-NAV is made up of green, blue, and gray stripes. The rest of the letters in X-NAV are in a dark blue color. The word "TECHNOLOGIES" is written in gray below the X-NAV logo.

	N/A	K023424
Components	X-Guide®	IGI-System™	Justification of Differences
Bone Screw	Bone Screw	Bone Screw	Intended use for this item is the same forboth systems.
CT Registration	X-Clip	Custom Registration Device(CRD) And3 Point Touch RegistrationFixture	Intended use for these items is the samefor both systems.
Patient Tracking Device	X-Corner Patient Tracker	Patient Tracker	Intended use for these items is the samefor both systems.
Surgical Tool Tracking Device	X-Corner Handpiece Tracker	Handpiece Tracker	Intended use for these items is the samefor both systems.
Screwdriver	Yes	Yes	Intended use for these items is the samefor both systems.
Endentulous Patient TrackingAttachment System	E-Clip	Splint	Intended use for these items is the samefor both systems.
Drill Bit Length Determination	Go Button	Operator Entry required	X-Guide® Drill Bit length measurementand recording process is automated withthe use of the Go-Button. The IGI-Systemrequires the surgeon to manually enterthe correct drill bit length.
Patient Tracker Attachment Arms	Posterior Tracker ArmAnterior Tracker Arm	6 Poles – 3 Upper, 3 Lower	Intended use for these items is the samefor both systems.

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Performance Testing:

Biocompatibility testing

The biocompatibility evaluation for the X-Guide® Surgical Navigation System was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

Cytotoxicity ●
Sensitization ●
Irritation / Intracutaneous ●
. Systemic toxicity

The components of the X-Guide® Surgical Navigation System are considered tissue contacting for a duration of less than 24 hours.

Electrical Safety and Electromagnetic Compatibility (EMC)

Comprehensive performance testing has been conducted on the X-Guide® Surgical Navigation System in accordance with various recognized industry standards, by a recognized third party organization. The system complies with IEC 60601-1.2005 3rd edition, ANSI/AAMI ES 60601-1, IEC 62471-1:2006, ISO 14971:2012, IEC 60601-1-6:2010 and IEC62366:2007 for product safety and IEC 60601-1-2:2007 for EMC Safety.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the patient or operator.

The combined testing and analysis of results provides assurance that the device performs as intended.

Non-clinical Comparisons to Predicate Device:

Hardware and software verification and validation testing has been performed at the system the performance of the X-Guide® and assess substantial equivalence claims to the predicate device.

Internal Validation testing was conducted clinical environment at the system and component level. The differences between the proposed and predicate devices are limited to differences in design, material, and operation.

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Clinical Testing:

Clinical testing has been conducted to assess the accuracy, usability, and performance of the X-Guide®. Clinical Test results indicate the X-Guide® is at least as accurate as the predicate device. IGI-System (K023424) supports our claim of navigation accuracy < 1 mm and substantial equivalence.

Over 150 patients participated in the study. The patient population included both adult and geriative patients. After 7 months of testing in a clinical environment, no adverse events or complications have been identified or reported.

Clinical testing was conducted by Board Certified Oral Surgeons and testing was conducted at their facilities. While each doctors Operatories have similar capabilities, the configuration of each operatory can vary. Therefore, Usability was assessed from a doctor and system perspective. Risks associated with Usability have been properly mitigated through product design. In comparison to the predicate device, no new Usability issues or risks have been identified.

Substantial Equivalence:

The X-Guide® Surgical Navigation System is be substantially equivalent to currently marketed Surgical Navigation Systems with regards to intended use and performance.

Similar to the predicate devices, the X-Guid® Surgical Navigation System provides positioning data to indicate the location of a Dental Handpiece in space during navigation. An LED Monitor provides a visual aide to the surgeon for procedural support during the execution of surgical procedures.

Conclusions:

The differences between the proposed and predicate devices are limited to differences in design, material,

Based upon the information provided within this 510(k) Premarket Notification, we conclude that the X-Guide® Surgical Navigation System is substantially equivalent to the identified predicate devices when used as intended.

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.