The IGI Image-Guided Implantation system, is a computerized navigational system intended to provide assistance in both the planning (preoperative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides accurate navigational guidance of surgical instruments, with regard to the pre-operative planning in dental implantation procedure.

Device Description

The IGI-System is an electro-optical device, which was specifically designed to greatly improve the surgical implantation procedure by providing the surgeon an accurate guidance to the location of the surgical tools prior to, and more importantly, during the surgical operation. The novel device both increases surgical success rate, and reduces potential damage to adjacent anatomical structures and tissues. The IGI-System introduces, for the first time, the element of objective, state-of-the-art measurements to the field of dental implantation. Equipped with the IGI-System, the dental surgeon is able to plan the implantation procedure and align the actual placement of the implant in the pre-planned position with great accuracy. The IGI-System allows the user to view the reconstructed 2D images of the patient anatomy together with overlaid graphic information depicting the position of dental surgical instrument and pre-planned position of dental implant. The IGI-System utilises an infra-red (IR) optical tracking system, comprised of emitters, camera and a tracking data processor (computer), to determine the location and orientation of the dental hand-piece and the patient. The position and orientation of both the dental surgical instrument and the patient are transmitted to an image data processor (computer) which makes necessary calculations to provide the guidance graphic overlay depicting the dental surgical instrument and planned dental implant location on the medical image. Alignment of the patient and medical images is accomplished through a process termed fiducial registration. The goal is to indicate to the dentist, based on the preimplantation medical images, the exact position of the tracked dental surgical instrument together with the location of planned dental implant location, with regard to the patient's anatomy. The dentist will place a virtual implant image in the optimal location by use of the IGI software and available CT data. Once an implant has been optimally positioned, the system will correlate between the dentist's plan and the actual performance. In case of significant variance between the plan and the performance the system will alert the user. The system is used in two stages of the implantation procedure. The first stage is preplanning of the surgical implantation procedure. The second stage is the clinical one in which the system is used for accurate guidance of dental surgical instruments according to the pre-planned implant position. In addition, the system assists the dentist in avoiding critical anatomical structures. The system is used to pre-plan the surgical implantation procedure. Consequently, the system provides accurate guidance during the dental implantation, of surgical instruments with regard to pre-operative planning, and assists the dentist in avoiding the risk of causing damage to critical anatomical structures. The IGI-System is defined as a supporting device, providing a significant contribution to the decision-making process, which continuously takes place during the implantation process. It is by no means intended to replace human judgement. The final decisions as to the exact location, timing, intensity and depth of the drilling are the sole responsibility of the surgeon. The surgeon is at liberty, at any time throughout the surgical procedure, to determine the final drilling position, or to modify implants' planned position. Thus, under no circumstances does the device relieve the surgeon of his or her ultimate clinical responsibility.

AI/ML Overview

The provided text describes the IGI-System™, an image-guided implantation system for dental surgery, and its substantial equivalence to predicate devices. It discusses performance standards and the acceptance criteria for accuracy.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Navigational Accuracy: +/- 1mm	Navigational Accuracy: +/- 0.5mm (Better than criterion)

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

The document does not explicitly state a sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). The claim of +/- 0.5mm accuracy is made in the context of comparing the IGI-System to predicate devices, stating that "All three devices provide navigational accuracy of +/-0.5mm." This suggests the accuracy was likely established through internal testing or by referencing the accuracy of the predicate devices, rather than a specific clinical study described here.

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

The document states, "The level of accuracy, defined to be acceptable in dental implantation navigation, was +/-1mm. This level of accuracy was defined based on review of state of the art technology, opinions by experts in the field..."
However, the number and specific qualifications of these experts are not provided. It's unclear if these experts were involved in establishing ground truth for a test set, or merely in defining the acceptable accuracy threshold.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method for a test set. This implies that there was no formal human adjudication process for evaluating the device's performance against a ground truth in a clinical or simulated setting described here.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with AI assistance. The device is described as a "supporting device" that provides "accurate guidance" and "significant contribution to the decision-making process," but "is by no means intended to replace human judgement." This suggests its role is assistive rather than a direct replacement or an AI that significantly alters human reader performance in a diagnostic context.

6. Standalone Performance Study

The document implies a standalone performance due to the statement: "All three devices provide navigational accuracy of +/-0.5mm. This level of accuracy cannot be achieved by human visual inspection." This highlights that the device's accuracy is a standalone measurement of its navigational capability, independent of human input, though it is used with a human surgeon. However, a dedicated standalone study is not detailed. The accuracy is presented as an inherent characteristic of the device and its predicate technologies.

7. Type of Ground Truth Used

The type of ground truth used to establish the +/-0.5mm accuracy is not explicitly stated. Given it's a navigational system based on CT scans, the ground truth for accuracy would likely involve precise physical measurements against a known spatial reference, potentially using phantoms or highly accurate instruments to verify the device's ability to track and guide to precise locations defined by the CT data. The "optimal location" of an implant is planned using CT data and IGI software, and the system correlates this plan with "actual performance."

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is common for devices of this nature, which are typically based on established principles of optical tracking and image processing rather than machine learning models that require large training datasets in the conventional sense.

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

Since there is no mention of a training set, there is no information on how its ground truth was established. The device's functionality relies on algorithms for image reconstruction, instrument tracking, and registration, which are likely developed and validated through engineering principles and calibration rather than a machine learning training paradigm.

Summary

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MAY - 9 2003

8.A 510(k) SUMMARY

(As required by Section 807.92(c))

Applicant's Name: : Denx Ltd. DENX Advanced Dental Systems Ltd. Moshav Ora 106 Jerusalem 90880 ISRAEL Tel: +972 (2) 641-7748 Fax: +972 (2) 642-6901

Contact Person: Dr. Koby Ben-Barak

Arazy Group Mitzpe Aviv, Industrial Park 13 Misgav 20187, ISRAEL Tel: +972 (4) 994-0337 Fax: +972 (4) 994-4224 e-mail: koby@arazygroup.com

Date Prepared: October 2002

Trade Name: IGI-System™

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Classification: The FDA has classified "sterotaxic Instruments" devices as class II, pursuant to 21 C.F.R. § 882.4560 (product code HAW), and it is reviewed by the General & Plastic Surgery Advisory Committee.

Predicate Devices: Orthopilot, by Kinamed Inc. (K003347), and Vectorvision2, by BrainLab AG (K983831).

Description of the Device: The IGI-System is an electro-optical device, which was specifically designed to greatly improve the surgical implantation procedure by providing the surgeon an accurate guidance to the location of the surgical tools prior to, and more importantly, during the surgical operation.

The novel device both increases surgical success rate, and reduces potential damage to adjacent anatomical structures and tissues.

The IGI-System introduces, for the first time, the element of objective, state-of-the-art measurements to the field of dental implantation. Equipped with the IGI-System, the dental surgeon is able to plan the implantation procedure and align the actual placement of the implant in the pre-planned position with great accuracy.

The IGI-System allows the user to view the reconstructed 2D images of the patient anatomy together with overlaid graphic information depicting the position of dental surgical instrument and pre-planned position of dental implant.

The IGI-System utilises an infra-red (IR) optical tracking system, comprised of emitters, camera and a tracking data processor (computer), to determine the location and orientation of the dental hand-piece and the patient.

The position and orientation of both the dental surgical instrument and the patient are transmitted to an image data processor (computer) which makes necessary calculations to provide the guidance graphic overlay depicting the dental surgical instrument and planned dental implant location on the medical image.

Alignment of the patient and medical images is accomplished through a process termed fiducial registration. The goal is to indicate to the dentist, based on the preimplantation medical images, the exact position of the tracked dental surgical instrument together with the location of planned dental implant location, with regard to the patient's anatomy.

The dentist will place a virtual implant image in the optimal location by use of the IGI software and available CT data. Once an implant has been optimally positioned, the

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system will correlate between the dentist's plan and the actual performance. In case of significant variance between the plan and the performance the system will alert the user.

The system is used in two stages of the implantation procedure. The first stage is preplanning of the surgical implantation procedure. The second stage is the clinical one in which the system is used for accurate guidance of dental surgical instruments according to the pre-planned implant position. In addition, the system assists the dentist in avoiding critical anatomical structures.

The system is used to pre-plan the surgical implantation procedure. Consequently, the system provides accurate guidance during the dental implantation, of surgical instruments with regard to pre-operative planning, and assists the dentist in avoiding the risk of causing damage to critical anatomical structures.

The IGI-System is defined as a supporting device, providing a significant contribution to the decision-making process, which continuously takes place during the implantation process. It is by no means intended to replace human judgement. The final decisions as to the exact location, timing, intensity and depth of the drilling are the sole responsibility of the surgeon.

The surgeon is at liberty, at any time throughout the surgical procedure, to determine the final drilling position, or to modify implants' planned position.

Thus, under no circumstances does the device relieve the surgeon of his or her ultimate clinical responsibility.

Intended Uses: The IGI Image-Guided Implantation system, is a computerized navigational system intended to provide assistance in both the planning (preoperative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides accurate navigational guidance of surgical instruments, with regard to the pre-operative planning in dental implantation procedure.

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Substantial Equivalence: IGI-System shares technological and clinical features with two FDA-cleared tracking devices - The Orthopilot® (K003347) and the VectorVision® (K983831).

The Orthopilot@ is a system for computer-aided navigation of surgical instruments, whose purpose is to optimally position the cutting guides for total knee replacement surgery and provided intra-operative measurements of bone alignment.

The VectorVision® (K983831) is an intra-operative image guided localization system to enable open or percutaneous surgery. It is indicated for any medical condition, where a reference to a rigid anatomical structure, such as the skull, a long bone or vertebra can be identified relative to a CT, MR or X-ray based model of anatomy.

The IGI-System and its two predicates share a principal feature - they provide their users with accurate guidance of surgical tools and/or implantable devices or organs. This guidance, achieved by the use of optical tracking of the surgical instruments, is an objective and accurate navigational guidance, used as an adjunct in implantation surgical procedures.

The devices are not intended to replace human assessment, but to provide objective information as to the positioning and alignment of the surgical instruments or implantable devices in reference to the patient's body.

The IGI-System and its two predicates share, in addition, several other significant features:

. All three devices are used as an aid for freehand operation by a surgeon.
All three devices employ optical, infra-red light, tracking systems, for tracking, . and two cameras for spatial reconstruction of instrument alignment and position.
. All three devices employ dedicated reconstruction software, intended to simultaneously visualize the anatomical structure of interest and the trajectory of the surgical instrument.
All three devices reduce potential damage to adjacent anatomical structures. .
All three devices provide navigational accuracy of +/-0.5mm. This level of . accuracy cannot be achieved by human visual inspection.

In addition, it is important to emhasize the similarities between the IGI-System and the Vector Vision® (K983831). Both use CT scans as a reference for the determination of the exact positioning of the tools during the surgical procedure. Also, although the VectorVision system is intended primarily for bone surgery, its intended use does indicate broader potential uses. Specifically, this device's

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"Indications for Use" stipulates the use of this device "for any medical condition, where a reference to a rigid anatomical structure, such as the skull, a long bone or vertebra can be identified relative to a CT, MR or X-ray based model of anatomy". Although the use of this device in dental implantation is not specifically noted, it is valid to envision dental CT scans a rigid spatial reference for navigation, as are the skull, long bones or vertebra. In this respect, dental use of a navigation tracking system is subsumed within VectorVision's general indications for use, and is encompassed by the predicate device's specific indications for use.

It is also significant to note that all three devices, the IGI-System and its two predicate devices, are intended to be used primarily on three different body organs.

The Orthopilot® (K003347) is a system for computer-aided navigation of surgical instruments, whose purpose is to optimally position the cutting guides for total knee replacement surgery and provided intra-operative measurements of bone alignment.

VectorVision® (K983831), as mentioned above, is an intra-operative image guided localization system to enable open or percutaneous surgery. It is indicated for any medical condition, where a reference to a rigid anatomical structure, such as the skull. a long bone or vertebra can be identified relative to a CT, MR or X-ray based model of anatomy.

However, as the effectiveness of all three devices is defined by the accuracy of the guidance they provide, the difference in body organs for which the three devices are intended affect neither their effectiveness, nor their safety, and does not raise any new question regarding the performance of these devices.

In summary, the IGI-System is substantially equivalent to its two cleared predicate devices in all its major characteristics.

Conclusions: Data presented above clearly demonstrate that the Image-Guided Implantation Device is substantially equivalent to its predicate devices in its technological features, clinical intended uses and its safety and effectiveness.

Performance Standards:

EN 60601-1 1990 Medical electrical equipment. Part 1: General requirements . for safety - IEC 601-1:1988
. Amendment A1 to EN 60601-1:1992 Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988/A1:1991

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Amendment A2 to EN 60601-1: 1995 Medical electrical equipment. Part 1: ● General requirements for safety - IEC 601-1:1988/A2:1995 + corrigendum June 1995
Amendment A13 to EN 60601-1:1995 Medical electrical equipment. Part 1: . General requirements for safety
EN 60601-1-1 : 1993 Medical electrical equipment. Part 1: General ● requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems - IEC 601-1-1-1:1992
Amendment A1 to EN 60601-1-1:1995 Medical electrical equipment . Part ● 1 : General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems IEC 601-1-1:1992/A1:1995
. EN 60601-1-2:1993 Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility - Requirements and tests IEC 601-1-2: 1993
IEC 60601-1-4 : 1996 Medical electrical equipment Part 1: General . requirements for safety - 4. Collateral standard: Programmable electrical medical systems
. EN 1041: 1998 Information supplied by the manufacturer with medical devices
EN 1441: 1997 Medical devices Risk analysis ●
EN 980 /+A1: 1999 1996 Graphical symbols for use in the labeling of . medical devices
. EN 540:1993 Clinical investigation of medical devices for humans

Accuracy and functional performance standard:

As of today, there are no specific FDA Guidance documents regarding the Image-Guided surgery systems for oral and maxillofacial surgery.

The level of accuracy, defined to be acceptable in dental implantation navigation, was +/-1mm. This level of accuracy was defined based on review of state of the art technology, opinions by experts in the field, and the accuracy specified for the FDAcleared predicate devices (see Section 7).

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2003

Denx Advanced Dental Systems c/o Dr. Koby Ben-Barak Arazy Group Mitzpe Aviv, Industrial Park 13 M.P. Misgav, 20187 Israel

Re: K023424 Trade/Device Name: IGI System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 6, 2003 Received: April 8, 2003

Dear Dr. Ben-Barak:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Dr. Koby Ben-Barak

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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8. C INDICATION FOR USE STATEMENT

IGI-System™, Image-Guided Implantation The System, is computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides accurate navigational guidance of surgical instruments, with regard to the pre-operative planning in dental implantation procedure.

דנקס בע"מ
DENX LTD.
ALON HAYLA

General Manager (Name & Signature)

8.10.2002
Date

(Premarket Notification [510(k)] Number)

Muriam C. Provost

and Neurological De

510(k) Number K023424

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).