(114 days)
The Neocis Guidance System (NGS) is a 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 software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.
The Neocis Guidance System (NGS) is a stereotaxic medical device that guides surgeons during dental implant surgery. The system allows the user to plan the surgery virtually in software using a CT scan of the patient, and the plan is used by a quidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation.
The implant process occurs in two phases. First, the dental surgeon plans the surgical procedure with the planning software. A virtual implant is placed at the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Second, when the implant plan is optimally positioned, the NGS provides accurate guidance of the dental surgical instruments according to the pre-operative plan.
Physical guidance is provided via the Guidance Arm. The Guidance Arm grips a standard dental drill from the back end, allowing the surgeon to grip the drill as normal. The Guidance Arm does not move unless the surgeon applies a manual force to the drill. The Guidance Arm will constrain the surgeon to drill according to the prescribed surgical plan, preventing deviation. The surgeon is constantly in control of the drilling.
Visual guidance is provided by 3D graphics and 2D cross sections that indicate the position and orientation of the drill in relation to the pre-operative plan and scan. The visual feedback is updated in real-time so any relative motion between the dental handpiece and the patient properly update the visualization.
The patient tracking portion of the NGS is comprised of the Patient Splint and the Patient Tracker. The Patient Splint is attached to the contralateral side of the patient's mouth. The Patient Splint is placed on the patient prior to the CT scan. A fiducial array with fiducial markers is placed on the Patient Splint prior to the CT scan so the virtual plan can be related to the physical space of the system. The Patient Tracker is a mechanical feedback system that is connected to the Patient Splint on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle and position to accommodate the patient movement, which will maintain the accuracy of the drill placement.
Several steps are required for calibration and measurement during the procedure. The drill is calibrated using the Calibration Drill Bit inserted into a precise position on the Patient Tracker. During the surgery, each drill bit must be measured with the Depth Gauge to determine the proper length of the bit. These measurements complete the loop so the entire NGS is accurate to the tip of the drill.
The NGS is a supporting device, providing additional information and quidance to the decisionmaking process during the surgical procedure. It is not intended to replace the surgeon's iudgment. The final clinical decisions are the sole responsibility of the surgeon. The surgeon can at any time during the surgical procedure modify the planned implant positions. Under no circumstances does the device relieve the surgeon of his or her ultimate clinical responsibility.
The subject device is the same as the NGS cleared under K161399 (the predicate device), except for a change to the splint. The Patient Splint of the predicate device has been modified to allow for a chairside workflow. This modified splint is referred to as the Chairside Splint.
The splint is a key component for patient tracking for the NGS. The patient tracking portion of the NGS is comprised of the Chairside Splint and the Patient Tracker. The Chairside Splint is attached to the contralateral side of the patient's mouth. The Chairside Splint is affixed to the patient's teeth using Lang Jet Tooth Shade Dental Acrylic (K083195). The Chairside Splint is placed on the patient prior to the CT scan. A fiducial array with fiducial markers is placed on the Chairside Splint prior to the CT scan so the virtual plan can be related to the physical space of the system. The Patient Tracker is a mechanical feedback system that is connected to the Patient Chairside on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle and position to accommodate the patient movement, which will maintain the accuracy of the drill placement.
The Neocis Guidance System (NGS) with Chairside Splint is a computerized navigational system intended to assist in planning and performing dental implantation surgery. The device provides software for pre-operative planning and navigational guidance for surgical instruments.
The acceptance criteria for the NGS, and the reported device performance, are as follows:
1. Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| System Lateral Accuracy | RMS < 1 mm | RMS < 1 mm |
| System Depth Accuracy | RMS < 1 mm | RMS < 1 mm |
| System Angular Accuracy | RMS < 6.0° | RMS < 6.0° |
| Chairside Splint Application | Verified and Validated | Verified and Validated |
| Chairside Splint Removal | Verified and Validated | Verified and Validated |
| Biocompatibility | ISO 10993-1, -5, -10, -11, -12 compliant | Compliant |
| Sterilization | Steam validated to ISO 17665-1:2006 | Validated |
| Electrical Safety | IEC 60601-1:2005 compliant | Compliant |
| Electromagnetic Compatibility | IEC 60601-1-2:2007 compliant | Compliant |
| Software Level of Concern | Moderate | Moderate |
| Software Development | IEC 62304:2006 compliant | Compliant |
| Risk Analysis | ISO 14971:2012 compliant | Compliant |
| Human Factors (Splint Application/Removal) | Evaluated through objective and subjective criteria | Study results supported substantial equivalence |
2. Sample Size and Data Provenance for Clinical Test Set
- Sample Size: 75 subjects.
- Data Provenance: The document does not explicitly state the country of origin but implies a clinical study at two different sites. The study was prospective in nature, as it involved the application and removal of the Chairside Splint on subjects by investigators for evaluation.
3. Number of Experts and Qualifications for Clinical Test Set Ground Truth
- Number of Experts: 15 dentists.
- Qualifications of Experts: The document states "a variety of experience levels" for the investigator population. Specific years of experience or specializations (e.g., radiologist) are not provided.
4. Adjudication Method for Clinical Test Set
The document does not explicitly describe an adjudication method for the clinical test set data. It mentions "objective criteria and subjective criteria" for evaluation but not a process for resolving discrepancies if multiple assessors were involved in evaluating a single case/subject.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of an MRMC comparative effectiveness study was made. The clinical study focused on human factors related to the Chairside Splint rather than comparing the effectiveness of human readers with and without AI assistance or quantifying an effect size of AI improvement.
6. Standalone (Algorithm Only) Performance Study
The document indicates that the NGS is a "computerized navigational system" and a "supporting device, providing additional information and guidance to the decision-making process during the surgical procedure. It is not intended to replace the surgeon's judgment." This strongly suggests that the device is designed for human-in-the-loop performance, and there is no mention of a standalone algorithm-only performance study. Accuracy metrics (System Lateral, Depth, and Angular Accuracy) are defined for the "System," implying the integrated device rather than an isolated algorithm.
7. Type of Ground Truth Used (Clinical Test Set)
The clinical study primarily focused on human factors related to the Chairside Splint application and removal. The "ground truth" for this aspect appears to be:
- Objective Criteria: Duration of application and removal, photos and intra-oral scans, occurrence of adverse events.
- Subjective Evaluation: Investigator assessments.
8. Sample Size for the Training Set
The document does not provide information about a "training set" or its sample size. The studies described are verification and validation efforts for the modified device (Chairside Splint) and the overall NGS system, rather than the development and training of a machine learning algorithm in the typical sense that would involve a distinct training set. The NGS, as described, is a navigational guidance system, not explicitly an AI diagnostic or predictive tool that undergoes a training phase with a labeled dataset.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, the method for establishing its ground truth is not applicable or provided. The system's "accuracy" (lateral, depth, angular) is based on engineering verification and validation testing against known physical standards and simulated clinical scenarios.
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February 22, 2018
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Neocis Inc. Alon Mozes, Ph.D. CEO and Co-Founder 2800 Biscayne Blvd Suite 600 Miami, Florida 33137
Re: K173402
Trade/Device Name: Neocis Guidance System (NGS) with Chairside Splint Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: January 22, 2018 Received: January 25, 2018
Dear Alon Mozes:
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.
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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Mary S. Runner -S
For Tina Kiang, Ph.D. Acting 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) K173402
Device Name
Neocis Guidance System (NGS) with Chairside Splint
Indications for Use (Describe)
The Neocis Guidance System (NGS) is a 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 software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.
| 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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Section 7. 510(k) Summary
| Submitter Name: | Neocis Inc.2800 Biscayne Blvd.Suite 600Miami, FL 33137Tel: 1-855-9NEOCIS |
|---|---|
| Contact Person: | Alon Mozes, Ph.D.2800 Biscayne Blvd.Suite 600Miami, FL 33137Tel: (305) 409-2819 |
| Date Prepared: | January 22, 2018 |
| Trade Name: | Neocis Guidance System (NGS) with Chairside Splint |
| Common Name: | Dental Stereotaxic Instrument |
| Classification Name: | Bone cutting instrument and accessories (21 CFR 872.4120) |
| Classification: | Class II |
| Product Code: | PLV |
| Predicate Device: | Neocis Guidance System (K161399) |
Indications for Use:
The Neocis Guidance System (NGS) is a 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 software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.
Device Description:
The Neocis Guidance System (NGS) is a stereotaxic medical device that guides surgeons during dental implant surgery. The system allows the user to plan the surgery virtually in software using a CT scan of the patient, and the plan is used by a quidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation.
The implant process occurs in two phases. First, the dental surgeon plans the surgical procedure with the planning software. A virtual implant is placed at the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Second, when the implant plan is optimally positioned, the NGS provides accurate guidance of the dental surgical instruments according to the pre-operative plan.
Physical guidance is provided via the Guidance Arm. The Guidance Arm grips a standard dental drill from the back end, allowing the surgeon to grip the drill as normal. The Guidance Arm does
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Image /page/4/Picture/0 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font and is colored in yellow. Above the word is a gray line, and to the right of the word is a gray symbol that looks like a plus sign with a circle in the middle.
not move unless the surgeon applies a manual force to the drill. The Guidance Arm will constrain the surgeon to drill according to the prescribed surgical plan, preventing deviation. The surgeon is constantly in control of the drilling.
Visual guidance is provided by 3D graphics and 2D cross sections that indicate the position and orientation of the drill in relation to the pre-operative plan and scan. The visual feedback is updated in real-time so any relative motion between the dental handpiece and the patient properly update the visualization.
The patient tracking portion of the NGS is comprised of the Patient Splint and the Patient Tracker. The Patient Splint is attached to the contralateral side of the patient's mouth. The Patient Splint is placed on the patient prior to the CT scan. A fiducial array with fiducial markers is placed on the Patient Splint prior to the CT scan so the virtual plan can be related to the physical space of the system. The Patient Tracker is a mechanical feedback system that is connected to the Patient Splint on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle and position to accommodate the patient movement, which will maintain the accuracy of the drill placement.
Several steps are required for calibration and measurement during the procedure. The drill is calibrated using the Calibration Drill Bit inserted into a precise position on the Patient Tracker. During the surgery, each drill bit must be measured with the Depth Gauge to determine the proper length of the bit. These measurements complete the loop so the entire NGS is accurate to the tip of the drill.
The NGS is a supporting device, providing additional information and quidance to the decisionmaking process during the surgical procedure. It is not intended to replace the surgeon's iudgment. The final clinical decisions are the sole responsibility of the surgeon. The surgeon can at any time during the surgical procedure modify the planned implant positions. Under no circumstances does the device relieve the surgeon of his or her ultimate clinical responsibility.
The subject device is the same as the NGS cleared under K161399 (the predicate device), except for a change to the splint. The Patient Splint of the predicate device has been modified to allow for a chairside workflow. This modified splint is referred to as the Chairside Splint.
The splint is a key component for patient tracking for the NGS. The patient tracking portion of the NGS is comprised of the Chairside Splint and the Patient Tracker. The Chairside Splint is attached to the contralateral side of the patient's mouth. The Chairside Splint is affixed to the patient's teeth using Lang Jet Tooth Shade Dental Acrylic (K083195). The Chairside Splint is placed on the patient prior to the CT scan. A fiducial array with fiducial markers is placed on the Chairside Splint prior to the CT scan so the virtual plan can be related to the physical space of the system. The Patient Tracker is a mechanical feedback system that is connected to the Patient Chairside on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle and position to accommodate the patient movement, which will maintain the accuracy of the drill placement.
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Image /page/5/Picture/0 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a gray horizontal line that extends to the left and right of the word. A gray vertical line intersects the horizontal line at a point above the "i" in "neocis", forming a crosshair-like symbol.
Comparison of Technological Characteristics:
This submission involves only a modification to the Patient Splint for the NGS. The new version will be referred to as the Chairside Splint, to be differentiated from the previous Patient Splint. Otherwise, all performance characteristics of the NGS are the same. The Chairside Splint involves a modification that allows for a chairside creation of the Patient Splint rather than requiring a patient impression and model and fabrication through a dental lab. The differences introduced by this modification are detailed in Table 1.
| TechnologicalCharacteristics | NGS with Chairside Splint | NGS with Patient Splint | Comments |
|---|---|---|---|
| Subject Device | Predicate Device (K161399) | ||
| Indications for Use | |||
| Indications forUse | The Neocis Guidance System(NGS) is a computerizednavigational system intendedto provide assistance in boththe planning (pre-operative)and the surgical (intra-operative) phases of dentalimplantation surgery. Thesystem provides software topreoperatively plan dentalimplantation procedures andprovides navigational guidanceof the surgical instruments. | The Neocis Guidance System(NGS) is a computerizednavigational system intendedto provide assistance in boththe planning (pre-operative)and the surgical (intra-operative) phases of dentalimplantation surgery. Thesystem provides software topreoperatively plan dentalimplantation procedures andprovides navigational guidanceof the surgical instruments. | No difference |
| Materials | |||
| Materials | lxef®-HC-1022 | lxef®-HC-1022 | No difference |
| Technology / Performance Characteristics | |||
| Supply Voltage | 120 V | 120 V | No difference |
| Phases | 1 | 1 | No difference |
| Type of Current | AC | AC | No difference |
| Rated Frequency(Hz) | 60 Hz | 60 Hz | No difference |
| Rated PowerInput (VA) | 600 VA | 600 VA | No difference |
| Types andRatings ofexternalaccessible fuses | 5.0 A for 240 V | 5.0 A for 240 V | No difference |
| Type of Protectionagainst ElectricShock | Class I Equipment | Class I Equipment | No difference |
| Degree ofProtection againstElectric Shock | Type BF | Type BF | No difference |
| Technological | NGS with Chairside Splint | NGS with Patient Splint | Comments |
| Characteristics | Subject Device | Predicate Device (K161399) | |
| EquipmentSuitable for use inthe presence ofFlammableMixtures? | No | No | No difference |
| Mode ofOperation | Continuous Operation | Continuous Operation | No difference |
| System LateralAccuracy | RMS < 1 mm | RMS < 1 mm | No difference |
| System DepthAccuracy | RMS < 1 mm | RMS < 1 mm | No difference |
| System AngularAccuracy | RMS < 6.0° | RMS < 6.0° | No difference |
| CT Scan QualityRequirements | 0.3 mm Voxel, 0.3 mm SliceThickness, Matrix 512x512, Full13cm 21 sec, Multi 2 DICOMformat. | 0.3 mm Voxel, 0.3 mm SliceThickness, Matrix 512x512, Full13cm 21 sec, Multi 2 DICOMformat. | No difference |
| F/T Sensor ForceMeasurementRange | +/- 30 N | +/- 30 N | No difference |
| F/T SensorTorqueMeasurement Range | +/- 2 Nm | +/- 2 Nm | No difference |
| F/T Sensor SingleAxis ForceOverload Limit | 200 N | 200 N | No difference |
| F/T Sensor SingleAxis TorqueOverload Limit | 20 Nm | 20 Nm | No difference |
| Upper limitspecification forGuidance ArmTranslation Speed | 1.25 m/s | 1.25 m/s | No difference |
| StorageRequirements | Store powered at RoomTemperature (68°F to 76°F or20°C to 24.4°C) and standardambient humidity (5% to 95%) in adust free, clean environment. | Store powered at RoomTemperature (68°F to 76°F or20°C to 24.4°C) and standardambient humidity (5% to 95%) in adust free, clean environment. | No difference |
| Splint Attachment | Chairside Splint can be attachedchairside with use of acrylic ordeveloped with acrylic on a patientmodel in a dental lab. | Patient Splint is developed withacrylic on a patient model in adental lab. | Difference in splintattachment hasbeen verified andvalidated throughnonclinical andclinical testing. |
| Splint Removal | Chairside Splint may be removedeither by cutting bridges along aseam of the splint or manuallypulling off. | Patient Splint is removed bymanually pulling off. | Difference in splintremoval has beenverified andvalidated throughnonclinical andclinical testing. |
| Fiducial ArrayAttachment to | The Fiducial Array attaches to thesplint during the CT scan to | The Fiducial Array attaches to thesplint during the CT scan to | No difference |
| TechnologicalCharacteristics | NGS with Chairside Splint | NGS with Patient Splint | Comments |
| Subject Device | Predicate Device (K161399) | ||
| Splint | provide a reference in the image. | provide a reference in the image. | |
| Kinematic MountAttachment toSplint | The Kinematic Mount attaches tothe splint to provide a mountingpoint for the Fiducial Array andPatient Tracker. | The Kinematic Mount attaches tothe splint to provide a mountingpoint for the Fiducial Array andPatient Tracker. | No difference |
| Splint Shape andKinematic MountLocation | The shape of the splint and thelocation of the Kinematic Mountattachment point are designed toallow for proper ergonomicapproach of the Patient Trackerand Guidance Arm. | The shape of the splint and thelocation of the Kinematic Mountattachment point are designed toallow for proper ergonomicapproach of the Patient Trackerand Guidance Arm. | No difference |
| Safety Features | |||
| Biocompatibility | Yes (ISO 10993-1, -5, -10, -11, -12) | Yes (ISO 10993-1, -5, -10, -11, -12) | No difference |
| Sterilization | Steam | Steam | No difference. Bothsplint versions aredisposable and one-time use. |
| Components | |||
| Patient TrackingDevice | Patient Tracker | Patient Tracker | No difference |
| Patient TrackingAttachmentSystem | Chairside Splint | Patient Splint | Intended use forthese items is thesame. |
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Image /page/6/Picture/0 description: The image shows the logo for Neocis. The logo is a stylized wordmark with the word "neocis" in a sans-serif font. The letters are connected by a horizontal line above the word. There is a small circle above the "i" in "neocis".
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Image /page/7/Picture/0 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a gray horizontal line that extends to the left and right of the word. There is a gray circle above the "i" in "neocis" with a vertical line extending upwards from the circle.
Table 1: Summary of Technological Characteristics Comparison
Performance Testing:
Non-clinical Testing
Chairside Splint verification and validation testing is described below in Table 2.
| Verification / ValidationType | Description |
|---|---|
| Simulated Use (End User Validation) | Run through of typical splint affixation cases using typodonts, performed by Surgeons. |
| Total System Accuracy | The Total System was evaluated for accuracy via simulated use with a typodont as simulation of a patient with three osteotomies per typodont in four locations (Upper Right / Upper Left / Lower Right / Lower Left). |
| Patient Tracker and Splint Mounting Verifications | Evaluating the effect of 2x Patient Tracker weight as total downward force on a standard splint mounted on a typodont per the IFU. In addition, evaluation of kinematic mount repeatability and patient anatomy accommodation analysis. |
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Image /page/8/Picture/0 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a gray horizontal line that extends slightly beyond the letters on either side. A gray vertical line intersects the horizontal line at the center, forming a cross shape with a small circle at the intersection point.
Table 2: Summary of component and system verification and validation.
The subject of this 510(k) was only a modification to the patient splint. As such, non-clinical testing performed in support of clearance of the predicate NGS itself did not need to be repeated. Below is a list of the non-clinical testing performed on the predicate NGS that were relied upon for clearance of the modified splint.
Biocompatibility Testing
The biocompatibility evaluation for NGS components 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 cytotoxicity (ISO 10993-5), sensitization and irritation (ISO 10993-10).
The components of the NGS are considered tissue contacting for a duration of less than 24 hours.
Cleaning and Sterilization Validation
A representative sample of the re-usable NGS components were tested to validate that the components can withstand the steam sterilization process and that acceptable sterility is achieved using the recommended sterilization protocols. The sterilization validation testing was conducted according to ISO 17665-1:2006 and it validated that the reusable NGS components can be sterilized to reach an acceptable sterility assurance level.
Electrical Safety and Electromagnetic Compatibility (EMC)
Comprehensive performance testing has been conducted on the NGS in accordance with various recognized industry standards, by a recognized third party organization. IEC 60601-1:2005 + Corr. 1 (2006) + Corr. 2 (2007) ANSI/AAMI ES60601-1:2005@2012 and C1:2009/® 2012 and A2:2010/® 2012 (Consolidated Text) Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance was used for product safety and IEC 60601-1-2:2007 was used for EMC.
Software and System Verification and Validation
Software and system 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 Contained 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 result in minor injury to the patient or operator.
Software Development and Testing was performed per IEC 62304: 2006 Medical Device Software - Software Lifecycle Processes, FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002).
Risk analysis was conducted in compliance with ISO 14971: 2012 and includes FMEA analysis to review the following:
- · risks associated with the use, usability and performance of the device (Use FMEA)
- · the risks associated with and specific to the design aspects of the device (Design FMEA)
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- · the risks associated with the electrical safety of the device design as it applies to IEC 60601-1 (60601 FMEA)
- the risks associated with software functionality and software interaction with the user (Software FMEA)
The combined software and system testing and analysis of results (details in Table 3 below) provide assurance that the device performs as intended.
| Verification / ValidationType | Description |
|---|---|
| Simulated Use | Run through of Typical Use Case |
| Boundary Condition | Testing of all potential boundary parameters in the ApplicationSoftware |
| Registration | Testing of registration process |
| Case File Contents | Simulated use testing of features associated with saving / loadingCases |
| Error Case Injection | Simulating all error messages and pop-ups. |
| CT Scan Verification | Verification of the resolution and validity of CT Scans |
| Control SW BoundaryCondition Testing | Testing the mechanical boundaries of the Control Software andGuidance Arm. |
| Control Software GravityCalibration Verification | Verifying that the Gravity Calibration is effective over multiple start-up /shut down cycles |
| Work Volume and FloorGrid Verification | Verifying the design and functionality of the Work Volume and FloorGrid features in the application software. |
| Accuracy Verification:Patient Tracker | The Patient Tracker was evaluated for accuracy per ASTM F2554. |
| Guidance Arm Accuracy /Repeatability | The positional accuracy of the Guidance Arm was evaluated bycollecting 27 data points in spaces within two work volumes (54 totalpoints) against a calibrated CMM. |
| Communication RateVerification | Force-Torque (F/T) Sensor to Control Software, Patient Tracker toControl Software, Guidance Arm to Control Software andcommunication between Application Software and Control Softwarerates were evaluated for appropriate speed. |
| Verification / ValidationType | Description |
| End User CalibrationVerification | Dimensional analysis and verification of Calibration Materials(Calibration Drill Bit and Calibration End Effector Divot) |
| F/T Sensor Verification | Guidance Arm speed limit testing and drift / idle F/T Sensorverification, intended to evaluate safety mitigations for Guidance Armmotion. |
| Start-Up / ShutdownProcess Verification | Qualitative evaluation of all start-up / shutdown steps performed in asimulated clinical environment. |
| Start-Up Joint PositionIdentification | Verification to ensure system integrity of Guidance Arm in case anyjoint motion that may have occurred while system was not powered. |
| User Emergency SafetyVerification | Evaluation of time required for a Guidance Arm emergency shutdown,and emergency disconnection of the patient. |
| Guidance Arm Adjustmentto Patient Motion | Simulation of Patient Tracker motion while system is in Drill Mode, anddrill bit is in simulated bone block |
| Work Volume Verification | Assessment of physical design and cable management throughoutavailable work volumes. |
| Speed Trap Verification | Evaluation of the Guidance Arm and Patient Tracker speed trap safetymitigations. |
| End User Validation ofUser Requirements | Validation of User Requirements as they pertain to NGS Design andDevelopment, and Software Lifecycle Design and Development,performed by End User in simulated environment. |
| End User Validation ofUser Requirements forSplint Application andRemoval | An addendum to the NGS End User Validation to repeat validationsteps associated with changes made to the design and instructions forthe use of the NGS Splint. |
| End User Validation ofUser Requirements forChanges made to PatientTracker End Effector | An addendum to the NGS End User Validation to repeat validationsteps associated with changes made to the design, and proceduralsteps associated with the Patient Tracker End Effector |
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Table 3: Summary of all software and system verification and validation.
Nonclinical Comparisons to Predicate Device
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Hardware and software verification and validation testing has been performed at the component and system level to confirm the performance of the NGS and assess substantial equivalence to the predicate device. Verification tests included:
- . Patient Splint attachment, stability, and removal testing
- . Total system use testing
Nonclinical validation testing was conducted in a simulated clinical environment and included full use of the system through the complete workflow. Testing demonstrated that the device is substantially equivalent to the predicate device.
Clinical Testing
Clinical testing has been conducted to assess the application and removal of the Chairside Splint, with a primary focus on human factors issues. The study included objective criteria and subjective criteria evaluated by 15 dentists at two different sites over a total of 75 subjects. The investigator population included a variety of experience levels and the subject population included both upper and lower jaw testing.
The primary study endpoint was:
-
Evaluation of human factors regarding Chairside Splint application and removal ●
It was evaluated using the following criteria and data: -
. Duration of Chairside Splint application and removal
-
Photos and intra-oral scans of the site before and after Chairside Splint placement ●
-
Occurrence of adverse events related to acrylic fixation
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Occurrence of adverse events during removal due to drilling the Chairside Splint .
-
Occurrence of adverse events due to debris or other swallowing or aspiration potential ● hazards
-
. Subjective evaluation by Investigators
Study results support the substantial equivalence of the NGS Chairside Splint to the cleared Patient Splint.
No significant adverse events or complications have been reported. In comparison to the predicate device, no significant new issues or risks have been identified.
Conclusion:
The nonclinical and clinical testing demonstrated that the modified splint is substantially equivalent to the predicate device splint when used as intended.
§ 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.