The IMPLANTER DENTAL PLANNING SOFTWARE is a device that employs previously scanned DICOM CT images in a software tool which serves as an aid to visualizing and preplanning of dental implant surgery.

Device Description

The Implanter Dental Implant Planning Software is a software aimed to help simplifying dental implant surgery and enhancing its mechanical and esthetic implications in the prosthetic stage. Implanter Dental Implant Planning Software allows dental implant professionals to plan their implant surgeries and/or to design surgical appliances that will be used during surgery. The program will present the clinician with various reformatted CT/CBCT images of their patient's jaw(s), allow the placement and manipulation of virtual implants, and provide measurement and other tools to assist the clinician. Since the primary purpose of Implanter Dental Implant Planning Software is to aid the planning of implant surgeries, Implanter Dental Implant Planning Software will allow the surgeon to place simulated implants on the image and to gauge their size and position relative to the surrounding anatomy.

Implanter is a digital image processing software for Windows that loads images in DICOM format (CT and CBCT images) and rebuilds them in order to get different views that allows the dentist to assess the patient´s anatomy, plan a dental implant surgery, and design a printable surgical guide based on the former.

The software allows the dentist to:

· use a dental virtual implant gallery to plan a surgery choosing the proper implant size. The IMPLANTER software contains a virtual dental implants library based on the Groovy Implants from Noble Biocare® (FDA cleared under K050258).
Implanter Dental Planning Software generates 3D models and exports these . models in a format suitable for 3D printing to be used as physical models for visualization or educational purposes only. This clearance does not cover medical devices manufactured from those output files.
save the surgical planning session of a patient for later analysis. .

AI/ML Overview

The provided text is a 510(k) summary for the IMPLANTER DENTAL PLANNING SOFTWARE. This document indicates that clinical testing was not required for this 510(k) submission. Therefore, a study proving the device meets acceptance criteria via clinical performance data, as typically associated with a medical device approval and the type of information requested about sample sizes, experts, MRMC studies, and ground truth, is not provided or required in this submission.

The section "EFFECTIVENESS AND SAFETY CONSIDERATIONS" states:
Clinical Test: Clinical testing is not required.
Non-clinical Test: The IMPLANTER DENTAL PLANNING SOFTWARE has documented, validated and verified its software system. Performance tests have been conducted to verify equivalent performance to predicate devices. Performance tests include measurement accuracy of 3D and 2D measuring tools, nerve tracing and implant positioning, and implant drilling accuracy. Report generation has also been validated to verify accuracy of the information reported.

Based on the provided document, the assessment for substantial equivalence relies on non-clinical performance tests and a comparison of technical characteristics with predicate devices.

Here's a breakdown of the available information relevant to your request, noting where information is explicitly not provided due to the nature of this 510(k) submission:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in the format typically used for clinical study outcomes (e.g., sensitivity, specificity, accuracy). Instead, it states that "Performance tests have been conducted to verify equivalent performance to predicate devices."

The non-clinical performance tests mentioned include:

Measurement accuracy of 3D and 2D measuring tools
Nerve tracing
Implant positioning
Implant drilling accuracy
Report generation accuracy

No quantitative results from these performance tests are disclosed in the 510(k) summary. The comparison table focuses on features and technical specifications rather than specific performance metrics and their acceptance thresholds.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided due to the absence of a clinical test. The non-clinical performance tests mentioned do not specify sample sizes for test cases or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided due to the absence of a clinical test that would typically involve expert assessment for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not provided due to the absence of a clinical test.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. The document explicitly states "Clinical testing is not required." This device is a preplanning software aid, and there's no indication of an MRMC study comparing human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is described as "a software tool which serves as an aid to visualizing and preplanning of dental implant surgery." This inherently implies a human-in-the-loop scenario. The non-clinical performance tests focused on the accuracy of the software's tools (e.g., measurement, positioning) rather than autonomous diagnostic performance. No standalone performance metrics are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance tests, implicit ground truth would be based on known geometric properties of test objects for measurement accuracy, or perhaps predefined anatomical references for nerve tracing and implant positioning. However, the exact methods for establishing this ground truth are not detailed in the summary.

Type of Ground Truth (for non-clinical tests): Not explicitly stated, but inferred to be based on predefined technical specifications or known values for the performance tests (e.g., actual distances for measurement accuracy tests).

8. The sample size for the training set

Not applicable/Not provided. This device is described as a "software tool" for planning, not an AI/ML device that requires a "training set" in the context of learning algorithms. It processes DICOM images and provides tools for user interaction. The summary does not mention any machine learning components that would necessitate a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided, as there is no mention of a training set for a machine learning algorithm.

Summary

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December 3, 2018

Implanter LLC % Dr. Jorge Millan Regulatory Affairs Manager 7600 NW 69th Avenue MEDLEY, FL 33166

Re: K173083

Trade/Device Name: IMPLANTER DENTAL PLANNING SOFTWARE Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: October 26, 2018 Received: October 30, 2018

Dear Dr. Millan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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,

Michael D.'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173083

Device Name

IMPLANTER DENTAL PLANNING SOFTWARE

Indications for Use (Describe)

The IMPLANTER DENTAL PLANNING SOFTWARE is a device that employs previously scanned DICOM CT images in a software tool which serves as an aid to visualizing and preplanning of dental implant surgery.

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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FORM FDA 3881 (8/14)

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510K SUMMARY IMPLANTER DENTAL PLANNING SOFTWARE K173083 SUBMITTER IMPLANTER LLC 7600 NW 69™ AVENUE MEDLEY, FL 33166 US AGENT JORGE MILLAN, PHD REGULATORY AFFAIRS MANAGER Email: sigmabiomedical@gmail.com Web: https://www.sigmabiomedical.com DATE OF SUMMARY: Dec 3, 2018 DEVICE NAME AND CLASSIFICATION TRADE NAME: IMPLANTER DENTAL PLANNING SOFTWARE 892.2050 Picture Archiving and Communication System CLASSIFICATION NAME:

Product Code: LLZ

REGULATORY CLASS: Class II PANEL IDENTIFICATION Radiology

DEVICE DESCRIPTION

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The software allows the dentist to:

· use a dental virtual implant gallery to plan a surgery choosing the proper implant size. The IMPLANTER software contains a virtual dental implants library based on the Groovy Implants from Noble Biocare® (FDA cleared under K050258).
Implanter Dental Planning Software generates 3D models and exports these . models in a format suitable for 3D printing to be used as physical models for visualization or educational purposes only. This clearance does not cover medical devices manufactured from those output files.
save the surgical planning session of a patient for later analysis. .

Indications for Use: The IMPLANTER DENTAL PLANNING SOFTWARE is a device that employs previously scanned DICOM CT images in a software tool which serves as an aid to visualizing and preplanning of dental implant surgery.

Comparison with the Predicate Devices [21 CFR 807.92(a) (6)]

The IMPLANTER DENTAL PLANNING SOFTWARE is equivalent to the VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE by Implant Logic Systems Ltd cleared under K060267 and the IPS software by Symbio Dental LLC cleared under K113404.

Technical Characteristics Comparison:

The basic and main technical features of the subject device IMPLANTER DENTAL PLANNING SOFTWARE are the same as the predicated device

Feature Comparison:

Subject device has similar features and functionality as the predicate device:

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Table of comparison similarities and differences

Feature	IMPLANTERK#173083	VIRTUALPLACEMENTK060267	IPSK113404
Image Source	CT Scanner	CT Scanner	CT Scanner, Cone beam CT machines, CT scanners
IFU	This device employspreviously scannedDICOM CT images ina software tool whichserves as an aid tovisualizing and pre-planning of dentalimplant surgery	This device employspreviously scannedDICOM CT images in asoftware tool whichserves as an aid tovisualizing and pre-planning of dentalimplant surgery	IPS is a prescriptionuse software used bydentist and dental labtechnicians for thevisualization andimage segmentationof DICOM data frommedical scanners suchas CT. The softwareaids the users in thecreation of 3D modelsof oral maxillofacialregion and inplanning dentalsurgical treatmentsand placement ofdental implants
Prescription use	Yes	Yes	Yes
Tools	Visualization, ImplantPlacement, distancemeasurement	Visualization, ImplantPlacement, Distancemeasurement,	Visualization, implantand nerve placement,measurement odistance, anglemeasurement, densitydetermination,segmentation tool
Image FormatStandard	DICOM PS 3.1	DICOM PS 3.1	DICOM
Reads DICOMdirectly	Yes	Yes	Yes
Displays axial, cross sectionaland panoramic images	Yes	Yes	Yes
Implants modeledas conical sections	Yes	Yes	-
Implants modeledas 3D objects	No	No	Yes
3D view	Yes	Yes	Yes
Distance and ROItools	Yes	Yes	Yes
Sinus lift tool	No	No	-
3D segmentation	No	No	Yes
Input implantmodels*	Yes	Yes	Yes
Report generation	Yes	Yes	Yes
Host Platform	PC	PC	PC
Outputcompatibility	CAD, rapid prototyping machines	---	CAD, rapid prototyping machines
Operating System	Windows 7.0 and later	Windows 98, 2000 and XP	Windows XP, Vista, 7
Host RAM	4 GB RAM	256 MB RAM	Not specified
Host MagneticStorage	500 MB	10 GB hard drive	Not specified
CD ROM	Yes (for installation)	Yes (for installation)	Yes
Host Processor	Quad Core	Pentium III, 500 MHz	Not specified

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*Implant models based on Groovy Implants from Noble Biocare® (FDA cleared under K050258).

Discussion of similarities: The IMPLANTER system features and functionalities are equivalent as those of predicate devices. All devices are software-based PC systems, using DICOM libraries and image controls for viewing and image manipulation. All systems use standard menu based graphical user interface.

Discussion of differences: The IPS system (K113404) has additional features and functionalities than the IMPLANTER system has. IMPLANTER system requires more RAM memory and less hard disk space than the VIRTUAL IMPLANT PLACEMENT device

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(K060267), making it faster for image viewing. These differences and features do not raise safety or effectiveness concerns.

EFFECTIVENESS AND SAFETY CONSIDERATIONS

Clinical Test:

Clinical testing is not required.

Non-clinical Test:

The IMPLANTER DENTAL PLANNING SOFTWARE has documented, validated and verified its software system. Performance tests have been conducted to verify equivalent performance to predicate devices. Performance tests include measurement accuracy of 3D and 2D measuring tools, neve tracing and implant positioning, and implant drilling accuracy. Report generation has also been validated to verify accuracy of the information reported.

Substantially Equivalent Determination

The subject device has similar technology characteristics and has the same intended use, as legally marketed devices. There are no differences between the devices that affect the usage, safety and effectiveness, thus no new question is raised regarding the safety and effectiveness. In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, IMPLANTER IMPLANT PLANNING SOFTWARE is substantially equivalent to the predicate device with regards to safety and effectiveness.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).