ImplaStation is intended for use as a pre-operative tool for the dental implant(s) positioning based on the CT/CBCT image dataset aligned to optical 3D surface scan(s) and for the surgical guide planning result file creation. The surgical guide can be manufactured using a planning result file when used as input to 3D manufacturing systems.

3D manufacturing is out of ImplaStation software control, depends on many external factors and lie within the sole responsibility of the user.

Device Description

ImplaStation is stand-alone software designed for trained qualified dental practitioners.

The key scientific concept (807.92(a)(4)) of the ImplaStation software is the visualization of a patient's medical image data (DICOM file from third-party CT/CBCT scanners) to pre-operative digital implant planning, surgical guide (drill guide) file (output of the pre-operative implant planning) creation.

The data acquired by the optical scanner (scanned surface of the maxilla or mandible) can be aligned to the CT/CBCT reconstruction through a point-based registration technique.

Virtual crown(s) design and nerve tracing can be used as additional tools to assist the specialist during an implant planning process.

The ImplaStation library contains implant, abutment, drill, and sleeve files, which are encrypted files and approved by the corresponding implant manufactures. The software allows designing the surgical guide (drill guide) file and exporting the generated file to a 3th party external system for manufacturing. The device has no patient contact, nor does it control any life-sustaining devices.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the ImplaStation device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific numerical acceptance criteria for the ImplaStation device's performance. Instead, it relies on a comparison to a predicate device and general software validation principles. The performance data is primarily demonstrated through non-clinical testing to ensure the software functions as intended and is substantially equivalent to the predicate.

Feature/Metric	Acceptance Criteria (Implied/General)	Reported Device Performance (ImplaStation)
Overall Functionality	Functions as intended, similar to the predicate device, for pre-operative dental implant planning and surgical guide creation.	Nonclinical verification and validation testing performed. ImplaStation functions as intended, providing visualization of medical image datasets, pre-operative digital implant planning, and surgical guide file creation. Key functionalities (image registration, project management, case visualization, DICOM/STL processing, measurement tools, nerve tracing, virtual wax-up, implant planning tools, surgical guide design, surgical protocol design) are present.
Safety and Effectiveness Profile	Similar to the predicate device (CoDiagnostiX Implant Planning Software K130724). No additional concerns regarding safety and effectiveness compared to the predicate, despite minor differences.	Found to have a safety and effectiveness profile similar to the predicate device. The difference in bone density measurement (ImplaStation does not offer it) is stated not to raise additional concerns as CBCT bone density measurements are not reliable.
Compliance with Standards	Adherence to relevant medical device software and quality management standards.	Complies with IEC 62304, ISO 13485, ISO 14971, IEC 80001-2-2, NEMA PS 3.1-3.20.

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

Sample Size for Test Set: The document does not specify a distinct "test set" size in terms of patient cases or images for the nonclinical testing. The validation processes mentioned are general software engineering practices rather than a clinical performance study with a specific dataset.
Data Provenance: Not explicitly stated for specific test data. The input sources for the software are stated as medical image datasets in DICOM format from third-party CT/CBCT scanners and optical 3D surface scans (.stl files). There is no mention of country of origin or whether data was retrospective or prospective.

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

This information is not provided in the document. The nonclinical testing focuses on software functionality validation against predetermined requirements rather than a clinical "ground truth" derived from expert consensus on patient cases.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided as the document describes nonclinical software validation, not a study involving human readers and adjudicated outcomes.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not needed to support a claim of Substantial Equivalence to the predicate device." Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. Standalone Performance Study:

Yes, a standalone (algorithm only) performance assessment was done in the form of "Nonclinical verification and validation testing." This testing was performed to "ensure that the ImplaStation subject to this 510(k) Premarket Notification functions as intended." This refers to evaluating the software's functionality, adherence to requirements, and internal consistency. However, it's not a standalone clinical performance study in the sense of evaluating diagnostic accuracy against clinical ground truth.

7. Type of Ground Truth Used:

For the nonclinical testing, the "ground truth" was essentially the pre-defined software requirements, specifications, and expected functionality. The validation aimed to confirm that the software behaved as designed and met these internal criteria, rather than comparing its output to external clinical ground truth (e.g., pathology, outcomes data, or expert consensus on patient cases).

8. Sample Size for the Training Set:

This information is not provided. The document describes a medical image management and processing system and planning software, not a machine learning or AI algorithm that typically requires a distinct training set. While the software utilizes medical image data, it's presented as a tool for visualization and planning, implying rule-based or deterministic algorithms rather than trainable models with specific training data.

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

This information is not applicable/not provided for the reasons stated above. As there is no mention of a traditional "training set" for a machine learning model, the concept of establishing ground truth for it doesn't apply within this document's scope.

Summary

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December 3, 2021

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

Prodigident, Inc. % Andrii Gromov Chief Executive Officer 1350 Lake Street. Suite 1B ROSELLE IL 60172

Re: K210241

Trade/Device Name: ImplaStation Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: September 26, 2021 Received: November 1, 2021

Dear Andrii Gromov:

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

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

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

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

. for

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210241

Device Name ImplaStation

Indications for Use (Describe)

ImplaStation is stand-alone software designed for trained qualified dental practitioners, including dental technicians.

The software can be used to visualize a patient's medical image dataset output in DICOM format from third-party CT/ CBCT scanners.

3D manufacturing is out of ImplaStation software control, depends on many external factors and lie within the sole responsibility of the user.

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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I. SUBMITTER

PRODIGIDENT, Inc. 1350 Lake Street, Suite 1B Roselle, IL 60172, United States

Phone: 13 (0) 5290-7190 E-mail: andrey.gromov@prodigident.com

Contact Person:	Andrii Gromov, CEO
Date Prepared:	December 30, 2020

II. DEVICE

Name of Device:	ImplaStation
510(k) number:	K210241
Common or Usual Name:	Implant Planning and Surgical Guide Creation Software
Classification Name:	Medical image management and processing system
Regulation Number:	21 CFR 892.2050
Regulatory Class:	II
Product Code:	LLZ

III. PREDICATE DEVICE

Name of Device:	CoDiagnostiX Implant Planning Software
510(k) number:	K130724
Common or Usual Name:	Implant Planning and Surgical Guide Creation Software
Classification Name:	Medical image management and processing system
Regulation Number:	21 CFR 892.2050
Regulatory Class:	II
Product Code:	LLZ

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

ImplaStation is stand-alone software designed for trained qualified dental practitioners.

The data acquired by the optical scanner (scanned surface of the maxilla or mandible) can be aligned to the CT/CBCT reconstruction through a point-based registration technique.

Virtual crown(s) design and nerve tracing can be used as additional tools to assist the specialist during an implant planning process.

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Warning: Pathways of imaged nerves cannot be used as sole information for the clinician to make clinical decisions.

V. INDICATIONS FOR USE

ImplaStation is stand-alone software designed for trained qualified dental practitioners, including dentists and dental technicians.

The software can be used to visualize a patient's medical image dataset output in DICOM format from third-party CT/CBCT scanners.

3D manufacturing is out of ImplaStation software control, depends on many external factors and lie within the sole responsibility of the user.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The ImplaStation software covered in this submission is based on the same technological characteristics and has the same intended use as the legally cleared coDiagnostiX Implant Planning Software (predicate device).

Table 1. Identification of Similarities/Differences in Technological Characteristics between the ImplaStation software and coDiagnostiX Implant Planning Software (predicate device):

No	Feature	Proposed DeviceImplaStation	Predicate Device coDiagnostiX ImplantPlanning Software (K130724)
1.	Indications for Use	ImplaStation is stand-alone softwaredesigned for trained qualified dentalpractitioners, including dentists and dentaltechnicians. The software can be used tovisualize a patient's medical image datasetoutput in DICOM format from third-partyCT/CBCT scanners. The software aids theuser in the guided implant surgeryplanning to provide a design of dentalrestorative solutions.ImplaStation is intended for use as a pre-operative tool for the dental implant(s)positioning based on the CT/CBCT imagedataset aligned to optical 3D surfacescan(s) and for the surgical guide filecreation, and export of the created file toan external system for manufacturing.	CoDiagnostiX is an implant planning andsurgery planning software tool intended foruse by dental professionals who haveappropriate knowledge in dentalimplantology and surgical dentistry. Thissoftware reads imaging information outputfrom medical scanners such as CT or DVTscanners. It allows pre-operativesimulation and evaluation of patientanatomy and dental implant placement.For automated manufacturing of drillguides in the dental laboratoryenvironment, the coDiagnostiX canprovide printouts of template plans for thecreation of surgical templates using amanually operated gonyX table.
2.	Input Source	CT / CBCT scanner	CT / CBCT, DVT scanners
No	Feature	Proposed DeviceImplaStation	Predicate Device coDiagnostiX ImplantPlanning Software (K130724)
3.	Input Data	DICOM, .stl files	DICOM, .stl files
4.	Output Data	.stl file	.stl file
5.	Minimum systemhardware and softwarerequirements	macOS X 10.9 or newer; OS - Windows 7,64-bit;Central Processing Unit (CPU) - Intel Corei3;Memory (RAM) - 2GB;Graphics Card - Intel HD Graphics 615;Intel HD Graphics 620; NVIDIA GeForce1GB,HDD - 3GB of free space,Monitor resolution - 1600 x 900 pixels	macOS X 10.9 or newer; OS - Windows 7,64-bitCentral Processing Unit (CPU) - Intel®Core™ 2 Duo processor P8600Memory (RAM) - 8GBGraphics Card - Not specifiedHDD - 128 GB of free spaceMonitor resolution - 1680 x 1050 pixels
6.	Image registration(alignment)	The scanned surface data acquired by theoptical/intraoral scanner can be aligned tothe CT/CBCT reconstruction through apoint-based registration technique	The scanned surface data acquired by theoptical/intraoral scanner can be aligned tothe CT/CBCT reconstruction through apoint-based registration technique
7.	Projects management	Project exporting/importing	Project exporting/importing
8.	Case visualization	2D gray value images3D model renderingPanoramic modeMPR modeIndividual editing of imaging artifacts	2D gray value images3D model renderingPanoramic modeMPR modeIndividual editing of imaging artifacts
9.	DICOM data processing	DICOM segmentation, DICOM to STLconversion	DICOM segmentation, DICOM to STLconversion
10.	STL data processing	System allows to process STL files, groupfiles, fix errors, edit and copy STL files	System allows to process STL files, groupfiles, fix errors, edit and copy STL files
11.	Measurement tool	Distance/Angle	Distance/Angle:Bone density measurement
12.	Nerve tracing	Possible	Possible
13.	Virtual Wax-up	Possible	Possible
14.	Implant Planning tools	Implant, sleeve, drill, abutment, analog,and pin positioning;Custom Implant, Sleeve, Drill, Abutment,and Pin creation;Implant-to-implant, Implant-to-nervecanal, Sleeve-to-Sleeve, and Sleeve-to-STL surface distance/collision warning.	Implant, sleeve, drill, abutment, analog,and pin positioning;Custom Implant, Sleeve, Drill, Abutment,and Pin creation;Implant-to-implant, Implant-to-nervecanal, and Sleeve-to-Sleeve surfacedistance/collision warning.
No	Feature	Proposed DeviceImplaStation	Predicate Device coDiagnostiX ImplantPlanning Software (K130724)
15.	Surgical guide design	Tooth-supported surgical guide designpossible;Gingiva-supported surgical guide designpossible;Bone-supported surgical guide designpossible;Export of surgical guide design data setpossible:Offset, wall thickness and connectorthickness setting possible.	Tooth-supported surgical guide designpossible;Gingiva-supported surgical guide designpossible;Bone-supported surgical guide designpossible;Export of surgical guide design data setpossible;Offset, wall thickness and connectorthickness setting possible.
16.	Surgical protocol designand creation tool	Details protocol: available per implantproviding detailed implant, sleeve andsurgical protocol information together withimages of the planning views;Surgical protocol: The sequence ofsurgical instruments to be used as specifiedby the selected guided surgery system(selected manufacturers only)	Details protocol: available per implantproviding detailed implant, sleeve andsurgical protocol information together withimages of the planning views;Surgical protocol: The sequence ofsurgical instruments to be used as specifiedby the selected guided surgery system(selected manufacturers only)
17.	Payment model	Pay per useLicense FeeAnnual Fee	License FeeAnnual Fee

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Guided oral surgery consists of the insertion of dental implants in the exact position, and depth, through the use of customized tooth-, bone-, or mucosa-supported surgical guides designed with dedicated software and physically realized by three-dimensional (3D) printing.

ImplaStation covered in this submission and the previously cleared coDiagnostiX Implant Planning Software (predicate devices) are meant for use with standard PC hardware and include similar intended use, technology, level of concern and major functionality related to visualization and processing medical image DICOM files, implant planning and surgical guide designing.

It should be noted that in addition to the Implant, Implant-to-nerve canal, and Sleeve-to-Sleeve collision warning system, ImplaStation has a Sleeve-to-STL surface distance/collision warning system. The ImplaStation software does not offer tools for bone density measurement. Studies regarding grev values in CBCT data showed that they cannot be standardized and allocated to specific anatomical structures as in CT. Therefore, Hounsfield units used for interpretation of CT data are not applicable for CBCT data and bone density measurements in CBCT are not reliable.

The difference between ImplaStation and coDiagnostiX Implant Planning Software does not raise additional concerns regarding its safety and effectiveness.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Nonclinical Testing:

Nonclinical verification and validation testing were performed to ensure that the ImplaStation subject to this 510(k) Premarket Notification functions as intended. Testing has been carried out in accordance with the FDA guidance document: "General Principles of Software Validation: Final Guidance for Industry and FDA Staff", issued on January 11, 2002.

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The Prodigident ImplaStation complies with the following standards:

· IEC 62304
ISO 13485
ISO 14971
· IEC 80001-2-2
NEMA PS 3.1 3.20

Clinical Testing:

Clinical testing was not needed to support a claim of Substantial Equivalence to the predicate device.

Based on the performance as documented in the non-clinical study, the ImplaStation software was found to have a safety and effectiveness profile that is similar to the predicate device.

VII. CONCLUSIONS

Based on a comparison of intended use, technical characteristics, principle of operations, features and tools, and the test results, the subject device ImplaStation is found to be substantially equivalent in safety and effectiveness to the predicate device. Intended use and performance is found to be substantially equivalent to the predicate device.

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).