Implant 3D is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CAT scanner. It is also intended as pre-planning software for dental implant placement.

Device Description

Implant 3D is a software that allows to perform three-dimensional implant simulation directly on the PC. It enables to simulate the position of the implants in bi-dimensional and three-dimensional models. It also consent to identify the mandibular canal and to draw overviews and sections of the bone mode. Implant 3D enables to view the three dimensional bone model with the possibility to provide a qualitative indication of bone density. Implant 3D generates the overview, the sections and the three-dimensional bone model by reading the axial images.

AI/ML Overview

This 510(k) submission for IMPLANT 3D does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria. The provided document is a summary of the 510(k) submission, focusing on establishing substantial equivalence to a predicate device rather than presenting a standalone performance study with specific acceptance criteria.

Here's an breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be fully provided. The document states that "MEDIA LAB S.R.L. has conducted laboratory testing and determined device functionality and conformance to design input requirements" and "The device has been designed and validated in such a way that, when used under the conditions and for the purposes intended, it will not compromise the clinical condition or the safety of patients, or the safety and health of users or other people...". However, it does not specify any quantitative acceptance criteria or corresponding reported performance metrics for the device's clinical functionality (e.g., accuracy of implant simulation, segmentation accuracy of the mandibular canal, or reliability of bone density indication). The "Software testing" section lists general testing types (Unit, Integration, IR, Smoke, Formal, Acceptance, Alpha, Beta testing) but does not provide specific performance outcomes against measurable criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not mention any sample sizes for a test set, nor does it describe the provenance of any data used for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. The document does not describe any specific "test set" in the context of clinical performance evaluation that would require expert-established ground truth.

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

Cannot be provided. No adjudication method is mentioned, as there is no described test set requiring this.

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

Cannot be provided. The document does not describe an MRMC study or any study comparing human reader performance with and without AI assistance. The device is a "software interface and image segmentation system" and "pre-planning software," implying a tool for clinicians, but no a comparative effectiveness study is presented to measure its impact on human reader performance.

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

Partially addressed, but no specific performance data is given. The document implies standalone software testing ("Unit testing", "Integration testing", etc.) was conducted to confirm functionality and conformance to design input requirements. However, it does not provide any quantitative results from such standalone performance tests relevant to clinical metrics. The device itself is software (algorithm only) that assists a human user.

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

Cannot be provided. Since no specific clinical performance study with annotated data is described, the type of ground truth used is not mentioned.

8. The sample size for the training set

Cannot be provided. No information about a training set for an algorithm is provided. The document focuses on the functionality of the software for simulation and segmentation, rather than a machine learning model that would require a distinct training set.

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

Cannot be provided. As no training set is mentioned, the method for establishing its ground truth is also not provided.

Summary of available information:

The provided document describes IMPLANT 3D as a software for 3D implant simulation and pre-planning for dental implant placement, functioning as an image segmentation system. It establishes substantial equivalence to the SIMPLANT 2011 predicate device based on intended use, fundamental technology, and operation characteristics. The document states that "laboratory testing and determined device functionality and conformance to design input requirements" were conducted and that the "device has been designed and validated... it will not compromise the clinical condition or the safety of patients." General software testing types (Unit, Integration, IR, Smoke, Formal, Acceptance, Alpha, Beta testing) are listed.

In essence, this 510(k) summary focuses on regulatory substantial equivalence and general safety/functionality assertions, rather than presenting detailed clinical performance studies with quantitative acceptance criteria and supporting data. This is common for certain Class II devices seeking 510(k) clearance, where substantial equivalence to a legally marketed predicate can be demonstrated without comprehensive clinical trials, especially if the new device shares the same fundamental technology and intended use.

Summary

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

February 25, 2016

Media Lab S.r.l. % Mr. Massimo Ivani CEO Via Trieste 4 Follo, La Spezia 19020 ITALY

Re: K153091

Trade/Device Name: IMPLANT 3D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 19, 2016 Received: February 23, 2016

Dear Mr. Ivani:

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

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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.

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

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

Sincerely yours.

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) K153091

Device Name

IMPLANT 3D

Indications for Use (Describe)

Implant 3D is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CAT scanner.

It is also intended as pre-planning software for dental implant placement.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510 (K)SUMMARY

SUBMITTER/510(K) HOLDER:

Company Name:	MEDIA LAB S.R.L.
Company Address:	Via Trieste 419020 Follo - Italy
Company Phone:	039- 0187517775
Company Fax:	039- 0187511833
Company e-mail:	massimo.ivani@mlsw.com
Contact person:	Mr. Massimo Ivani
	CEO
Date Summary Prepared:	October 19, 2015

DEVICE IDENTIFICATION

Common Usual Name:	Image processing system and software forevaluating dental implant placement
Trade/Proprietary Name:	IMPLANT 3D
Classification:	Class II
Product Code:	LLZ
Classification Panel:	892 Radiology Devices
Regulation Number:	892.2050

LEGALLY MARKETED PREDICATE DEVICE

Predicate device	510 (k) Holder	510 (k) No.
SIMPLANT 2011	MATERIALISE DENTAL NV	K110300

DEVICE DESCRIPTION

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dimensional bone model with the possibility to provide a qualitative indication of bone density.

Implant 3D generates the overview, the sections and the three-dimensional bone model by reading the axial images.

INDICATIONS FOR USE STATEMENT

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

MEDIA LAB S.R.L. claims substantial equivalence of IMPLANT 3D to the predicate device based on the intended use, fundamental technology, and operation characteristics. A side-by-side comparison of IMPLANT 3D and the cited predicate device is included below.

ATTRIBUTE /CHARACTERISTICS	IMPLANT 3D(Submitted Device)	LEGALLY MARKETEDPREDICATE DEVICES OFMaterialised Dental NV
510(k) number	NA	K110300
Device Name	IMPLANT 3D	SIMPLANT 2011
CFR Section	892.2050	892.2050
Pro-code	LLZ	LLZ
Device Class	II	II
Classification panel	Radiology	Radiology
Intended / IndicationsFor Use	Implant 3D is intended for use as asoftware interface and imagesegmentation system for the transferof imaging information from amedical scanner such as a CATscanner.It is also intended as pre-planningsoftware for dental implant.	SimPlant 2011 is intended for use asa software interface and imagesegmentation system for the transferof imaging information from amedical scanner such as a CTscanner or a Magnetic Resonancescanner. It is also intended as pre-planning software for dental implantplacement and surgical treatment.
Materials	Software - Magnetic Media	Software - Magnetic Media
Design	Software for use in pre-operativeplanning.	Software for use in pre-operativeplanning.
Functions	IMPLANT 3D provides a means fortransferring patient images from amedical scanner to an output file.	SimPlant 2011 provides a means fortransferring patient images from amedical scanner to an output file.
	IMPLANT 3D is used to provide ameans for advanced pre-operativeplanning of dental implantplacements.	SimPlant 2011 is used to provide ameans for advanced pre-operativeplanning of dental implantplacements and orthognatictreatment.
	IMPLANT 3D contains a library ofdental implants	SimPlant 2011 contains a library of

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		dental implants
	Surgical templates may be designed
	and fabricated based on the output of	Surgical templates may be designed
	the pre-operative planning.	and fabricated based on the output of
		the pre-operative planning.
Operating System	Windows , MAC OS with Parallel	Windows
	Desktop
Hardware testing	N/A	N/A
Software testing	• Unit testing	• Unit testing
	• Integration testing	• Integration testing
	• IR testing	• IR testing
	• Smoke testing	• Smoke testing
	• Formal testing.	• Formal testing.
	• Acceptance testing	• Acceptance testing
	• Alpha testing	• Alpha testing
	• Beta testing	• Beta testing

PERFORMANCE DATA

MEDIA LAB S.R.L. has conducted laboratory testing and determined device functionality and conformance to design input requirements.

The device has been designed and validated in such a way that, when used under the conditions and for the purposes intended, it will not compromise the clinical condition or the safety of patients, or the safety and health of users or other people, provided that any risk which may be associated with its use constitute acceptable risks when weighed against the benefits to the patient and is compatible with a high level of protection of health and safety.

CONCLUSION

Based on the foregoing, IMPLANT 3D is substantially equivalent to the legally marketed, claimed predicate device for the purposes of this 510 (k) submission. Safety and effectiveness were reasonably assured, justifying 510 (k) clearance.

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).