The REVOIS® Implant System is an implant system recommended for: Surgical placement in the edentulous or partially edentulous jaw bone (upper or lower jaw bone) to create support for prosthetic devices such as single artificial teeth, fixed or removable bridges or dentures. The titanium implant can be applied either in a one-stage surgical procedure with immediate loading when good primary stability is achieved and with appropriate occlusal loading, or in a two-stage surgical procedure (after osseointegration of the implant).

Device Description

The REVOLS® Implant System is a self-contained, modular dental implant system for placement into the jaw bone (upper or lower jaw bone) to support prosthetic devices for dental restoration. The system is designed for one-stage or two-stage surgical procedures. The REVOIS® Implant System is composed of titanium, screw type implant, preassembled with a multifunctional precision abutment and a transfer tool that snaps onto the abutment (Snap-on-tool). The implant is also available with a transfer tool only. A cover screw is contained in the top of the snap-on or transfer tool. The system offers implants in various diameters and lengths (3.8; 4.3; 5.0 mm diameter; 9; 11; 13; 15 mm lengths). The REVOIS® Implant System is provided with a number of corresponding tools and surgical instruments, as well as a variety of prosthetic components which are definitely 510(K)-exempt or still cleared by the submission K063106. For ease of identification the implants and corresponding tools are color coded according to diameter. The main components of the implant system are made of Grade V Titanium. The used materials comply with the ASTM standards ASTM F067, ASTM F0136-2a, and ASTM F2026. The implant surface is blasted with aluminium oxide and then acid-etched for microroughness. Blasting and acid -etching contributes to the implant surface characteristics. Furthermore grooves increase resistance to shear forces in difficult clinical cases. The REVOIS® titanium implant (pre-assembled with the multifunctional precision abutment and snap-on-tool or with the transfer tool only) is supplied in double sterile packages (sterile inner plastic vial in a sterile glass vial, which is sealed in a blister) and is for single use only. Tools and other re-usable instruments must be sterilized prior to use.

AI/ML Overview

This document is a 510(k) summary for the REVOIS® Implant System. It describes a medical device, specifically a dental implant system, and its substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request:

1. Acceptance Criteria and Reported Device Performance

The submission for the REVOIS® Implant System is a Special 510(k) Summary, not a de novo submission or a traditional PMA application that typically requires defining and meeting specific performance acceptance criteria for clinical outcomes.

Instead, the primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device already legally marketed. The submission aims to show that the new REVOIS® Implant System is as safe and effective as its predicate.

The reported device performance is based on demonstrating this substantial equivalence. The document states:

"The stability of the implant body of the REVOIS® implant system thread was tested in non-clinical performance testing as fatigue testing according to ISO 14801 and Bench testing with Animal Model." This indicates mechanical performance testing was conducted.
Essential similarity conclusion: The document emphasizes the comparability in "main and most important characteristics" and that "differences between the systems represent minor updates as described and do not affect the device safety or effectiveness."

Therefore, a table of acceptance criteria and reported numeric device performance as typically expected for clinical validation studies (e.g., sensitivity, specificity, accuracy) cannot be directly extracted from this document because the regulatory pathway chosen (Special 510(k)) does not require such criteria in this format. The performance is implicitly "accepted" if substantial equivalence to the predicate is shown through design, materials, and non-clinical testing.

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

Test Set Sample Size: The document mentions "fatigue testing according to ISO 14801" and "Bench testing with Animal Model." However, it does not specify the sample size (e.g., number of implants, number of animals) for these tests.
Data Provenance:
- Country of Origin: The manufacturing company is Riemser Arzneimittel AG, located in Greifswald-Insel Riems, Germany. The tests mentioned (ISO 14801 and animal model) would likely have been conducted in Germany or a location compliant with international standards, but this is not explicitly stated.
- Retrospective or Prospective: The "fatigue testing" and "Bench testing with Animal Model" are by nature prospective non-clinical studies. They are laboratory or controlled animal experiments designed to evaluate specific aspects of the device's physical performance before widespread clinical use.

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

The concept of "ground truth" and expert consensus as applied to diagnostic or AI-driven devices for medical image interpretation is not applicable to this submission.

This is a submission for a dental implant system, a physical medical device.
The "testing" referenced (ISO 14801, animal model) relates to the mechanical and biological properties of the implant, not to the interpretation of medical data by experts.
Therefore, there were no experts establishing "ground truth" concerning diagnostic accuracy in the context you describe.

4. Adjudication method for the test set

Not applicable for the same reasons as #3. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among human readers interpreting data, which is not the type of testing described here.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.

This type of study is relevant for AI-powered diagnostic or assistive devices where human readers (e.g., radiologists) interact with or are assisted by AI.
The REVOIS® Implant System is a physical dental implant. There is no AI component that would assist human readers in, for instance, interpreting dental images.

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

No, a standalone algorithm-only performance assessment was not done.

This type of assessment is also specific to AI/software as a medical device (SaMD). The REVOIS® Implant System is a physical surgical implant device.

7. The type of ground truth used

The relevant "ground truth" for this device would be established by:

Defined engineering standards and physical measurements: For fatigue testing (ISO 14801), the "ground truth" is whether the implant can withstand specified forces for a certain number of cycles without failure, as defined by the standard.
Histopathological or biological outcome measures: For the "Bench testing with Animal Model," the "ground truth" would involve histological examination of bone integration, absence of inflammation, mechanical stability post-implantation, etc., compared to established benchmarks or the predicate device.
Clinical outcomes (implicitly): While not directly part of the substantial equivalence argument summarized here, the predicate device's existing safety and effectiveness in clinical use forms an implicit "ground truth" that the new device aims to match.

8. The sample size for the training set

Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant to the provided document.

In summary, the provided document is a regulatory submission for a physical medical device (dental implant) seeking clearance via the 510(k) pathway. It focuses on demonstrating substantial equivalence to an existing predicate device through design, materials, and non-clinical performance testing, not on clinical performance metrics or AI algorithm validation using expert ground truth or training/test sets.

Summary

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KII 3042

REVOIS®

Special 510 (k) Summary

Section 4

RIEMSER C

Arzneimittel AG

Special 510 (k) Summary:

REVOIS® Implant System

MAR 8 2013

SUBMISSION INFORMATION 1.

Name and Addressof the Sponsor:	Riemser Arzneimittel AGAn der Wiek 717493 Greifswald-Insel RiemsGermany
Date created	March 5, 2013
Contact person:	Dr. Andreas PüttnerHead of Regulatory AffairsTel.: +49-3835-1760Fax: +49-3835-176778E - Mail: dr.puettner@riemser.de
Registered U. S. Agent:	James M. Clinton5105 Fairoaks Rd.Durham, NC 27712, USAPhone: 919-247-0479, fax: 919-287-2551E - Mail: clintonjm@earthlink.net

DEVICE IDENTIFICATION 2.

Proprietary Name:	REVOIS® Implant System
Common Name:	Dental implant system
Classification Name:	Endosseous Dental Implant
Classification:	Class II, Special Controls
Classification regulation Number:	21CFR 872.3640
Product Code:	DZE, Endosseous implant

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KII3042

REVOIS® Section 4 Special 510 (k) Summary

3. PREDICATE DEVICE

REVOIS® Implant System: K063106

DESCRIPTION OF THE DEVICE 4.

The REVOIS® Implant System is composed of titanium, screw type implant, preassembled with a multifunctional precision abutment and a transfer tool that snaps onto the abutment (Snap-on-tool). The implant is also available with a transfer tool only. A cover screw is contained in the top of the snap-on or transfer tool.

The system offers implants in various diameters and lengths (3.8; 4.3; 5.0 mm diameter; 9; 11; 13; 15 mm lengths). The REVOIS® Implant System is provided with a number of corresponding tools and surgical instruments, as well as a variety of prosthetic components which are definitely 510(K)-exempt or still cleared by the submission K063106. For ease of identification the implants and corresponding tools are color coded according to diameter.

The main components of the implant system are made of Grade V Titanium. The used materials comply with the ASTM standards ASTM F067, ASTM F0136-2a, and ASTM F2026.

The implant surface is blasted with aluminium oxide and then acid-etched for microroughness. Blasting and acid -etching contributes to the implant surface characteristics. Furthermore grooves increase resistance to shear forces in difficult clinical cases.

The REVOIS® titanium implant (pre-assembled with the multifunctional precision abutment and snap-on-tool or with the transfer tool only) is supplied in double sterile packages (sterile inner plastic vial in a sterile glass vial, which is sealed in a blister) and is for single use only.

Tools and other re-usable instruments must be sterilized prior to use.

5. STATEMENT OF INTENDED USE

The REVOIS® Implant System is an implant system recommended for:

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KI13042

REVOIS ®	Section 4
Special 510 (k) Summary	Image: RIEMSER logo

Surgical placement in the edentulous or partially edentulous jaw bone (upper or lower jaw bone) to create support for prosthetic devices such as single artificial teeth, fixed or removable bridges or dentures.

The titanium implant can be applied either in a one-stage surgical procedure with immediate loading when good primary stability is achieved and with appropriate occlusal loading, or in a two-stage surgical procedure (after osseointegration of the implant).

STATEMENT OF TECHNOLOGICAL COMPARISON, BASIS FOR 6. SUBSTANTIAL EQUIVALENCE

The REVOIS® Implant System by Riemser is identical to the REVOIS® Implant System by cursan that was cleared by K063106. The ownership of the K063106 device was transferred from CURASAN AG to Riemser AG and FDA was notified by a letter to file. The Riemser device like the curasan device provides the same state-of-the art implant technology and options. The design and pre-assembled version of implant, abutment (which fits for all implants and implant diameters) and snap-on/transfer tool offer easy handling for the dentist/surgeon by reducing the number of components needed for successful placement of the implant, while ensuring precision and stability.

The stability of the implant body of the REVOIS® implant system thread was tested in non-clinical performance testing as fatigue testing according to ISO 14801 and Bench testing with Animal Model.

The essential similarity conclusion regarding the comparability of REVOIS® and REVOIS® (CURASAN, K063106)) are displayed in the following:

Both implant systems share similar indications for use. Both systems consist of screw form implants with internal hex connection consisting of different grades which is an inert, very durable material well known and used in implant surgery. They feature special threads and surfaces intended to support the primary stability of the implant and to ease the insertion, tissue adhesion and osseointegration of the implant into the bone. Both the curasan AG and Reimser AG systems provide implants in various diameters, lengths and color codes to accommodate different clinical situations as well as the matching tools, surgical instruments and accessories. The implants and pre-mounted components where applicable (REVOIS®, REVOIS® (CURASAN, K063106)), are supplied gamma sterilized in double sterile packaging. Differences between the Riemser REVOLS® and the curasan predicate device exist in the implant surface treatment; aluminium oxide blasted / acid etched (Riemser REVOIS®) and zirconium blasted / acidetched (REVOIS® (CURASAN, K063106)). Each system has a triple layer of sterility protection: PETG vial in glass vial, sealed in a blister at REVOIS®; the REVOIS® (CURASAN) comes with PET vial instead of PETG, while the blister and glass vial remain the same.

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K113042

REVOIS ®	Section 4
Special 510 (k) Summary	Arzneimittel AG

In summary, both systems are comparable in their main and most important characteristics. The differences between the systems represent minor updates as described and do not affect the device safety or effectiveness. The Riemser REVOIS® and the REVOIS® (CURASAN) implant systems are therefore substantially equivalent.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three distinct lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is positioned around the upper and lower portions of the circular logo.

Public Health Service

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

March 8, 2013

Riemser Arzneimittel AG C/O Mr. James M. Clinton Principal Consultant Quality & Regulatory Consulting, Limited Liability Company 5105 Fairoaks Road DURHAM NC 27712

Re: K113042

Trade/Device Name: REVOIS® Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 3, 2013 Received: February 13, 2013

Dear Mr. Clinton:

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.

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Page 2 - Mr. Clinton

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 devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Image /page/5/Picture/6 description: The image shows the text "Kwame O. Ulmer for". The text "Kwame" is in a standard font, while "O. Ulmer" is stylized with a geometric, layered design. The word "for" is in a smaller, plain font to the right of "Ulmer".

Anthony D. Watson, B.S., M.S., M.B.A. 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 STATEMENT

K113042 510(k) Number (if known):

REVOIS® Implant System Device Name:

Indications for Use:

The REVOIS® Implant System is an implant system recommended for:

V Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary.S. Runner -
Susan Runner, DDS, BA
2013.03.07
09:15:53-05'00'

(Division Sign-Off) lon of Anesthesiology, General Hospital Infection Control. Dantal Devic

510(k) Number:

Page 1 of 1

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.