EASY GRIP implants are designed for use in partially edentulous mandibles or maxillae for attachment of complete denture prostheses or as a terminal or intermediary abutment for fixed or removable bridgework or as a free-standing single tooth replacement. EASY GRIP implant system uses a two-stage implantation procedure or one-stage procedure.

Device Description

EASY GRIP dental implants are root-form endosseous dental implant devices made out of biocompatible medical titanium, commercially pure or alloyed. There are three types of implants: cylindrical, anatomical, conical, available in different diameters from 3.3 to 5.5 mm and lenghts that vary from 8 to 16 mm. The anchorage surface of the implant is roughened by a sand-blasting and an acid-etching process, for better osseointegration. This submission also include compatible screws and prosthetic components.

AI/ML Overview

The provided text is a 510(k) summary for the EASY GRIP dental implant system. It describes the device, its intended use, and its substantial equivalence to legally marketed predicate devices.

However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way you've outlined for AI/software-based devices.

Dental implants like the EASY GRIP are typically cleared based on substantial equivalence to existing devices, meaning they are demonstrated to be as safe and effective as a legally marketed predicate device. This often involves:

Material composition: Ensuring the materials (e.g., biocompatible titanium) are identical or equivalent to those in predicate devices.
Design features: Comparing dimensions, thread patterns, surface treatments (sand-blasting and acid-etching for better osseointegration), and component compatibility with predicate devices.
Intended use: Confirming the intended applications (e.g., attachment of prostheses, abutment for bridgework, single tooth replacement) are consistent with predicate devices.
Biocompatibility testing: (Implied, though not detailed in this summary) ensuring the materials are safe for use in the human body.
Mechanical/Physical testing: (Implied, though not detailed here) demonstrating the implant's strength, fatigue resistance, and other physical properties meet standards comparable to predicate devices. This is where "acceptance criteria" for physical performance might be applied, but they are not reported in this specific 510(k) summary.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, experts, ground truth, or MRMC studies, as those types of studies and reporting are not part of this 510(k) summary for a physical medical device.

The 510(k) process for devices like dental implants relies on demonstrating that the new device is substantially equivalent to devices already on the market (predicates), rather than proving novel performance against acceptance criteria in a clinical study with human readers/AI, as would be the case for a diagnostic AI.

If you have a document describing a clinical study or performance testing with specific criteria for a device, I can help you extract that information. However, based solely on this 510(k) summary, the information you requested is not present.

Summary

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510(k) NOTIFICATION

EASY GRIP

1672

K073622

MAY 1 4 2008

510 (k) Summary of safety and effectiveness

SUBMITTER INFORMATION

ಗಿ	Company Name:	I.F.I. System s.r.I.
B.	Company Address:	Via Alessandro D'Ancona, 23Roma, Italy 00137
C.	Company Phone:Company Fax:	+39 06 87201371+39 06 87232518
D.	Contact Person:	Claudio MechelliManaging DirectorT.F.I. System s.r.I.

ய் Date Summary Prepared: December 20, 2007

DEVICE IDENTIFICATION

A.	Device name:	Endosseous Dental Implant System
B.	Trade/Proprietary Name:	EASY GRIP® dental implant system
C.	Classification name:	Endosseous dental implant (21 CFR 872.3640) andEndosseous dental implant abutment (21 CFR 872.3630)
D.	Product Code:	DZE

E mail info@tfisystem.it

LEGALLY MARKETED DEVICES (PREDICATE DEVICES)

Straumann USA & AG, ITI® Dental Implant Systems K033922, K984104, K003271, -K012757, K030007, K031055,
Sudimplant SA, T.B.R.® ide@ conic, K050956, -
ACE Surgical Supply Co., Inc., ACE CONNECT ™ Internal Connection Screw Dental " Implant System K041759,
Implant Innovations, Inc., 3i Restorative Dental Implant Systems, K041402, K063286, -K022009.
SIC Invent AG, SIC Dental Implant Systems, K040757, K061500, ・
FRIADENT GmbH, XIVE® Dental Implant Systems, K013867, K021318, K024004 -

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EASY GRIP

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K073622

DESCRIPTION OF THE DEVICE

INTENDED USE

SUBSTANTIAL EQUIVALENCE

EASY GRIP dental implant system and the predicate devices are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with roughened surfaces. The subject and predicate devices use the same materials and are similar in size. In further support of a substantial equivalence determination, Section 5 provides a comparison chart of the Easy Grip implant system and the predicate devices.

Based on the available 510(k) summaries and the information provided herein, we conclude that Easy Grip implant system is substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2008

Mr. Claudio Mechelli Managing Director T.F.I. System Srl Via Alessandro D'Ancona, 23 00137 Roma ITALY

Re: K073622

Trade/Device Name: Easy Grip Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 18, 2008 Received: April 24, 2008

Dear Mr. Mechelli:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Mechelli

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clus

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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T.F.I. SYSTEM S.R.L.

510(k) NOTIFICATION

EASY GRIP

INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

EASY GRIP

Indications for Use:

EASY GRIP implants are designed for use in partially edentulous mandibles or maxillae for attachment of complete denture prostheses or as a terninal cr intermediary abutment for fixed or removable bridgework or as a free-standing single tooth replacement. EASY GRIP implant system uses a two-stage implantation procedure or one-stage procedure.

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runoz

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: KC073622

EASY GRIP 510(k) Page 3-2

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.