The iMARK™ Internal Hexagon Dental Implant System is used in indications for oral endosseous implants in the maxilla and/or mandible as part of a functional and aesthetic oral rehabilitation in partial or fully edentulous patients.

The IMARK™ Internal Hexagon Dental Implant System is designed for use in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system can also be used for single tooth restorations. The IMARK™ Internal Hexagon Dental Implant System uses a two-stage implantation process.

The iMARK™ Internal Hexagon Dental Implant System is compatible with Zimmer® Tapered Screw Vent prosthetics.

Device Description

The ACE Surgical iMARK™ Internal Hexagon Dental Implant System is a screw type dental implant system designed with technology established with the ACE Surgical Screw Dental Implant System (K954513) and the Zimmer® Tapered Screw Vent Dental Implant (K011028). The ACE Surgical iMARK™ Internal Hex dental implant screw raw material is made of Ti-6-AL-4V ELI per ASTM F13& standard and surface treated with resorbable blast media (RBM). The self tapping internal horning and features tapered external thread geometry consistent with industry standard screw implant fixtures. The implants are provided sterile and sterility is achieved by gamma radiation pursuant to ISO 11137

AI/ML Overview

The provided text describes the 510(k) summary for the ACE Surgical iMARK™ Internal Hexagon Dental Implant System. This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than an AI-based device's performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this type of submission.

However, I can extract the relevant performance characteristics that were tested and the type of ground truth used (in this case, mechanical test standards and predicate device performance).

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance/Comparison (Implied Acceptance)
Mechanical Performance	Torsional Insertion	Conducted to support substantial equivalence to predicate devices (K954513 and K011028).
	Shear (Coaring)	Conducted to support substantial equivalence to predicate devices (K954513 and K011028).
	Compressive Bending	Conducted to support substantial equivalence to predicate devices (K954513 and K011028).
	Fatigue Strength	Conducted to support substantial equivalence to predicate devices (K954513 and K011028).
Material Composition	Ti-6-AL-4V ELI per ASTM F13 standard	Stated as the raw material for the implant screw.
Surface Treatment	Resorbable Blast Media (RBM)	Applied to the implant screw, comparable to predicate devices.
Sterilization	Gamma radiation pursuant to ISO 11137	Provided sterile, achieved by gamma radiation, identical to predicate device methods.

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

Sample Size: Not explicitly stated in the document (typical for mechanical testing, usually a small number of samples per test type to meet standard requirements).
Data Provenance: Not specified, but generally, mechanical testing is performed in a controlled laboratory environment. Retrospective/prospective distinction is not applicable here.

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

Not applicable. The "ground truth" for mechanical testing is established by adherence to recognized industry standards (e.g., ASTM F13, ISO 11137) and comparison to predicate device performance, not by expert consensus on data interpretation.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for expert review of clinical data, not for mechanical performance testing.

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. This is not an AI-based device, and therefore no MRMC study was performed.

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

Not applicable. This is a medical implant, not an algorithm.

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

The "ground truth" or reference for the mechanical testing was primarily based on:
- Industry Standards: Adherence to established mechanical testing standards (e.g., relevant ASTM standards for materials and ISO standards for sterilization).
- Predicate Device Performance: Comparison of the new device's mechanical performance to that of legally marketed predicate devices (ACE Surgical Screw Dental Implant System K954513 and Zimmer® Tapered Screw Vent Dental Implant K011028) to demonstrate "substantial equivalence."

8. The sample size for the training set

Not applicable. This is a medical implant, not a machine learning model, so there is no training set.

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

Not applicable. There is no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria involved a series of mechanical tests designed to demonstrate the material properties, structural integrity, and functional performance of the ACE Surgical iMARK™ Internal Hex Dental Implant System. These tests included:

Torsional insertion: To assess the torque required for placement/insertion.
Shear (coaring): To evaluate resistance to shearing forces.
Compressive bending: To test the implant's ability to withstand compressive and bending loads.
Fatigue strength: To determine the implant's durability under repeated stress cycles, simulating physiological conditions over time.

These tests were performed to support the substantial equivalence of the iMARK™ system to two predicate devices: the ACE Surgical Screw Dental Implant System (K954513) and the Zimmer® Tapered Screw Vent Dental Implant (K011028). The implicit "acceptance criteria" for these tests were that the new device's performance characteristics must be comparable to or better than those of the predicate devices, thereby demonstrating that it is as safe and effective.

Additionally, material composition (Ti-6-AL-4V ELI per ASTM F13 standard) and sterilization methods (gamma radiation per ISO 11137) were confirmed to meet recognized standards, further supporting the device's safety and effectiveness. The successful completion of these tests, leading to a determination of substantial equivalence by the FDA, indicates that the device met the necessary performance characteristics for market clearance.

Summary

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K10298i

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Manufacturer Name:	ACE Surgical Supply Co., Inc.	DEC 2 0 2010
Manufacturer Address:	1034 Pearl St., Brockton, MA 02301
Telephone Number:	(508) 588-3100
Fax Number:	(508) 523-3140
Date Prepared:	October 1, 2010
Official Contact:	Carol A. Houts, Director of Compliance
DEVICE NAME:
Device Trade Name:	ACE Surgical iMARKTM Internal Hexagon Dental Implant
Device Common Name:	Screw Dental Implant

Reason for submission: Not previously marketed in the USA

ESTABLISHMENT REGISTRATION NUMBER:

The Establishment License Number for ACE Surgical Supply Co. Inc. is 1287163.

DEVICE CLASSIFICATION:

Implant, Endosseous, Root-Form, product code, DZE, 21CFR 872.3640.

PREDICATE DEVICES:

ACE Surgical Screw Dental Implant System (K954513) Zimmer® Tapered Screw Vent Dental Implant (K011028)

INTENDED USE:

. .

The ACE Surgical IMARK™ Internal Hexagon Dental Implant System is designed for use in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system can also be used for single tooth restorations. The ACE Surgical iMARK™ Internal Hexagon Dental Implant System uses a two-stage implantation process..

The ACE Surgical iMARK™ Internal Hexagon Dental Implant System is used in indications for oral endosseous implants in the maxilla and/or mandible as part of a functional and aesthetic oral rehabilitation in partial or fully edentulous patients.

The ACE Surgical iMARK™ Internal Hexagon Dental Implant System is compatible with Zimmer® Tapered Screw Vent prosthetics cleared under K011028.

DEVICE DESCRIPTION:

The ACE Surgical iMARK™ Internal Hexagon Dental Implant System is a screw type dental implant system designed with technology established with the ACE Surgical Screw Dental Implant System

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(K954513) and the Zimmer® Tapered Screw Vent Dental Implant (K011028). The ACE Surgical iMARK™ Internal Hex dental implant screw raw material is made of Ti-6-AL-4V ELI per ASTM F13& standard and surface treated with resorbable blast media (RBM). The self tapping internal horning and features tapered external thread geometry consistent with industry standard screw implant fixtures. The implants are provided sterile and sterility is achieved by gamma radiation pursuant to ISO 11137

PERFORMANCE CHARACTERISTICS:

The following mechanical tests were conducted to support the substantial equivalence of the ACE Surgical IMARK™ Internal Hex to the ACE Screw Dental Implant System (K954513) and the Zimmer@ Tapered Screw Vent Dental Implant (K011028): torsional insertion and shear (oaring and compressive bending and fatigue strength.

EQUIVALENCE TO MARKETED DEVICE:

The ACE Surgical IMARK™ Internal Hexagon Dental Implant is substantially equivalent to the ACE Screw Dental Implant System (K954513) and the Zimmer® Tapered Screw Vent Dental Implant (K011028) The candidate device and the predicate devices have the same intended use and similar technological characteristics. The candidate device and predicate devices are made of titanium alloy and commercially pure titanium. The candidate and predicate devices have comparable roughened surface treatments. The candidate and predicate devices encompass a similar range of physical dimensions such as diameter and length. The candidate and predicate devices are packaged and sterilized by identical Both the ACE Surgical Screw Implant and the ACE Surgical IMARK™ Internal Her use a 2 methods. stage implantation process. The Zimmer® Tapered Screw Vent utilizes either a one or wor stage implantation process.

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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 features the department's seal on the left, which includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". To the right of the seal is a stylized graphic consisting of three curved lines that resemble a human figure.

Public Health Service

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

DEC 2 0 2010

Ms. Carol A. Houts Director of Compliance Ace Surgical Supply Company Incorporated 1034 Pearl Street Brockton, Massachusetts 02401

Re: K102981

Trade/Device Name: ACE SURGICAL iMARK™ Internal Hex Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseeous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 2, 2010 Received: December 2, 2010

Dear Ms. Houts:

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- Ms. Houts

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.

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.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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DEC 2 0 2010

Indications for Use

510(k) Number: ¥102981

Device Name: ACE SURGICAL iMARK™ Internal Hex Dental Implant System

Indications For Use:

The iMARK™ Internal Hexagon Dental Implant System is compatible with Zimmer® Tapered Screw Vent prosthetics.

Prescription Use X (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)

Susan Runne

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

510(k) Number: K102981

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.