The ACE Surgical Secure™ Locator® 3.25mm Implant System is is designed to provide intra-bony long term fixation of denture installations in partially or fully edentulous patients.

Device Description

The ACE Secure™ Locator® 3.25mm Implant System is a set of machined commercially pure (CP) titanium (Grade 4) screws, intended to provide Intra-bony long term fixation of denture installations in partially or fully edentulous patients. The implants are supplied sterlie in 3.25 mm diameter, and in lengths of 8, 10, 11.5, 13, and 15 mm, and with Zest Locator® implant Anchor Abutments and Denture Cap Males (Identical to those cleared under K092594)/n standard tray packaging and include placement instruments.

The screw raw material is Ti (CP-Grade 4) per ASTM F67 standard. The screw Implants, abutments and denture caps are identical In materials and characteristics to that cleared under K092594 and K954513. These screws are supplied sterile in standard Tyveke tray packaging along with applicable instructions for use.

The ACE Secure™ Locatore 3,25mm Implant System Is a comprehensive system using same and similar surgical tools (a Two Step Lag Bur CA is replaced by a Kirschner Pliot Bur, and the optional Parallel Pin/Depth Gauge and 2.8 mm twist drill are now supplied standard) made from high strength corrosive resistant stainless steel (17-4, H-900) and a similar (the predicate tray had holes and markings to accommodate the predicate screw implant sizes, the candidate device will have two trays - one solely for candidate screw implant sizes, and another for the combined predicate and candidate screw implant sizes) polycarbonate sterlization tray accessory as in the predicate ACE Surgical Secure-Mini™ Locator® Implant svstem.

AI/ML Overview

The provided text describes a submission for a 510(k) premarket notification for a dental implant system. The focus of this submission is to demonstrate substantial equivalence to previously marketed predicate devices, rather than conducting a de novo study to establish acceptance criteria based on new performance data.

Therefore, the acceptance criteria and study information typically sought for a new device's performance evaluation (such as those involving AI or diagnostic accuracy) are not present in this document. The "acceptance criteria" here implicitly refer to the demonstration of equivalence to existing, legally marketed devices.

Here's an analysis based on the provided text, addressing your questions where applicable, and highlighting where information is not available:

Acceptance Criteria and Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Summary of Bench Testing)
No difference in fundamental technology compared to predicate devices.	The ACE Surgical Secure™ 3.25mm Implant System demonstrated "no difference in the fundamental technology" compared to the specified predicate devices (ACE Surgical Secure-Mini™ Locator® Implant System, K092594 and ACE Screw Dental Implant System, K954513).
No difference in performance compared to predicate devices.	Bench testing demonstrated "no difference in... performance" compared to the specified predicate devices.
No difference in safety compared to predicate devices.	Bench testing demonstrated "no difference in... safety" compared to the specified predicate devices.
No difference in effectiveness compared to predicate devices.	Bench testing demonstrated "no difference in... effectiveness" compared to the specified predicate devices.
Identical materials and characteristics to devices cleared under K092594 and K954513.	The screws, implants, abutments, and denture caps are "identical in materials and characteristics to that cleared under K092594 and K954513." The raw material is Ti (CP-Grade 4) per ASTM F67 standard.
Use of same and similar surgical tools as predicate (with minor specified changes).	The system uses "same and similar surgical tools" (e.g., Kirschner Pliot Bur replaced a Two Step Lag Bur CA, optional Parallel Pin/Depth Gauge and 2.8 mm twist drill now supplied standard).
Similar sterilization tray accessory with accommodation for new implant sizes.	The polycarbonate sterilization tray accessory is "similar" to the predicate, with modifications to accommodate both predicate and candidate screw implant sizes.

Study Details

The provided document describes a bench testing study, not a clinical trial or a study assessing AI performance.

Sample size used for the test set and the data provenance: Not applicable in the context of this 510(k) submission. The "test set" here refers to components undergoing bench testing rather than a dataset for an AI model. The document does not specify the number of implants or components tested during bench testing, nor their provenance. The "data provenance" would relate to the manufacturing and testing environment for the physical components.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For bench testing comparing physical device characteristics and performance, "ground truth" would be established by scientific and engineering measurements against established standards or predicate device specifications, not typically by expert consensus in the way clinical diagnostic ground truth is formed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI algorithm evaluations to resolve discrepancies in expert opinions for ground truth establishment. This is a bench testing scenario.
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 submission is for a physical medical device (dental implant system), not an AI/ML-driven diagnostic or assistive device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench testing described, the "ground truth" implicitly relies on engineering standards (e.g., ASTM F67 for titanium raw material) and direct comparison to the physical and functional characteristics of the predicate devices. The goal was to show identical or similar performance.
The sample size for the training set: Not applicable. This is not an AI/ML algorithm.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML algorithm.

In summary, this 510(k) notification focuses on demonstrating substantial equivalence to predicate devices through a comparison of device description, materials, intended use, and bench test results. It does not involve the types of studies typically conducted for AI/ML-based devices or devices requiring extensive clinical performance data beyond comparisons to existing, cleared products.

Summary

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Mr. Michael Nilo January 11, 2010 Page 3

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.

Submitter Name:	ACE Surgical Supply Co., Inc.
Submitter Address :	1034 Pearl St., Brockton, MA 02301	JAN 1 4 2010
Contact Person:	J. Edward Carchidi, DDS
Phone Number:	(508) 588-3100
Fax Number:	(508) 523-3140
Date Prepared:	November, 2009
Device Trade Name:	ACE Surgical Secure™ Locator® 3.25mm Implant System
Device Common Name:	Endosseous Implant Screw
Classification Name:	Implant, Endosseous, Root form, product code DZE,Endosseous Dental Implant Abutment, product code NHA
Predicate device:	ACE Surgical Secure-Mini™ Locator® Implant System, K092596ACE Screw Dental Implant System, K954513
Reason for submission:	Not previously marketed in the USA

Device Description and Materials:

Intended Use:

ACE Surgical Secure™ Locator® 3.25mm Implant System is is designed to provide Intra-bony long term fixation of denture installations in partially or fully edentulous patients.

Substantial Equivalence/ Device - Technological Characteristics and Comparison to Predicate Device(s):

The ACE Surgical Secure™ Locator® 3.25mm Implant System is substantially equivalent to the ACE Surgical Secure-Mini™ Locator® Implant System, K092594 and the ACE Screw Dental Implant System . K954513.

Among the information and data presented in the 510(K) submission to support the substantial equivalency of the ACE Surgical Secure™ Locator® 3.25mm Implant System to the specified predicate devices are: 1) device description, 2) Indications for use and Intended use(s), 3) bench test results, 4) materials, and 5) labeling. In particular, the bench testing demonstrated there was no difference in the fundamental technology, performance, safety, or effectiveness between the ACE Surgical Secure™ 3.25mm Implant System and the specified predicate devices.

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and monochromatic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

J. Edward Carchidi, D.D.S. President ACE Surgical Supply Company, Incorporated 1034 Pearl Street Brockton, Massachusetts 02301

JAN 1 4 2010

Re: K093518

Trade/Device Name: ACE Surgical Secure™ Locator® 3.25mm Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: December 14, 2009 Received: December 16, 2009

Dear Dr. Carchidi:

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 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 - Dr. Carchidi

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ph for

Anthony D. Watson, BS, MS, MBA 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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Indications for Use

510(k) Number: K093518

Device Name: ACE Surgical Secure™ Locator® 3.26mm Implant System

Indications For Use:

The ACE Surgical Secure™ Lecation 3.25mm Implant System is is designed to provide intra-bony long term fixation of denture installations in partially or fully edentulous patients.

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)

Abbotz DDS for Dr. K.P. Mulaly (Acting)
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number. K093518

A-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.