The ACE Surgical Orthodontic Bone Screw System is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. It is intended for single use only.

Device Description

The ACE Surgical Orthodontic Screw System is a is a set of machined surgical grade titanium alloy (Ti-6AI-4V ELI) screws, intended for orthodontic use, constructed with a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. This head design also permits the use of the screw with the orthodontic appliances (bracket, wire, elastic head, etc.) The tip of the screw is designed available to self drilling and self-tapping, supplied in 1.2/1.5mm and 1.5/1.8mm tapered thread, both with a 3.0mm diameter head and in lengths of 6,8,10mm. The screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in materials and characteristics that cleared under K951392. These screws are supplied sterile in standard Tyvek™ mylar packaging.

The ACE Surgical Orthodontic Bone Screw System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Miniboneplate system.

AI/ML Overview

The provided text describes a 510(k) submission for the ACE Surgical Orthodontic Bone Screw System. This is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria through a clinical or algorithmic study in the way a diagnostic AI device might.

Therefore, many of the requested categories for AI device evaluation (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) are not applicable to this type of submission.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Substantial Equivalence): The primary acceptance criterion for this 510(k) notification is to demonstrate that the ACE Surgical Orthodontic Bone Screw System is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.

Reported Device Performance:
The submission states the following to support substantial equivalence:

Category	Description / Performance
Intended Use	Identical to predicate devices (fixed anchorage for orthodontic appliances, temporary use).
Materials	Machined surgical grade titanium alloy (Ti-6Al-4V ELI) per ASTM F136 standard. Identical to predicate.
Technological Characteristics	Orthodontic bone screws with self-drilling/self-tapping tips, specific head design for wire/appliances. Sizes 1.2/1.5mm and 1.5/1.8mm tapered thread, 3.0mm head diameter, 6, 8, 10mm lengths. Stated as identical in materials and characteristics to predicate K951392.
Bench Testing	"Demonstrated there was no difference in the performance, safety, or effectiveness between the ACE Surgical Orthodontic Screw System and the specified predicate devices."
Labeling	Submitted and reviewed as part of the 510(k).

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

Sample Size: Not applicable. This submission relies on bench testing, material specifications, and comparison to predicate devices, not a clinical "test set" of patient data for performance evaluation in the context of an AI/diagnostic device.
Data Provenance: Not applicable. The "data" here refers to design specifications, material standards (ASTM F136), and results from bench tests conducted by the manufacturer, rather than clinical patient data.

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

Not applicable. There is no "ground truth" derived from expert review of a test set in this 510(k) submission. The evaluation is based on engineering principles, material science, and comparison to existing devices.

4. Adjudication method for the test set

Not applicable. No clinical test set or adjudication process for diagnostic performance is described.

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 a study assessing human reader performance or AI assistance.

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

Not applicable. This device is a physical orthodontic screw, not an algorithm, and therefore doesn't have "standalone" algorithmic performance in the sense of AI.

7. The type of ground truth used

Ground Truth: For the purpose of a 510(k) of this nature, the "ground truth" for demonstrating substantial equivalence is effectively derived from established engineering standards, material specifications, and the historical safety and effectiveness records of the legally marketed predicate devices. The bench test results serve to confirm the new device meets performance characteristics equivalent to those established standards and predicates.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of medical device submission.

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

Not applicable.

Summary

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K061397

Ace Surgical Supply Co., Inc.

Special 510(k) Notification: ACE Surgical Orthodontic Bone Screw System

Attachment 1 - 510(k) Summary

Submitter Name: Submitter Address : Contact Person: Phone Number: Fax Number: Date Prepared: Device Trade Name: Device Common Name: Classification Name: Predicate device: Reason for submission:

ACE Surgical Supply Co., Inc. 1034 Pearl St., Brockton, MA 02301 J. Edward Carchidi, DDS (508) 588-3100 (508) 523-3140 May 2006 ACE Surgical Orthodontic Bone Screw System Endosseous Implant Screw Implant, Endosseous, Root form, product code DZE ACE Surgical Miniboneplate system. K951392 Not previously marketed in the USA

Device Description and Materials:

Intended Use:

The ACE Surgical Orthodontic Bone Screw System is intended to be used to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

Substantial Equivalence/ Device Technological Characteristics

and Comparison to Predicate Device(s): The ACE Surgical Orthodontic Bone Screw System is substantially equivalent to the: ACE Surgical Screw Miniboneplate System, K951392 KLS-Martin Ortho Anchorage System, K033483

Osteomed Orthodontic Screw System, K031936

Among the information and data presented in the 510(k) submission to support the substantial equivalency of the ACE Surgical Orthodontic Bone Screw System to the specified predicate devices are: 1) device description, 2) indications for use, 3) bench test results, 4) materials, and 5) labeling. In narticular, the bench testing demonstrated there was no difference in the performance, safety, or effectiveness belveen the ACE Surgical Orthodontic Screw System and the specified predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 2007

Dr. J Edward Carchidi President Ace Surgical Supply Company, Limited 1034 Pearl Street Brockton, Massachusetts 02301

Re: K061397

Trade/Device Name: ACE Surgical Orthodontic Bone Screw System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: OAT Dated: May 15, 2006 Received: May 24, 2006

Dear Dr. Carchidi:

This letter corrects our substantially equivalent letter of August 16, 2006.

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 (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); 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 continue 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Chin-S. Lin, Ph.D.

Chiu S. Lin, PhD 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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Ace Surgical Supply Co., Inc.

Special 510(k) Notification: ACE Orthodontic Bone Screw System

Attachment 3 - Indications for Use Enclosure

510(k) Number:

Device Name: ACE Surgical Orthodontic Bone Screw System

Intended Use / Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clue

sion of Amesthesiolnov. General Hospital, ston Control, Demal De

× Prescription Use (per 21 CFR 801.109)

Over the Counter Use Optional Format 1-2-96

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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.