The Maestro System™ endosseous implants may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and dental retention.

Device Description

The 7mm and 10.5mm length Maestro System dental implants are a machined titanium. screw-form implant supplied in diameters of 3.5mm, 4mm and 5mm. Implant raw material is titanium alloy as specified in ASTM F136 - Specification for Wrought Titanium 6AL-4V ELI Alloy for Surqical Implant Applications.

The device is further processed by treating the surface with resorbable blast media (RBM) or coating with synthetic hydroxylapatite (HA). The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 108, validated in compliance to ANSI/AAMI/ISO 11137. Sterilization of healthcare products - Requirements for validation and routine control - Radiation sterilization.

The Maestro System ™ is a comprehensive system containing implants, surgical components, and prosthetic components. The implants are specifically designed to optimize strain distribution to contiguous bone under functional loading in order to promote strain-induced bone growth and interface maintenance over the long term. This is achieved by optimizing implant designs based on bone quality.

AI/ML Overview

This document describes a Special 510(k) Notification for a device modification, specifically the addition of new sizes (7mm and 10.5mm lengths) to the existing BioHorizons Maestro System™ screw-type dental implants. This type of submission focuses on demonstrating substantial equivalence to a predicate device and typically does not involve new clinical studies or detailed performance acceptance criteria, as the fundamental technology and indications for use remain unchanged. Therefore, a direct response to many of the requested categories (acceptance criteria, specific study details, sample sizes, expert involvement, ground truth, etc.) is not applicable or cannot be extracted from the provided text.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. Special 510(k) applications for minor modifications like adding new sizes generally rely on demonstrating that the new sizes have the same technological characteristics and intended use as the predicate device, implying that the established performance of the predicate device applies. There is no new performance data or acceptance criteria presented for the modified device sizes.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable/provided. The submission is a Special 510(k) for a device modification, not a submission based on new clinical testing that would involve a test set. The focus is on demonstrating equivalence of the new sizes to the existing, predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. As explained above, no new clinical test set requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. No test set or associated adjudication methods are 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

This information is not applicable/provided. This is a submission for a dental implant, not an AI-powered diagnostic device. Therefore, MRMC studies or AI assistance are not relevant to this submission.

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

This information is not applicable/provided. This is a submission for a dental implant, not an algorithm or AI device.

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

This information is not applicable/provided. No new ground truth establishment is described as the submission focuses on demonstrating equivalence of new sizes to an already approved predicate device. The "ground truth" for this modification essentially relies on the established safety and effectiveness of the existing Maestro System implants.

8. The sample size for the training set

This information is not applicable/provided. No training set is described as this is not an AI/algorithm submission, nor does it include a de novo clinical study requiring a training set.

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

This information is not applicable/provided. As above, no training set is described.

Summary of the K030463 Application:

The BioHorizons Implant Systems, Inc. K030463 submission is a Special 510(k) Notification for a Device Modification. The modification involves adding new lengths (7mm and 10.5mm) to the existing Maestro System™ screw-type dental implants.

The core argument for acceptance is Substantial Equivalence to the predicate device (The Maestro System™ already marketed by BioHorizons, with various K-numbers listed).

The justification for substantial equivalence is based on the following:

No change in fundamental scientific technology: The implants are still machined titanium, screw-form.
Same materials: Titanium alloy (ASTM F136 - 6AL-4V ELI) and surface treatments (RBM or HA) remain unchanged.
Same suppliers, processing, packaging, and sterilization methods.
No change in intended use or indications for use: The implants are for single tooth replacement or as abutments for fixed bridgework and dental retention in the mandible and maxilla.

Because this is a submission for a modification to an existing, approved device, and not a de novo device or a significant change requiring new clinical data, the acceptance criteria are implicitly that the new sizes do not introduce new questions of safety or effectiveness and maintain the same technological characteristics as the predicate. The "study" proving this is the comparative analysis of technological characteristics and intended use against the predicate device, which is documented in the 510(k) submission itself. No new clinical trials or performance studies with specific acceptance criteria are mentioned or required for this type of submission.

Summary

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BioHorizons Implant Systems, Inc. The Maestro System™ 7mm & 10.5mm 510(k) Notification: Special 510(k) - Device Modification 02/10/03

510(k) summary

K030463

21 CFR 807.92

02/10/03 Date:

Official Contact: Winston Greer, Director, QA & RA FEB 2 6 2003

BioHorizons Implant Systems, Inc. Manufacturer: One Perimeter Park South Suite 230 South Birmingham, AL 35243 Phone: (205) 967-7880 Fax: (205) 870-0304

Proprietary Name

The Maestro System™

Common Name

Screw-type Dental Implant

Classification Name

Endosseous implants, surgical components, and prosthetic attachments

Predicate Device

The predicate device is The Maestro System ™, a screw-type dental implant manufactured and distributed by BioHorizons Implant Systems Inc. Authorization to legally market the predicate BioHorizons Maestro System dental implants has been documented under the following 510(k) numbers: K960026, K964330, K972313, K010458, K020133, K020645, and K022795.

Device Description

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Diameter(mm)	Lengths(mm)	Design	Coating	CatalogREF Numbers
$\phi$3.5	7, 10.5	D3	RBM	3507D3, 35105D3
	7	D3	HA	3507D3-HA
$\phi$4	10.5	D2	RBM	40105D2
$\phi$4	7, 10.5	D3	RBM	4007D3, 40105D3
	7	D3	HA	4007D3-HA
$\phi$4	7, 10.5	D4	RBM	40105D4
$\phi$5	10.5	D2	RBM	50105D2
$\phi$5	7, 10.5	D3	RBM	5007D3, 50105D3
	7	D3	HA	5007D3-HA
$\phi$5	7, 10.5	D4	RBM	50105D4

The following table provides a summary of the proposed new implant sizes

Intended Use

The Maestro System™ may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and dental retention. The indications and intended use of the modified Maestro System™ endosseous implants as described in its labeling has not changed.

Technological Characteristics

The fundamental scientific technology of the modified device has not changed; the only change has been to add implant lengths of 7mm and 10.5mm. All materials, suppliers, processing, packaging and sterilization methods remain the same. The 7mm and 10.5mm length Maestro System ™ dental implants are substantially equivalent to all features of the predicate devices which could affect safety or effectiveness due to the similarities in design, material and intended use.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles incorporated into its design.

Public Health Service

FEB 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Winston Greer Director, QA/RA BioHorizons Implant Systems, Incorporated One Perimeter Park South, Suite 230 South Birmingham, Alabama 35243

Re: K030463

Trade/Device Name: The Maestro System™ 7mm & 10.5 Endosseous Implants Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: February 10, 2003 Received: February 12, 2003

Dear Mr. Greer:

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. Greer

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 (301) 594-4613. 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/dsma/dsmamain.html

Sincerely yours.

Susan Runes

Susan Runner, DDS, MA Interim 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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BioHorizons Implant Systems, Inc. The Maestro System™ 7mm & 10.5mm Special 510(k) Notification - Device Modification 02/10/03

Page 1 of 1

510(k) Number (if known): __

Device Name: The Maestro System™ 7mm & 10.5mm Endosseous Implants

Indications for Use:

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Riones

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

510(k) Number. K030463

Prescription Use
(per 21 CFR 801.109) X

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

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.