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 Indication/Intended use of the modified device, the Maestro System™, as described in its labeling has not changed.

Device Description

The 15 mm length Maestro System screw-type dental implant is a machined titanium, screw-form implant supplied in diameters of 3.5 mm , 4.0 mm and 5.0 mm, and in lengths of 9 mm, 12 mm, and15 mm. The implant raw material is titanium alloy as specified in ASTM F136 - Specification for Wrought Titanium 6AL-4V ELI Alloy for Surgical 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 will be provided sterile, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products -- Requirements for validation and routine control - Radiation Sterilization, with a minimum sterility assurance level of 10-

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.

Following four years of clinical use, this submission proposes altered sizing to assist the dental practitioner in treatment planning and ease of use with the product. Three base implant designs, corresponding to each bone density classification (D1/D2, D3 and D4) will be available in 3.5 mm, 4.0 mm and 5.0 mm diameters. Each implant design, manufactured from titanium alloy conforming to ASTM F 136, will be available in three lengths and may feature a Resorbable Blast Media (RBM) surface treatment, or hydroxylapatite (HA) coating.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "The Maestro System™," a screw-type dental implant. The purpose of this submission is to introduce altered sizing for existing implants and reintroduce a 15mm length implant. It claims substantial equivalence to previously cleared Maestro System implants.

Based on the provided information, there is no study described that demonstrates and provides acceptance criteria for device performance based on objective measures, such as a diagnostic accuracy study. The entire submission focuses on establishing substantial equivalence to previously cleared predicate devices through similarities in design, material, and intended use, rather than presenting a performance study with specific acceptance criteria.

The acceptance criteria for this 510(k) submission are implicitly tied to the concept of substantial equivalence to the predicate device. This means the device must be demonstrated to be as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).

Here's an analysis of the provided information in the context of your request, explicitly noting where information is not available in the document:

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

Acceptance Criteria (Implicit)	Reported Device Performance
Design Similarity: The modified device must have similar design characteristics to the predicate device.	The 15 mm length Maestro System screw-type dental implant is described as having "an apical geometry configuration that reduces the insertion force required (as measured in torque) to place the implant." The submission also details revised diameter, design, and length combinations for various coatings (RBM, HA). These are presented as modifications within the existing system.
Material Similarity: The modified device must use the same or equivalent materials as the predicate device.	"All materials... remain the same." (Titanium alloy as specified in ASTM F136 - Specification for Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant Applications).
Intended Use Similarity: The modified device must have the same intended use as the predicate device.	"The Indication/Intended use of the modified device, the Maestro System™, as described in its labeling has not changed." Used in mandible and maxilla for single tooth replacement, fixed bridgework, and dental retention.
Technological Characteristics Similarity: The fundamental scientific technology must be the same or provide equivalent safety and effectiveness.	"The Fundamental Scientific Technology of the modified device has not changed." The only change is the reintroduction of the 15mm length with a specific apical geometry.
Processing and Sterilization Similarity: The processing, packaging, and sterilization methods must be the same or equivalent.	"All... processing, packaging and sterilization methods remain the same." (Sterile, validated in compliance to ANSI/AAMI/ISO 11137, with a minimum sterility assurance level of 10^-6).
Performance (Implicit - Safety/Effectiveness): The modified device must be as safe and effective as the predicate device.	The document states: "The 15 mm length Maestro System ™ dental implant is 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." No specific performance metrics (e.g., success rates, complication rates, osseointegration rates) are provided for the modified device or comparative data against the predicate. The only performance mention is the reduced insertion force for the 15mm implant, but no quantitative acceptance criteria or comparative data are given.

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

Not applicable / Not provided. This document does not describe a performance study with a test set. The submission relies on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices.

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)

Not applicable / Not provided. There is no test set or ground truth described in this submission.

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

Not applicable / Not provided. There is no test set or adjudication method 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 / Not provided. This device is a physical dental implant, not an AI software. Therefore, an MRMC study related to human readers and AI assistance is entirely outside the scope of this submission.

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

Not applicable / Not provided. This device is a physical dental implant, not an algorithm or software. No standalone performance study for an algorithm is relevant here.

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

Not applicable / Not provided. No specific "ground truth" for a performance study is mentioned. The ground truth for this submission is implicitly the established safety and effectiveness of the predicate devices based on their legal marketing history and previous FDA clearances.

8. The sample size for the training set

Not applicable / Not provided. There is no training set described. This is not a machine learning or AI device.

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

Not applicable / Not provided. As there is no training set, this information is not relevant.

Summary of the "Study" (Implicit)

The "study" presented in this 510(k) is a comparative analysis against predicate devices to demonstrate substantial equivalence. It's not a clinical trial or a performance study with a test set in the traditional sense you might expect for a diagnostic or AI device. The evidence for "meeting acceptance criteria" is the comprehensive argument that the modifications to the Maestro System do not raise new questions of safety or effectiveness when compared to the already cleared versions of the Maestro System. The FDA's decision to clear the device (K020133) indicates that they accepted this argument for substantial equivalence.

Summary

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21 CFR 807.92

K020133

12/27/01 Date:

Donald E. Dalton Official Contact:

JAN 2 5 2002

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 implant has been documented under the following 510(k) numbers: K010458, K972313, K960026, K964330.

Device Description

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healthcare products -- Requirements for validation and routine control - Radiation Sterilization, with a minimum sterility assurance level of 10-

The following table provides a comprehensive summary of the implant sizes for which authorization to market has been received.

Diameter	Design	Lengths (mm)	Coating
$3.5	D2	9, 12	RBM
	D3	9, 13	TPS
$4.0	D1	9, 11, 13	RBM
	D2		RBM
	D3	9, 12, 14	TPS
	D4	9, 13, 15	HA
$5.0	D1	9, 11	RBM
	D2	10, 12	RBM
	D3	9, 11, 13	TPS
	D4	9, 12, 14	HA

Table. Previously cleared implant size (RBM = Resorbable Blast Media Surface; TPS = Titanium Plasma Spray Coating; HA = Hydroxylapatite Coating).

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Diameter	Design	Lengths (mm)	Coating
$\phi3.5$	D3	9, 12, 15	RBM
$\phi4.0$	D2	9, 12, 15	RBM, HA
	D3	9, 12, 15	RBM, HA
	D4	9, 12, 15	HA
$\phi5.0$	D2	9, 12, 15	RBM, HA
	D3	9, 12, 15	RBM, HA
	D4	9, 12, 15	HA

Intended Use

Technological Characteristics

The Fundamental Scientific Technology of the modified device has not changed. The only change has been to reinstate an implant with a 15 mm overall length which includes an apical geometry configuration that reduces the insertion force required (as measured in torque) to place the implant. All materials, suppliers, processing, packaging and sterilization methods remain the same. The 15 mm length Maestro System ™ dental implant is 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/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2002

Mr. Donald E. Dalton Director, Quality Assurance BioHorizons Implant Systems, Incorporated One Perimeter Park South, Suite 230 South Birmingham, Alabama 35243

Re: K020133

Trade/Device Name: The Maestro System™ Regulation Number: 872.3640 Regulation Name: Screw-Type Implants Regulatory Class: III Product Code: DZE Dated: January 15, 2002 Received: January 15, 2002

Dear Mr. Dalton:

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.

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.

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Page 2 - Mr. Dalton

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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

Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): _ KO20133

The Maestro System™ Device Name:

Indications for 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.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use / (per 21 CFR 801.109) Over-the-Counter Use

Susan Purro

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _

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.