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

Device Description

The Maestro System is a comprehensive system containing implants, surgical components, and prosthetic components. This 510(k) submission notification is for the purpose of obtaining authorization to offer Ti-N coated prosthetic abutments as part of The Maestro System. The abutments will continue to be machined from titanium alloy but will undergo a Ti-N coating process. BioHorizons proposes to coat all exposed surfaces of the implant abutments during the coating process; current dimensional characteristics and specifications for abutments coated with Ti-N do not change. Cleaning, packaging and sterilization operations will be the same for the Ti-N coated abutments as for the non-coated abutments. In clinical practice, the implant and abutments surgical placement and restorative procedures will not change. The purpose of Ti-N coating implant abutments is two-fold: first, the yellow color of the Ti-N coating presents an esthetically-pleasing tint when visible through tissue, compared with the gray tint of uncoated titanium; second, the yellow color provides a distinct demarcation line at the interface of the implant body and the abutment, which will provide a visual aide in determining implant depth during the placement process. 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 10-6.

AI/ML Overview

I am unable to provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria, along with the specified information points, based on the provided text.

Here's why:

The provided text is a 510(k) summary for a device modification (adding a Titanium-Nitride coating to existing dental implant abutments). This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving that a new device meets specific, pre-defined acceptance criteria through a comprehensive performance study with statistical endpoints.

Here's a breakdown of why each requested point cannot be fully addressed:

A table of acceptance criteria and the reported device performance: The document does not define specific quantitative "acceptance criteria" for the performance of the Ti-N coated abutments in a clinical or functional sense. It primarily discusses the characteristics of the coating itself (adhesion, thickness, elemental composition) and its biocompatibility. It does not provide performance metrics like success rates, fracture rates, or patient outcomes that would be compared against acceptance criteria.
Sample size used for the test set and the data provenance: There is no mention of a "test set" in the context of clinical or performance data for the Ti-N coated abutments. The non-clinical testing refers to material property tests of the coating.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as there's no clinical "test set" requiring expert ground truth establishment for diagnostic or outcome assessment.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the same reasons as above.
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 is entirely unrelated to the device described. The device is a physical dental implant component, not an AI diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the device type or the nature of the 510(k) submission. The "ground truth" for the material tests would be the established scientific methods for measuring adhesion, thickness, and elemental composition.
The sample size for the training set: Not applicable. This is not a machine learning or AI device.
How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "studies" and "acceptance":

The document focuses on demonstrating that the modification (the Ti-N coating) does not alter the safety or effectiveness of the previously cleared predicate device. This is achieved through:

Predicate Device Comparison: The core of a 510(k) is showing substantial equivalence to existing, legally marketed devices.
Biocompatibility Testing: The text explicitly states, "Biocompatibility testing has been conducted on Ti-N using the International Organization for Standardization (ISO 10993-1) guidelines. This testing, and subsequent clinical applications, has demonstrated that titanium nitride is biocompatible and appropriate for human use in implant medical devices that come in contact with bone, skin, tissue, or blood." This is a crucial "study" showing the material's safety.
Non-Clinical Material Property Testing: "Ti-N coating applied to The Maestro System abutments was assessed in a number of tests, including adhesion and coating thickness to IonBond specification MS 70-722, and elemental composition using Energy Dispersive Spectroscopy in a scanning electron microscope at the University of Alabama at Birmingham School of Dentistry." These tests confirm the physical properties of the coating meet a specified standard (IonBond MS 70-722) and its chemical composition is as expected. This represents the "acceptance criteria" for the coating itself, not the overall device performance.

In summary, this 510(k) demonstrates the modified device is substantially equivalent by confirming the new material (Ti-N) is biocompatible and has appropriate physical properties, and that these changes do not alter the intended use or fundamental technological characteristics of the existing, cleared device. It is not a clinical effectiveness study with performance acceptance criteria for the entire device.

Summary

{0}------------------------------------------------

BioHorizons Implant Systems, Inc. Titanium-Nitride Coating Special 510(k) Notification - Device Modification 08/21/02

KO 22-795

510(k) summary

21 CFR 807.92

08/21/2002 Date:

AUG 3 0 2002

Official Contact: Winston Greer

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 system manufactured and distributed by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate BioHorizons Maestro System has been documented under 510(k) numbers K010458, K960026, K964330, K972313, K010458, K020133, K020645.

The GingiHue™ abutment from Implant Innovations Inc. (31), is a competitive abutment utilizing a titanium nitride (Ti-N) coating. Authorization to legally market the predicate 3i abutment and implant system has been documented under 510(k) number K992334.

Device Description

{1}------------------------------------------------

BioHorizons Implant Systems, Inc. Titanium-Nitride Coating Special 510(k) Notification - Device Modification 08/21/02

Device Description (cont'd)

The purpose of Ti-N coating implant abutments is two-fold: first, the yellow color of the Ti-N coating presents an esthetically-pleasing tint when visible through tissue, compared with the gray tint of uncoated titanium; second, the yellow color provides a distinct demarcation line at the interface of the implant body and the abutment, which will provide a visual aide in determining implant depth during the placement process.

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 10-6.

Intended Use

The indications for use of the Ti-N coated implants and abutments do not change from non-coated implants and abutments. 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 as described in its previouslycleared labeling has not changed.

Technological Characteristics

The fundamental scientific technology of the modified device has not changed: all materials, suppliers, processing, packaging and sterilization methods remain the same with the exception of the additional Ti-N coating process. Ti-N coating has been cleared by FDA for use in a variety of implant medical device applications since first reviewed in the 1980s. Biocompatibility testing has been conducted on Ti-N using the International Organization for Standardization (ISO 10993-1) guidelines. This testing, and subsequent clinical applications, has demonstrated that titanium nitride is biocompatible and appropriate for human use in implant medical devices that come in contact with bone, skin, tissue, or blood. The proposed Ti-N modification to The Maestro System abutment components is substantially equivalent to all features of the predicate devices which may affect safety or effectiveness, because of the similarities in design, material, and intended use.

Non-Clinical Testing

Ti-N coating applied to The Maestro System abutments was assessed in a number of tests, including adhesion and coating thickness to lonBond specification MS 70-722, and elemental composition using Energy Dispersive Spectroscopy in a scanning electron microscope at the University of Alabama at Birmingham School of Dentistry.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined serpents.

AUG 3 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Winston Greer Director, Quality Assurance and Regulatory Affairs BioHorizons Implant Systems, Incorporated One Perimeter Park South, Suite 230 South Birmingham, Alabama 35243

Re: K022795

Trade/Device Name: The Maestro System™ Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: August 21, 2002 Received: August 23, 2002

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.

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.

{3}------------------------------------------------

Page 2 - Mr. Greer

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,

Timothy J. Ulstowski

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

BioHorizons Implant Systems, Inc. Titanium-Nitride Coating Special 510(k) Notification - Device Modification 08/21/02

Page 1 of 1

510(k) Number (if known): _K022795

Device Name: ___ The Maestro System™

Indications for Use:

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

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

Robert I Betz DDS for Dr. Susan Runner

General Hospital,

510(k) Number: K022793

Prescription Use (per 21 CFR 801.109) OR

Over-the-Counter Use

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)