BioHorizons Implant Site Dilators are indicated for use to aid in the placement of root form implants in soft maxillary bone. Rather than removing valuable bone from the surgical site, the function of these instruments is to manually form the osteotomy by compressing the bone laterally, causing a denser bone to implant interface.

Device Description

The Implant Site Dilators are hand-operated instruments which provide an aid in the placement of root form implants in soft maxillary bone. All components are made from surgical grade stainless steel.

AI/ML Overview

The provided 510(k) notification for the BioHorizons Implant Site Dilators (K980874) does not contain detailed information regarding acceptance criteria and a specific study proving the device meets those criteria in the way typically expected for submissions involving AI/Machine Learning devices. This document is for a medical device (surgical tools), not a software device, and therefore the evaluation methods are different.

However, based on the information provided, here's a breakdown of what can be gleaned:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the document. For a physical device like surgical instruments, "acceptance criteria" would typically relate to factors like material strength, sterility, biocompatibility, and functional performance (e.g., ability to expand bone without breaking, ease of use). The document indicates a general "safety and effectiveness" evaluation.

Acceptance Criteria (Implied)	Reported Device Performance
Safety	"safe"
Effectiveness	"effective"
Functionality	"aid in the placement of root form implants in soft maxillary bone"
Material Composition	"All components are made from surgical grade stainless steel."

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The term "test set" in the context of this document would refer to the physical devices that were evaluated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document states: "These evaluations indicate that the Implant Site Dilators should be safe and effective when used as intended." The evaluations were conducted by:

"consulting implantologists"
"oral and maxillofacial surgeons"

The number of experts is not specified. Their qualifications are given by their titles: "implantologists" and "oral and maxillofacial surgeons," implying they are qualified medical professionals with expertise in dental implant procedures. Specific experience (e.g., "10 years of experience") is not mentioned.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of a physical instrument evaluation, adjudication would likely involve expert opinion and potentially subjective assessment of performance during simulated or actual use.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done, as this type of study is primarily relevant for diagnostic imaging systems and AI algorithms where multiple human readers interpret cases. This document is for surgical hand instruments.

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

This question is not applicable. This device is a manual surgical instrument, not an algorithm, so there is no "standalone" algorithm performance to evaluate. Its performance is inherently human-in-the-loop.

7. The Type of Ground Truth Used

For this type of device, the "ground truth" for safety and effectiveness would have been established through a combination of:

Expert Consensus/Opinion: The evaluations by consulting implantologists and oral and maxillofacial surgeons.
Laboratory Conditions: Testing to ensure material properties, dimensions, and perhaps simulated functional performance (e.g., ability to withstand forces during bone compression).

There is no mention of pathology or outcomes data in this summary.

8. The Sample Size for the Training Set

This question is not applicable. This device does not involve a training set as it is not an AI/Machine Learning algorithm.

9. How the Ground Truth for the Training Set was Established

This question is not applicable, as there is no training set.

Summary

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BioHorizons Implant Systems, Inc. 510(k) Notification January 28, 1998

K980874

MAR - 4 1998

510(k) Summary of Safety and Effectiveness

Proprietary Name

Implant Site Dilators

Common Name

Osteotomes

Classification Name

Dental Surgical Instruments

Classification

Class III (revised 24Feb98)

Official Contact

Winston Greer, VP of Operations and Director of Quality Assurance BioHorizons Implant Systems, Inc. 2129 Montgomery Highway Birmingham, Alabama 35209 (205) 871-1345 Fax (205) 870-0304

Device Description

Product Evaluation

The BioHorizons Implant Site Dilators have been evaluated in laboratory conditions and by consulting implantologists and oral and maxillofacial surgeons. These evaluations indicate that the Implant Site Dilators should be safe and effective when used as intended.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked vertically and slightly offset from each other. The profiles are abstract and formed by curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 4 1998

Mr. Winston Greer Vice President of Operations & Director of Quality Assurance BioHorizons Implant Systems, Incorporated 2129 Montgomery Highway Birmingham, Alabama 35209

Re: K980374 Trade Name: Implant Site Dilators Regulatory Class: III Product Code: DZE Dated: January 28, 1998 Received: January 30, 1998

Dear Mr. Greer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Greer

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

BioHorizons Implant Site Dilators Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Peaser

(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, and General Hospity OxC 510(k) Number

Prescription Use (per 21 CFR 801.109)

Over-The-Counter Use

Page 28

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.