BioHorizons Tapered Internal Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

Device Description

The BioHorizons Tapered Internal Implants are machined titanium, screw-form endosseous dental implants supplied in 3.4mm and 4.6mm diameters. The 3.4mm diameter implant includes lengths of 9mm, 10.5mm, 15mm and 18mm while the 3.8mm and 4.6mm diameter implants include an 18mm length option to complement currently cleared implant lengths within those implant body diameters. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (tricalcium phosphate) and by micro-machining grooves, known as Laser• Lok® microchannels, to the implant collar of select models. 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 10-6, validated in compliance with ANSVAAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part I: Requirements for development, validation and routine control of a sterilization process for medical devices.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "BioHorizons Tapered Internal Implants." It aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than establishing de novo acceptance criteria and performance through a clinical study.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not applicable to this type of submission. The document primarily focuses on technical characteristics and mechanical testing to justify equivalence.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable as this is a substantial equivalence claim, not a de novo clearance with specific acceptance criteria from a clinical trial. The "acceptance criteria" here relate to demonstrating equivalence in design, materials, and mechanical performance to predicate devices. The performance reported is that the device "performs as well as the referenced predicate device."

Feature/Performance Aspect	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance
Mechanical Strength (Implant-Abutment Connection)	Must meet or exceed the performance of predicate devices as tested by ISO 14801.	"The results of the fatigue load testing demonstrate that the subject devices are substantially equivalent to the predicate devices."
Material Composition	Must be ASTM F136 compliant (Ti-6Al-4V ELI Alloy).	"Implant material is titanium alloy as specified in ASTM F136..."
Surface Treatment	Must be RBT and/or Laser-Lok microchannels, proven effective in predicate devices.	"Roughening the threaded surface with Resorbable Blast Texture (RBT) media... and by micro-machining grooves, known as Laser-Lok® microchannels..."
Sterility Assurance Level	Minimum 10-6 SAL, validated per ANSVAAMI/ISO 11137-1.	"Provided with a minimum sterility assurance level of 10-6, validated in compliance with ANSVAAMI/ISO 11137-1..."
Intended Use	Must align with the intended use of predicate devices.	The intended use for the subject device is virtually identical to that of the BioHorizons Tapered Internal Implant System (K071638).
Overall Equivalence	Must be substantially equivalent in design, materials, intended use, and performance to predicate devices.	"The data presented in this submission demonstrates that the new devices are substantially equivalent with respect to performance, safety and effectiveness for their intended use and perform as well as the referenced predicate device."

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

Sample Size: Not specified for a "test set" in the context of a clinical study. The testing refers to "Mechanical testing of the 3.0mm implant-abutment connection... in conjunction with angled prosthetic abutments representative of the worst-case scenario." This implies an engineering test, not a clinical trial with human subjects. Thus, the "sample size" would refer to the number of devices mechanically tested, which is not detailed but is typically a small number for such engineering tests.
Data Provenance: The 'data' generated is from mechanical testing conducted according to ISO 14801 and FDA guidance documents. This is laboratory-based engineering data, not clinical data from countries of origin.

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

Not applicable. This submission relies on engineering and material standards (ASTM, ISO) and comparison to predicate devices, not on expert consensus for ground truth on clinical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication in this 510(k) submission.

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 device is a dental implant, not an AI-powered diagnostic tool. No MRMC study was performed.

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

Not applicable. This device is a dental implant, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this 510(k) is based on:

Established engineering standards (e.g., ISO 14801 for fatigue testing, ASTM F136 for material).
Performance of legally marketed predicate devices (K071638 and K093321), which have already demonstrated safety and effectiveness through their own clearance/approval processes.
Physical and chemical properties of the materials and design features.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the machine learning/AI sense.

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

Not applicable. As above, no training set for an AI algorithm is involved.

In summary: The provided document is an FDA 510(k) clearance letter and summary for a dental implant, not a study evaluating acceptance criteria for a diagnostic device or AI software. The "study" referenced is mechanical testing to demonstrate substantial equivalence to existing devices.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 8,2015

BioHorizons Implant Systems, Inc. Michael Davis Regulatory Affairs Manager 2300 Riverchase Center Birmingham, AL 35244

Re: K143022

Trade/Device Name: BioHorizons Tapered Internal Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 9, 2014 Received: December 10, 2014

Dear Mr. Davis:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

Page 2 - Mr. Davis

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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

Indications for Use

510(k) Number: K143022

Device Name: BioHorizons Tapered Internal Implants

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

K143022

S10(k) Summary 21 CFR 807.92

Submitter's Name & Address
Manufacturer: BioHorizons Implant Systems, Inc.2300 Riverchase CenterBirmingham, AL 35244Phone(205)967-7880Fax (205) 870-0304
Official contact: Michael Davis, Regulatory Affairs Manager
Date prepared: December 2, 2014

Name of the Device

Trade Name:	BioHorizons Tapered Internal Implants
Common or Usual Name:	Screw-type dental implant
Classification Name:	Endosseous dental implant
Classification Number:	Class II (21 CFR 872.3640)

Predicate Devices

1. BioHorizons Tapered Internal Implant System, documented under 510(k) number K071638, concurrence date of October 10,2007.
BioHorizons Laser-Lok 3.0 Implant System, documented under 510(k) number K093321, 2. concurrence date of April 2, 2010.

Device Description

Tapered Internal Implants are machined titanium, screw-form endosseous The BioHorizons dental implants supplied in 3.4mm and 4.6mm diameters. The 3.4mm diameter implant includes lengths of 9mm, 10.5mm, 15mm and 18mm while the 3.8mm and 4.6mm diameter implants include an 18mm length option to complement currently cleared implant lengths within those implant body diameters. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (tricalcium phosphate) and by micro-machining grooves, known as Laser• The product is packaged using Lok® microchannels, to the implant collar of select models. materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10-6, validated in compliance with ANSVAAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part I: Requirements for development, validation and routine control of a sterilization process for medical devices.

Intended Use

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

Technological Characteristics

The fundamental scientific technology of the BioHorizons Tapered Internal endosseous dental implant devices subject to this 510(k) is substantially equivalent to the referenced predicate The threaded portion of the implants is RET-blasted, and Laser-Lok microchannels are devices. applied to the implant collar of select models.

Laser-Lok is a surface feature in which patterns of micro-machined grooves are applied to the collar of a dental implant, providing a roughened surface to establish a physical, connective tissue attachment. This tissue connection:

1. is functionally oriented,
1. inhibits epithelial cell downgrowth and
1. enables crestal bone adjacent to the implant to attach and be retained.

All materials, suppliers, processing, packaging and sterilization methods remain the same as for the predicate BioHorizons Tapered Internal Implant System (K071638) and BioHorizons Laser® Lok 3.0 Implant System (K093321). The Laser-Lok feature is substantially equivalent to that cleared for the predicate devices. The BioHorizons Tapered Internal Implants are substantially equivalent to the features of the predicate implant devices which could affect safety or effectiveness because of the similarities in design, materials and intended use. Refer to Table 1, Summary Table of Substantial Equivalence, immediately following on the next page.

Summary of Testing

Mechanical testing of the 3.0mm implant-abutment connection (as featured in the subject devices) was performed in accordance with the Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004 and ISO 14801. The load-bearing features of the implant-abutment connection were tested in conjunction with angled prosthetic abutments representative of the worst-case scenario. The results of the fatigue load testing demonstrate that the subject devices are substantially equivalent to the predicate devices.

Conclusion

The data presented in this submission demonstrates that the new devices are substantially equivalent with respect to performance, safety and effectiveness for their intended use and perform as well as the referenced predicate device.

{5}------------------------------------------------

	Subject Device	Predicate Devices
	BioHorizons Implant Systems, Inc.	BioHorizons Implant Systems, Inc.	BioHorizons Implant Systems, Inc.
	!Modified! Tapered Internal Implants	Tapered Internal Implant System K071638	Laser-Lok 3.0 Implant System K093321
Intended Use	Biol-lorizons Tapered Internal Implants areintended for use in the mandible or maxilla as anartificial root structure for single toothreplacement or for fixed bridgework and dentalretention.Biol-Iorizons Tapered Internal Implants may berestored immediatelyI) with a temporary prosthesis that is not infunctional occlusion, or2) when splinted together for multiple toothreplacement, or when stabilized with anoverdenture supported by multiple implants.	Biol-lorizons Tapered Internal Implant System isintended for use in the mandible or maxilla for use asan artificial root structure for single toothreplacement or for fixed bridgework and dentalretention.Biol-lorizons Tapered Internal Implant System maybe restored immediatelyI) with a temporary prosthesis that is not infunctional occlusion, or2) when splinted together for multiple toothreplacement, or when stabilized with anoverdenture supported by multiple implants.	Biol-lorizons Laser-Lok 3.0 Implants may beused as an artificial root structure for singletooth replacement of mandibular central andlateral incisors and maxillary lateral incisors.The implants may be restored immediatelyI) with a temporary prosthesis that is not infunctional occlusion,2) when splinted together as an artificial rootstructure for multiple tooth replacement ofmandibular incisors, or3) for denture stabilization using multipleimplants in the anterior mandible andmaxilla.The implants may be placed in immediatefunction when good primary stability has beenachieved and with appropriate occlusal loading.
Design
Implant shape	Tapered	Tapered	Parallel-wall with 2.5mm apical taper
Implant bodydiameter	3.4mm, 3.8mm, 4.6mm	3.8mm, 4.6mm, 5.8mm	3.0mm
Implant length	9mm, 10.5mm, 12mm, 15mm, 18mm	7.5mm (except 3.8mm body), 9mm, 10.5mm,12mm、15mm	10.5mm, 12mm, 15mm
Outer thread	External Buttress	External Buttress	Square
Surface	Implant- RBTCollar- Laser-Lok or RBT	Implant- RBT or HACollar- Laser-Lok	Implant - RBTCollar- Laser-Lok
Hex connection	Internal	Internal	Internal
Internal thread	Spiralock UNF 1-72	Spiralock UNF 1-72	Spiralock UNF 1-72
Prostheticplatform	3.0mm, 3.5mm, 4.5mm	3.5mm, 4.5mm, 5.7mm	3.0mm
Material and Manufacturing
Implant Material	Ti-6Al-4V (ASTM F136)	Ti-6AI-4V (ASTM Fl36)	Ti-6Al-4V (ASTM F136)
Manufacturingprocess	Machined by BioHorizons or A-levelsupplier, surface treated with micro-machined grooves (Laser-Lok) and RBT orRBTonly	Machined by BioHorizons or A-level supplier,surface treated with micro-machined grooves(Laser-Lok) and RBT or HA	Machined by BioHorizons or A-levelsupplier, surface treated with micro-machined grooves (Laser-Lok) and RBT
Packaging	Tyvek-lidded blister tray (primarypackage), placed inside a tamper-evidentouter box (secondary package)	Tyvek-lidded blister tray	Tyvek-lidded blister tray
Sterilization	25-40 kGy gamma irradiation dose range	20-40 kGy gamma irradiation dose range	20-40 kGy gamma irradiation dose range

Table 1. Summary Table of Substantial Equivalence

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.