The three implants of the TREFOIL System are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol.

The following prerequisites must be fulfilled:

Adequate quantity of bone (minimum height of 13 mm and minimum width of 6-7 mm).
Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments.
Implant-supported prosthetics seated directly on dedicated implants

Device Description

The TREFOIL System is a method of placing three dental implants in predetermined positions (between the mental foramina) and using a pre-designed prosthetic bar to act as a screw-retained framework seated on the implants. The TREFOIL System restores chewing function and esthetics in the mandible in completely edentulous patients.

The TREFOIL System consists of dental implants, surgical components necessary to place the implants in predetermined positions, and prosthetic components that are included in the prosthetic bar or are used in the dental lab during the creation of the prosthetic bar.

The dental implants are threaded endosseous implants made of CP4 titanium. The implant is parallel walled and has an internal conical abutment connection. The implant is available in 11.5 mm length with two available collar lengths (4.5, 6.0 mm). The apex of the implants have cutting chamber allowing for self-tapping. The implant bone interface has the TiUnite implant surface treatment. The TREFOIL System bar is made of titanium vanadium alloy. The TREFOIL System surgical tooling is made of stainless steel.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the TREFOIL System, an endosseous dental implant system. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, much of the requested information about acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly available in the provided text.

However, I can extract the information related to the performance data presented and what it aimed to establish.

Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format, nor does it provide numerical performance results against such criteria. Instead, it describes types of testing performed and their general conclusions.

Acceptance Criterion (Inferred from testing)	Reported Device Performance
Surgical Accuracy (Angular and Translational)	Established the angular and translational accuracy errors generated by the surgical procedure, indicating the system's ability to maintain precision during implant placement.
Framework Compensation Mechanism (Passive Fit)	The ability of the Trefoil framework compensation mechanism to adapt to expected angular and translational accuracy errors was established through 3D modeling. The modeling confirmed that the compensation mechanism ensures a passive fit of the framework bar on the implants.
Fatigue Strength (Withstand Mastication Forces)	Fatigue testing was performed to establish that the TREFOIL System will withstand foreseeable mastication forces. The results demonstrated a higher fatigue strength than the predicate Branemark Novum (K000018).
Sterilization Efficacy	For sterile devices, the sterilization method (Gamma radiation) is the same as the predicate and was validated in accordance with ANSI/AAMI/ISO 11137. For non-sterile devices (for end-user sterilization), pre-vacuum and gravity moist heat sterilization were validated in accordance with ANSI/AAMI/ISO ISO 17665-1. No additional testing was required.
Packaging Integrity	The packaging for the subject device is the same as the predicate (titanium cylinder in plastic vial with PVC shrink-wrap and tamper-resistant strip). No additional testing was required.
Shelf Life	The packaging for the subject device is the same as the predicate and has a 5-year expiration date, determined by real-time aging. No additional testing was required.
Biocompatibility	The device is manufactured from the same material using the same method as the predicate, has the same intended use, and patient contact type/duration. No additional testing was required.
Surface Treatment Qualification	The Trefoil implants use the same TiUnite surface treatment as the predicate NobelActive implants. This treatment was qualified through Auger analysis, IR spectrum analysis, and cytotoxicity testing. No additional testing was required.

2. Sample Size for the test set and data provenance:

Surgical Accuracy Test: Implants were placed "into bone models." The specific number of models or implants is not stated.
Data Provenance: The nature of the studies suggests these were retrospective (laboratory-based) tests conducted by the manufacturer, rather than prospective clinical trials with patient data. The country of origin for the data is not specified but is presumably where Nobel Biocare AB conducts its research.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

This information is not provided in the document. The tests described (surgical accuracy in bone models, 3D modeling for passive fit, fatigue testing) are physical or computational tests, not human-interpretation-based tests that would require expert ground truth.

4. Adjudication method for the test set:

This information is not applicable/not provided. The assessment of these non-clinical tests would have been based on measurement and engineering analysis, not expert adjudication of subjective findings.

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 is not applicable. The device is an endosseous dental implant system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or mentioned.

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

This is not applicable. The device is a physical medical device (dental implant system), not an algorithm or software.

7. The type of ground truth used:

Surgical Accuracy Test: Ground truth would have been based on physical measurements and engineering specifications of the implant placement within the bone models (e.g., deviation from planned position and angle).
Framework Compensation Mechanism: Ground truth was established through three-dimensional modeling and simulation, confirming the design's ability to achieve a "passive fit" based on engineering principles.
Fatigue Testing: Ground truth was based on material science and engineering standards (ISO 14801) and the device's ability to withstand a specified number of cycles at a given load.
Other tests (Sterilization, Packaging, Shelf Life, Biocompatibility, Surface Treatment): Ground truth was established through adherence to recognized industry standards (e.g., ISO, ANSI/AAMI), analytical chemistry (Auger analysis, IR spectrum), and established biological testing methodologies (cytotoxicity).

8. The sample size for the training set:

This information is not applicable/not provided. The device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable/not provided, as there is no training set for this type of device.

Summary

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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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

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

April 11, 2016

Nobel Biocare AB c/o Ms. Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887

Re: K152836

Trade/Device Name: TREFOIL System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA, DZI Dated: March 2, 2016 Received: March 3, 2016

Dear Ms. Chua:

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.

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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 devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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, Tina Kiang -S

for 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

Enclosure

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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

510(k) Number (if known)	K152836
Device Name	TREFOIL System
Indications for Use (Describe)	The TREFOIL System is used to restore chewing function in fully edentulous mandibles.
	The three implants of the TREFOIL System are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol.
	The following prerequisites must be fulfilled:
	- Adequate quantity of bone (minimum height of 13 mm and minimum width of 6-7 mm).
	- Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments.
	- Implant-supported prosthetics seated directly on dedicated implants

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (1/14)

MARCH 2016

Page 1 of 1

PSC Publishing Services (301) 443-6740

K152836-S001: Al Response (11-20-2015)

Page 20 of 270

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I. SUBMITTER

Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden

Submitted by Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887

Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348

Date Prepared: April 7, 2016

II. DEVICE

Name of Device: TREFOIL System Common or Usual Name: Endosseous Dental Implant Classification Name: Endosseous Dental Implant (21 CFR 872.3640) Regulatory Class: II Primary Product Code: DZE Other Product Code(s): NHA. DZI

III. PREDICATE DEVICE

Primary predicate: Nobel Biocare - Branemark Novum (K000018) This predicate has not been subject to a design-related recall.

Reference predicates: Nobel Biocare - NobelActive (K142260) This predicate has not been subject to a design-related recall

Nobel Biocare - NobelProcera Overdenture Bar (K132749) This predicate has not been subject to a design-related recall

IV. DEVICE DESCRIPTION

A.4.

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The dental implants are threaded endosseous implants made of CP4 titanium. The implant is parallel walled and has an internal conical abutment connection. The implant is available in 11.5 mm length with two available collar lengths (4.5, 6.0 mm). The apex of the implants have cutting chamber allowing for self-tapping. The implant bone interface has the TiUnite implant surface treatment. The TREFOIL System bar is made of titanium vanadium allov. The TREFOIL System surgical tooling is made of stainless steel.

V. INDICATIONS FOR USE

The TREFOIL System is used to restore chewing function in fully edentulous mandibles.

The following prerequisites must be fulfilled:

Adequate quantity of bone (minimum height of 13mm and minimum width of 6-7mm).
Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments.
Implant-supported prosthetics seated directly on dedicated implants

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VI. Comparison of Technological Characteristics

Comparison of indication for use statement

	Subject Device	Primary Predicate
	TREFOIL System	Branemark Novum (K000018)
Indication for use statement	The TREFOIL System is used to restore chewing functionin fully edentulous mandibles.The three implants of the TREFOIL System are placedbetween the mental foramina in fully edentulous mandiblesin a 1-stage surgical technique combined with animmediate function loading protocol, provided sufficientprimary stability for the selected technique is achieved.In cases where sufficient primary stability for two implants ormore is not reached, the implants along with the Frameworkmay also be used with an early or delayed loading protocol.The following prerequisites must be fulfilled:- Adequate quantity of bone (minimum height of13mm and minimum width of 6-7mm).- Adequate mouth opening (minimum 40 mm) toaccommodate the guided surgery instruments.- Implant-supported prosthetics seated directlyon dedicated implants	Totally edentulous mandibles with a minimum height of 13 mm and a minimum width of 6mm. Patient must be subject to dental treatment with endosseous implants. For use in a single stage procedure where the implants are immediately loaded.

Comparison of Indications for Use: The intended use of the TREFOL System is substantially equivalent to the Branemark Novum (K000018) predicate. The prerequisites for minimum bone with remain the same, while the TREFOL System provides additional safety prerequisites for mouth opening minimum size and implant supporting of seated prosiderations from the labeling of the Branemark Novum (K00018) predicate have been added to the indications for use of the TREFOL System regarding number of implants for placement, functional loading, and primary stability, which do not affect the intended use.

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Implant Comparison

Technologicalcharacteristics	Subject Device	Primary Predicate	Reference Predicate
Implant Design Features	TREFOIL System	Branemark Novum (K000018)	NobelActive (K142260)
	ImplantBody Design	Parallel walled	Parallel walled	Expanding Taper
	Implant TipDesign	Tapered self cutting3.8 mm apex w/9.5° angle	Tapered self cutting with through hole3.5 mm apex w/15° angle	Drilling blades on apex5.35 mm apex
	ImplantLength	16.0 mm overall (11.5 mm body w/ 4.5 mmcollar)17.5 mm overall (11.5 mm body w/ 6.0 mmcollar)	17.5 mm overall (11.5 mm body w/ 6.0 mmcollar)	6.5, 8, 9.5, 11, 12.5 mm
	ImplantDiameter	4.93 mm	5.0 mm	5.5
	PlatformDiameter	4.5 mm	4.5 mm	5.5
	Threadangle/pitch	60°/.8mm	60°/.8mm	variable
	ConnectionType	Internal Hex with snap feature	External hex	Internal Hex
	DeviceMaterial	CP titanium	CP titanium	CP titanium
	Surfacemodification	TiUnite (anodic oxidation)	Machined titanium	TiUnite (anodic oxidation)

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Framework Bar Comparison

Technologicalcharacteristics	Subject Device	Primary Predicate	Reference Predicate
Bar Design Features	TREFOIL System	Branemark Novum (K000018)	NobelProcera Overdenture Bar(K132749)
	Bar Design	Preshaped single piece design screwretained to implant.	Preshaped two piece design. Lower barscrew retained to implants directly. Upperprosthetic bar screw retained to lower bar.
	Intendedplatform	TREFOIL implant (intenal conical connectionwith snap fit)	Branemark Novum implant (external hex)
	Materials	Titanium vanadium alloy	CP titanium
	Surfacemodification	Machined titanium	Machined titanium
	Compensationmechanism	Round abutment and correspondingframework and screw disks	Implant collar partially shaped by pre-torquing technique.
	Prostheticmedia	Acrylic	Acrylic
	Fixedcantileverlength	18.8 mm	19.7
Technologicalcharacteristics			Subject Device	Predicate
			TREFOIL System	Branemark Novum (K000018)
Surgical tooling typeDrill	Diameter	2.0, 3.0, 3.8, 4.0, 4.2, 4.4 mm	2.0, 2.5, 3.0, 3.5, 3.8, 4.0, 4.2, 4.3, 4.4 mm
	Flute length	16.0 mm (including tip)	18.0, 24.0 mm (excluding tip)
	Material	Stainless SteelDIN EN 10027-2 – 1.4197DLC coated	Stainless Steel440F Hardened to MN 500 HV2No coating
	Connection	ISO 1797 Type 1	ISO 1797 Type 1
	Markings	All drills marked at 11.5 mm and 13.5 mm	18.0 mm length single marked for 11.5 mm implant thread24.0 mm length marked for both 11.5 mm implant thread
	Flute design	Two flutes	Three flutes
	Tip design	90° (2mm)130° (3.0, 3.8, 4.0, 4.2, 4.4 mm)	120°
	Intended use	The drills are used together with corresponding Templatesfor drills for the preparation of the implant sites.	The drills are used together with corresponding Templates fordrills for the preparation of the implant sites.
Screw Tap	Flute length	17.0 mm	15.5 mm
	Diameter	5.0 mm	4.5 mm
	Materials	Stainless SteelDIN EN 10027-2 – 1.4197DLC coated	Titanium vanadium alloy
	Connection	ISO 1797 Type 1	2.4 mm square
	Intended use	The screw tap is used when dense bone is present toprepare for the threaded implant	The screw tap is used when dense bone is present to prepare forthe threaded implant
Stabilizingscrew	Core diameter	1.8	1.8
	Length	14.0 mm (to stop)19.3 mm (overall)	13.0 mm (to stop)20.0 mm (overall)
	Materials	316 Stainless Steel	316 Stainless Steel
	Intended use	The stabilizing screw is used to temporarily connect the V-template to the alveolar ridge	Short and long screws used to stabilize the V-gage template tothe alveolar ridge

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Surgical Tooling Comparison

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VII. PERFORMANCE DATA

Laboratory testing was performed to establish the accuracy of the TREFOIL System surgical protocol. This testing included placement of the Trefoil implants into bone models following the Trefoil Instructions for Use and utilizing Trefoil surgical tooling. The results were evaluated by cone beam computed tomography. This testing established the angular and translational accuracy errors generated by the surgical procedure.

The ability of the Trefoil framework compensation mechanism to adapt to the expected angular and translational accuracy errors qenerated by the surgical procedure was established through the use of three-dimensional modeling. The modeling confirmed that the Trefoil compensation mechanism will ensure a passive fit of the framework bar on the Trefoil implants.

Fatigue testing was performed to establish that the TREFOIL System will withstand foreseeable mastication forces. Fatigue testing was done by using a test scenario developed for splinted implant applications. Fatigue testing was conducted and results analyzed in accordance with ISO 14801. The results demonstrate higher fatigue strength than the predicate Branemark Novum (K000018).

Summary of Non-Clinical Testing:

Since the subject device does not represent a new worst case, data from the predicate device was leveraged in the following aspects of the 510(k).

. Sterile Device Information
- The sterilization method for the subiect devices provided sterile is the same as o the predicate. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/ISO 11137. Therefore, no additional testing was required.
- The sterilization methods for the subject devices provided non-sterile and to be o end user sterilized are pre-vacuum and gravity moist heat sterilization and have been validated in accordance with ANSI/AAMI/ISO ISO 17665-1.
. Device Packaging
- The packaging for the subject device is the same as the predicate. This is a o titanium cylinder placed in a plastic vial with PVC shrink-wrap and tamper resistant strip. Therefore, no additional testing was required.
. Shelf Life
- The packaging for the subject device is the same as the predicate and is labeled o with a 5 year expiration date. Real time aging was used to determine the expiration dating. Therefore, no additional testing was required.
. Biocompatibility
- The subject device is manufactured from the same material using the same o manufacturing method as the predicate, has the same intended use, and the same patient contact type and duration. Therefore, no additional testing was required
. Surface Treatment
- The Trefoil implants have the same surface treatment (TiUnite) as the predicate O NobelActive implants. The TiUnite surface treatment was qualified through Auger analysis, IR spectrum analysis, and cytotoxicity testing. Therefore, no additional testing was required.

VIII. CONCLUSIONS

The information provided in this submission demonstrates that the device is substantially equivalent to the predicate devices.

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.