The TriStar Bone Graft Fixation System is indicated for stabilization and fixation of bone grafts, bone blocks, bone filling materials, and / or barrier membranes used to regenerate bone in the oral cavity.

Device Description

The TriStar Bone Graft Fixation System consists of titanium alloy self-drilling screws which are tapered and have a maximum diameter of 1.75mm with lengths of 3mm, 4mm, 5mm, 6mm, 8mm, 10mm, 12mm, 15mm, 18mm, 21mm, and 24mm. The screws are manufactured using a Ti-6Al-4V alloy (ASTM F-136) and adhere to standards tested under ASTM F-543. This system also includes a number of accessories used to fixate the screws and/or membranes or bone blocks to the host bone including a square headed morse tapered hand screw driver, screw driver handle, and latch type driver. The system includes titanium mesh in 40mm x 60mm or 18mm x 25mm sizes each having a thickness of 0.1mm. The screws and titanium mesh are designed to be removed from the patient after such time when sufficient bone regeneration is demonstrated. The devices are sold non-sterile. Single use only.

AI/ML Overview

This document describes the 510(k) premarket notification for the TriStar Bone Graft Fixation System. It 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 (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) is not applicable or provided in this type of regulatory submission.

Here's an analysis based on the provided text, addressing the points where information is available:

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

The document does not present a formal table of quantitative acceptance criteria with reported device performance values in the way one might see for a diagnostic AI device. Instead, the "acceptance criteria" for granting 510(k) clearance are related to demonstrating substantial equivalence to legally marketed predicate devices. This is achieved through comparisons of design, materials, indications for use, standards applied, and other characteristics.

The "reported device performance" is primarily qualitative, asserting that the device is substantially equivalent and raises no new safety or effectiveness concerns.

Feature/Criterion (for Substantial Equivalence to Predicate)	TriStar Bone Graft Fixation System Performance (as reported for equivalence)
Screw Material	Ti-6Al-4V (ASTM F-136) - Equivalent to predicates
Screw Design	Self-Drilling - Similar to some predicates, different from others, but considered equivalent
Screw Length	3mm - 24mm - Range falls within or is similar to predicates
Screw Diameter	1.75mm max - Range falls within or is similar to predicates
Mesh Material	Grade 1 Titanium - Equivalent to predicate
Mesh Thickness	0.1mm - Equivalent to predicate
Bench Testing - Screws	ASTM F-543 - Conforms to standard, also used for predicate
Bench Testing - Mesh	ASTM F-382 - Conforms to standard, also used for predicate
Biocompatibility	Tested under ISO 10993-5, found biocompatible - Consistent with regulatory requirements
Indications for Use	Stabilization and fixation of bone grafts, bone blocks, bone filling materials, and/or barrier membranes used to regenerate bone in the oral cavity. - Equivalent to at least one predicate (Alpha-Bio Tec) and within the scope of others.

The study that "proves the device meets the acceptance criteria" in this context is the 510(k) submission itself, which includes the results of non-clinical performance testing and a comparison to predicate devices to establish substantial equivalence.

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

Sample Size: Not applicable. This document is for a medical device (bone graft fixation system), not a diagnostic AI/software device. The "test set" here refers to the device components themselves undergoing bench testing. The testing mentioned (ASTM F543-13 for screws and ASTM F382 for mesh) likely involved specific sample sizes as dictated by the standards, but these details are not provided in this summary.
Data Provenance: Not applicable for a clinical study in this context, as "Clinical testing is not applicable to this device." The technical data comes from non-clinical laboratory bench testing.

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. "Ground truth" in the context of expert consensus is typically for diagnostic/AI evaluations. For this device, performance is evaluated against engineering standards and material specifications, not expert diagnostic assessments.

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

Not applicable. This concept is for clinical or diagnostic study design, not for mechanical device testing against engineering standards.

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 is a physical medical device, not an AI or software device that would assist human readers in interpretation.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the device's performance in this context is defined by:

Compliance with established international standards for metallic medical bone screws (ASTM F543-13) and mesh (ASTM F382).
Compliance with biocompatibility standards (ISO 10993-5).
Chemical composition of materials (e.g., Ti-6Al-4V (ASTM F-136)).
Substantial equivalence to previously cleared predicate devices in terms of design, material, and indications for use.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model that undergoes "training."

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

Not applicable. There is no training set for a physical medical device in this context.

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 features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing right, layered on top of each other, with a ribbon-like element flowing beneath them. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

December 18.2014

Impladent, Ltd. Maurice Valen President 198-45 Foothill Ave. Holliswood, New York 11423

Re: K141764

Trade/Device Name: TriStar Bone Graft Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZL Dated: November 18, 2014 Received: November 19, 2014

Dear Mr. Valen:

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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Page 2 - Mr. Valen

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 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,

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

Enclosures

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Premarket Notification 510(k) Submission

Indications for Use

K141764 510(k) Number: N/A

Device Name: TriStar Bone Graft Fixation System

Indications for Use:

Prescription Use YES

(Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter NO

(21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for IMPLADENT LTD. The logo consists of a black geometric shape on the left and the company name in red on the right. Below the company name is the address "198-45 Foothill Avenue, Holliswood NY 11423".

www.impladentltd.com

510(k) Summary

Type of Submission:	Traditional Premarket Notification 510(k), 21 CFR 807.92
Submitted by:	Impladent Ltd.198-45 Foothill AvenueHolliswood NY 11423-1611
Contact Person:	Maurice Valen, President; Director of R&DAndrew Valen, Vice PresidentPhone: 718 465-1810 Fax: 718 464-9620Email: maurice@impladentltd.comcc: andrew@impladentltd.com
Establishment Registration:	2431866
Common Name:	Titanium Fixation Screw System
Proprietary Name:	TriStar Bone Graft Fixation System
Classification:	Class II, 21 CFR 872.4760
Product Code:	JEY
Review Panel:	Dental
Confidentiality:	Under section 21 CFR 807.95, selected pages and/or sectionshave been marked as "CONFIDENTIAL"
Purpose of Submission:	New device. Evidence herein is submitted to establishsubstantial equivalence for the TriStar Bone Graft FixationSystem
Predicate Devices Screws:	Salvin Titanium Fixation Screw System (K073342)Frontier Devices Maxillofacial and Mesh System (K091812)BioPlate Rigid Fixation Bone Plating System forCraniomaxillofacial Surgery (K030806, K972463, K022890)Alpha-Bio Tec Bone Fixation Screw System (K063769)
Predicate Devices Mesh:	Unicare Biomedical Cytoflex Mesh (K021511)

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510(k) Summary

Device Description:

Indications for Use:

Technological Characteristics & Substantial Equivalence

As was established in this submission, the subject device is substantially equivalent to other devices cleared by the FDA for commercial distribution. Engineering drawings, labeling, advertising materials and mechanical testing have been submitted and demonstrate that the subject device is substantially equivalent to its predicate devices in terms of design, material composition, indications for use, standards applied and other characteristics. There are no unique applications, indications, materials or specifications for the TriStar Bone Graft Fixation System when compared to the predicate devices.

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Testing

Non-clinical performance testing has been conducted using ASTM F543-13 – Standard Specification and Test Methods for Metallic Medical Bone Screws. Mesh was tested under ASTM F382. Tests from these standard were also conducted on the predicate devices. Clinical testing is not applicable to this device. Biocompatibility of the patient contacting titanium devices has been tested under ISO 10993-5 and found to be biocompatible.

Conclusion

Based on the 510(k) Summary and the information provided in this submission, we conclude that the TriStar Bone Graft Fixation System is substantially equivalent to the existing legally marketed devices cited above and where minor differences exist, these differences raise no new safety, effectiveness and/or performance issues.

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Substantial Equivalence Predicate Device Table - Screws

Device	TriStar BoneGraft FixationSystem	Salvin DentalSpecialtiesTitaniumFixation ScrewSystem	FrontierDevicesMaxillofacialand MeshSystem	BioPlate RigidFixation Bone PlatingSystem forCraniomaxillofacialSurgery	Alpha-Bio TecBone FixationScrew System
510(k) Number	K141764	K073342	K091812	K030806, K972463,K022890	K063769
Applicant Name	Impladent Ltd.	Salvin DentalSpecialties	FrontierDevices	BioPlate	Alpha-Bio
Year 510(k)Cleared	2014	2008	2010	1997, 2002, 2003	2007
Screw Design	Self-Drilling	Self-Tapping	Self-Drilling &Self-Tapping	Self-Drilling	Self-Tapping
Screw Material	Ti-6Al-4V(ASTM F-136)	Ti-6Al-4V	Ti-6Al-4V(ASTM F-136)	Ti-6Al-4V	Ti-6Al-4V(ASTM F-136)
HeadConfiguration	Square	Cross	Cross	Square	Hexagonal
Screw Length	3mm - 24mm	4mm – 15mm	3mm - 24mm	3mm - 10mm	4mm – 12mm
Screw Diameter	1.75mm max	1.5 & 2.0 mm	1.5 – 2.3 mm	1.5, 1.8, 1.9, 2.3 mm	1.2, 1.6mm
Mesh Offered	Yes	Yes	Yes	Yes	No
Plates Offered	No	No	Yes	Yes	No
Bench Testing	ASTM F-543	ASTM F-543	Not Specified	Not Specified	Not Specified
Indications forUse	The TriStar BoneGraft FixationSystem is indicatedfor stabilization andfixation of bonegrafts, bone blocks,bone fillingmaterials, and / orbarrier membranesused to regeneratebone in the oralcavity.	The Salvin DentalSpecialties, Inc.Titanium FixationScrew is intended foruse in internalfixation of smallbones including thecraniofacial andmaxillofacial skeletonaffected by trauma,or for reconstruction.	Frontier DevicesMaxillofacial Systemis intended for use inselective trauma ofthe mid-face andmaxillofacialskeleton;maxillofacial surgery;reconstructiveprocedures; andselectiveorthognathic surgeryof the maxilla andchin.	The Bioplate Rigid FixationBone Plating System forCraniomaxillofacial Surgery isintended for use in thetreatment of fractures andreconstructive procedures ofthe Craniomaxillofacialskeleton and non-weightbearing fixation, includingcranial bone fixation, browfixation, and orbital fixation.Each device is intended forsingle use only and only inconjunction with othertitanium and titanium alloyimplants.	The Alpha-BioBone FixationScrew System isindicated tostabilize and fixatebone grafts, bonefilling materials,and/or barriermembranes usedfor regeneration ofbone in the oralcavity.
Marketed As Kit	Yes	Yes	Yes	Yes	Yes
Items in Kit	ScrewsHandleDriverMesh	CassetteScrewsHandleDriverDrillAdditional Drill	CassetteScrewsHandleDriverMeshMesh CutterTi-Plates	CassetteScrewsHandleDriverForecepsTi-Plates	ScrewsDriverDrill
Sterilization	Steam	Steam	Steam	Steam	n/a
Product Code /Regulation #	JEY872.4760	DZL872.4880	DZL872.4880	JEY872.4760	DZL872.4880

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Device	TriStar Bone Graft Fixation SystemTitanium Mesh	Unicare BiomedicalCytoflex Mesh
510(k) Number	K141764	K021511
Classification	JEY	JEY
Material	Grade 1 Titanium	Commercially Pure Titanium
Specification	Bending tests as per ASTM F 382-99(R2008)	Bending tests as per ASTM F 382-99(R2008)
Dimensions	(1) 18 x 25 mm(2) 40 x 60 mm	(1) 25 x 30mm
Thickness	0.1 mm	0.1 mm
Size of holes	0.8 mm	0.5 mm
Biocompatibility	Cytotoxicity	Unknown
Indications	Stabilization and fixation of bonegrafts, bone blocks, bone fillingmaterials, and / or barrier membranesused to regenerate bone in the oralcavity.[These are the same indications as kitoverall]	Used to ensure three dimensionalreconstruction of alveolar bonedefects and to facilitationaugmentation with adequate fixationof the augmentation material.

Substantial Equivalence Predicate Device Table - Mesh

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.