By itself in bone regeneration procedures
Mixed with other bone graft materials (e.g. PRP, bone allograft, bone xenograft, demineralized freeze dried bone and/or a pure calcium sulfate based bone graft material)

Oral Surgery: Post-extraction.
Periodontics: Infra-osseous defects.
Endodontics: Apioectomy, Root perforations, Open apices.
Implantology: Dehiscences, fenestrations, sinus lifts.

Device Description

BoneGen - TR is manufactured by BioLok-International Inc. It is a composite of medical grade calcium sulfate hemihydrate and poly (1 lactic acid) in a 96:4 ratio. It is produced in pellet form: the size of pellets ranging from 425 - 850 microns. This composite undergoes slower degradation than calcium sulfate, overcoming the occasional disadvantage of rapid degradation of the pure medical grade calcium sulfate hemihydrate. It has a half-life of approximately 60 days and is usually completely degraded by 120 days. It can be used as a bone graft material on its own or it can be combined with a pure medical grade calcium sulfate hemihydrate bone graft material such as BoneGen. BoneGen - TR will be presented in 1.5 gram packages. Bony defects can be packed with BoneGen - TR pellets and can be closed with calcium suffate based, absorbable polymer based, collagen based or ePTFE based barriers. With time, BoneGen - TR pellets undergo degradation and is replaced by a calcium phosphate "trellis" that stimulate bone growth in the defect.

AI/ML Overview

The provided text describes the 510(k) summary for BoneGen-TR, a bone filling augmentation material. While it outlines the device's composition, intended use, and substantial equivalence to predicate devices, it does not contain information regarding traditional "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, nor does it detail a clinical study proving such performance specifications.

Instead, the provided text focuses on:

Chemical composition testing: Ensuring the material meets specified purity and biocompatibility standards.
Literature review: Documenting the existing use of its components in bone grafting.
In vitro degradation profile testing: To understand its breakdown characteristics.
Animal experiment: To study its function as a bone graft material compared to a predicate device.

Therefore, many of the requested fields cannot be answered based on the provided input.

Here's a breakdown of what can and cannot be extracted:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative clinical performance metrics (e.g., success rate, bone volume increase, healing time with specific thresholds). The acceptance criteria were more related to chemical properties, degradation rate, and biocompatibility.
  - Chemical purity (USP NSF 18, ASTM Standard F2224-03).
  - Biocompatibility (ISO 10993-1).
  - Degradation rate (half-life of approximately 60 days, complete degradation by 120 days).
- Reported Device Performance:
  - Satisfied chemical purity as specified by ASTM Standard F2224-03.
  - Certified biocompatibility to ISO 10993-1 requirements.
  - Half-life of approximately 60 days, usually completely degraded by 120 days.
  - Functioned as a bone graft material comparable to the predicate device in an animal study.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not specified for the animal experiment.
- Data Provenance: The animal experiment was "conducted to study the function of BoneGen-TR as a bone graft material." Location and retrospective/prospective nature are not described in the provided text.
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/Not mentioned, as the study described is an animal experiment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned.
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 bone filling material, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a bone filling material, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the animal study: The "ground truth" would be determined by histological analysis, micro-CT, or other animal model-specific assessments of bone regeneration and degradation, compared to the predicate device. The text states "function...as a bone graft material."
The sample size for the training set:
- Not applicable. This document is about a medical device material, not a machine learning model.
How the ground truth for the training set was established:
- Not applicable.

Summary of Acceptance Criteria and Device Performance (based on available information):

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Chemical Composition	Chemical composition to USP NSF 18.	Tested utilizing test method USP NSF 18.
Purity of Calcium Sulfate Hemihydrate	Satisfy chemical purity as specified by ASTM Standard F2224-03.	Tested by an independent laboratory (NAMSA) using USP/NF monograph testing, and satisfied chemical purity as specified by ASTM Standard F2224-03.
Biocompatibility of PLLA	Certified biocompatibility to ISO 10993-1 for implantable contact > 30 days.	Poly(1 lactic acid) obtained from a supplier with FDA Device Master File, certified biocompatibility to ISO 10993-1 requirements for implantable contact greater than 30 days.
Residual Methylene Chloride	Acceptable levels (implicit).	Determined by gas chromatography flame ionization (GC/F1). (Acceptable level not explicitly stated but implied by certification).
Degradation Profile (In Vitro & Animal)	Slower degradation than pure calcium sulfate, half-life approx. 60 days, complete by 120 days.	Composite undergoes slower degradation than calcium sulfate. Has a half-life of approximately 60 days and is usually completely degraded by 120 days. Animal experiment conducted "to study the function of BoneGen-TR as a bone graft material as compared to the first predicate device, BoneGen pure calcium sulfate hemihydrate" (implying comparable function).
Substantial Equivalence	Equivalent in design, function, and intended use to predicate devices.	Determined to be substantially equivalent to named predicate devices (SurgiPlaster/BoneGen, CalMatrix, Polygraft, Atrisorb).

The document primarily states that the device was found substantially equivalent to predicate devices based on these tests and literature, which is the primary "acceptance criterion" for 510(k) clearance.

Summary

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SECTION 1

510 (k) Summary

K060285

Submitted by:

Company Name:	BioLok International Inc.
Address:	368 South Military TrailDeerfield Beach, FL 33442
Telephone:	954-698-9998
Fax:	954-698-9925

Harold Alexander, Ph.D. Contact Person: BioLok International Inc. Orthogen Biomaterials Division 505 Morris Avenue, Suite 104 Springfield, NJ 07081 973-467-2404 halexander@orthogencorp.com

Date Prepared: January 30, 2006

BoneGen-TR Trade Name:

Common Name: Bone filling augmentation material

SUBSTANTIAL EQUIVALENCE: BoneGen-TR is substantially equivalent in design, function and intended use to Orthogen Corporation's SurgiPlaster cleared as K011403 on September 11, 2001 (tradename changed to BioLok International Inc.'s BoneGen on June 21, 2005). The only difference is the addition of 4% PLLA to slow the degradation rate of the calcium sulfate hemihydrate. A second predicate device having substantially equivalent design, function and intended use is Lifecore Biomedical Inc.'s CalMatrix Calcium Sulfate Bone Graft Binder cleared as K041324 on June 19, 2004. This device, like BoneGen-TR, is a composite of calcium sulfate hemihydrate and an absorbable polymer. A third predicate device is OsteoBiologics, Inc.'s Polygraft Bone Graft Substitute cleared as K030288 on June 17, 2003. This device is substantially equivalent in function. The intended use of filling bony voids or gaps is equivalent except for the orthopaedic rather than dental emphasis. In design this material contains the two components of BoneGen-TR, calcium sulfate hemihydrate and polylactic acid containing polymer, in addition to polyglycolide fibers and a surfactant. A fourth predicate device is Atrix Laboratories. Inc.'s Atrisorb Bioabsorbable GTR Barrier cleared as K982865 on September 8, 1998. This device utilizes the PLA absorbable polymer as a bone contacting and repair material. It differs in that it does not contain calcium sulfate hemilydrate and softens the absorbable polymer with N-methyl-2-pyrrolidone.

DESCRIPTION OF THE DEVICE: BoneGen - TR is manufactured by BioLok-International Inc. It is a composite of medical grade calcium sulfate hemihydrate and poly (1 lactic acid) in a 96:4 ratio. It is produced in pellet form: the size of pellets ranging from 425 - 850 microns. This composite undergoes slower degradation than calcium sulfate, overcoming the occasional disadvantage of rapid degradation of the pure medical grade calcium sulfate hemihydrate. It has a half-life of approximately 60 days and is usually completely degraded by 120 days. It can be used as a bone graft material on its own or it

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can be combined with a pure medical grade calcium sulfate hemihydrate bone graft material such as BoneGen. BoneGen - TR will be presented in 1.5 gram packages. Bony defects can be packed with BoneGen - TR pellets and can be closed with calcium suffate based, absorbable polymer based, collagen based or ePTFE based barriers. With time, BoneGen - TR pellets undergo degradation and is replaced by a calcium phosphate "trellis" that stimulate bone growth in the defect.

INDICATIONS FOR USE:

BoneGen-TR is indicated for use as follows:

1. By itself in bone regeneration procedures
1. Mixed with other bone graft materials (e.g. PRP, bone allograft, bone xenograft, demineralized freeze dried bone and/or a pure calcium sulfate based bone graft material)

SUMMARY OF TESTING:

BioLok International, Inc. has:

tested the chemical composition of BoneGen-TR by an independent FDA registered laboratory utilizing test method USP NSF 18. The poly(1 lactic acid) is obtained from a supplier who has an FDA Device Master File for this material and has certified biocompatibility to ISO 10993-1 requirements for implantable contact greater than 30 days. Residual methylene chloride was determined by gas chromatography flame ionization (GC/F1). The chemical composition of the calcium sulfate hemilydrate has been tested by an independent laboratory (NAMSA) using the USP/NF monograph testing procedure. The material satisfied chemical purity as specified by ASTM Standard F2224-03, Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants.
provided extensive literature documenting the use of calcium sulfate, poly (1 lactic acid) and their composites in bone grafting procedures.
provided in vitro degradation profile testing and the results of an animal experiment conducted to study the function of BoneGen-TR as a bone graft material as compared to the first predicate device, BoneGen pure calcium sulfate hemidytrate.

Based upon this testing and literature data, BoneGen-TR has been demonstrated as biocompatible and safe for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 16 2008

Bio-Lok International, Incorporated C/O Mr. Harold Alexander Orthogen Biomaterials Division 505 Morris Avenue, Suite 104 Springfield. New Jersey 07081

Re: K060285

Trade/Device Name: BoneGen TR Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: January 30, 2006 Received: February 6, 2006

Dear Mr. Alexander:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Harold Alexander

submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. An 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, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA.

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 (240) 276-0115. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 at (301) 443-6597.

Sincerely vours.

Cuts

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K060285

Indications for Use

510(k) Number (if known):

Device Name:

BoneGen TR

Indications For Use:

1. Oral Surgery: Post-extraction.
1. Periodontics: Infra-osseous defects.
1. Endodontics: Apioectomy, Root perforations, Open apices.
1. Implantology: Dehiscences, fenestrations, sinus lifts.

Prescription Use × (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)

Susan Russo

m mode, General Hespi Dental Davices

K060285

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.