THE Graft Bone Substitute is a resorbable bone graft material made of porcine cancellous bone consisting of Hydroxyapatite(HA). THE Graft Bone Substitute is a natural and porous bone mineral matrix available in cancellous granules packaged in a vial or syringe. It is manufactured by removal of most organic components from porcine bone. The composition of THE Graft Bone Substitute meets the requirements of ASTM F1581 Standard Specification for Composition of Anorqanic Bone for Surgical Implants. Due to its natural structure of macro and microscopic structures, the anorqanic bone mineral of THE Graft Bone Substitute is physically and chemically comparable to the mineralized matrix of human bone. When packed into a bony site, THE Graft Bone Substitute is gradually resorbed and replaced with new bone during the healing process. The formation and ingrowth of new bone at the implantation site of THE Graft Bone Substitute is due to its trabecular architecture, interconnecting macro and micro pores and its natural consistency. THE Graft Bone Substitute is supplied sterile, non-pyrogenic, and for single use only.

AI/ML Overview

The provided document is a 510(k) summary for "THE Graft Bone Substitute". It focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria and detailed study results for standalone performance.

Therefore, much of the requested information, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, specific effect sizes, training set size, and detailed ground truth establishment for the training set, is not available within this document. This document is a summary of regulatory submission, not a scientific publication detailing performance studies.

However, based on the information available, here's what can be extracted:

Acceptance Criteria and Reported Device Performance

The document states, "All of the acceptance criteria were met" for the performance data. While the specific numerical acceptance criteria for each test are not explicitly detailed, the studies conducted and their purpose are mentioned. The general acceptance criterion is compliance with the referenced standards and guidance documents.

Acceptance Criterion (Implicit)	Reported Device Performance
Compliance with ASTM F1581 Standard Specification	Meets requirements of ASTM F1581
Biocompatibility according to ISO 10993-1, -3, -5, -6, -10, -11	Passed: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Implantation Test, Pyrogen Testing
Sterilization according to ISO 11137-1	Sterilized with gamma radiation (minimum 25 kGy), SAL 10^-6, Sterilization Validation (ISO 11137-2), Endotoxin Test, Packaging Validation passed
Viral Inactivation	Complete inactivation of viruses demonstrated
In-vivo performance (dog model) and Clinical Evaluation	Performed, and "All of the acceptance criteria were met."

Study Details

1. Sample sizes used for the test set and data provenance:

Not explicitly stated in the provided document. The document mentions "in-vivo dog model" and "Clinical data" were provided but does not specify the number of animals or human subjects, nor their geographical origin.

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

Not applicable / Not explicitly stated. For mechanical, physical, biocompatibility, and sterilization tests, the "ground truth" is typically defined by adherence to established international standards (e.g., ASTM F1581, ISO 10993, ISO 11137). For the in-vivo and clinical evaluations, the ground truth would be determined by the study's endpoints (e.g., bone formation, material resorption) assessed by qualified personnel, but the number and qualifications of experts involved in this assessment are not provided.

3. Adjudication method for the test set:

Not applicable / Not explicitly stated. This type of adjudication (e.g., 2+1) is typically relevant for studies involving subjective human interpretation of data (e.g., imaging reads). The performance data cited are primarily objective laboratory and animal/clinical study results.

4. 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 substitute material, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.

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

Not applicable. This is a medical device (bone substitute), not an algorithm or software. Its "standalone performance" refers to its inherent physical, chemical, and biological properties, which were assessed through the listed performance tests (mechanical, physical, biocompatibility, sterilization, viral inactivation) and in-vivo/clinical evaluations.

6. The type of ground truth used:

For Mechanical and Physical testing: Compliance with ASTM F1581 Standard Specification.
For Biocompatibility testing: Compliance with ISO 10993 series of standards.
For Sterilization: Compliance with ISO 11137-1 and ISO 11137-2.
For Viral Inactivation: Successful inactivation of viruses, which would be measured against specific validated viral assays.
For In-vivo dog model and Clinical data: Likely pathology (histological assessment of bone formation and material resorption) and potentially outcomes data (e.g., successful integration, absence of adverse events). The specific endpoints are not detailed.

7. The sample size for the training set:

Not applicable. There is no "training set" as this is a physical medical device and not a machine learning model.

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

Not applicable. As above, no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.

PURGO BIOLOGICS INC. Hana Jung RA Manager E-607, 700, Pangyo-ro, Bundang-gu Seongnam-si, Gyeonggi-do, Korea

Re: K173188

Trade/Device Name: The Graft Bone Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: June 14, 2018 Received: June 21, 2018

Dear Hana Jung:

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.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

July 20, 2018

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Mary S. Runner -S For Tina Kiang, Ph.D.

Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K173188

Device Name THE Graft Bone Substitute

Indications for Use (Describe)

THE Graft Bone Substitute is intended for use as a bone grafting material in dental surgery such as:

Filling of extraction sockets to enhance preservation of the alveolar ridge
Elevation of maxillary sinus floor

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)	☐

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Purgo Dental Biologics Solution. The logo consists of a gray circular icon with a smaller circle inside, followed by the word "Purgo" in a purple, sans-serif font. To the right of "Purgo" are the words "Dental Biologics Solution" stacked vertically, also in a purple, sans-serif font, but smaller in size.

510(k) Summary K173188

l. SUBMITTER

PURGO BIOLOGICS INC. E-607, 700, Pangyo-ro, Bundang-gu Seongnam-si, Gyeonggi-do, Korea Postal Code 13516

Contact Person: Hana Jung Regulatory Affairs Manager Phone: +82 70 4827 4863 Fax: +82 2 549 4003 Email: junghn@purgo.co.kr

Date Revised: 7-20-2018

II. DEVICE

Name of Device: THE Graft Bone Substitute Common or Usual Name: Bone Grafting Material Classification Name: Bone Grafting Material, Animal Source (21 CFR 872.3930) Regulatory Class: Class II (special controls) Product Code: NPM

III. PREDICATE DEVICE

Collagen Matrix Inc. Porcine Anorganic Bone Mineral, K140714

Reference device: Bio-Oss® , K952617 (Geistlich-Pharma)

IV. SPECIAL CONTROLS

FDA Guidance "Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices; Guidance for Industry and FDA Staff" was followed during the preparation of this submission.

510(k) Summary

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Image /page/4/Picture/0 description: The image contains the logo for "Purgo Dental Biologics Solution". The logo features a gray circular icon with a smaller circle inside and a line extending upwards to a small circle, followed by the word "Purgo" in a bold, purple font. To the right of "Purgo" are the words "Dental Biologics Solution" stacked vertically, also in purple.

V. DEVICE DESCRIPTION

THE Graft Bone Substitute is a resorbable bone graft material made of porcine cancellous bone consisting of Hydroxyapatite(HA).

THE Graft Bone Substitute is a natural and porous bone mineral matrix available in cancellous granules packaged in a vial or syringe. It is manufactured by removal of most organic components from porcine bone. The composition of THE Graft Bone Substitute meets the requirements of ASTM F1581 Standard Specification for Composition of Anorqanic Bone for Surgical Implants. Due to its natural structure of macro and microscopic structures, the anorqanic bone mineral of THE Graft Bone Substitute is physically and chemically comparable to the mineralized matrix of human bone. When packed into a bony site, THE Graft Bone Substitute is gradually resorbed and replaced with new bone during the healing process. The formation and ingrowth of new bone at the implantation site of THE Graft Bone Substitute is due to its trabecular architecture, interconnecting macro and micro pores and its natural consistency.

THE Graft Bone Substitute is supplied sterile, non-pyrogenic, and for single use only.

VI. INDICATIONS FOR USE

THE Graft Bone Substitute is intended for use as a bone grafting material in dental surgery such as:

Filling of extraction sockets to enhance preservation of the alveolar ridge ।
Grafting of maxillary sinus floor ।

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

THE Graft Bone Substitute is substantially equivalent to the predicate device: Porcine Anorganic Bone Mineral K140714, in which the basic features, raw materials, material composition, intended uses, technological characteristics and performance characteristics are similar.

THE Graft Bone Substitute and the predicate device have similar Indications for Use. Both devices are intended for the same population and sterilized by gamma irradiation. The devices are made of biocompatible calcium phosphate bone mineral derived from porcine cancellous tissue adequate for bone formation. The devices feature trabecular-like characteristics, including interconnected macro and micro pores.

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Image /page/5/Picture/0 description: The image contains the logo for Purgo Dental Biologics Solution. The logo consists of a gray circular icon with a smaller circle inside and a magnifying glass symbol attached to the top left. To the right of the icon, the word "Purgo" is written in a bold, purple font. Further to the right, the words "Dental Biologics Solution" are stacked vertically in a smaller, purple font.

Item	THE Graft	ZCORE; K140714	Bio-Oss; K952617
Indicationsfor Use	THE Graft BoneSubstitute is intended foruse as a bone graftingmaterial in dental surgerysuch as:- Filling of extraction socketsto enhance preservation ofthe alveolar ridge- Grafting of maxillary sinusfloor	Porcine Anorganic BoneMineral is intended for use indental surgery. The productsmay be used in surgicalprocedures such as:- Augmentation orreconstructive treatment ofalveolar ridge- Filling of infrabonyperiodontal defects- Filling of defects after rootresection, apicoectomy, andcystectomy- Filling of extraction socketsto enhance preservation ofthe alveolar ridge- Elevation of maxillary sinusfloor- Filling of periodontaldefects in conjunction withproducts intended forGuided Tissue Regeneration(GTR) and Guided BoneRegeneration (GBR)- Filling of peri-implantdefects in conjunction withproducts intended forGuided Bone Regeneration	Geistlich Bio-Oss® isintended for the followinguses:- Augmentation orreconstructive treatment ofthe alveolar ridge;- Filling of infrabonyperiodontal defects;- Filling of defects after rootresection, apicoectomy, andcystectomy;- Filling of extraction socketsto enhance preservation ofthe alveolar ridge;- Elevation of the maxillarysinus floor;- Filling of periodontaldefects in conjunction withproducts intended forGuided Tissue Regeneration(GTR) and Guided BoneRegeneration (GBR); and- Filling of peri-implantdefects in conjunction withproducts intended forGuided Bone Regeneration(GER).
MaterialSource	Porcine	Porcine	Bovine
MaterialsComposition	Calcium phosphate	Calcium phosphate	Calcium phosphate
MineralStructure	Hydroxyapatitecontaining Carbonate	Carbonate apatite	Hydroxyapatite
Form	Granules	Granules	Granules
Color	White	White	White
PhysicalAppearance	Porous, irregular-shapedparticles	Porous, irregular-shapedparticles	Porous, irregular-shapedparticles
Particle SizeRange	0.2 – 0.355 mm,0.25mm – 1.0mm or1.00mm – 2.0mm	0.25mm – 1.0mm or1.00mm – 2.0mm	0.25mm – 1.0mm or1.00mm – 2.0mm
ResorptionProfile	Gradual resorption	Gradual resorption	Gradual resorption
Package	Glass Vial or GlassSyringe in a single TyvekPouch	Plastic Jar in a singleBlister Tray with TyvekLid	Glass Vial in a singleBlister Tray with Tyvek Lid
Sterility	Sterile, SAL 10-6Gamma irradiation(ISO 11137)	Sterile, SAL 10-6Gamma irradiation(ISO 11137)	Sterile, SAL 10-6Gamma irradiation(ISO 11137)
Pyrogenicity	Non-pyrogenic	Non-pyrogenic	Non-pyrogenic
SingleUse/Reuse	Single use only	Single use only	Single use only

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Image /page/6/Picture/0 description: The image contains the logo for "Purgo Dental Biologics Solution". The word "Purgo" is in a large, bold, purple font. To the left of the word is a gray icon that looks like a microscope. To the right of the word "Purgo" is the phrase "Dental Biologics Solution" in a smaller, stacked font.

VIII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Mechanical and Physical testing

Non-clinical laboratory performance testing was conducted to confirm that the composition of THE Graft Bone Substitute meets the requirements of ASTM F1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants. This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices, issued on April 28th of 2005.

Biocompatibility testing

The biocompatibility evaluation for THE Graft Bone Substitute was conducted in accordance with the International Standard ISO 10993-1:2009 "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA to further ensure substantial equivalence with the predicate device.

Assessment of the candidate device included the following tests:

Cytotoxicity (ISO 10993-5) .
0 Sensitization Test (ISO 10993-10)
Intracutaneous Reactivity (ISO 10993-10) .
Acute Systemic Toxicity (ISO 10993-11) ●
Subchronic Toxicity Test (ISO 10993-11) ●
Genotoxicity (ISO 10993-3) 0
Implantation Test (ISO 10993-6) 0
. Pyrogen Testing
Shelf-Life 0

Sterilization

In accordance with ISO 11137-1. THE Graft Bone Substitute is sterilized with gamma radiation with the use of minimum dose 25 kGy for sterility assurance level of 10 °.

Sterilization Validation (ISO 11137-2) ●
Endotoxin Test ●
Packaging Validation

Viral Inactivation

Viral safety validation was performed and the result showed complete inactivation of viruses.

Non-clinical and Clinical Evaluation

In-vivo dog model was performed as well as Clinical data was provided to assess THE Graft and the predicate device as implantable materials.

All of the acceptance criteria were met.

510(k) Summary

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Image /page/7/Picture/0 description: The image shows the logo for Purgo Dental Biologics Solution. The logo features a gray circular icon with a smaller circle inside and a handle extending from the top. To the right of the icon, the word "Purgo" is written in a bold, purple font. Further to the right, the words "Dental Biologics Solution" are stacked vertically, also in purple.

IX. CONCLUSIONS

Based on the information provided within this 510(k) submission, Purgo Biologics Inc. concludes that THE Graft is substantially equivalent to the legally marketed predicate device listed according to the requirements of the Federal Food, Drug, and Cosmetic Act.

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.