Bongold is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the pelvis and extremities. Bongold must be used with autograft as a bone graft extender in the extremities. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Bongold resorbs and is replaced with bone during the healing process.

Device Description

Bongold™ Bone Graft Material is a composite of synthetic hydroxyapatite [Ca10(PO4)6(OH)2] and type I collagen. The composite material is a resorbable, porous, osteoconductive bone graft matrix. It is available as a lyophilized matrix in particle forms, cylinders and blocks. This bone graft material contains approximately 45% mineral by weight. Bongold"10 device is intended to be used as bone void filler for voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e., the pelvis, and/or extremities).

Bongold™ cylinders and blocks can be cut into shapes and are designed to retain their shape and physical integrity following implantation into a bony site, while the particle form can be packed to fit the bone defect. The product is sterile and for single use only.

AI/ML Overview

The provided text is a 510(k) summary for the Bongold™ Bone Graft Material. It describes the device, its intended use, and indicates that performance studies were conducted. However, it does not provide specific acceptance criteria or detailed results of those performance studies in a way that would allow the completion of the requested table and information points.

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

Information that can be extracted:

Study Type: Performance studies were "bone repair studies in a cancellous bone defect model in rabbit."
Comparison: The device was compared to "autograft in animal performance testing."
Endpoint measurements: "radiographs and histology at 4, 8 and 12 weeks."
Conclusion: The studies "demonstrated with respect to predicate device the safety and performance of the Bongold™ Bone Graft Material in supporting bone growth in orthopedic applications."
Ground Truth Type (for animal study): Most likely histology and potentially radiographic interpretation.
Nonclinical Tests: In vitro product characterization studies, in vitro and in vivo biocompatibility studies (passed FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing).

Information that cannot be extracted from this document to complete the request:

Acceptance Criteria and Reported Device Performance Table: The document states that performance studies were done but does not enumerate specific acceptance criteria (e.g., "bone density increase by X%") or report quantitative performance metrics against those criteria.
Sample size for the test set: The document mentions "a cancellous bone defect model in rabbit" but does not specify the number of rabbits or defect sites used.
Data provenance: Not specified beyond "rabbit model."
Number of experts and qualifications for ground truth: Not mentioned, as it's an animal study.
Adjudication method for the test set: Not mentioned.
MRMC comparative effectiveness study details: No human reader multi-case study is mentioned, as this is an animal study for a bone graft material.
If a standalone study was done: Yes, the described animal study is a standalone performance study.
Sample size for the training set: Not applicable for this type of device and study. The concept of a "training set" is typically for AI/ML models, not for bone graft material performance studies.
How the ground truth for the training set was established: Not applicable.

Based on the available information, here is the modified response:

The provided document describes the 510(k) summary for the Bongold™ Bone Graft Material and mentions performance studies. However, it does not specify the quantitative acceptance criteria or the reported device performance metrics that would be typically presented in a table for an AI/ML device. The context is a medical device (bone graft material) where performance is evaluated through animal studies and material characterization, rather than through AI algorithm metrics like sensitivity, specificity, or AUC against a ground truth dataset established by human experts.

Therefore, many of the requested fields are not applicable or cannot be answered from the provided text.

Here's what can be gathered:

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

Not provided in the document. The document states that animal studies "demonstrated with respect to predicate device the safety and performance of the Bongold™ Bone Graft Material in supporting bone growth in orthopedic applications." However, specific numerical acceptance criteria (e.g., percentage of bone ingrowth, material resorption rate) and quantitative performance results are not detailed.

2. Sample sized used for the test set and the data provenance:

Sample Size: Not specified. The study was conducted "in a cancellous bone defect model in rabbit." The exact number of animals or defect sites is not mentioned.
Data Provenance: Animal study (rabbit model). Country of origin is not specified. It is a prospective animal study.

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

Not applicable / Not specified. As this is an animal study involving radiographs and histology, the "ground truth" would implicitly be established by veterinary pathologists or radiologists. The number and qualifications of such experts are not mentioned.

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

Not applicable / Not specified. Adjudication methods are typically used for human expert review of image sets or clinical data, which is not the primary focus of performance evaluation for this type of bone graft material.

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:

No. This type of study is not relevant for the evaluation of a bone graft material. The performance study involved comparing the bone graft material to autograft in an animal model.

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

Yes, a standalone performance study was done. The animal study evaluated the device's intrinsic ability to support bone growth without human intervention in its function. This is not an "algorithm-only" study in the context of AI, but rather a direct performance evaluation of the medical device itself.

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

For the animal performance studies, the ground truth was established through histology and radiographic assessment. These are objective biological and imaging markers of bone repair.

8. The sample size for the training set:

Not applicable. This device is a bone graft material, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable. (See point 8).

Summary

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

July 9, 2015

Beijing Allgens Medical Science & Technology Company, Ltd Helen Cui, Ph.D. Director of RA/OA 7 Liberty Ridge Road Basking Ridge, New Jersey 07920

Re: K141725

Trade/Device Name: Bongold™ Bone Graft Material Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: June 1, 2015 Received: June 5, 2015

Dear Dr. Cui:

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

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Page 2 - Helen Cui, Ph.D.

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/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 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 vours.

Lori A. Wiggins -S

for

Mark N. Melkerson Director Division of Orthopedic 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) K141725

Device Name Bongold Bone Graft Material

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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Chapter 5: 510(k) Summary

June 30, 2015

Applicant Name and Address: Beijing Allgens Medical Science & Technology Co., Ltd Beijing BDA IPE Building #2, Disheng Donglu #1 Beijing, 100176 China

Helen Cui, Ph.D., Director of RA/QA, CTO Contact Person: Tel: (908) 3924742 Fax: 732.453.3862 Date of Summary: March 20, 2015 Device Common Name: Bone Void Filler Device Trade Name: Bongold "M Bone Graft Material Device Classification Name: Filler, Bone Void, Calcium Compound Regulation Number: 888.3045 Product Code: MQV Device Class: Class II Predicate Device(s):

HEALOS® Bone Graft Material (K012751) (Primary predicate)
OssiMend Tm Bone Graft Material (K052812) (Reference predicate)
MASTERGRAFT® Strip(K082166) (Reference predicate)
Vitoss® Scaffold Foam Bone Graft Material (K032288) (Reference predicate)

Description of the Device

Intended Use

Bongold™ is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the pelvis and extremities. Bongold™ must be used with autograft as a bone graft

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Beijing Allgens Medical Science & Technology Co., Ltd.

extender in the extremities. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Bongold resorbs and is replaced with bone during the healing process.

510(k) Summary of Safety and Effectiveness

Summary/Comparison of Technological Characteristics

(a) Technological Characteristics

Bongold TM Bone Graft Material and its predicates have the same key technological characteristics. In particular. Bone Graft Material and its predicates are the same with respect to intended use, design, material characterization, and product forms.

Bongold 110 Bone Graft Material and its predicates are designed as 3-dimensional, resorbable, porous, osteoconductive matrices intended to fill voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. The materials used are a combination of previously cleared and commercially marketed calcium phosphate mineral and type I collagen. The product was characterized by physical and chemical bench tests comparing its characteristics to those of the predicate devices. Such tests included mineral structure and content analysis, physical structure analysis, porosity and pore size analysis. Bongold ™ Bone Graft Material has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices.

(b) Performance Data

Performance studies supporting the product were bone repair studies in a cancellous bone defect model in rabbit.

The device was compared to autograft in animal performance testing in order to demonstrate substantial equivalence to the predicate. Endpoint measurements included radiographs and histology at 4. 8 and 12 weeks. These studies demonstrated with respect to predicate device the safety and performance of the Bongold ™ Bone Graft Material in supporting bone growth in orthopedic applications.

(c) Conclusions Drawn from Nonclinical Tests

The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, and animal performance studies show that the Bongold™ Bone Graft Material is safe with respect to predicate device and substantially equivalent to its predicate device.

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.