Bond Apatite™ is a synthetic osteoconductive, bioresorbable bone grafting material composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form. intended to fill. augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Device Description

Bond Apatite is composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form. The hydroxyapatite component is sintered hydroxyapatite granules that conform to ISO 13779-1 Implants for surgery - Hydroxyapatite - Part 1: Ceramic Hydroxyapatite and ISO 13779-3 Implants for surgery – Hydroxyapatite – Part 3: Chemical analysis and characterization of crystallinity and phase purity. The calcium sulfate material is Bond Bone™, a mixture of surgical grade calcium sulfate dihydrate and calcium sulfate hemihydrate, and cleared under K083858. The calcium suffate component conforms to the chemical requirements of ASTM F2224 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants. Bone Apatite is provided sterile, in a single unit size of 1 cc in a disposable applicator that is used for mixing the dry powder with sterile saline and for delivery to the treatment site.

AI/ML Overview

The provided text is a 510(k) summary for the Bond Apatite™ device. It thoroughly describes the device, its intended use, its composition, and its substantial equivalence to predicate devices. However, the document does not contain specific information about acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test or training sets, expert qualifications, or details of a multi-reader multi-case study.

The text focuses on demonstrating substantial equivalence to predicate devices based on:

Intended Use: "Bond Apatite™ is a synthetic osteoconductive, bioresorbable bone grafting material composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form. intended to fill. augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region." This is deemed substantially similar to existing predicate devices.
Materials: Composed of hydroxyapatite and biphasic calcium sulfate, conforming to ISO and ASTM standards. The calcium sulfate component is explicitly stated to be the predicate device, Bond Bone™ (K083858).
Design and Functional Characteristics: Dry powder mixed with saline, provided sterile in a single-unit mixing/delivery applicator, similar to predicate devices.
Performance Characteristics: Data submitted included "material characterization by Fourier transform infrared spectroscopy, x-ray diffraction, and inductively coupled plasma optical emission spectrometry; physical characterization by gravimetric methods, mechanical sieve separation, scanning electron microscopy; performance characteristics including setting time and reaction temperature measurements, compressive mechanical properties, pH. dissolution. device handling under simulated usage conditions, and clinical performance testing."

The document concludes that "Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy," and "The data included in this submission demonstrates substantial equivalence to the predicate devices listed above."

Therefore, based solely on the provided text, it is not possible to fill out the requested table and answer many of the specific questions. The submission isn't about demonstrating performance against independent acceptance criteria in a controlled study with a defined test set; it's about showing that the device is substantially equivalent to already-marketed devices based on material, design, and general performance characteristics.

Here's how I would answer based on the given information, with clear indications of what is not provided:

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

Acceptance Criteria	Reported Device Performance
Not explicitly defined in the document. The overarching "acceptance criterion" is Substantial Equivalence to predicate devices.	Demonstrated substantial equivalence to predicate devices based on: - Same intended use. - Same operating principle. - Same basic design. - Same or very similar materials (hydroxyapatite and biphasic calcium sulfate, with calcium sulfate being a predicate device). - Similar packaging and sterilization. - Conformity of components to ISO 13779-1, ISO 13779-3, and ASTM F2224 standards. - Material and physical characterization (FTIR, XRD, ICP-OES, gravimetric, sieve separation, SEM). - Performance characteristics (setting time, reaction temperature, compressive mechanical properties, pH, dissolution, device handling under simulated usage conditions, clinical performance testing [details not provided]).

Acceptance Criteria

Reported Device Performance

Not explicitly defined in the document. The overarching "acceptance criterion" is Substantial Equivalence to predicate devices.

Demonstrated substantial equivalence to predicate devices based on: - Same intended use. - Same operating principle. - Same basic design. - Same or very similar materials (hydroxyapatite and biphasic calcium sulfate, with calcium sulfate being a predicate device). - Similar packaging and sterilization. - Conformity of components to ISO 13779-1, ISO 13779-3, and ASTM F2224 standards. - Material and physical characterization (FTIR, XRD, ICP-OES, gravimetric, sieve separation, SEM). - Performance characteristics (setting time, reaction temperature, compressive mechanical properties, pH, dissolution, device handling under simulated usage conditions, clinical performance testing [details not provided]).

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 for Test Set: Not specified. The document mentions "clinical performance testing" but does not detail the size or nature of this testing.
Data Provenance: Not specified.

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)

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

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

Adjudication Method: Not specified.

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

MRMC Study: No, this is not an AI/software device that would typically involve a multi-reader multi-case study to assess improvement with AI assistance. It is a bone grafting material.

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

Standalone Performance: Not applicable for this device type. It is a physical bone grafting material, not an algorithm.

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

Type of Ground Truth: The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology for disease detection) is not directly applicable here. The "truth" for this submission revolves around the material's properties, in vitro performance, and "clinical performance testing" for safety and efficacy, which would likely involve histological or clinical outcome measures compared to predicate devices or established benchmarks, but these details are not provided.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not a device based on a machine learning algorithm requiring a "training set."

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

Ground Truth for Training Set: Not applicable.

Summary

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510(k) Summary K121177

DEC 0 5 2013

510(k) Summary Augma Biomaterials, Ltd. Bond Apatite™ K121177

December 5, 2013

ADMINISTRATIVE INFORMATION

Augma Biomaterials. Ltd. Manufacturer Name Usishkin 8 Netanya. Israel 42273 Telephone: +972-(0)77-559-1945 +972-(0)4-627-5337 Fax:

Official Contact

Dr. Amos Yahav, DMD

Representative/Consultant

Kevin A. Thomas, PhD Linda K. Schulz, BSDH. RDH PaxMed International. LLC 11234 El Camino Real. Suite 200 San Diego. CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 kthomas@paxmed.com Email: lschulz@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	Bond Apatite™
Classification Name	Bone Grafting Material, Synthetic.
Classification Regulations	21 CFR 872.3930, Class II
Product Code	LYC
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

INTENDED USE

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510(k) Summary K121177

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

Augma Biomaterials, Ltd., demonstrated that, for the purposes of FDA's regulation of medical devices Bond Apatite is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

Augma Biomaterials, Ltd., Bond Bone™, K083858;

BONESUPPORT AB, CERAMENT™BONE VOID FILLER (A0210-12), K090871; and

Lifecore Biomedical. Inc., HAPSET Hydroxylapatite Bone Graft Plaster, K910432.

The intended use, materials, design, and functional characteristics of Bond Apatite and the predicate devices are substantially the same. The subject device and the predicate device Bond Bone are indicated for use in dental bone regeneration procedures. The intended use of the subject device and both predicate devices is to fill bony defects. The calcium sulfate material in the subject device Bond Apatite is the predicate device. Bond Bone, cleared under K083858. By weight, Bone Apatite is approximately 38.6% hydroxyapatite and 61.4% biphasic calcium sulfate. The predicate devices CERAMENT™|BONE VOID FILLER and HAPSET Hydroxylapatite Bone Graft Plaster consist of powdered hydroxyapatite and calcium sulfate hemihvdrate.The subject device and the predicate devices are supplied as a dry powder to be mixed with saline or other liguid to form a putty before use, and all are provided sterile in a single unit mixing/deliverv applicator (syringe) for single patient use.

Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy.

Data submitted, referenced, or relied upon to demonstrate substantial equivalence included: material characterization by Fourier transform infrared spectroscopy, x-ray diffraction, and inductively coupled plasma optical emission spectrometry; physical characterization by gravimetric methods, mechanical sieve separation, scanning electron microscopy; performance characteristics including setting time and reaction temperature measurements, compressive mechanical properties, pH. dissolution. device handling under simulated usage conditions, and clinical performance testing.

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510(k) Summary K121177

The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

Overall, Bond Apatite™ has the following similarities to the predicate devices:

has the same intended use. o
uses the same operating principle, .
incorporates the same basic design, .
incorporates the same or very similar materials, and .
has similar packaging and is sterilized using the same materials and processes. .

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circular border.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

December 5, 2013

Augma Biomaterials, Limited C/O Kevin A. Thomas, PhD. PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130

Re: K121177

Trade/Device Name: Bond Apatite™ Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: November 26, 2013 Received: December 2, 2013

Dear Dr. Thomas:

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 - Dr. Thomas

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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Kwame O.
Ulmer-S

for

Erin 1. Keith, M.S. Acting 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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K121177

510(k) Summary

Bond Apatite™

Indications for Use

510(k) Number:

Bond Apatite™ Device Name:

Indications for Use:

Bond Apatite™ is a synthctic osteoconductive, bioresorbable bone grafting material composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form, intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

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Mary S. Runner -S BA 2013.12.05 14:40:01 -05'00'

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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.