Straumann® BoneCeramic is a fully synthetic bone graft substitute of medical grade purity in particulate form composed of biphasic calcium phosphate. It consists of a mixture of 60% hydroxyapatite (HA), which is 100% crystalline, and of 40% of the beta form of tricalcium phosphate (beta-TCP). BoneCeramic is 90% porous with interconnected pores of 100-500 microns in diameter. It is osteoconductive and gradually resorbed and replaced by vital bone during bone remodeling.
BoneCeramic is available in two granule sizes: 400-700 µm diameter and 500-1000 µm diameter and in three different filling volumes: 0.25g, 0.5g and 1.0g. It is delivered sterile.

AI/ML Overview

This document is an FDA 510(k) summary for the Straumann® BoneCeramic device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a novel device. Therefore, many of the requested elements are not applicable in the context of this 510(k) summary.

However, based on the provided text, here’s an analysis:

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

The document does not present specific acceptance criteria in a quantitative table format with corresponding device performance metrics for a clinical study. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (K040646 Straumann Granules) by showing similar technological characteristics and relying on the predicate's established safety and effectiveness.

The "reported device performance" is primarily qualitative and inferred from the long-term use of the predicate device and the new device sharing similar characteristics.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Meet ISO 10993 standards and FDA guidance.	Biocompatibility confirmed. (Evaluated for the new packaging material)
Packaging Validation: Meet ISO 11607 and ASTM F1980.	Packaging process and shelf life validated.
Sterilization Validation: Meet ISO 11137.	Sterilization process validated according to ISO 11137.
Pyrogenicity: LAL Endotoxin Analysis < 20 EU/device.	LAL Endotoxin Analysis performed on every batch, meeting the limit of 20 EU/device.
Clinical Performance: Safe and effective for indicated uses.	Device marketing and complaint history show an overall complaint rate of <0.05% over 13.5 years. Review of 18 clinical publications across relevant indications demonstrates successful product use.

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

This information is not provided. The document refers to "review of the relevant clinical literature included 18 clinical publications," but does not detail the sample sizes, study designs (retrospective/prospective), or data provenance of these publications. For the internal device performance checks (biocompatibility, packaging, sterilization, pyrogenicity), the "sample size" would refer to the number of units tested, but this detail is not given.

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. The document does not describe a test set with a ground truth established by experts in the context of an AI/image analysis device. The "ground truth" for the device's performance is inferred from compliance with standards and clinical literature demonstrating real-world efficacy.

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

Not applicable. There is no mention of an adjudication method as would be used in a study evaluating diagnostic accuracy with expert consensus.

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 device is a bone grafting material, not an AI-assisted diagnostic tool. Therefore, an MRMC study and effects on human reader performance are not relevant.

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

Not applicable. This is not an algorithm or AI device.

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

For the "clinical performance," the ground truth is indirectly based on outcomes data from the "device marketing and complaint history" and the "relevant clinical literature" (which would detail clinical outcomes in patients). For the technical characteristics (biocompatibility, sterilization, pyrogenicity, packaging), the ground truth is established by adherence to international standards (e.g., ISO, ASTM) and in vitro or in vivo test results demonstrating compliance.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a "training set."

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

Not applicable. As above, this is not an AI/machine learning device.

Summary

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September 24, 2020

Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801

Re: K201051

Trade/Device Name: Straumann® BoneCeramic Regulation Number: 21 CFR 872.3930 Regulation Name: Bone grafting material Regulatory Class: Class II Product Code: LYC Dated: August 23, 2020 Received: August 25, 2020

Dear Jennifer Jackson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

510(k) Number (if known)

K201051

Device Name:

Straumann® BoneCeramic

Indications for Use (Describe)

Straumann® BoneCeramic is indicated for filling and/or augmenting the following intraoral/maxillofacial osseous defects:

Intrabony periodontal osseous and furcation defects
Augmentation of bony defects of the alveolar ridge ●
Filling tooth extraction sites ●
Sinus elevation grafting .

Type of Use (Select one or both, as applicable) 図Prescription Use (Part 21 CFR 801 Subpart D)

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

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Form Approved: OMB No. 0910-0120

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Straumann® BoneCeramic

510(k) Summary

510(k) Summary 5

5.1 Submitter's Contact Information

Submitter:	Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 900505-On the behalf of:Institut Straumann AGPeter Merian-Weg 12CH-4002 Basel, Switzerland
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory Affairs and QualityPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023
Prepared By:	Christelle Gerspach-GasserSenior Lead RA BiomaterialsInstitut Straumann AGPhone number: +41 61 965 1666
Date Prepared:	September 23, 2020

Name of the Device 5.2

Trade Names:	Straumann® BoneCeramic
Common Name:	Bone Grafting Material
Classification Name:	Bone Grafting Material, Synthetic
Regulation Number:	§872.3930
Device Classification:	II
Product Code(s):	LYC
Classification Panel:	Dental

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Straumann® BoneCeramic

510(k) Summary

Predicate Device(s) 5.3

Primary Predicate:

K040646 Straumann Granules .

5.4 -Device Description

BoneCeramic is available in two granule sizes: 400-700 µm diameter and 500-1000 µm diameter and in three different filling volumes: 0.25g, 0.5g and 1.0g. It is delivered sterile.

Intended Use 5.5

Straumann® BoneCeramic is intended to be used for filling and/or augmenting intraoral/maxillofacial osseous defects.

5.6 Indications for Use

Straumann® BoneCeramic is indicated for filling and/or augmenting the following intraoral/maxillofacial osseous defects:

. Intrabony periodontal osseous and furcation defects
. Augmentation of bony defects of the alveolar ridge
Filling tooth extraction sites .
. Sinus elevation grafting

Technological Characteristics 5.7 -

The chemical composition, structure and indications for use of the subject device are identical to those of the predicate device. The only difference between the two relies in the different primary packaging utilized for the subject device. A comparison of the technological characteristics between the subject device and the primary predicate is provided in Table 1.

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Straumann® BoneCeramic

510(k) Summary

FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE
K Number	K201051	K040646
Indications foruse	Straumann® BoneCeramic is indicated forfilling and/or augmenting the followingintraoral/maxillofacial osseous defects:Intrabony periodontal osseous andfurcation defects Augmentation of bony defects of thealveolar ridge Filling tooth extraction sites Sinus elevation grafting	Straumann Granules are indicated for fillingand/or augmenting intraoral /maxillofacialosseous defects, such as:Intrabony periodontal osseous defects Furcation defects Augmentation of bony defects of thealveolar ridge Filling of tooth extraction sites andsinus elevation grafting.
Material(Chemicalcomposition)	Hydroxyapatite (60%) and beta-tricalciumphosphate (40%)	Hydroxyapatite (60%) and beta-tricalciumphosphate (40%)
Structure /Porosity	Matrix consisting of interconnected pores(90% porosity), the size of the pores lieswithin a range of approx. 100 – 500 micronsin diameter.	Matrix consisting of interconnected pores(90% porosity), the size of the pores lieswithin a range of approx. 100 – 500 micronsin diameter.
Particle sizes	400 - 700 µm and 500 – 1000 µm	400 - 700 µm and 500 – 1000 µm
Packaging	Sterile barrier system and protectivepackaging:1) Primary packaging: polystyrene jar closedwith a polypropylene cap2) Secondary packaging: PETG blistersealed with a Tyvek lid (sterile barrier)3) Tertiary packaging: cardboard box	Sterile barrier system and protectivepackaging:1) Primary packaging: PET blister with PEsealing layer2) Secondary packaging: PET blister sealedwith a Tyvek lid (sterile barrier)3) Tertiary packaging: cardboard box
Sterilization	Gamma irradiation	Gamma irradiation
Biologicalcharacteristics	Biocompatible	Biocompatible

Performance Testing 5.8

Chemical characterization and biological testing were conducted according to the ISO standard for the biological evaluation of medical devices, ISO 10993, and to the FDA guidance document for this standard (FDA 2016, Use of International Standard ISO-10993). The new packaging material has been assessed in accordance to the above-mentioned standard and the biocompatibility of the device was confirmed. Furthermore, the packaging process and shelf life of the device have been validated per ISO 11607 and ASTM F1980.

The sterilization process for the subject device as indicated in the labeling has been validated according to ISO 11137 "Sterilization of health care products – Radiation", part 1 and 2. The

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Straumann® BoneCeramic

510(k) Summary

devices will not be marketed as non-pyrogenic. Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis on every batch with a testing limit of 20 EU/device, based on a blood contacting and implanted device.

Device marketing and complaint history and review of the relevant clinical literature was provided. Over a period of 13.5 years, the overall complaint rate based on individual units sold globally for the subject devices was <0.05%. The review of the relevant clinical literature included 18 clinical publications across the relevant indications for use: intrabony osseous and furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting. The device marketing and complaint history and review of the relevant clinical literature provided demonstrates successful product use.

5.9 Conclusion

The documentation submitted in this premarket notification demonstrates that the subject devices are substantially equivalent to the predicate devices.

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.

Indications for Use

Device Name:

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Straumann® BoneCeramic

510(k) Summary 5

5.1 Submitter's Contact Information

Name of the Device 5.2

Straumann® BoneCeramic

Predicate Device(s) 5.3

5.4 -Device Description

Intended Use 5.5

5.6 Indications for Use

Technological Characteristics 5.7 -

Straumann® BoneCeramic

510(k) Summary

Performance Testing 5.8

Straumann® BoneCeramic

510(k) Summary

5.9 Conclusion

§ 872.3930 Bone grafting material.

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