Straumann® cerabone® is a xenogeneic hydroxyapatite ceramic for implantation into a vital bone bed during intra-oral surgical procedures. It is manufactured from bovine cancellous bone in a high temperature sintering process lasting several hours at temperatures of up to 1250°C. This high temperature process results in all organic components being eliminated so that the risk of occurrence of allergic side effects or the occurrence of rejection reactions is reduced. Straumann® cerabone® is made of over 95% of Pentacalcium-hydroxy-[tri]-phosphate Ca5(PO4)3(OH)

AI/ML Overview

This is a 510(k) summary for a medical device called Straumann® cerabone®, a bone grafting material. There is no mention of an AI device in the provided text, therefore, the request cannot be fully fulfilled.

However, I can extract information related to the device's acceptance criteria and the studies that prove it meets those criteria, as if it were a non-AI device.

Device Name: Straumann® cerabone®
Device Type: Xenogeneic hydroxyapatite ceramic bone grafting material

Here's the closest representation of the requested information based on the provided text, adapted for a non-AI medical device:

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance
Primary Claim: Substantial Equivalence to Predicate Device	Comparison of design, technological characteristics, and indications for use.	The subject device (Straumann® cerabone®) and the predicate device (Geistlich Bio-Oss® K122894) are both sterile, biocompatible porous bone mineral materials for use in the same intra-oral surgical procedures. Both are based on pure cancellous bovine bone mineral (free from organic compounds), have a rough surface structure, interconnecting macro- and micro-pores, and act as a scaffold. The comparison table (pages 5 & 6) indicates a high degree of similarity in material, origin, form, structure/density, sterilization method, and shelf life. The indications for use for the subject device are a subset of the predicate's indications.
Sterilization & Shelf Life	Validation of sterilization process (per ISO 11137-1) and shelf life (per ASTM F1980).	Validation performed per ISO 11137-1 for sterilization and per ASTM F1980 for shelf life.
Biocompatibility	Biocompatibility testing per ISO 10993-1, including: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10), Subchronic Toxicity (ISO 10993-11), Genotoxicity (ISO 10993-3), Implantation (ISO 10993-6).	Biocompatibility testing performed per ISO 10993-1 and the specified sub-parts. (Results implicitly met as determined substantially equivalent).
Physicochemical/Material Characterization	Physicochemical and material characterization per ASTM F 1185-03 and ASTM F 1581-99.	Characterization performed per ASTM F 1185-03 and ASTM F 1581-99. (Results implicitly met as determined substantially equivalent).
Viral Inactivation	Demonstration of viral inactivation through validation of manufacturing steps, assessment of potential pathogenic burden, and quality management system. Compliance with ISO 22442-3.	Viral inactivation demonstrated through validation of manufacturing steps and assessment of potential pathogenic burden. A quality management system is in place. Zoonosis assessment demonstrated validated manufacturing processes are sufficient to ensure reduction of viral burden in accordance with FDA-recognized standard ISO 22442-3.
Osteoconductive Capacity	Assessment of osteoconductive capacity in intra-oral defects, with comparison to predicate device.	The osteoconductive capacity of Straumann® cerabone® in intra-oral defects was assessed in a kinetic study in minipigs with comparison to the primary predicate Bio-Oss®. The performance of cerabone was equivalent to the primary predicate device Bio-Oss.
Clinical Efficacy/Safety	Review of clinical literature to support proposed Indications for Use.	A review of the clinical literature was performed. The reviewed literature supports the use of Straumann® cerabone® in the proposed Indications for Use.

Regarding the other requested points, which are typically relevant for AI/Diagnostic devices:

2. Sample sized used for the test set and the data provenance: Not applicable for this type of medical device's performance testing. The "test set" here refers to the subjects in the animal study and potentially the scope of the literature review.
- Animal study: Minipigs were used. The exact number is not specified, but it's referred to as a "kinetic study."
- Clinical Literature Review: No specific sample size as it's a review of existing literature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a bone graft material is typically established through histological analysis in animal models or clinical outcomes in human studies/literature, not expert consensus on images or interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Animal Study: Histological and potentially macroscopic evaluation of bone formation and integration in minipigs. Comparative performance against the predicate device.
- Clinical Literature Review: Published clinical outcomes data and evidence from human studies.
8. The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

In summary, the provided document details the non-clinical performance data (sterilization, biocompatibility, material characterization, viral inactivation, and an animal study) and a clinical literature review to demonstrate that Straumann® cerabone® is substantially equivalent to its predicate device, Geistlich Bio-Oss®, for its indicated uses. The information provided is typical for a medical device submission but lacks the specifics about AI-related criteria.

Summary

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October 19, 2018

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

Re: K173594

Trade/Device Name: Straumann® cerabone® Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: September 17, 2018 Received: September 20, 2018

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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,

Andrew I. Steen -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

Enclosure

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Indications for Use

510(k) Number (if known) K173594

Device Name Straumann® cerabone®

Indications for Use (Describe)

Straumann® cerabone® is used in the following intra-oral surgical procedures:

· Alveolar ridge augmentation/ reconstruction
· Filling of defects after root resection and apicoectomy
· Filling alveoli after tooth extraction
Sinus elevation

Type of Use (Select one or both, as applicable)	Research Use (Part 21 CFR 201.3 Subpart D) Testing Conducted (21 CFR 201.3 Subpart G)	Research Use (Part 21 CFR 201.3 Subpart D)	Testing Conducted (21 CFR 201.3 Subpart G)
Research Use (Part 21 CFR 201.3 Subpart D)
Testing Conducted (21 CFR 201.3 Subpart G)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Submitter:	Straumann USA, LLC(on behalf of Institut Straumann AG)
	60 Minuteman RoadAndover, MA 01810
	Registration No.: 1222315Owner/Operator No.: 9005052
Contact Person:	Jennifer M. Jackson, MSDirector, Regulatory Affairs+1 (978) 747-2509
Prepared By &Secondary Contact:	Christelle Gerspach-GasserRegulatory Affairs and Compliance ManagerInstitut Straumann AG+41 61 965 1666
Date Prepared:	October 19, 2018
Product Code(s):	NPM 21 CFR 872.3930
Device Class:	II 21 CFR 872.3930
Classification Panel:	Dental Devices
Classification Name:	Bone Grafting Material
Common Name:	Bone Grafting Material
Proprietary Name:	Straumann® cerabone®
Predicate Device(s):	K122894 Geistlich Bio-Oss
Device Description:	Straumann® cerabone® is a xenogeneic hydroxyapatiteceramic for implantation into a vital bone bed duringintra-oral surgical procedures. It is manufactured frombovine cancellous bone in a high temperature sinteringprocess lasting several hours at temperatures of up to1250°C. This high temperature process results in allorganic components being eliminated so that the risk ofoccurrence of allergic side effects or the occurrence ofrejection reactions is reduced.Straumann® cerabone® is made of over 95% ofPentacalcium-hydroxy-[tri]-phosphate Ca5(PO4)3(OH)

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Due to the animal-derived starting material, Straumann® cerabone® possesses an interconnected macro- and micro-porous structure that strongly resembles human bone structure. The macroporosity lies within a range of 65–80 vol % and the pore size lies within a range of approximately 100 - 1,500 um. After implantation, the particles serve as an osteoconductive guide rail for new bone formation. The grafting material has high stability over several years with only minor signs of graft resorption.

Straumann® cerabone® acts as a scaffold for stabilization and the deposition of new bone matrix. Due to porosity and rough surface structure, Straumann® cerabone® facilitates cell adhesion. Subsequently, bone formation starts by deposition of primarily not yet mineralized bone matrix. Within a time period of six to eight months following implantation, the graft is integrated into the newly formed bone matrix.

Straumann® cerabone® is biocompatible and packed in a triple sterile barrier system consisting of a glass vial and two outer blisters and subject to sterilization by qammairradiation.

Straumann® cerabone® is offered in two particle size ranges (0.5 – 1.0 mm and 1.0 – 2.0 mm) and various pack sizes (0.5, 1.0, 2.0 and 5.0 cc).

Art. No.	Article Name
BS-1510	Straumann® cerabone®, 0.5 - 1.0 mm, 1 x 0.5 cc
BS-1511	Straumann® cerabone®, 0.5 - 1.0 mm, 1 x 1.0 cc
BS-1512	Straumann® cerabone®, 0.5 - 1.0 mm, 1 x 2.0 cc
BS-1515	Straumann® cerabone®, 0.5 - 1.0 mm, 1 x 5.0 cc
BS-1520	Straumann® cerabone®, 1.0 - 2.0 mm, 1 x 0.5 cc
BS-1521	Straumann® cerabone®, 1.0 - 2.0 mm, 1 x 1.0 cc
BS-1522	Straumann® cerabone®, 1.0 - 2.0 mm, 1 x 2.0 cc
BS-1525	Straumann® cerabone®, 1.0 - 2.0 mm, 1 x 5.0 cc

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Straumann® cerabone® is used in the following intra-oral Indications For Use: surgical procedures:

Alveolar ridge augmentation/ reconstruction ●
Filling of defects after root resection and ● apicoectomy
Filling alveoli after tooth extraction .
Sinus elevation .

Technological The subject and the predicate device are both sterile, Characteristics: biocompatible porous bone mineral materials for use in the same intra-oral surgical procedures.

The subject and predicate devices are based on the following same technological elements:

Pure cancellous bovine bone mineral (free from . organic compounds)
. Rough surface structure, interconnecting macroand micro pores
. Scaffold provision as mode of action
. Same sterilization method and shelf life

The comparison between the features of the subject device and the predicate are provided in the table below. The Indications for Use for the subject device are a subset of the Primary Predicate Indications for Use.

Feature	Subject DeviceStraumann® cerabone®	Primary Predicate DevicesGeistlich Bio-OssK122894
Indicationsfor use	Straumann® cerabone® is used in the following intra-oral surgical procedures:Alveolar ridge augmentation/reconstruction Filling of defects after root resection and apicoectomy Filling alveoli after tooth extraction Sinus elevation	Geistlich Bio-Oss® is indicated for:Augmentation or reconstructive treatment of the alveolar ridge Filling of intrabony periodontal defects Filling of defects after root resection, apicoectomy and cystectomy Filling of extraction sockets to enhance preservation of the alveolar ridge Elevation of the maxillary sinus floor Filling of periodontal defects in conjunction with products identified for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

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Feature	Subject DeviceStraumann® cerabone®	Primary Predicate DevicesGeistlich Bio-OssK122894
Material	xenogenic hydroxyapatite (calciumphosphate) ceramic manufacturedfrom cancellous (spongiosa)bovine bone	xenogenic hydroxyapatite (calciumphosphate) ceramic manufacturedfrom cancellous (spongiosa)bovine bone
Origin	Femoral heads of cattle	Femoral heads of cattle
Form	Granules	Granules
Composition	- Hydroxyapatite (Pentacalcium-hydroxy-[tri]-phosphateCa5(PO4)3(OH)) (≥95%)- ≤2.5% other calcium phosphates(traces of calcium carbonate(CaO3) (<0.1%))- No water (0%)- No organic components (0%)	- Hydroxyapatite (Pentacalcium-hydroxy-[tri]-phosphateCa5(PO4)3(OH)) (93.6%),- Calcium carbonate (CaO3)(3,4%)- Water (3%)- No organic components (0%)
Appearance(dry state)	Whitish up to beige	Whitish
Structure /Density	Matrix possessing aninterconnected macro- and micro-porous structure.	Matrix consisting of interconnectedmacro- and micropores, highlyporous with a large inner surfacearea.
Specifications/ Granulessizes	Granule sizes0.5 – 1.0 mm1.0 – 2.0 mm	Granule sizes0.25 – 1.0 mm1.0 – 2.0 mm
Packaging &Sterilization	Single use, triple sterile barriersystem, terminally gammasterilized by gamma irradiation	Single use, double sterile barriersystem, terminally gammasterilized by gamma irradiation
Sterilization	Gamma-irradiation	Gamma-irradiation
Shelf life	3 years	3 years

Performance Data:

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

Sterilization and Shelf Life:

Validation of sterilization process per ISO 11137-1 ●
. Validation of shelf life per ASTM F1980

Biocompatibility Testing:

Biocompatibility testing per ISO 10993-1 and the . following:
- Cytotoxicity per ISO 10993-5 o
- Sensitization per ISO 10993-10 o
- Irritation per ISO 10093-10 O
- Subchronic Toxicity per ISO 10993-11 o
- O Genotoxicity per ISO 10993-3
- Implantation per ISO 10993-6 o

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Performance Testing - Bench:

Physicochemical and material characterization per ● ASTM F 1185-03 and ASTM F 1581-99
. Viral inactivation demonstrated through validation of manufacturing steps, and the assessment of the potential pathogenic burden, quality management system in place. The Zoonosis assessment demonstrated that the validated manufacturing processes are sufficient to ensure a reduction of viral burden in accordance with the recommendation of the FDA recognized standard ISO 22442-3 and are sufficient for the demonstration of substantial equivalence to the predicate device.

Performance Testing - Animal:

The osteoconductive capacity of Straumann® . cerabone® in intra-oral defects was assessed in a kinetic study in minipigs with comparison to the primary predicate Bio-Oss®. The performance of cerabone was equivalent to the primary predicate device Bio-Oss.
Performance Testing – Clinical:
A review of the clinical literature was performed. . The reviewed literature supports the use of Straumann® cerabone® in the proposed Indications for Use.
Conclusions: Following assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate device.

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.