Anorganic Bone Mineral with Collagen in Delivery Applicator is intended for use in dental surgery. The products may be used in surgical procedures such as:

Augmentation or reconstructive treatment of alveolar ridge
Filling of infrabony periodontal defects
Filling of defects after root resection, apicoectomy, and cystectomy
Filling of extraction sockets to enhance preservation of the alveolar ridge
Elevation of maxillary sinus floor
Filling of periodontal defects in conjuncts intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.

Device Description

Anorganic Bone Mineral with Collagen in Delivery Applicator are porous bone mineral matrices consisting of calcium phosphate derived from bovine bone with the addition of bovine type I collagen, pre-loaded into a delivery applicator for ease of placement in the defect site. The anorganic bone mineral component is produced by removal of the organic components from bovine bone. The type I collagen component is derived from bovine Achilles tendon. Anorganic Bone Mineral with Collagen in Delivery Applicator is sterilized by gamma irradiation. The products are non-pyrogenic and for single use only.

AI/ML Overview

The provided document is a 510(k) summary for the "Anorganic Bone Mineral with Collagen in Delivery Applicator" device. It describes the device, its indications for use, and a comparison with predicate devices to establish substantial equivalence. However, it does not contain information typically found in a study proving a device meets specific acceptance criteria for performance metrics like sensitivity, specificity, accuracy, or reader effectiveness for an AI/ML medical device.

This document describes a bone grafting material and its delivery applicator, a Class II medical device. The focus is on demonstrating substantial equivalence to existing predicate devices through material properties, biocompatibility, sterilization, and functionality. It is not an AI/ML device, and therefore the concepts of "acceptance criteria" in the context of statistical performance metrics, "test set," "training set," "ground truth," "expert adjudication," or "MRMC studies" as they apply to AI/ML devices are not relevant here.

Therefore, I cannot provide the requested information for an AI/ML device.

Here's what I can extract based on the document's content, focusing on non-clinical performance testing:

While not in the format of AI/ML acceptance criteria, the document describes "Non-Clinical Performance Testing" which serves a similar purpose of verifying device performance.

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

Since this is not an AI/ML device evaluation, the "acceptance criteria" are related to physical, chemical, and biological properties, not statistical performance metrics.

Feature	Acceptance Criteria (Implied / Stated)	Reported Device Performance
Biocompatibility	Non-cytotoxic, non-irritating, non-sensitizing, non-pyrogenic, non-toxic	Sterile Finished Device: Cytotoxicity, irritation, and sensitization confirmed acceptable. Delivery Applicator: Cytotoxicity, physicochemical attributes of a polymeric material, containers - plastics, physicochemical tests USP <661>, physicochemical (material/chemical) characterization testing of non-aged and 36 month real time aged delivery applicators with extraction conditions and methods in accordance with ISO 10993-12 and ISO 10993-18. Anorganic Bone Mineral & Purified Type I Collagen: Cytotoxicity, sensitization, acute systemic toxicity, genotoxicity, pyrogenicity, implantation, subacute/subchronic toxicity confirmed acceptable (previously submitted).
Sterility	Sterility Assurance Level (SAL) 10⁻⁶	Gamma irradiation, SAL 10⁻⁶ (validated in accordance with ISO 11137-1)
Pyrogenicity	Non-pyrogenic	Non-pyrogenic (confirmed by testing)
Single Use	Single use only	Single Use Only (as designed)
Plunger Force	Specific force range for dispensing (for the delivery applicator)	4.5 N ± 1.3 N (preformed plug)4.1 N ± 1.1 N (moldable plug)
Functionality	Successful delivery of material, ease of placement	Bench testing of delivery applicator functionality and customer assessment (results not detailed, but implied as successful for substantial equivalence).
Animal Performance	Acceptable integration/performance in bone regeneration models	Porcine Anorganic Bone Mineral: Intraoral defect in a canine model. Anorganic Bone Mineral with and without Collagen: Rabbit femoral condyle defect model. Purified Type I Collagen: Rat subcutaneous implantation study. (Results are implied to be acceptable for substantial equivalence, but specific metrics are 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)

This information is not applicable in the context of an AI/ML "test set" and statistical performance. For the non-clinical testing:

Sample sizes for biocompatibility, sterility, and pyrogenicity: Not specified in the document, but understood to adhere to relevant ISO standards (e.g., ISO 10993, ISO 11137).
Sample size for plunger force: Not specified for how many units were tested.
Sample sizes for animal studies: "a canine model," "a rabbit femoral condyle defect model," "a rat subcutaneous implantation study." Specific numbers of animals are not provided.
Data provenance: Not explicitly stated, but assumed to be from internal lab studies and potentially contract research organizations. No country of origin for test data is mentioned. The studies are prospective in the sense that they were conducted for the purpose of this submission.

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. "Ground truth" in the context of an AI/ML device (e.g., disease presence/absence) is not relevant here. The "ground truth" for this device's performance is established by the direct physical, chemical, and biological testing results against predefined specifications and regulatory standards.

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

Not applicable. This is not an AI/ML device requiring human adjudication of performance outputs.

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/ML device.

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

Not applicable. This is not an AI/ML device.

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

As explained, "ground truth" for AI/ML devices is not applicable. For this device, the "truth" is established by:

Direct analytical measurements (e.g., plunger force, material composition, physicochemical tests).
Standardized biological assays (e.g., cytotoxicity, sensitization, pyrogenicity tests).
Histopathological and physiological observations from animal models of bone regeneration.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. There is no training set for this type of device.

Summary

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October 30, 2017

Collagen Matrix, Inc. Danielle Lindner Senior Regulatory Affairs Associate II 15 Thornton Road Oakland, New Jersey 07436

Re: K171008

Trade/Device Name: Anorganic Bone Mineral with Collagen in Delivery Applicator Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: September 26, 2017 Received: September 28, 2017

Dear Danielle Lindner:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 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 (DICE) 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,

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

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Anorganic Bone Mineral with Collagen in Delivery Applicator

Indications for Use (Describe)

Anorganic Bone Mineral with Collagen in Delivery Applicator is intended for use in dental surgery. The products may be used in surgical procedures such as:

· Augmentation or reconstructive treatment of alveolar ridge
· Filling of infrabony periodontal defects
· Filling of defects after root resection, apicoectomy, and cystectomy
· Filling of extraction sockets to enhance preservation of the alveolar ridge
· Elevation of maxillary sinus floor
· Filling of periodontal defects in conjuncts intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
· Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.

Type of Use (Select one or both, as applicable)

|X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

K171008

Applicant Information

Applicant Name:	Collagen Matrix, Inc.
Owner Operator No.:	9043463
Address:	15 Thornton RoadOakland, New Jersey 07436
Telephone:	(201) 405-1477
Fax:	(201) 405-1355
Contact Person:	Peggy HansenSenior VP, Quality and Regulatory Affairs(201) 405 -1477phansen@collagenmatrix.com
Date Prepared:	September 25, 2017

Name of Device

Trade Name:	Anorganic Bone Mineral with Collagen in Delivery Applicator
Common Name:	Bone Grafting Material
Classification Name:	Bone Grafting Material, Animal Source21 CFR 872.3930NPMClass IIDental

Legally Marketed Devices to Which Substantial Equivalence is Claimed

Predicate Device(s)	Anorganic Bone Mineral
	Anorganic Bone Mineral with Collagen
	Anorganic Bone Mineral with Collagen Blocks

K043034

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Reference Predicates:
Porcine Anorganic Bone Mineral in Delivery Applicator
K162158
21 CFR 872.3930
Bone Grafting Material
Class II
NPM
Geistlich Bio-Oss Pen®
K120601
21 CFR 872.3930
Bone Grafting Material
Class II
NPM

Description of the Device

Indications for Use

Anorganic Bone Mineral with Collagen in Delivery Applicator is intended for use in dental surgery. The products may be used in surgical procedures such as:

. Augmentation or reconstructive treatment of alveolar ridge
Filling of infrabony periodontal defects
Filling of defects after root resection, apicoectomy, and cystectomy ●
. Filling of extraction sockets to enhance preservation of the alveolar ridge
. Elevation of maxillary sinus floor
Filling of periodontal defects in conjunction with products intended for Guided Tissue . Regeneration (GTR) and Guided Bone Regeneration (GBR)
. Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.

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Summary/Comparison of Technical Characteristics

The delivery applicator has been designed to deliver the anorganic bone mineral products to the intended treatment area that may be more difficult to reach. The significant modifications that were made are (i) additional sizes offered to the user in a pre-loaded applicator and (ii) new packaging configuration. The key device characteristics, environment for use, performance specifications, principals of operation, mechanism of action and technological characteristics remain unchanged.

The addition of the delivery applicator does not affect the product performance of the bone grafting material, and therefore does not affect substantial equivalence when comparing the subject device to its predicate device. The table below summarizes the comparison of technical characteristics.

Feature	Anorganic Bone Mineral with Collagenin Delivery Applicator (Subject Device)	Anorganic Bone Mineral with Collagen(K043034)
Indications for Use	- Augmentation or reconstructive treatmentof alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection,apicoectomy, and cystectomy- Filling of extraction sockets- Elevation of maxillary sinus floor- Filling of periodontal and peri-implantdefects in conjunction with productsintended for GTR and GBR	- Augmentation or reconstructive treatmentof alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection,apicoectomy, and cystectomy- Filling of extraction sockets- Elevation of maxillary sinus floor- Filling of periodontal and peri-implantdefects in conjunction with productsintended for GTR and GBR
Material	Anorganic Bone Mineral with Purified TypeI Collagen	Anorganic Bone Mineral with Purified TypeI Collagen
Source	Bovine bone (anorganic bone mineral) withbovine tendon (collagen)	Bovine bone (anorganic bone mineral) withbovine tendon (collagen)
Form:	Preformed Plug & Moldable Plug	Block
Sizes	0.25 cc, 0.5 cc, 1.0 cc	0.25 g, 0.5 g, 1.0 g, 2.0 g
Biocompatibility	Biocompatible for the cleared indicationsfor use	Biocompatible for the cleared indicationsfor use
Packaging	Plastic delivery applicator in a single blistertray with Tyvek lid	Glass vial with plastic screw cap in a singleblister with Tyvek lid
Plunger Force	4.5 N ± 1.3 N (preformed plug)4.1 N ± 1.1 N (moldable plug)	Not applicable
Sterility	Gamma irradiation, SAL 10⁻⁶	Gamma irradiation, SAL 10⁻⁶
Pyrogenicity	Non-pyrogenic	Non-pyrogenic
Single Use	Single Use Only	Single Use Only

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Non-Clinical Performance Testing

To demonstrate substantial equivalence, the following non-clinical performance testing on the subject device was performed:

Biocompatibility of Sterile Finished Device: cytotoxicity, irritation, and sensitization .
. Biocompatibility of Delivery Applicator: cytotoxicity, physicochemical attributes of a polymeric material, containers - plastics, physicochemical tests USP <661>. physicochemical (material/chemical) characterization testing of non-aged and 36 month real time aged delivery applicators with extraction conditions and methods in accordance with ISO 10993-12 and ISO 10993-18.
Biocompatibility of Anorganic Bone Mineral and Purified Type I Collagen (previously . submitted in the company's own predicate device premarket notification and applicable to the subject device): cytotoxicity, sensitization, acute systemic toxicity, genotoxicity, pyrogenicity, implantation, subacute/subchronic toxicity
Sterilization validation was performed in accordance with ISO 11137-1 Sterilization of health care products - Radiation
Bench testing of delivery applicator functionality and customer assessment. ●
Animal performance testing of the Anorganic Bone Mineral derived from porcine bone . tissue (K140714) in an intraoral defect in a canine model and the Anorganic Bone Mineral with and without Collagen (K043034) in a rabbit femoral condyle defect model.
Animal performance testing of the Purified Type I Collagen derived from bovine Achilles ● tendon in a rat subcutaneous implantation study.

Conclusion

The results of the in vitro product characterization studies, functionality testing, animal performance testing, and biocompatibility studies show that the Anorganic Bone Mineral with Collagen in Delivery Applicator is substantially equivalent to its 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.