Augmentation or reconstructive treatment of alveolar ridge ●
o 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 o
Elevation of maxillary sinus floor .
Filling of periodontal defects in conjunction with products intended for Guided . Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
o Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.

Device Description

Porcine Anorganic Bone Mineral in Delivery Applicator is a porous bone mineral matrix consisting predominantly of calcium phosphate, pre-loaded into a delivery applicator. Porcine Anorganic Bone Mineral in Delivery Applicator is produced by removal of the organic components from porcine bone. Porcine Anorganic Bone Mineral in Delivery Applicator is sterilized by gamma irradiation. The product is non-pyrogenic and for single use only.

AI/ML Overview

This document pertains to a 510(k) premarket notification for a medical device called "Porcine Anorganic Bone Mineral in Delivery Applicator" (K162158). It does not describe an AI/ML device or its performance criteria. Therefore, most of the requested information cannot be extracted.

However, I can provide information about the acceptance criteria and the studies performed to demonstrate substantial equivalence to its predicate device, as presented in the document:

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

The document does not explicitly present a "table of acceptance criteria" with numerical performance metrics for the device itself in the way one would for an AI/ML diagnostic or measurement device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Porcine Anorganic Bone Mineral, K140714) through a comparison of technical characteristics and performance testing.

The "acceptance criteria" are implied by the comparison to the predicate device and the successful completion of specified tests. The "reported device performance" is essentially that the device met the requirements of these tests and was found to be substantially equivalent.

Here's a table based on the provided "Summary/Comparison of Technical Characteristics" and "Non-Clinical Performance Testing" sections, focusing on functional acceptance as being equivalent to the predicate or meeting standard test requirements.

Feature / Test Category	Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Indications for Use	Identical to predicate device	Match predicate device
Material Source	Identical to predicate device (Porcine Bone)	Match predicate device
Material Composition	Identical to predicate device (Calcium phosphate)	Match predicate device
Mineral Structure	Identical to predicate device (Carbonate apatite)	Match predicate device
Form	Identical to predicate device (Granules)	Match predicate device
Color	Identical to predicate device (White to off-white)	Match predicate device
Physical Appearance	Identical to predicate device (Porous, irregular-shaped particles)	Match predicate device
Product Sizes	New sizes offered, but overall range consistent with predicate's capabilities	0.25 and 0.5 cc offered. Predicate offered 0.25 cc, 0.5 cc, 1.0 cc, 2.0 cc, and 4.0 cc. (Considered an "additional size" offering rather than a deviation)
Particle Size Range	Consistent with predicate device (0.25 - 1 mm or 1 - 2 mm)	0.25 - 1 mm. Predicate offered 0.25 – 1 mm and 1 - 2 mm. (Within predicate specification)
pH	$7.3 \pm 0.1$ (identical to predicate)	$7.3 \pm 0.1$
Resorption Profile	Gradual resorption (identical to predicate)	Gradual resorption
Unit Package	Delivery applicator (new feature, but no performance degradation)	Pre-loaded into plastic delivery applicator
Sterility	Sterile, SAL 10-6, Gamma irradiation, ISO 11137 (identical to predicate)	Sterile, SAL 10-6, Gamma irradiation, ISO 11137
Pyrogenicity	Non-pyrogenic (identical to predicate)	Non-pyrogenic
Single Use/Reuse	Single use only (identical to predicate)	Single use only
Biocompatibility of Sterile Finished Device	Meet requirements for cytotoxicity, irritation, and sensitization	Tests performed and demonstrated substantial equivalence
Biocompatibility of Delivery Applicator	Meet requirements for cytotoxicity, physicochemical attributes of a polymeric material, containers - plastics, and USP <661>	Tests performed and demonstrated substantial equivalence
Biocompatibility of Anorganic Porcine Bone Mineral	Meet requirements for cytotoxicity, sensitization, acute systemic toxicity, genotoxicity, pyrogenicity, implantation, subacute/subchronic toxicity (previously established by predicate)	Applicable previous data used and demonstrated substantial equivalence
Sterilization Validation	In accordance with ISO 11137-1	Performed in accordance with ISO 11137-1
Bench Testing (Delivery Applicator)	Demonstrate functionality and customer assessment	Performed and demonstrated substantial equivalence
Animal Performance Testing (Anorganic Porcine Bone Mineral)	Demonstrate performance in an intraoral defect in a canine model (previously established by predicate)	Applicable previous data used and demonstrated substantial equivalence

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

The document does not specify a "test set" in the context of an AI/ML algorithm. The performance testing outlined involved:

Biocompatibility testing: Standardized tests for medical devices. The sample sizes for these tests are not provided but would typically be dictated by the relevant ISO standards (e.g., ISO 10993).
Sterilization validation: Performed according to ISO 11137-1. Sample sizes are not specified here but are standard for such validations.
Bench testing: For delivery applicator functionality. No sample size given.
Animal performance testing: Referenced as being previously submitted for the predicate device in a canine model. The specific sample size or provenance of this animal study is not detailed in this document.

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. This device is not an AI/ML diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. This device is not an AI/ML diagnostic device requiring expert adjudication.

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-assisted 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 algorithm.

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

Not applicable for an AI/ML context. However, for a medical device such as this bone mineral, the "ground truth" for its performance is established through:

In vitro and material characterization: Chemical composition analysis, physical properties, pH, particle size, etc., against defined standards.
Biocompatibility studies: Demonstrating safety and biological compatibility according to ISO 10993 standards.
Sterilization validation: Conforming to sterility assurance level (SAL) requirements.
Animal performance studies: Demonstrating expected biological response and bone regeneration characteristics in a relevant animal model (canine model referenced).

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. This is not an AI/ML device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

February 9, 2017

Collagen Matrix, Inc. Peggy Hansen Senior Vice President, Quality And Regulatory Affairs 15 Thornton Road Oakland. New Jersey 07436

Re: K162158

Trade/Device Name: Porcine Anorganic Bone Mineral In Delivery Applicator Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: January 13, 2017 Received: January 17, 2017

Dear Peggy Hansen:

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 (reporting of medical devicerelated 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.

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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 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. 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 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,

Michael J. Ryan -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: Porcine Anorganic Bone Mineral in Delivery Applicator

Indications for Use:

Porcine Anorganic Bone Mineral 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 ●
o 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 o
Elevation of maxillary sinus floor .
Filling of periodontal defects in conjunction with products intended for Guided . Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
o Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

X -Prescription Use (Part 21 CFR 801.109)

AND/OR

Over-The-Counter Use

Page 1 of 1

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K162158

510(k) SUMMARY

Applicant Information

Applicant Name:Owner Operator No.:	Collagen Matrix, Inc.9043463
Address:	15 Thornton RoadOakland, New Jersey 07436
Telephone:Fax:	(201) 405-1477(201) 405-1355
Contact Person:	Peggy HansenSenior VP, Quality and Regulatory Affairs201-405-1477phansen@collagenmatrix.com
cc:	Danielle LindnerSenior Regulatory Affairs Associate II201-405-1477dlindner@collagenmatrix.com
Date Prepared:	February 8, 2017
Name of Device
Trade Name:	Porcine Anorganic Bone Mineral 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) Porcine Anorganic Bone Mineral K140714

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Description of the Device

Indications for Use

Porcine Anorganic Bone Mineral 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

Summary/Comparison of Technical Characteristics

The delivery applicator has been designed to deliver the porcine anorganic bone mineral granules to the intended treatment area that may be more difficult to reach. The only 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.

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Feature	Porcine Anorganic Bone MineralIn Delivery Applicator(this submission)	Porcine Anorganic Bone Mineral(K140714)
Indications for Use	Intended for use in dental surgery. Theproducts may be used in surgicalprocedures such as:• Augmentation or reconstructivetreatment of alveolar ridge• Filling of infrabony periodontaldefects• Filling of defects after root resection,apicoectomy, and cystectomy• Filling of extraction sockets toenhance preservation of the alveolarridge• Elevation of maxillary sinus floor• Filling of periodontal defects inconjunction with products intendedfor Guided Tissue Regeneration(GTR) and Guided BoneRegeneration (GBR)• Filling of peri-implant defects inconjunction with products intendedfor Guided Bone Regeneration.	Intended for use in dental surgery.The products may be used in surgicalprocedures such as:• Augmentation or reconstructivetreatment of alveolar ridge• Filling of infrabony periodontaldefects• Filling of defects after root resection,apicoectomy, and cystectomy• Filling of extraction sockets toenhance preservation of the alveolarridge• Elevation of maxillary sinus floor• Filling of periodontal defects inconjunction with products intendedfor Guided Tissue Regeneration(GTR) and Guided BoneRegeneration (GBR)• Filling of peri-implant defects inconjunction with products intendedfor Guided Bone Regeneration.
Material Source	Porcine Bone	Porcine Bone
MaterialComposition	Calcium phosphate	Calcium phosphate
Mineral Structure	Carbonate apatite	Carbonate apatite
Form	Granules	Granules
Color	White to off-white	White to off-white
PhysicalAppearance	Porous, irregular-shaped particles	Porous, irregular-shaped particles
Product Sizes	0.25 and 0.5 cc	0.25 cc, 0.5 cc, 1.0 cc, 2.0 cc, and 4.0 cc
Particle SizeRange	0.25 - 1 mm	0.25 – 1 mm and 1 - 2 mm
pH	$7.3 \pm 0.1$	$7.3 \pm 0.1$
Resorption Profile	Gradual resorption	Gradual resorption
Unit package	Pre-loaded into plastic deliveryapplicator	Plastic jar
Feature	Porcine Anorganic Bone MineralIn Delivery Applicator(this submission)	Porcine Anorganic Bone Mineral(K140714)
Sterility	Sterile, SAL 10-6Gamma irradiationISO 11137	Sterile, SAL 10-6Gamma irradiationISO 11137
Pyrogenicity	Non-pyrogenic	Non-pyrogenic
Single Use/ Reuse	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>
Biocompatibility of Anorganic Porcine Bone Mineral (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 Porcine Bone Mineral in an intraoral defect . in a canine model (previously submitted in the company's own predicate device premarket notification and applicable to the subject device).

Conclusion

The results of the in vitro product characterization studies, functionality testing, animal performance testing and biocompatibility studies show that the Porcine Anorganic Bone Mineral 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.