Mineral Collagen Composite Bioactive Moldable combined with either autogenous bone marrow or autograft with saline is indicated for bony voids or gaps, that are not intrinsic to the stability of the bony structure; Mineral Collagen Composite Bioactive Moldable can also be used with autograft as a bone graft extender.

The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

Device Description

Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process.

The anorganic bone mineral component of the bone graft matrix is a natural, porous bone graft material produced by removal of all organic components from bovine bone. The composition of the anorganic bone mineral meets ASTM F1581 standard specifications for composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meets ASTM F1538 standard specifications for glass and glass ceramics biomaterials for implantation. The purified type I collagen is derived from bovine deep flexor Achilles tendon.

The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called "Mineral Collagen Composite Bioactive Moldable." It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain the specific information required to answer your request regarding acceptance criteria and a study proving the device meets them.

Here's why and what's missing:

Acceptance Criteria and Reported Device Performance: This document states that in vivo and in vitro testing was conducted to demonstrate substantial equivalence, and "The results of the animal study demonstrate performance substantially equivalent to the predicate device Vitoss BA and performance substantially equivalent to autograft when used as an autograft extender." However, it does not explicitly list quantitative acceptance criteria for specific performance metrics (e.g., bone formation percentage, fusion rates, mechanical strength) or provide tables comparing the device's performance against these criteria. It only makes a general statement of "substantially equivalent."
Sample Size for Test Set and Data Provenance: The document mentions "posterolateral spine fusion rabbit model" for the in vivo study, but does not specify the sample size (number of rabbits or test articles) used in this test set. It also doesn't explicitly state the country of origin or whether the data was retrospective or prospective, though animal studies are typically prospective.
Number of Experts and Qualifications for Ground Truth: This information is not present in the document. Ground truth for animal studies often involves histological analysis by veterinary pathologists, but this detail is missing.
Adjudication Method: This information is not present in the document.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document does not mention an MRMC study. The study described is an animal in vivo study comparing the device to a predicate and autograft, not a human reader study.
Standalone (Algorithm Only) Performance: This device is a physical bone graft matrix, not an algorithm. Therefore, a "standalone algorithm performance" assessment is not applicable.
Type of Ground Truth Used: For the animal study, the ground truth would likely be based on histological analysis and potentially imaging (e.g., X-rays, micro-CT) assessed by experts (e.g., veterinary pathologists, radiologists). While not explicitly stated, this is standard for such studies.
Sample Size for Training Set: Since this is a physical device and not an AI/ML algorithm, there is no "training set" in the context of an algorithm's development. The "training" for the device would be its manufacturing process.
How Ground Truth for Training Set Was Established: As above, this concept is not applicable to a physical medical device.

In summary, while the document confirms that studies were conducted to support the device's substantial equivalence, it lacks the detailed breakdown of acceptance criteria, specific performance metrics, sample sizes, and expert involvement that your request specifies for AI/ML or diagnostic device evaluations. The information provided is typical for a 510(k) summary for a physical implantable device, focusing on material composition, biocompatibility, and in vivo performance relative to predicates.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.

March 21, 2019

Collagen Matrix, Inc. Gloria Zuclich Director, Regulatory Affairs 15 Thornton Road Oakland, New Jersey 07436

Re: K182074

Trade/Device Name: Mineral Collagen Composite Bioactive Moldable Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: February 18, 2019 Received: February 19, 2019

Dear Ms. Zuclich:

We have reviewed vour 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.

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

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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 (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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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,

Laurence D. Coyne -S

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K182074

Device Name

Mineral Collagen Composite Bioactive Moldable

Indications for Use (Describe)

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

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

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510(k) SUMMARY

1.	Applicant Information
	Applicant Name:	Collagen Matrix, Inc.
	Address:	15 Thornton RoadOakland, New Jersey 07436
	Telephone:	(201) 405-1477
	Fax:	(201) 405-1355
	Contact Person:	Gloria ZuclichDirector of Regulatory Affairsgzuclich@collagenmatrix.com
	Date Prepared:	March 19, 2019
2.	Name of the Device
	Device Trade Name:	Mineral Collagen Composite Bioactive Moldable
	Device Common Name(s):	Bone Void FillerBone Graft MatrixBone Graft Substitute
	Device Classification Name:	Filler, Bone Void, Calcium Compound888.3045MQVClass II
3.	Legally Marketed Devices to Which Substantial Equivalence is Claimed
	Primary Predicate Device:	Vitoss® Bioactive Foam Bone Graft SubstituteOrthovita, Inc.K083033
	Predicate Device:	MASTERGRAFT® Strip/PuttyMedtronic Sofamor Danek USA, Inc.K140375

4. Description of the Device

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anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meets ASTM F1538 standard specifications for glass and glass ceramics biomaterials for implantation. The purified type I collagen is derived from bovine deep flexor Achilles tendon.

The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.

5. Intended Use

6. Summary/Comparison of Technical Characteristics

Feature	Mineral CollagenComposite BioactiveBone Graft Matrix(This submission)	VITOSS Bioactive FoamBone Graft Substitute*K083033	MASTERGRAFT Strip/PuttyK140375
Indications forUse	Mineral Collagen CompositeBioactive Moldablecombined with eitherautogenous bone marrow orautograft with saline isindicated for bony voids orgaps, that are not intrinsic tothe stability of the bonystructure; Mineral CollagenComposite BioactiveMoldable can also be usedwith autograft as a bonegraft extender.The device is to be gentlypacked into bony voids orgaps of the skeletal system(i.e., posterolateral spine).These defects may besurgically created osseousdefects or osseous defectscreated from traumatic injuryto the bone. The deviceresorbs and is replaced withbone during the healingprocess.	Vitoss Bioactive Foam BoneGraft Substitute is intended foruse as a bone void filler forvoids or gaps that are notintrinsic to the stability of thebony structure. VitossBioactive Foam is indicated foruse in the treatment ofsurgically created osseousdefects or osseous defectscreated from traumatic injury tothe bone.Vitoss Bioactive Foam BoneGraft Substitute is intended tobe used for filling bony voids orgaps of the skeletal system(i.e. the extremities, pelvis, andspine, which includesposterolateral fusionprocedures), and may becombined with saline,autogenous blood, and/orbone marrow. Followingplacement in the bony void orgap, the scaffold resorbs andis replaced with bone duringthe healing process.	MASTERGRAFT® Puttycombined with eitherautogenous bone marrow,and/or sterile water, and/orautograft is indicated as abone void filler for bony voidsor gaps that are not intrinsic tothe stability of the bonystructure. Additionally,MASTERGRAFT® Putty canbe used with autograft as abone graft extender.MASTERGRAFT® Putty is tobe gently packed into bonyvoids or gaps of the skeletalsystem (e.g., the posterolateralspine, pelvis, ilium, and/orextremities). These defectsmay be surgically createdosseous defects or osseousdefects created from traumaticinjury to the bone.MASTERGRAFT® Puttyresorbs and is replaced withbone during the healingprocess.
Physical Form	Strip or Cylindrical matrix(moldable upon hydration)	Foam Pack (moldable uponhydration)	Strip or Putty Matrix(Putty is moldable upon)

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		Foam Strip	hydration)
Color	White to off-white	White to off-white	White to off-white
MaterialComposition	• Calcium phosphate(anorganic bone mineral)• Bioactive glass• Type I bovine collagen	• β-Tricalcium phosphate• Bioactive glass• Type I bovine collagen	• β-Tricalcium phosphate andHydroxyapatite• Type I bovine collagen
Product Sizes	2.5 cc – 40 cc	1 cc – 10 cc	0.75 cc – 43 cc
Biocompatibility	BiocompatibleISO 10993	BiocompatibleISO 10993	BiocompatibleISO 10993
Sterility	Sterile, SAL 10-6Gamma irradiationISO 11137	Sterile, SAL 10-6Gamma irradiation	Sterile, SAL 10-6Gamma irradiation
Pyrogenicity	Non-pyrogenic	Non-pyrogenic	Non-pyrogenic
Single Use/Reuse	Single use only	Single use only	Single use only

Nonclinical Tests Submitted

In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device to its predicate devices. The performance of the device in posterolateral spine fusion rabbit model was compared to the performance of the predicate device, Vitoss BA and to the performance of the Autograft control. The results of the animal study demonstrate performance substantially equivalent to the predicate device Vitoss BA and performance substantially equivalent to autograft when used as an autograft extender.

The materials are safe and biocompatible as demonstrated through ISO 10993 Biological Evaluation of medical Devices. The device is considered bioactive based on in vitro testing, that show apatite laver formation on the surface of the bioactive glass particles following immersion in simulated body fluid (SBF). In vitro characterization studies included evaluation of physical properties such as density, mineral content, absorbency and an evaluation of physicochemical properties such as pH. The characterization test results of the subject device were equivalent to those of the predicate devices. Viral inactivation studies were performed to ensure the viral safety of the product.

Material-mediated pyrogenicity testing was performed on the finished device in accordance with USP<151>. Bacterial endotoxin testing performed using the limulus amebocyte lysate (LAL) method showed that the device meets the endotoxin limits in accordance with ANSI/AAMI ST72:2011.

Conclusions Drawn from Non-clinical Studies

The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to its predicate devices.

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.