OssiMend, combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone.

Device Description

OssiMend™ Bone Graft Material (OssiMend) is a collagen mineral composite matrix processed into strips, pads, or granular form for surgical implantation. The principle components of OssiMend are bovine type I collagen and anorganic bovine bone mieral. The mineral particles are dispersed within collagen fibers forming a three-dimensional open porous matrix consisting of 55% bone mineral and 45% collagen. OssiMend is provided as a sterile, dry material that is hydrated with autogenous bone marrow at the point of use. OssiMend strips and pads can be cut into shapes and are designed to retain their shape and physical integrity following implantation into a bony site, while the granular form can be molded to fit the bone defect. OssiMend is fully resorbed during the natural process of bone formation and remodeling.

AI/ML Overview

This a 510(k) premarket notification for a medical device called OssiMend™ Bone Graft Material. Generally, 510(k)s do not contain detailed study reports as a PMA (Pre-Market Approval) submission would. Instead, they demonstrate substantial equivalence to a predicate device.

Based on the provided text, here's a breakdown of the acceptance criteria and the study information available:

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

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics for OssiMend in the way one might expect for a diagnostic or imaging device. Instead, the "Effectiveness" section states:

Criterion Type	Acceptance Criteria (Implied)	Reported Device Performance
Effectiveness	Meet design requirements for an effective bone grafting material	Confirmed effectiveness for use as a bone void filler
Safety/Biocompatibility	Pass specified biological evaluation tests	Passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing

The "Conclusion" summarizes that the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, and an animal study show that OssiMend Bone Graft Material is safe and substantially equivalent to its predicates. This implies the acceptance criteria were met by demonstrating substantial equivalence in these aspects.

2. Sample sized used for the test set and the data provenance

The document mentions "an animal study" but does not provide details on the sample size for this study or the specific animals used.

Data provenance: The study was an "animal study," indicating non-human data. There is no information regarding the country of origin. The study was likely prospective, as it was conducted to evaluate the device's effectiveness.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. As an animal study for a bone graft material, the "ground truth" would likely be based on histological analysis or imaging assessments by veterinarians or pathologists, rather than expert human interpretation of medical images.

4. Adjudication method for the test set

This information is not provided. Given it's an animal study assessing bone regeneration, it's unlikely to involve adjudication in the typical sense of a human reader study. Assessment would more likely be by objective measures and pathologist reports.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation of images, not for a bone graft material. The device itself is a material for implantation, not an AI or imaging diagnostic tool.

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

This question is not applicable as the device is a bone graft material, not a diagnostic algorithm.

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

For the animal study, the ground truth for effectiveness would likely be based on histopathology, imaging (e.g., radiography, CT scans) to assess bone formation, and possibly biomechanical testing of the regenerated bone. The document states "an animal study confirmed the effectiveness of the product," which implies objective biological measures of bone healing.

8. The sample size for the training set

This information is not applicable. This is a biological material, not an AI algorithm that requires a training set. The "design requirements" and "material characterization" would be based on scientific principles and in vitro testing, not machine learning training.

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

This information is not applicable for the reasons stated in point 8.

Summary

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510(k) Summary of Safety and Effectiveness

JAN 2 5 2006

Applicant Name and Address:	Collagen Matrix, Inc.509 Commerce StreetFranklin Lakes, New Jersey 07417
Contact Person:	Peggy Hansen, RACDirector, Clinical, Regulatory, and Quality AssuranceTel: (201) 405-1477Fax: (201) 405-1355
Date of Summary:	December 21, 2005
Device Common Name:	Bone Grafting MaterialBone Void Filler
Device Trade Name:	OssiMend™ Bone Graft Material
Device Classification Name:Regulation Number:Device Class:Product Code:	Filler, Bone Void, Calcium Compound888.3045Class IIMQV
Predicate Device(s):	HEALOS® Bone Graft Material, K012751CopiOs™ Bone Void Filler, K033679Collagraft Strip Bone Graft Matrix, K000122Vitoss® Scaffold Foam Bone Graft Material, K032288ORTHOSS™ Resorbable Bone Void Filler, K014289OsteoGuide® Anorganic Bone Mineral Products, K043034

Description of the Device

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Intended Use

Summary/Comparison of Technical Characteristics

OssiMend and its predicates have the same technological characteristics. In particular, OssiMend and their predicates are the same with respect to intended use, design, materials, material characterization, form, and sizes.

Safety

OssiMend has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all selected FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.

Effectiveness

The characteristics of the OssiMend meet the design requirements for an effective bone grafting material, and an animal study confirmed the effectiveness of the product for use as a bone void filler.

Conclusion

The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, and an animal study show that OssiMend Bone Graft Material is safe and substantially equivalent to its predicates.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

JAN 2 5 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Peggy Hansen, RAC Director, Clinical, Regulatory, and Quality Assurance Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K052812/S1

Trade/Device Name: OssiMend™ Bone Graft Material Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MOV Dated: December 22, 2005 Received: December 23, 2005

Dear Ms. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Ms. Peggy Hansen, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ KO52812___________________________________________________________________________________________________________________________________________

Device Name: _ OssiMend TM Bone Graft Material

Indications for Use:

OssiMend, combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, spine, and pelvis) that arr not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the hone.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number K052812

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.