Augmentation or reconstructive treatment of alveolar ridge .
. Filling of periodontal defects
Filling of defects after root resection, apicocectomy, 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

Device Description

"OsteoGuide™ Anorganic Bone Mineral," "OsteoGuide Collagen™ Anorganic Bone Mineral with Collagen,"and "OsteoGuide Blocks™ Anorganic Bone Mineral with Collagen Blocks" are natural, porous bone mineral matrices with and without collagen. The anorganic bone mineral is produced by removal of all organic components from bovine bone. Due to its natural structure, the anorganic bone mineral component of the OsteoGuide products is physically and chemically comparable to the mineralized matrix of human bone. The composition of OsteoGuide Anorganic Bone Mineral meets the requirements of ASTM F1581-99 Standard Specification for Composition of Anorganic bone for Surgical Implants. OsteoGuide Collagen and OsteoGuide Blocks are product extensions that include highly purified fibrillar type I collagen mixed in with the anorganic bone mineral. The product is supplied in granules or blocks, and it is sterile, non-pyrogenic, and for single use only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, OsteoGuide™ Anorganic Bone Mineral Products. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to prove efficacy against acceptance criteria. Therefore, the information typically requested for devices requiring a standalone or comparative effectiveness study (like AI-based devices) is not present in this document.

Here's a breakdown of why and what information is available:

No Acceptance Criteria or Device Performance Table: The document explicitly states that the device's effectiveness is demonstrated by meeting "design requirements for an effective bone grafting material" and by the "substantial equivalence" to predicate devices. There are no specific quantitative acceptance criteria or reported device performance metrics in the way one would find for an AI algorithm (e.g., sensitivity, specificity, AUC).
No Study Details for Efficacy: Because this is a substantial equivalence submission, there isn't a "study" in the traditional sense to prove the device meets acceptance criteria. Instead, the "effectiveness" section states: "The characteristics of the OsteoGuide Anorganic Bone Mineral Products meet the design requirements for an effective bone grafting material." The primary evidence for effectiveness is the comparison to predicates and the material characterization.

Let's address the specific points you asked for, explaining why they are mostly not applicable or how they are addressed within the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by 510(k) Substantial Equivalence to Predicate)	Reported Device Performance (Implied by 510(k) Substantial Equivalence and Material Characterization)
Safety: Device passes all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for biological evaluation of medical devices.	Device passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for biological evaluation of medical devices.
Effectiveness: Characteristics meet design requirements for an effective bone grafting material and are "substantially equivalent" to predicate devices in intended use, material, material characterization, form, and sizes.	OsteoGuide Anorganic Bone Mineral is "physically and chemically comparable to the mineralized matrix of human bone." Composition "meets the requirements of ASTM F1581-99 Standard Specification for Composition of Anorganic bone for Surgical Implants." Characteristics are the same as predicates in intended use, material, material characterization, form, and sizes.
Biocompatibility: Demonstrated through in vitro and in vivo studies.	In vitro and in vivo biocompatibility studies demonstrated safety.
Sterility & Non-pyrogenicity: Device is sterile and non-pyrogenic.	Product is supplied as sterile and non-pyrogenic.

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

Not Applicable. This device is a biomaterial, not an AI algorithm. Its "performance" is assessed through material characterization and biocompatibility testing, not through a "test set" of patient data or images. The document mentions "in vitro product characterization studies, in vitro and in vivo biocompatibility studies," but does not provide sample sizes for these, as they are typically standardized tests rather than clinical trials with patient cohorts.

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. See point 2. Ground truth in the context of an AI device is typically expert consensus on medical images or diagnoses. For a bone grafting material, the "ground truth" relates to its material properties and biological response, which are assessed through laboratory tests and histological evaluations, not expert clinical reviews of a "test set."

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

Not Applicable. See point 2 and 3.

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 a biomaterial, not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant.

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

Not Applicable. This is a biomaterial, not an AI algorithm.

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

For the safety/biocompatibility evaluation, the "ground truth" would be established by the results of standardized biological tests as specified in FDA Blue Book Memorandum G95-1 and ISO 10993-1. These tests assess parameters such as cytotoxicity, sensitization, irritation, acute systemic toxicity, and implantation effects, which are objectively measured and interpreted against established criteria for biological safety.
For the effectiveness/material characteristics, the "ground truth" is defined by the chemical and physical comparability to human bone and conformance to industry standards like ASTM F1581-99. This involves analytical chemistry techniques (e.g., elemental analysis, spectroscopy) and microscopic evaluation to ensure the material properties match the requirements and the predicate devices.

8. The sample size for the training set

Not Applicable. This is a biomaterial. There is no concept of a "training set" as there would be for an AI algorithm.

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

Not Applicable. See point 8.

Summary

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AUG 4 2005
K043034

510(k) Summary of Safety and Effectiveness

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:	February 17, 2005
Device Common Name:	Bone Grafting Material
Device Trade Name:	OsteoGuide™ Anorganic Bone MineralOsteoGuide Collagen™ Anorganic Bone Mineral withCollagenOsteoGuide Blocks™ Anorganic Bone Mineral withCollagen Blocks
Device Classification Name:	Bone Grafting MaterialUnclassifiedNPM
Predicate Device(s):	Bio-Oss®, Bio-Oss® Blocks, Bio-Oss® Collagen, K033815Bio-Oss® Granules, K952617Bio-Oss® Blocks, K970569Bio-Oss® Collagen, K974399

Description of the Device

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Intended Use

OsteoGuide Anorganic Bone Mineral Products are 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 periodontal defects
Filling of defects after root resection, apicocectomy, 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

OsteoGuide Anorganic Bone Mineral Products and their predicates have the same technological characteristics. In particular, the OsteoGuide Anorganic Bone Mineral Products and their predicates are the same with respect to intended use, material, material characterization, form, and sizes.

Safety

OsteoGuide Anorganic Bone Mineral Products have 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 OsteoGuide Anorganic Bone Mineral Products meet the design requirements for an effective bone grafting material.

Conclusion

The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, show that the OsteoGuide Anorganic Bone Mineral Products are safe and substantially equivalent to Bio-Oss Granules, Bio-Oss Collagen, and Bio-Oss Blocks.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 4 - 2005

Ms. Peggy Hansen Director, RAC Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K043034

Trade/Device Name: Osteoguide Anorganic Bone Mineral Products Regulation Number: 21 CFR 872.3930 Regulation Name: Tricalcium phosphate granules for dental bone repair Regulatory Class: II Product Code: NPM Dated: July 21, 2005 Received: July 22, 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.

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Page 2 - Ms. Hansen

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. 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) 276-0115. 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,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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<043034

Indications for Use

510(k) Number (if known):
Device Name:	OsteoGuide™ Anorganic Bone Mineral
	OsteoGuide Collagen™ Anorganic Bone Mineral with Collagen
	OsteoGuide Blocks™ Anorganic Bone Mineral with Collagen - Blocks

Indications for Use:

Natural Mineral Bone Graft Substitutes are 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 periodontal defects
Filling of defects after root resection, apicocectomy, 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

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)

Siva Russo

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K043034

Page 1 of 1

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.