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

SynOss™ Synthetic Bone Graft Material is an osteoconductive calcium phosphate based bone graft material with an apatite structure similar to that of human bone. The product is supplied in granular form, and it is sterile, non-pyrogenic, and for single use only.

AI/ML Overview

The provided document is a 510(k) summary for the SynOss™ Synthetic Bone Graft Material. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that measures against specific acceptance criteria for performance.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth for training set) are not applicable or not available within this type of regulatory submission. The submission primarily addresses safety and effectiveness through characterization studies and biocompatibility testing, asserting equivalence to a previously approved device.

Here's the information that can be extracted or deduced from the provided text:

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

Acceptance Criteria	Reported Device Performance
Safety: Device meets biocompatibility standards as per FDA Blue Book Memorandum G95-1 and ISO 10993-1.	The device passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices.
Effectiveness: Device characteristics meet design requirements for an effective bone grafting material.	"The characteristics of the SynOss Synthetic Bone Graft Material meet the design requirements for an effective bone grafting material." (This is a general statement, not specific quantitative criteria).
Substantial Equivalence: SynOss™ Synthetic Bone Graft Material is substantially equivalent to OsteoGuide™ Anorganic Bone Mineral Products (K043034) in terms of intended use, material structure, material characterization, form, and sizes.	"The SynOss Synthetic Bone Graft Material and its predicate have the same technological characteristics. In particular, both SynOss and its predicate are the same with respect to intended use, material structure, material characterization, form, and sizes."

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

Sample Size: Not specified. The document refers to "a number of tests" for safety/biocompatibility and "in vitro product characterization studies." It does not mention a "test set" in the context of clinical performance or diagnostic accuracy.
Data Provenance: Not specified. The studies mentioned are general "in vitro and in vivo biocompatibility studies" and "in vitro product characterization studies."

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 submission does not involve expert-established ground truth for a test set of clinical images or outcomes.

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

Not Applicable. No clinical test set requiring adjudication is described.

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. This is not an AI/software device. The submission describes a synthetic bone graft material.

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

No. This is not an AI/software device.

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

For safety (biocompatibility): Ground truth was established by adherence to recognized standards (FDA Blue Book Memorandum G95-1 and ISO 10993-1) through specific biological tests (e.g., cytotoxicity, sensitization, irritation).
For effectiveness/equivalence: Ground truth was established by comparing material characteristics (structure, physical properties, chemical composition) of the SynOss product to those of the predicate device (OsteoGuide™ Anorganic Bone Mineral Products).

8. The sample size for the training set

Not Applicable. This is not an AI/software device with a training set.

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

Not Applicable. This is not an AI/software device with a training set.

Summary

{0}------------------------------------------------

K07-2397

2007

510(k) Summary of Safety and Effectiveness

Applicant Name and Address:	Collagen Matrix, Inc.509 Commerce StreetFranklin Lakes, New Jersey 07417	OCT 1 8
Contact Person:	Peggy Hansen, RACSr. Director, Clinical, Regulatory, and QATel: (201) 405-1477Fax: (201) 405-1355
Date of Summary:	August 24, 2007
Device Common Name:	Bone Grafting Material
Device Trade Name:	SynOss™ Synthetic Bone Graft Material
Device Classification Name:	Bone Grafting Material, Synthetic872.3930LYCClass II
Predicate Device(s):	OsteoGuide™ Anorganic Bone Mineral ProductsK043034

Description of the Device

Intended Use

SynOss Synthetic Bone Graft Material 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 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

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Collagen Matrix, Inc. 510(k) Summary of Safety and Effectiveness SynOss™ Synthetic Bone Graft Material

Summary/Comparison of Technical Characteristics

SynOss Synthetic Bone Graft Material and its predicate have the same technological characteristics. In particular, the both SynOss and its predicate are the same with respect to intended use, material structure, material characterization, form, and sizes.

Safety

SynOss Synthetic Bone Graft Material 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 SynOss Synthetic Bone Graft Material 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 SynOss Synthetic Bone Graft Material is safe and substantially equivalent to OsteoGuide Anorganic Bone Mineral Granules.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, along with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2007

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

Re: K072397

Trade/Device Name: SynOss™ Synthetic Bone Graft Material Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: August 24, 2007 Received: August 27, 2007

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,

Sautie y. Michino mD.

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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Indications for Use

Device Name: SynOss™ Synthetic Bone Graft Material

Indications for Use:

SynOss Synthetic Bone Graft Material 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 periodontal defects .
Filling of defects after root resection, apicocectorny, and cystectorny ●
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)

Suss Juara

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"sion of Anesthesiology, General Hospital, Imaginon Control, Dental Devices

ber: K67R317

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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.