OsSatura™ Dental is a bone filling augmentation material for used for augmentation or reconstructive treatment of alveolar ridge. This includes, 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 and treatment of periodontal defects.

Device Description

OsSatura™ Dental is a synthetic, osteoconductive bone void filler, which consists of a biphasic ceramic (e.g. hydroxyapatite/tri-calcium phosphate) scaffold. The open porous structure of OsSatura™ Dental is similar in structure to human cancellous bone. OsSatura™ Dental is available as irregular shaped chips of size 200μm -2000um.

AI/ML Overview

This document, a 510(k) Summary for IsoTis NV OsSatura™ Dental, relies on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving those criteria are met for the device itself.

Therefore, many of the requested categories (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, training set details) are not applicable (N/A) in the context of this 510(k) submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Material Composition and Structure: Composed of calcium salts, specifically a biphasic ceramic (hydroxyapatite/tri-calcium phosphate) scaffold with an open porous structure similar to human cancellous bone.	OsSatura™ Dental is a synthetic, osteoconductive bone void filler, which consists of a biphasic ceramic (e.g. hydroxyapatite/tri-calcium phosphate) scaffold. The open porous structure of OsSatura™ Dental is similar in structure to human cancellous bone. The OsSatura™ Dental product and the predicate devices are all made of calcium salts. The hydroxyapatite and tricalcium phosphate in the OsSatura™ Dental meet the requirements in ASTM F1185-88 and F1088-87.
Functionality: Osteoconductive, provides an interconnected, porous scaffold and an environment for new bone ingrowth, degraded and resorbed over time.	The proposed and predicate devices are all osteoconductive. The OsSatura™ Dental product and all the predicate devices provide an interconnected, porous scaffold and an environment for new bone ingrowth. Biocompatibility, extensive bench and animal testing using OsSatura Dental have successfully been performed to confirm that the device is degraded and resorbed over time and allow bone ingrowth.
Sterility and Non-pyrogenicity: Provided sterile and non-pyrogenic for single patient use.	All of the devices are provided sterile and non-pyrogenic for single patient use.
Indications for Use: Bone filling augmentation for reconstructive treatment of alveolar ridge, including filling defects after root resection, apicoectomy, cystectomy; filling extraction sockets to enhance preservation of alveolar ridge; elevation of maxillary sinus floor; and treatment of periodontal defects.	OsSatura™ Dental claims the exact same indications for use as listed.
Safety and Biocompatibility: Safe for clinical use, no remarkable safety issues, and biocompatible.	The safety and biocompatibility testing performed for calcium phosphates and the long history of safe clinical use for hydroxyapatite and tri-calcium phosphate products support the safe use of OsSatura™ Dental. Pre-clinical animal data demonstrate that OsSatura™ Dental chips support bone ingrowth into a variety of bony defects. Biocompatibility, extensive bench and animal testing using OsSatura Dental have successfully been performed. Calcium-based ceramic materials, including hydroxyapatite and tri-calcium phosphate, have been used in clinical practice for more than 25 years with no remarkable safety issues. The predicate devices have been used safely for many years in the clinical environment.
Regulatory Compliance: Meets applicable requirements of FDA guidance documents on bone void fillers.	Testing performed on the proposed device confirmed that OsSatura™ Dental meets the applicable requirements of the FDA guidance documents on bone void fillers.

2. Sample size used for the test set and the data provenance:

N/A. This submission is a 510(k) for substantial equivalence. It refers to "pre-clinical animal data" and "extensive bench and animal testing" but does not specify sample sizes for these tests in a way that aligns with a traditional "test set" for performance evaluation in the context of AI/software. The primary "data provenance" is the long history of safe clinical use of the material class and the predicate devices.

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

N/A. Ground truth in the context of expert consensus is not relevant to this submission. The "ground truth" for the safety and effectiveness claims is derived from the established safety profile of the material class (calcium phosphates) and the safe use of predicate devices, as well as general biological principles verified in animal models.

4. Adjudication method for the test set:

N/A. No formal adjudication method is mentioned as this is not a study requiring expert consensus on specific cases.

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:

N/A. This device is a bone graft material, not an AI or diagnostic imaging device. Therefore, MRMC studies and "human readers" are irrelevant.

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

N/A. This is a physical medical device (bone graft material), not an algorithm or software. "Standalone performance" in this context refers to the device's inherent material properties and biological performance, which were assessed through bench and animal testing.

7. The type of ground truth used:

The "ground truth" for this submission is based on:
- Established Material Standards: Compliance with ASTM F1185-88 and F1088-87 for hydroxyapatite and tricalcium phosphate.
- Biological/Physiological Response: Demonstrated bone ingrowth, degradation, and resorption through pre-clinical animal data and extensive bench and animal testing.
- Historical Clinical Data: Over 25 years of safe clinical use for calcium-based ceramic materials (hydroxyapatite and tri-calcium phosphate) and safe use of predicate devices.
- Regulatory Guidance: Compliance with applicable FDA guidance documents on bone void fillers.

8. The sample size for the training set:

N/A. This is not an AI/machine learning device. The concept of a "training set" is not applicable.

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

N/A. As above, this is not an AI/machine learning device.

Summary

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Image /page/0/Picture/1 description: The image shows a handwritten number, "K042706", in black ink on a white background. The numbers are written in a slightly slanted, cursive style. The number is oriented diagonally across the image, starting from the upper left corner and extending towards the lower right corner.

510(k) Summary for IsoTis NV OsSatura™ Dental

SPONSOR

IsoTis OrthoBiologics Inc 2 Goodyear, Suite B Irvine, CA 92618 U.S.A

IsoTis NV Prof. Bronkhorstlaan 10 3723 MB Bilthoven The Netherlands

Contact Person: E. Schutte
Telephone:	+31-(0) 30-2295125
Facsimile:	+31-(0) 30-2280255

Date Prepared: September 10, 2004

2. DEVICE NAME

Proprietary Name: OsSatura™ Dental Common/Usual Name: Synthetic bone graft material Classification Name: Bone filling augmentation (Unclassified)

PREDICATE DEVICES 3.

Interpore 200 porous hydroxyapatite® (K 860983)

BioOss Collagen (K974399)

4. DEVICE DESCRIPTION

OsSatura™ Dental is a synthetic, osteoconductive bone void filler, which consists of a biphasic ceramic (e.g. hydroxyapatite/tri-calcium phosphate) scaffold. The open

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porous structure of OsSatura™ Dental is similar in structure to human cancellous bone. OsSatura™ Dental is available as irregular shaped chips of size 200μm -2000um.

INTENDED USE ડ.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The OsSatura Dental and the predicate devices are all similar in design, materials of construction and function. The OsSatura™ Dental product and the predicate devices The proposed and predicate devices are are all made of calcium salts. osteoconductive. The OsSatura™ Dental product and all the predicate devices provide an interconnected, porous scaffold and an environment for new bone ingrowth. All of the devices are provided sterile and non-pyrogenic for single patient use. The only difference between the proposed device and the predicate devices is that they are composed of different forms of calcium phosphate salts. These minor differences do not affect safety or effectiveness since they all carry out the same function. The safety and biocompatibility testing performed for calcium phosphates and the long history of safe clinical use for hydroxyapatite and tri-calcium phosphate products support the safe use of OsSatura™ Dental. The hydroxyapatite and tricalcium phosphate in the OsSatura™ Dental meet the requirements in ASTM F1185-88 and F1088-87. Additionally, testing performed on the proposed device confirmed that OsSatura™ Dental meets the applicable requirements of the FDA guidance documents on bone void fillers.

7. TESTING

Pre-clinical animal data demonstrate that OsSatura™ Dental chips support bone ingrowth into a variety of bony defects. Biocompatibility, extensive bench and animal testing using OsSatura Dental have successfully been performed to confirm that the device is degraded and resorbed over time and allow bone ingrowth.

Calcium-based ceramic materials, including hydroxyapatite and tri-calcium phosphate, have been used in clinical practice for more than 25 years with no

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remarkable safety issues. The devices to which OsSatura™ Dental claims substantial equivalence Interpore 200 porous hydroxyapatite and Bio-Oss Collagen have been used safely for many years in the clinical environment.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird with three curved lines representing its wings. The image is in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2004

Mr. Paul Doner Regulatory Affairs Manager IsoTis OrthoBiologics, Incorporated 2 Goodyear, Suite B Irvine, California 92618 U.S.A

Re: K042706

Trade/Device Name: OsSatura™ Dental Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LYC Dated: September 23, 2004 Received: September 30, 2004

Dear Mr. Doner:

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 - Mr. Doner

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/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph. 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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Image /page/5/Picture/0 description: The image shows the word "ISOTIS" in bold, black letters. Below the word "ISOTIS" is the word "OrthoBiologics" in a smaller font size. The letters are all capitalized except for the "i" in "Biologics."

510(k) Number (if known):

Device Name: OsSatura™ Dental

Indications for Use:

OsSatura™ Dental is a bone filling material indicated for augmentation or reconstructive treatment of the alveolar ridge. This includes:

Filling of defects after root resection, apicoectomy and cystectorny -
Filling of extraction sockets to enhance preservation of the alveolar ridge -
Elevation of maxillary sinus floor -
Treatment of periodontal defects -

AND/OR Prescription Use: X (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Swa Rinnr

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

510(k) Number: K042706

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.