OsSatura™ BCP (Biphasic Calcium Phosphate) is bone void filler intended only for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. OsSatura™ BCP is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Device Description

OsSatura™ BCP is a synthetic, osteoconductive bone void filler, which consists of a biphasic ceramic (e.g., hydroxyapatite/tri-calcium phosphate) scaffold. The interconnected and open porous structure of OsSatura™ BCP is similar in structure to human cancellous bone. OsSatura™ BCP is available as irregular-shaped chips of different sizes.

AI/ML Overview

The provided document, K030131 for OsSatura™ BCP Bone Void Filler, describes a pre-market notification (510(k)) submission to the FDA. The information focuses on showing substantial equivalence to previously approved predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for the device itself in the way that would typically be done for a novel AI/software device.

Therefore, many of the requested elements for describing acceptance criteria and a study proving those criteria are not applicable to this type of document and device. This 510(k) submission relies on:

Similarity of design, materials, and function to already-approved predicate devices.
Existing safety and biocompatibility data for calcium phosphates.
General pre-clinical animal data demonstrating bone ingrowth and resorption, without specific quantitative acceptance criteria reported in this summary.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility:	Confirmed by testing (details not provided in summary); calcium-based ceramics have 25+ years of safe clinical use.
Resorbability:	Confirmed by testing (details not provided in summary); degraded and resorbed over time.
Bone Ingrowth:	Confirmed by pre-clinical animal data; supports bone ingrowth into a variety of bony defects.
ASTM F1185-88 (HA):	Meets requirements.
ASTM F1088-87 (TCP):	Meets requirements.
FDA Guidance Documents for Bone Void Fillers (Applicable Requirements):	Meets requirements.
Sterility:	Provided sterile.
Non-pyrogenicity:	Provided non-pyrogenic.

Note: The document does not provide specific numerical targets or quantitative acceptance criteria (e.g., "resorption must be X% by Y weeks," or "bone ingrowth must be Z% of void volume"). Instead, it states that the device "meets requirements" or "confirmed by testing."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document mentions "pre-clinical animal data" and "extensive bench and animal testing" but does not detail the number of animals or specific test samples used.
Data Provenance: Pre-clinical animal data and bench testing. Country of origin not specified, but likely within the Netherlands (sponsor's location) or a collaborating institution. Data is prospective in the context of these specific tests for the OsSatura™ BCP device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not Applicable. The ground truth for this type of device, which is a physical bone void filler, is typically established by laboratory measurements (e.g., chemical composition analysis, porosity measurement, degradation rates) and histological evaluation in animal models (e.g., presence and quality of bone ingrowth, evidence of resorption) performed by qualified scientists and veterinary pathologists. There is no mention of "experts" establishing a "ground truth" for a "test set" in the context of human interpretation, which would be relevant for AI/imaging devices.

4. Adjudication Method for the Test Set

Not Applicable. As there are no human experts "reading" or classifying outcomes in a way that requires adjudication for a physical device like a bone void filler, this is not relevant.

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 device is a physical bone void filler, not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant.

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

Not Applicable. This device is a physical bone void filler, not an algorithm.

7. The Type of Ground Truth Used

Laboratory measurements and histological/imaging analysis in animal models. This includes:
- Chemical composition analysis: To confirm HA/TCP ratios and purity.
- Physical properties testing: Porosity, pore size, mechanical strength.
- Biocompatibility assays: In vitro and in vivo.
- Histological examination of animal tissue: After implantation, to assess bone ingrowth, integration, and material resorption.

8. The Sample Size for the Training Set

Not Applicable. As this is a physical medical device, there is no "training set" in the computational or AI sense. The development of the device would involve iterative design and testing, but not a formally defined "training set" for an algorithm.

9. How the Ground Truth for the Training Set was Established

Not Applicable. See point 8.

Summary

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

K030131

510(k) Summary for IsoTis NV OsSatura™ BCP Bone Void Filler

1. SPONSOR

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: April 4, 2003

2. DEVICE NAME

Proprietary Name:	OsSatura TM BCP
Common/Usual Name:	Bone void filler
Classification Name:	Bone void filler (Unclassified)

3. PREDICATE DEVICES

Vitoss™ scaffold Synthetic Cancellous Bone void filler(K994337) Pro Osteon® 500(R) Resorbable Bone void filler (K980817)

DEVICE DESCRIPTION 4.

{1}------------------------------------------------

5. INTENDED USE

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The OsSatura™ BCP and the predicate devices are all similar in design, materials of construction, and function. The OsSatura™ BCP product and the predicate devices are all made of calcium salts. The proposed and predicate devices are osteoconductive. The OsSatura™ BCP 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 are all resorbable and 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 tricalcium phosphate products support the safe use of OsSatura™ BCP. The hydroxyapatite and tri-calcium phosphate in the OsSatura™ BCP meet the requirements in ASTM F1185-88 and F1088-87. Additionally, testing performed on the proposed device confirmed that OsSatura™ BCP meets the applicable requirements of the FDA guidance documents on bone void fillers.

7. TESTING

Pre-clinical animal data demonstrate that OsSatura™ BCP chips support bone ingrowth into a variety of bony defects. Biocompatibility, extensive bench and animal testing using OsSatura™ BCP have been successfully performed to confirm that the device is degraded and resorbed over time and allows 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 remarkable safety issues. The devices to which OsSatura™ BCP claims substantial equivalence, Pro Osteon 500(R) and Vitoss scaffold, have been used safely for many years in the clinical environment.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.

MAY 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IsoTis NV c/o Ms. Mary McNamara-Cullinane, RAC Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K030131

Trade/Device Name: OsSatura™ BCP (Bi-Calcium Phosphate) Bone Void Filler Regulatory Class: Unclassified Product Code: MQV Dated: April 9, 2003 Received: April 10, 2003

Dear Ms. McNamara-Cullinane:

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.

{3}------------------------------------------------

Page 2 - Ms. Mary McNamara-Cullinane, 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 (301) 594-4660. 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,

Mark A Milliken

Celia M. Witten, Ph.D., M.D Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known): K030131

Device Name: OsSatura™ BCP Bone Void Filler

Indications for Use:

OsSatura™ BCP (Biphasic Calcium Phosphate) is bone void filler intended only for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. OsSatura™ BCP is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced by bone during the healing process.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mash A. Milken

Division of General, Restorative and Neurological Devices

510(k) Number K030131

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use OR

(Per 21 CFR 801.109)

OsSatura™ BCP Bone Void Filler Additional Information - K030131 April 4, 2003 Appendix C . Page 1 of 1

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.