CERAMENT™|BONE VOID FILLER is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. CERAMENT™|BONE VOID FILLER is indicated to be injected into bony voids or gans in the skeletal system, i.e. extremities, pelvis and spine (only during open surgery in spine). These defect smav he surgically created osseous defects or osseous defects from traumatic injury to the bone.

CERAMENT™ (BONE VOID FILLER provides a bone void filler that resorbs and is replaced by bone during the healing process.

Device Description

CERAMENT™|BONE VOID FILLER is an injectable ceramic bone substitute material intended for bone voids/gaps. The material consists of a powder and a liquid component. The major constituents of the powder are calcium sulfate and hydroxyapatite. The liquid component contains iohexol as a radio-opacity enhancer. Mixing the components, with the combined mixing injection device, results in a viscous material suitable for injection into a bone void/gap. During resorption of the calcium sulfate dihydrate, the hydroxyapatite remains intact providing osteoconductive support for in-growth of new bone. The ceramic bone substitute material is injected into the bone void/gap, under visual inspection or under radiographic monitoring, with the use of the accompanying injection devices.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (CERAMENT™ BONE VOID FILLER) and includes information about its intended use, description, and regulatory classification. However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or any details about performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

The document primarily focuses on regulatory approval based on demonstrating "substantial equivalence" to a predicate device (K073316) and refers to general pre-clinical testing without providing details of the tests, their results, or how they relate to specific acceptance criteria.

Therefore, I cannot fulfill most of your request from the provided text. I can only provide the information that is explicitly stated in the document.

Here's what can be extracted based on the document's content:

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

Not available in the provided text. The document states: "Extensive in vitro and in vivo testing has shown that the CERAMENT™|BONE VOID FILLER (A0210 –12 ) meets the requirements of all relevant standards for Calcium Salt Bone Voilt VOID Fillers." However, it does not specify what those "requirements" (acceptance criteria) are, nor does it provide a table of performance results against them.

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

Not available in the provided text.

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 available in the provided text. This type of information is typically relevant for AI/ML device studies, which is not what this 510(k) submission describes.

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

Not available in the provided text.

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 / Not available in the provided text. This device is a bone void filler, not an AI diagnostic or assistive device that would involve human readers.

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

Not applicable / Not available in the provided text. This device is a physical bone void filler, not an algorithm.

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

Not applicable / Not available in the provided text. For a bone filler, "ground truth" would relate to successful bone formation and resorption, typically assessed through histology, imaging, and clinical outcomes in animal or human studies. The document only vaguely refers to "extensive in vitro and in vivo testing" without detailing the methodology or metrics used.

8. The sample size for the training set

Not available in the provided text.

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

Not available in the provided text.

Summary of what the document does provide:

Device: CERAMENT™ BONE VOID FILLER (A0210-12)
Intended Use: As a ceramic bone void filler for orthopedic applications, specifically for gaps and voids not intrinsic to the bony structure in extremities, pelvis, and spine (during open surgery). It resorbs and is replaced by bone.
Predicate Device: CERAMENT™ BONE VOID FILLER (A 0210), 510(k) number K073316.
Demonstration of Safety and Effectiveness: Through "extensive in vitro and in vivo testing," which is stated to show it "meets the requirements of all relevant standards for Calcium Salt Bone Void Fillers." This is the basis for its substantial equivalence determination. However, no specific details of these tests or their results are provided.

Summary

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K090871

BONE SUPPOR injecting new strength

SEP - 4 2009

510(k) Summary

Submitter Information
Manufacturer	BONESUPPORT ABScheelevägen 19 AIdeon Science ParkSE-223 70 LUND, SWEDEN
TelephoneCompany fax	+ 46 46 286 53 70+ 46 46 286 53 71
Contact person	Ann-Christine Provoostann-christine.provoost@bonesupport.com+ 46 46 286 53 22 (direct phone)
Date of preparation	9th of June, 2009
Trade name, Classification name, Class, Regulation
Trade Name	CERAMENT™BONE VOID FILLER (A 0210-12)
Classification Name	Resorbable calcium salt bone void filler device
Class	CLASS II (Special Control)
Regulation Number	CFR 888.3045
Product Code	MQV

Predicate devices

510(k) number	Trade name	Manufacturer
K073316	CERAMENT™BONE VOID FILLER (A 0210)	BONESUPPORT AB

Device description

hydroxyapatite remains intact providing osteoconductive support for in-growth of new bone. The ceramic bone substitute material is injected into the bone void/gap, under visual inspection or under

radiographic monitoring, with the use of the accompanying injection devices.

pg 1 of 2

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K090871

BONE

Intended use

CERAMENT™|BONE VOID FILLER is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that not intinue only for of officer only for orthopedic applications as a
filler for gaps and voids that are not intinsic to the bony structure. CE FILLER is indicated the themse oi the stable of the oorly structure. CERAMEN "HBONE VOL
FILLER is indicated into bony voids or gaps in the skeletal system, i.e. extremities, spine (only during a a hysecul in the skelets ystem, i.e. extremities, pelvis
spine (only during open surgety). These defects may be surgically created osseous defects on osseous defects from traumatic injury to the bone.

CERAMENT™|BONE VOID FILLER provides a bone void filler that resorbs and is replaced by bone during the healing process.

Pre-clinical Testing

Summary

Extensive in vitro and in vivo testing has shown that the CERAMENT™|BONE VOID FILLER (A0210 –12 ) meets the requirements of all relevant standards for Calcium Salt Bone Voilt VOID Fillers .

Based on the information provided in this premarket notification, the CERAMENT™|BONE VOID FILLER (A

0210-12 ) is equivaled in this premarket notification : the CERAMENT "JONE VOID FILLER (A
of operation of operation.

19 2 of 2

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DEPARTMENT OF HEAL.TH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized graphic of an abstract human figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

BONESUPPORT AB % Ms. Ann-Christine Provoost Regulatory Affairs Scheelevägen 19A Ideon Science Park SE-223 70 LUND, Sweden

SEP - 4 2009

Re: K090871

Trade/Device Name: CERAMENT™ BONE VOID FIILLER (A0210-12) Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: August 24, 2009 Received: August 27, 2009

Dear Ms. Provoost:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Ann-Christine Provoost

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Barbara Buehm

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K090871

Device Name:

CERAMENT™|BONE VOID FILLER (A0210-12)

Indications for Use:

CERAMENT™ (BONE VOID FILLER provides a bone void filler that resorbs and is replaced by bone during the healing process.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lawrence M. Hayes

Bivision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090871

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.