OSTENE®CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces in cardiothoracic surgery surgery following sternotomy .

Device Description

Ostene® CT is a water-soluble surgical implant material for use in cardiothoracic surgery. Ostene CT is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired.

Ostene CT is comprised of a sterile mixture of water-soluble alkylene oxide copolymers. Ostene®CT contains no other additives or colorants. The wax-like material is formed into sticks of various weights ranging from .5 to 5 grams each.

As a bone hemostasis agent, Ostene®CT stops bone bleeding by the creation of a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. Ostene CT, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.

Ostene CT is provided sterile by irradiation and must not be resterilized.

AI/ML Overview

The provided text is a 510(k) summary for the Ostene®CT Soluble Bone Hemostasis Implant Material. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance. As such, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, or standalone algorithm performance) is not available in the provided document.

However, I can extract the following:

1. Acceptance Criteria and Reported Device Performance:

The document states: "The non-clinical evaluations used to determine substantial equivalence included indications, intended use, design, materials, sterilization, and performance. The comparison demonstrates that the device in this substantially equivalent in indications and intended use; and is identical in design, materials, sterilization, and performance to the predicate Ostene®CT (K091636)."

This indicates that the acceptance criterion was "identical performance" to the predicate device. Specific quantitative performance metrics are not provided in this summary.

Acceptance Criteria	Reported Device Performance
Identical performance to the predicate device (K091636) in design, materials, sterilization, and performance.	The device is identical to the predicate device (K091636) in design, materials, sterilization, and performance.

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

Sample Size: Not specified.
Data Provenance: Not specified. The evaluations were "non-clinical."

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

Not applicable/Not specified, as this appears to be a non-clinical evaluation comparing device characteristics to a predicate, not an evaluation against a clinical ground truth established by experts.

4. Adjudication method for the test set:

Not applicable/Not specified.

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 not an AI/software device.

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

Not applicable. This is not an AI/software device.

7. The type of ground truth used:

For the non-clinical evaluation, the "ground truth" was essentially the established characteristics and performance of the predicate device (Ostene®CT, K091636).

8. The sample size for the training set:

Not applicable. This is not a study involving a training set in the context of machine learning or AI.

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

Not applicable.

Summary

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K10207/

OCT - 8 2010

Ceremed, Inc. · Page 6 - 1 Rev b 510 (k) - Ostene®CT Soluble Bone Hemostasis Implant Material

VI - 510 (K) SUMMARY

Submitted by:

Tadeusz Wellisz, M.D. Ceremed, Inc. 3643 Lenawee Ave. Los Angeles, California 90016 Tel: (310) 815-2125 Fax: (310) 815-2130

Contact Person:	Tadeusz Wellisz, M.D.
Date Prepared	October 06, 2010
Common/Usual Name:	Soluble Bone Hemostasis Implant Material
Proprietary Name:	Ostene®CT Bone Hemostasis ImplantMaterial, AOC™ CT, Osteotene™,Ceretene™
Regulatory Class:	Unclassified
Classification Name:	Wax, Bone
Product Code:	MTJ
Predicate Device:	Ceremed, Inc.Ostene®CT Soluble Bone HemostasisImplant Material (K091636)

Description of the device:

Ostene CT is provided sterile by irradiation and must not be resterilized.

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4102071

Page 6 - 2 Rev b Zo FZ Ceremed, Inc. 510 (k) - Ostene®CT Soluble Bone Hemostasis Implant Material

Intended use:

Ostene®CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.

Substantial equivalence:

The non-clinical evaluations used to determine substantial equivalence included indications, intended use, design, materials, sterilization, and performance. The comparison demonstrates that the device in this substantially equivalent in indications and intended use; and is identical in design, materials, sterilization, and performance to the predicate Ostene®CT (K091636).

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an eagle or bird with three wing-like shapes extending upwards.

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

Ceremed, Inc. % Tadeusz Wellisz M.D. Chairman 3643 Lenawee Avenue Los Angeles, California 90016

OCT - 8 2010

Re: K102071

Trade/Device Name: Ostene®CT, AOC™ CT, Osteotene™, Ceretene™ Regulatory Class: Unclassified Product Code: MTJ Dated: September 24, 2010 Received: September 29, 2010

Dear Dr. Wellisz:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Tadeusz Wellisz M.D.

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.

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/CDRHOffices/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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Ceremed, Inc. Page 5 - 1 Rev 510 (k) - Ostene®CT Soluble Bone Hemostasis Implant Material

V. INDICATIONS FOR USE:

510 (k) Number (if known): K102071

OCT - 8 2010

Device Name: Ostene®CT, AOC*CT, Osteotene™, Ceretene"

Indications For Use:

OSTENE®CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces in cardiothoracic surgery surgery following sternotomy .

Prescription Use	X
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

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

CONCURRANCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Daniel Krane for UXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102071

Division Sign-Off

: : 510(k) Number_

Regulation Number and Section

N/A