AOC Bone Wax 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 additional handling and manipulation, if so desired. AOC Bone Wax is provided sterile by irradiation and must not be resterilized.

Used for over 100 years, bone waxes stop 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. The wax, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.

AI/ML Overview

This 510(k) submission for AOC Bone Wax does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a 510(k) Summary of Safety and Effectiveness, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria.

Therefore, I cannot fulfill your request for the following information based on the provided text:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
If a standalone performance (algorithm only) was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc).
The sample size for the training set.
How the ground truth for the training set was established.

Key points from the document relevant to its purpose:

Device Name: AOC Bone Wax, Ostene™, Osteotene™, Ceretene™
Intended Use/Indications for Use: Control of bleeding from bone surfaces.
Substantial Equivalence: The submission asserts that the modified AOC Bone Wax has the "same intended use fundamental scientific technology as the legally marketed AOC Bone Wax (K041363)." This is the core of a 510(k) submission – to show the new device is as safe and effective as an existing one, not necessarily to prove new performance metrics against predefined acceptance criteria through clinical trials.
Predicate Device: Ceremed, Inc. AOC Bone Wax K041363.

This type of submission often relies on a comparison of technical characteristics, material properties, and intended use to an already approved device, rather than new extensive performance studies.

Summary

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

K050440

Page 9 - 1

Ceremed, Inc. AOC Bone Wax Special 510 (k) Submission

MAR 2 4 2005 IX - 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS:

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: Date Prepared

Common/Usual Name:

Proprietary Name:

Classification Name:

Predicate Device:

Tadeusz Wellisz, M.D. March 21, 2005

Bone Wax

AOC Bone Wax Ostene™, Osteotene™ Ceretene™

Unclassified

Ceremed, Inc. AOC Bone Wax K041363

Description of the device:

Intended use:

AOC Bone Wax is intended for use in the control of bleeding from bone surfaces.

Substantial equivalence:

The modified AOC Bone Wax has the same intended use fundamental scientific technology as the legally marketed AOC Bone Wax.

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

Image /page/1/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple, yet conveys the department's mission of promoting health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 2005

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

Re: K050440

K030440
Trade/Device Name: AOC™ Bone Wax, Ostene™, Osteotene™, Ceretene™ Regulatory Class: Unclassified Product Code: MTJ Dated: February 16, 2005 Received: February 22, 2005

Dear Dr. Wellisz:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(t) premailer is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Ior use stated in the encrosale) (o tegain) to tegains the Medical Device Amendments, or to commerce prior to May 20, 1978, are encordance with the provisions of the Federal Food. Daug. devices mat have been require approval of a premarket approval application (PMA). and Costlictic Act (71ct) that to not requent of the general controls provisions of the Act. The You may, merciole, market the do result of the more of annual registration. Insting of general controls provisions of the rice, 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 If your device is crassified (500 a0070) ins. Existing major regulations affecting your device can hay be subject to sublications, Title 21, Parts 800 to 898. In addition. FDA may be found in the Obecannents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act that 11.7A has made a acted regulations administered by other Federal agencies. You must or any i caetar statues and registements, including, but not limited to: registration and listing (21 Comply with an the Act 870cm mores) (); good manufacturing practice requirements as set CI IS Far 607), attoring (21 CFR Part 820); and if applicable the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 -- Tadeusz Wellisz, M.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you we cognifinding of substantial equivalence of your device to a legally premarked 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 If you desire specific acreoliare at (240) 276-0115. Also, please note the regulation entitled. Contact the Oriece of Complained in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Shall other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octess http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Stypt Rurchs

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Ceremed, Inc. Special 510 (k) - AOC Bone Wax

YII. INDICATIONS FOR USE:

510 (k) Number (if known): K050440

Device Name: AOC™ Bone Wax, Ostene™, Osteotene™, Ceretene™

Indications For Use: AOC Bone Wax is indicated for use in the control of bleeding from bone surfaces.

CONCURRANCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

× OR Prescription Use (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.)

Stept Rlurchu
K050440

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Division Sign-Off

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

N/A