Orthocon Orthostat™ Hemostatic Bone Putty is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries.

Device Description

Orthocon Orthostat™ Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency intended for use in the management of bleeding from the cut surface of bone. The material is a mixture of calcium stearate (a wax-like tamponade), Vitamin E Acetate (for handling properties) and alkylene oxide copolymer (a dispersing agent). The material is virtually odorless, off-white in color and can be spread easily with minimal adhesion to surgical gloves. The bone putty requires no kneading prior to application and does not soften appreciably at body temperature.

When applied manually to surgically incised or traumatically broken bone, Orthostat™ Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty will be dispersed and absorbed within a period of 60 days.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called Orthostat™ Hemostatic Bone Putty. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other quantitative measures typically found in clinical trials for diagnostic or AI-powered devices.

This submission is a Special 510(k) and focuses on changes to the labeling (adding contraindications) of a device that is otherwise substantially equivalent to its own predicate (meaning, the device itself is unchanged from its prior clearance). Therefore, the provided documentation does not include details about device performance studies that would typically define and measure acceptance criteria in the way described in the prompt.

Given the nature of this submission (a Special 510(k) for labeling changes of a Class I/Unclassified device), the "acceptance criteria" and "study proving the device meets the acceptance criteria" are primarily related to:

Biocompatibility: Ensuring the material is safe for contact with the body.
Material properties: Ensuring the putty maintains its physical characteristics and function (hemostatic barrier, absorbability, handling properties).
Manufacturing controls: Ensuring the device is produced consistently and safely.
Labeling accuracy: Ensuring contraindications and intended use are clearly stated.

The document states: "This Special 510(k) Notice contains revised Risk Management documents, summaries of biocompatibility testing and reports from investigations of the use of the device. Conformance to applicable Special Controls has been verified. The data presented demonstrate the substantial equivalence of the modified device to the original device." This implies that data exists for these aspects, but the specifics (like acceptance criteria and study results in a table format) are not included in the provided text.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the information provided because:

No quantitative performance acceptance criteria are mentioned for the device itself. The device's "performance" is its ability to act as a mechanical barrier for hemostasis and its absorbability. These are generally accepted based on previous clearances, material science, and preclinical testing, rather than a clinical study with specific sensitivity/specificity metrics.
No clinical study demonstrating performance against such criteria is detailed. The document refers to "reports from investigations of the use of the device," but no specifics of these investigations are given (e.g., sample size, type of study, results, comparison to a gold standard).
The questions about AI, ground truth, experts, and adjudication are not applicable. This device is a physical medical device (hemostatic bone putty), not a diagnostic device or an AI/software as a medical device (SaMD).

In summary, the provided document does not contain the information required to answer the prompt's specific questions regarding acceptance criteria and performance study details typical for diagnostic or AI devices.

If this were a typical diagnostic or AI device submission, the required information would be present in a section detailing clinical performance studies.

Summary

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K091121 page 1/2

ORTHOCON

APR 2 8 2009

510(k) Summary Of Safety And Effectiveness (Per 21 CFR 4 807.92)

General Company Information

Name:	Orthocon Inc.
Contact:	Kenneth Collins
Address:	675 US Highway OneNorth Brunswick, NJ 08902
Telephone:	732.418.0025
Fax:	732-418-0221
Date Prepared:	March 30, 2009

General Device Information

Product Name:	Orthostat™ Hemostatic Bone Putty
Classification:	Unclassified
:	"Bone Wax". Product code: MTJ

Predicate Device

Device Name:	Orthostat™ Hemostatic Bone Putty
510(k) Number:	043260
Decision Date:	August 12, 2005
Decision:	Substantially Equivalent (SE)

Device Description

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K091121 Page 42

ORTHOCON

Intended Use (Indications)

Substantial Equivalence

In this Special 510(k) submission the device is its own predicate. Orthostat™ Hemostatic Bone Putty is unchanged in its formulation from its predicate 510(k) clearance. The Indications for Use also remain unchaged. This Special 510(k) is to add the following contraindications to the labeling of the device.

Do not use Orthostat in joints or in contact with synovial membrane or in procedures where the material will be in direct intra-articular contact with the joint (e.g. bunionectomy).

Do not use Orthostat as a bone void filler or graft extender.

This Special 510(k) Notice contains revised Risk Management documents, summaries of biocompatibility testing and reports from investigations of the use of the device. Conformance to applicable Special Controls has been verified.

The data presented demonstrate the substantial equivalence of the modified device to the original device.

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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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Orthocon Corporation % Dr. Kenneth A. Collins 675 US Highway One North Brunswick, New Jersey 08902

APR 2 8 2009

Re: K091121

Regulatory Class: Unclassified Product Code: MTJ Dated: April 15, 2009 Received: April 17, 2009

Dear Dr. Collins:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 - Dr. Kenneth A. Collins

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ORTHO

The Role of the State in the Economy The role of the state in the economy is a complex and multifaceted issue that has been debated for centuries. There are many different perspectives on what the state's role should be, ranging from laissez-faire capitalism, where the state plays a minimal role, to socialism, where the state controls most of the economy. In general, the state plays a role in the economy by providing public goods and services, regulating economic activity, and redistributing income. Public goods and services are those that are non-excludable and non-rivalrous, meaning that they are available to everyone and that one person's use of them does not diminish their availability to others. Examples of public goods and services include national defense, law enforcement, and infrastructure. The state also regulates economic activity to protect consumers, workers, and the environment. Regulations can take many forms, such as setting minimum wages, banning certain products, and requiring businesses to meet certain standards. Finally, the state redistributes income through taxes and transfer payments. Taxes are used to fund public goods and services, while transfer payments are used to provide income support to low-income individuals and families. The appropriate role of the state in the economy is a matter of ongoing debate. There are many different perspectives on what the state's role should be, and there is no easy answer. However, it is clear that the state plays a significant role in the economy, and that its actions can have a major impact on people's lives.

2.1 Orthostat™ Indications for Use

510(k) Number (if known): K09

Device Name:

Orthostat™ Hemostatic Bone Putty

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for MXM

(Division Sign-C Division of General, Restorative, and Neurological Devices

510(k) Number K091121

Regulation Number and Section

N/A