The OsteoMed Cranial Distraction System is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation. The OsteoMed Cranial Distraction System implants are intended for single use only.

Device Description

The OsteoMed Cranial Distraction System is comprised of distractors, spacers, screws and instrumentation. The distractor is an internal distraction device for bone elongation of cranial bones. The distractor is anchored between the osteotomy with 1.2mm standard or 1.2mm AutoDrive screws previously cleared under K924138 and K023260, respectively. The distractor is activated using a distractor tool via the distraction rod. The distraction rod is preassembled within the distractor device. The non-threaded portion of the distractor rod can be removed during the consolidation period. The distractors, spacers, and screws are removed after consolidation. The instruments include distractor tool, drills, plate bending forceps, plate cutters and screwdrivers to facilitate the placement of screws and modification of the distractor assembly plates. A distractor rod removal tool is also available to partially remove the distractor rod leaving the distracted device in place. The distractor assembly is made from Titanium (ASTM F-67) and Titanium Allov (ASTM F-136), and the spacer is made from Titanium (ASTM F-67). The screws are made from Titanium Alloy (ASTM F-136). The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.

AI/ML Overview

The provided text describes the OsteoMed Cranial Distraction System and its clearance via a 510(k) submission. However, the document does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any similar quantitative measures that would be found in a study about a software algorithm or diagnostic device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (KLS-Martin, K003883) based on inherent characteristics and verification testing.

Therefore, many of the requested categories for a study are not applicable or cannot be extracted from this document, as it's not a performance study of a device against specific diagnostic or algorithmic metrics.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance (implied): The device should function as an internal distractor for bone elongation.	The OSTEOMED Cranial Distraction System performed equivalently to the KLS predicate device based on verification testing. Verification testing consisted of mechanical testing and comparisons against the KLS predicate device.
Materials Biocompatibility (implied): Materials used should be biocompatible.	Materials used for the distractor (Titanium/Titanium Alloy) are the same as the predicate devices and are biocompatible.
Intended Use Equivalence: The device's intended use should be equivalent to the predicate device.	Intended use is equivalent to the KLS and OsteoMed predicate devices. The device is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated, for temporary stabilization and gradual lengthening of cranial bones, and to be removed after consolidation.
Safety and Effectiveness (overall): The device should be safe and effective.	"In conclusion, the device is safe and effective and performs as well as the predicate device."
No New Safety/Effectiveness Issues: The device should not raise new safety or effectiveness issues compared to the predicate.	"Due to the similarity of materials and design to the predicate device, OsteoMed believes that the OsteoMed Cranial Distraction System does not raise any new safety or effectiveness issues."

Regarding the "study that proves the device meets the acceptance criteria," the document states:

"Verification testing consisted of mechanical testing and comparisons against the KLS predicate device."
"Clinical Testing is not required to support substantial equivalence."

This indicates that the "study" was a non-clinical verification testing phase, primarily mechanical in nature, comparing the OsteoMed device to the KLS predicate device to ensure similar performance characteristics.

Here's a breakdown of the other requested information, highlighting what is not applicable (N/A) or not provided in the document for the reasons explained above:

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

Sample Size: Not specified for the mechanical verification testing. It would likely refer to the number of device units tested.
Data Provenance: N/A as it's mechanical testing, not patient data.

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

N/A. This does not apply to mechanical verification testing of a distraction system. Ground truth, in the context of diagnostic performance, is not relevant here.

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

N/A. This is for assessment of diagnostic findings, not mechanical device performance.

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:

N/A. This device is a mechanical cranial distraction system, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant.

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

N/A. This device is a mechanical system, not an algorithm.

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

N/A. For mechanical testing, the "ground truth" would be established engineering specifications derived from the predicate device's performance, as well as general engineering principles and material standards (e.g., ASTM standards cited for materials).

8. The sample size for the training set:

N/A. This is for machine learning models; this document describes a mechanical device.

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

N/A. This is for machine learning models; this document describes a mechanical device.

Summary

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K 12 1304

Image /page/0/Picture/1 description: The image shows the logo for Osteomed. The logo is in black and white and features the word "OSTEOMED" in a bold, sans-serif font. The word is enclosed in an oval shape. The logo has a modern and professional look.

510(k) Summary

AUG 222 2012

Submitter Information:

OsteoMed 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-4601

Contact Person:

Mrs. Piedad Peña

Date Prepared:

August 20, 2012

Device Information:

Proprietary/Trade Name: Common Name:

OsteoMed Cranial Distraction System Cranial Distraction System

Classification Name:

· Regulation Number: 21 CFR 882.5330
· Regulation Name: Preformed nonalterable cranioplasty plate
· Product Code:
PBJ o

Device Class: II

Predicate Devices:

KLS-Martin, K003883 Classification Name: Bone Plate (21CFR 872.4760, Product Code JEY) Device Class: II

Device Description:

The instruments include distractor tool, drills, plate bending forceps, plate cutters and screwdrivers to facilitate the placement of screws and modification of the distractor assembly plates. A distractor rod removal tool is also available to partially remove the distractor rod leaving the distracted device in place.

OsteoMed 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (972) 677-4601 Customer Service: (800) 456-7779

Image /page/0/Picture/25 description: The image shows a logo with the word "Colson" in a stylized font inside a circle. To the right of the circle, the text "A COLSON ASSOCIATE" is written in a smaller, sans-serif font. The logo appears to be for a company or organization named Colson and its associates.

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K121304

Image /page/1/Picture/1 description: The image shows the logo for OsteoMed. The logo is in black and white and features the word "OsteoMed" in bold, sans-serif font. The word is enclosed in an oval shape with a black stripe above the word. The oval shape is outlined in black.

The distractor assembly is made from Titanium (ASTM F-67) and Titanium Allov (ASTM F-136), and the spacer is made from Titanium (ASTM F-67). The screws are made from Titanium Alloy (ASTM F-136). The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.

Intended Use:

The OSTEOMED Cranial Distraction System intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation. The OSTEOMED Cranial Distraction System is intended for single patient use only.

Intended use is equivalent to the KLS and OsteoMed predicate devices.

Technological Characteristics:

The KLS predicate device is an internal distractor for bone elongation, which distracts via a threaded rod. OsteoMed internal distractor also uses a threaded rod for distraction and is anchored using bone screws. Both use a distraction tool for distraction.

Materials used for the distractor are the same as the predicate devices, Titanium/Titanium Alloy. These materials are biocompatible.

Performance / Clinical Data:

The OSTEOMED Cranial Distraction System performed equivalent as the KLS predicate device based on verification testing. Verification testing consisted of mechanical testing and comparisons against the KLS predicate device. The intended use if the device is the same as the KLS Predicate Device.

Clinical Testing is not required to support substantial equivalence.

In conclusion, the device is safe and effective and performs as well as the predicate device.

Substantial Equivalence:

The basis of substantial equivalence for this device is based on similarities in intended use, material, function, performance, sterilization design, technology and operational principle to the predicate device, KLS-Martin (K003883) Distraction System, based on their promotional materials, labeling and clearance letter.

Due to the similarity of materials and design to the predicate device, OsteoMed believes that the OsteoMed Cranial Distraction System does not raise any new safety or effectiveness issues.

OsteoMed 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (972) 677-4601 Customer Service: (800) 456-7779

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DEPARTMENT OF HEALTH & 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 a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

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

OsteoMed c/o Mrs. Piedad Peña Sr. Regulatory Affairs Specialist 3885 Arapaho Road Addison, TX 75001

AUG 222 2012

Re: K121304

OsteoMed Cranial Distraction System Regulation Number: 21 CFR 885.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: PBJ Dated: July 29, 2012 Received: July 31, 2012

Dear Mrs. Peña:

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, Drig, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not maching.

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 not in 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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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/CDRH0ffices/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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K121304

Device Name: OsteoMed Cranial Distraction System

. Indications for Use:

The OsteoMed Cranial Distraction System implants are intended for single use only.

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)

(Division Sign Off,

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K121304

Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).