The OSTEOMED Low Profile Neuro Fixation System is comprised of plates, screws and instrumentation. The system features plates ranging from 0.25mm to 1.0mm thick, 1.2 mm to 1.6mm diameter standard screws in lengths from 2.0mm to 8.0mm and Auto-Drive screws in 1.2mm to 1.6mm diameters in lengths from 3.0mm to 8.0mm.

The instruments include drill bits, plate bending forceps, plate holding forceps, plate cutters, cannulae, taps, countersinks and screwdrivers to facilitate the placement of screws and modification of plates.

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

AI/ML Overview

The OsteoMed Low Profile Neuro Fixation System is a medical device used for cranial bone fixation.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Mechanical Strength	Equivalent or greater strength than existing neuro predicate devices	"performed equivalent or with greater strength than the existing neuro predicate devices based on verification testing."
Biocompatibility	Materials are biocompatible and already part of predicate neuro devices	"Materials used for the device are the same as the predicate device with changes from CP Ti to Ti-Alloy to maintain equivalent or greater strength to the predicate devices. These materials are biocompatible and already part of the predicate neuro devices."
Material Equivalence	Similar materials to predicate devices (with justified improvements)	"Materials used for the device are the same as the predicate device with changes from CP Ti to Ti-Alloy to maintain equivalent or greater strength to the predicate devices."
Design Equivalence	Similarities in design to predicate devices	Basis of substantial equivalence is "based on the similarities in design... to the predicate device."
Function Equivalence	Similarities in function to predicate devices	Basis of substantial equivalence is "based on the similarities in ... function... to the predicate device."
Performance Equivalence	Similarities in performance (as demonstrated by mechanical testing/FEA)	"Verification consisted of mechanical testing and finite element analysis comparisons against the predicate neuro plates."
Sterilization Equivalence	Similar sterilization methods to predicate devices	Basis of substantial equivalence is "based on the similarities in ... sterilization... to the predicate device."
Intended Use Equivalence	Similar intended use to predicate devices	Basis of substantial equivalence is "based on the similarities in ... intended use to the predicate device."
Endotoxin Level	LAL testing conducted in accordance with ANSI/AAMI ST72:2002 to ensure low endotoxin levels.	"Limulus Amebocyte Lysate (LAL) testing was conducted in accordance to ANSI/AAMI ST72:2002."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a sample size for a "test set" in the traditional sense of clinical trials or AI model evaluation. The performance evaluation was primarily based on mechanical testing and finite element analysis (FEA) rather than a test set of patient data.

The data provenance is retrospective, comparing the new device's mechanical characteristics to existing predicate devices. It does not involve prospective data collection from human or animal subjects for performance evaluation in this context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The "ground truth" for this device's performance was established through engineering principles and established mechanical testing standards, not expert human interpretation of medical images or clinical outcomes. The "experts" involved would be mechanical engineers and material scientists who designed the tests and analyzed the results.

4. Adjudication Method for the Test Set

Not applicable. There was no "adjudication method" in the context of clinical or diagnostic testing. The evaluation was based on objective mechanical measurements and computational modeling (FEA).

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

No. This device is a surgical implant (fixation system) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to its evaluation.

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

This question is not directly applicable. The device itself is a physical component. Its "standalone performance" refers to its mechanical integrity and biocompatibility, which were assessed through the described mechanical testing, FEA, and material analysis. There is no "algorithm" in this context.

7. The Type of Ground Truth Used

The ground truth used for assessing the device's performance was:

Mechanical properties of predicate devices: The established strength and performance characteristics of legally marketed predicate neuro plates served as the benchmark.
Engineering specifications and standards: Mechanical testing was conducted according to established engineering principles and likely internally defined specifications, as well as biocompatibility standards (e.g., ASTM F-136, ASTM F-67, ANSI/AAMI ST72:2002).
Material properties: The known properties of Titanium Alloy and commercially pure Titanium contributed to the "ground truth" regarding material strength and biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth to establish for it in this context.

Summary

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KIIII76

510(k) Summary

CG 1 5 2011

Submitter Information:

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

Piedad Peña Contact Person:

July 27, 2011 Date Prepared:

Device Information:

Proprietary/Trade Name:	OsteoMed Low Profile Neuro Fixation System
Common Name:	Low Profile Neuro Plates

Classification Name:

· Regulation Number: 21 CFR 882.5320
· Regulation Name: Preform alterable cranioplasty plate
· Product Code: GWO, Plate, cranioplasty, preformed, alterable o o GXR. Burr hole cover

Device Class: 2 510(k): K111176

Predicate Devices:

OsteoMed SBF system, K911936 Classification Name: Intraosseous fixation screw or wire (21CFR 872.4880, Product Code DZL) Device Class: 2

OsteoMed M3 SBF system (Addendum), K924138 Classification Name: Bone Plate (21CFR 872.4760, Product Code JEY) Device Class: 2

Device Description:

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

Image /page/0/Picture/22 description: The image shows a logo with the word "Colson" in a stylized font inside a black circle. To the right of the circle, there are two letters, "A" and "C", which are likely part of a larger word or phrase. The logo appears to be for a company or organization, with a simple and recognizable design.

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Intended Use:

The OsteoMed Low Profile Neuro Fixation System is indicated for use in osteotomies, fractures or reconstruction of the cranial bones. The implants and drills are single use only.

Technological Characteristics:

The basis of substantial equivalence for the modification of the OsteoMed SBF system, K911936, is based on the similarities in design, material, function, performance, sterilization, and intended as the predicate device.

Performance / Clinical Data:

The low profile neuro plates performed equivalent or with greater strength than the existing neuro predicate devices based on verification testing. Verification consisted of mechanical testing and finite element analysis comparisons against the predicate neuro plates. Limulus Amebocyte Lysate (LAL) testing was conducted in accordance to ANSI/AAMI ST72:2002.

Materials used for the device are the same as the predicate device with changes from CP Ti to Ti-Alloy to maintain equivalent or greater strength to the predicate devices. These materials are biocompatible and already part of the predicate neuro devices.

Clinical Testing was not required for this modification to support substantial equivalence.

Conclusion:

The basis of substantial equivalence for the addition of the low profile neuro plates to the current neuro plates of the OsteoMed SBF system, K911936, is based on the similarities in design, material, function, sterilization, and intended use to the predicate device. OsteoMed believes that the modifications do not raise any new safety or effectiveness issues.

Image /page/1/Picture/14 description: The image shows the logo for "A Colson Associate". The logo consists of the word "Colson" inside of a black circle with a vertical line extending from the top of the circle. To the right of the circle is the text "A Colson Associate".

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

Osteomed L.P. Mr. Piedad Pena Senior Regulatory Specialist 3885 Arapaho Road Addison, Texas 75001

AUG 1 5 2011

Re: K111176

Trade/Device Name: OsteoMed Low Profile Neuro Fixation System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: II Product Code: GWO, GXR Dated: July 27, 2011 Received: July 28, 2011

Dear Mr. Pena:

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. 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.

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Page 2 – Mr. Pena

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.

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,

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

OSTEOMED Low Profile Neuro Fixation System ___________________________________________________________________________________________________________________________________ Device Name:

Indications for Use:

The OsteoMED Low Profile Neuro Fixation System is indicated for use in osteotomies, fractures or reconstructions of the cranial bones.

Implants and drills are single use only.

Prescription Use (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)

Susan Runne

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: 11176

Page 1 of 1

Regulation Number and Section

§ 882.5320 Preformed alterable cranioplasty plate.

(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).