The AxSOS® SPS Monoaxial Locking Plates in the Stryker Locked Plating system are intended for use in long bone fracture fixation. The AxSOS® SPS Monoaxial Locking Plates are indicated for fixation of long bone fractures including fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia, and the distal femur.

Device Description

This Special 510(k) submission is intended to address modifications to the Stryker Locked Plating System. This line extension is to add additional styles of Cable Plugs. The AxSOS® Cable Plug is being modified as part of a line extension of the Stryker Locked Plating System. The AxSOS® Locked Plating System currently contains 4mm and 5mm Cable Plugs.

AI/ML Overview

Here's an analysis of the provided text regarding the AxSOS® Stryker Locked Plating System Line Extension of Cable Plugs, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device (bone plating system), not an AI/software device. Therefore, many of the requested categories (e.g., ground truth for test set, MRMC study, training set size) are not applicable to this type of submission. This document describes a "line extension" for existing hardware, focusing on demonstrating equivalence to predicate devices through mechanical and functional testing, not clinical performance metrics related to diagnostic accuracy typically seen with AI systems.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Details/Methodology
Mechanical & Functional Properties	Comparable mechanical & functional properties to predicate devices (K050512, K060514, K061012, K060798).	"Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject AxSOS® Stryker Locked Plating System to the predicate device..."	Study Type: Functional and mechanical testing. The specific tests are not detailed in this summary but would typically involve static and fatigue testing, torque tests, and other biomechanical assessments relevant to bone fixation devices to ensure the new cable plugs do not compromise the system's integrity or performance.
Material Equivalence	Subject device made from the same material as predicate devices.	The subject device (AxSOS® Stryker Locked Plating System with new cable plugs) and predicate devices are both made from Stainless Steel.	Study Type: Material verification. This would involve confirming the material composition of the new components matches that of the predicate devices.
Intended Use	New line extension does not alter the intended use of the predicate systems.	The AxSOS® modifications do not alter the intended use of the predicate systems. The indications for use of the plates (long bone fracture fixation, including distal radius, proximal humerus, distal tibia, proximal tibia, and distal femur) remain the same.	Study Type: Review of indications for use and design impact analysis. The submission confirms that the added cable plugs do not change the fundamental medical application or target patient population.

Study Details (Applicable to this Device Type)

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

Sample Size: Not explicitly stated as "test set" in the context of clinical data. For mechanical testing, samples of the cable plugs and the plating system would be used, but the exact number isn't quantified in this summary.
Data Provenance: Not applicable in the context of clinical data. For mechanical testing, the data would originate from laboratory testing of the manufactured devices, most likely conducted by the manufacturer (Howmedica Osteonics Corp.). The nature of the submission (510(k) for a hardware line extension) indicates a focus on engineering and material equivalence rather than clinical efficacy studies with patient data. This would be considered prospective manufacturing and mechanical test data from the manufacturer’s facilities.

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

Not Applicable. This is a hardware device focused on mechanical and material equivalence, not diagnostic or clinical interpretation where "experts" would establish "ground truth" on a test set (e.g., radiologists interpreting images). The "ground truth" for this device is its physical properties and performance as measured through engineering tests, compared to predicate devices.

4. Adjudication Method for the Test Set

Not Applicable. As there are no human-interpreted "cases" or "ground truth" in the clinical sense, no adjudication method would be required. The "results" are objective measurements from mechanical testing.

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 a hardware medical device, not an AI or software device. Therefore, no MRMC study on human readers and AI assistance was conducted or would be relevant.

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

Not Applicable. This is a hardware medical device; there is no algorithm to assess.

7. The Type of Ground Truth Used

Engineering Specifications and Predicate Device Performance: For this device, the "ground truth" is established by the specified mechanical properties required for bone fixation devices and the demonstrated performance of the legally marketed predicate devices. The new cable plugs must perform equivalently to or better than the predicate devices under relevant mechanical stress tests.

8. The Sample Size for the Training Set

Not Applicable. This is a hardware device, not an AI or software model that requires a "training set."

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

Not Applicable. As there is no training set, this question is irrelevant.

Summary

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510(k) Summary of Safety and Effectiveness: AxSOS® Stryker Locked Plating System Line Extension of Cable Plugs

Submission Information

Name and Address of the Sponsor of the 510(k) Submission

For Information contact:

Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430

NOV 2 0 2009

Melissa A. Matarese, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5116 Fax: (201) 831-4116

Date Summary Prepared:

Device Identification Proprietary Name:

Common Name: Classification Name and Reference:

Device Product Code:

July 15, 2009

AxSOS® Stryker Locked Plating System Line Extension of Cable Plugs Bone plates and screws Single/multiple component metallic bone fixation appliances and accessories, 21 CFR 888.3030

87 HRS: Plate, Fixation, Bone 87 HWC: Screw, Fixation, Bone

Description:

Intended Use:

Stryker Locked Plating System Line Extension of Cable Plugs The AxSOS® modifications do not alter the intended use of the predicate systems as cleared in their respective premarket notifications. The indications for use for the subject plates are provided below.

Indications for Use:

The AxSOS® SPS Monoaxial Locking Plates in the Stryker Locked Plating system are intended for use in long bone fracture fixation. The AxSOS® SPS Monoaxial Locking

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Plates are indicated for fixation of long bone fractures including the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.

Statement of Technological Comparison:

The subject and predicate devices are made from Stainless Steel. Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject AxSOS® Stryker Locked Plating System to the predicate device K050512, K060514, K061012, and K060798. .

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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 three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Howmedica Osteonics Corporation c/o Ms. Melissa Matarese Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430

NOV 20 2009

Re: K092178

Trade/Device Name: AxSOS® Locked Plating System Line Extension of Cable Plugs Regulation Number: 21 CFR 888.3030

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: Class II Product Code: HRS, HWC Dated: October 30, 2009 Received: November 5, 2009

Dear Ms. Matarese:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2 - Ms. Melissa Matarese

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Jonetta Jr

Image /page/3/Picture/7 description: In this image, there is a close-up of a document with some text. The text includes the name "Mark N. Mel" followed by the title "Director Div". The text also includes the words "and Restora" and "Office of De".

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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510(k) Number (if known):

Device Name: AxSOS® Locked Plating System Line Extension of Cable Plugs

Indications For Use:

Prescription Use X (Part 21 CFR 801

Subpart D)

Over-The-Counter Use

(21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Soutte

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(Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092178

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.