The Stryker® Foot Plating System is intended for use in internal fixation, reconstruction or arthrodeses of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.

Device Description

This submission is a line extension to the Stryker® Plating System to add alternate styles of plates and screws including locking plates, bone screws and locking screws for use in the foot and ankle.

AI/ML Overview

The provided text is a 510(k) summary for the Stryker® Foot Plating System, which is a metallic bone fixation device. This type of device, being a physical implant, does not typically involve the kinds of "acceptance criteria" or "studies" that would include performance metrics like sensitivity, specificity, or reader studies, as requested by the prompt for AI/diagnostic devices.

Instead, the "acceptance criteria" and "study" for such a device are primarily focused on substantial equivalence to legally marketed predicate devices, and the physical and mechanical properties of the materials and design. The FDA's review for this type of device evaluates:

Intended Use: Is it similar to predicate devices?
Design: Are the plates and screws designed similarly?
Materials: Are the materials (e.g., metals) known to be safe and effective for this application?
Operational Principles: Does it function similarly for internal fixation?

The document confirms that this device is a "line extension" and is "substantially equivalent" to predicate devices like the Profyle® System, Stryker® Plating System, DARCO Locking Bone Plate System, and Synthes LCP Locking Calcaneal Plates and Modular Foot System.

Therefore, many of the requested fields are not applicable to this type of medical device submission. I will provide the information based on what is available and indicate when a field is not applicable or relevant to this specific device type.

Acceptance Criteria and Device Performance for Stryker® Foot Plating System

1. A table of acceptance criteria and the reported device performance

For a metallic bone fixation device, formal "acceptance criteria" in terms of clinical performance metrics (like those used for diagnostic algorithms) are not typically defined in a 510(k) summary. Instead, acceptance is based on demonstrating substantial equivalence to predicate devices regarding:

Acceptance Criterion (Demonstrating Substantial Equivalence)	Reported Device Performance (as stated in the 510(k) Summary)
Intended Use	The Stryker® Foot Plating System is intended for use in internal fixation, reconstruction or arthrodeses of small bones including the fore, mid- and hind foot and ankle, for procedures like replantation, lag screw techniques, joint fusions, corrective osteotomies, and treatment of fractures. This is found to be substantially equivalent to other plating systems regarding intended use.
Design	The device is a line extension to add alternate styles of plates and screws (including locking plates, bone screws, and locking screws) for use in the foot and ankle. It is found to be substantially equivalent to other plating systems regarding design.
Materials	The device uses metallic bone fixation materials. It is found to be substantially equivalent to other plating systems regarding materials.
Operational Principles	The device functions as internal fixation components. It is found to be substantially equivalent to other plating systems regarding operational principles.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable: This product is a physical implant (bone plate/screw system), not a diagnostic device or algorithm requiring a "test set" for performance evaluation in the context of imaging or clinical data. Substantial equivalence for such devices relies on physical, mechanical, and material testing, and comparison to predicates, rather than human data sets of the kind implied by the prompt.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable: As above, a "test set" with "ground truth" derived from human experts is not relevant for demonstrating substantial equivalence of a physical orthopedic implant.

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

Not Applicable: No test set or expert adjudication in this context.

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 physical implant, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant.

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

Not Applicable: This is a physical implant, not an algorithm.

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

Not Applicable (or rather, different type of "ground truth"): For this device, the "ground truth" for demonstrating safety and effectiveness comes from established engineering principles, material science standards (e.g., biocompatibility confirmation), mechanical testing (e.g., fatigue, static strength), and the clinical history of the predicate devices. There is no biological "ground truth" in terms of a disease state as would be relevant for a diagnostic device.

8. The sample size for the training set

Not Applicable: This product is a physical implant, not a machine learning model requiring a training set.

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

Not Applicable: No training set.

Summary

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K063875

510(k) Summary of Safety and Effectiveness Stryker® Foot System

MAR 1 5 2007

Proprietary Name:	Stryker® Foot Plating System
Common Name:	Bone plates and screws
Classification Name/Reference:	Single/multiple component metallic bone fixationappliances and accessories, 21 CFR §888.3030
Device Product Code:	87 HRS
Proposed Regulatory Class:	Class II
For Information contact:	Vivian Kelly, Senior Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5581 Fax: (201) 831-6038
Date Summary Prepared:	December 28, 2006

Description

Indications:

Substantial Equivalence:

The subject Stryker® Foot Plating System is substantially equivalent to other plating systems in regards to intended use, design, materials, and operational principles as internal fixation components such as the Profyle® System, Stryker® Plating System, DARCO Locking Bone Plate System, Darco International, Inc. and Synthes LCP Locking Calcaneal Plates and Modular Foot System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Howmedica Osteonics Corp % Ms. Vivian Kelly Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430

MAR 1 5 2007

Re: K063875

Trade/Device Name: Stryker Foot Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: December 28, 2006 Received: December 29, 2006

Dear Ms. Kelly:

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 CFR Part 807); labeling (21 CFR Part 801); 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 - Ms. Vivian Kelly

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Charbare MuenD

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Stryker® Foot Plating System

Indications for Use:

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Joubare BuemP

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

510(k) Number K063875

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.