SPS Small Fragment Set: The Stryker® Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following: One third tubular plate: fibula, metatarsals, metacarpals Fibular plate: fibula Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle Oblique T-plate: distal radius T-plate: distal radius, calcaneus, lateral clavicle Cloverleaf plate: proximal humerus, distal tibia Calcaneal plate: calcaneus Reconstructive plate: humerus, pelvis. Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone.

SPS Basic Fragment Set: The Basic Fragment Set is intended for use in long bone fracture fixation. Reconstruction plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis. T-plates, T-buttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.

Device Description

This Special 510(k) submission is a line extension to address modifications to the Stryker® Plating System (SPS), which includes the SPS Small Fragment Set, the SPS Basic Fragment Set, the SPS Pelvic Set and the Stryker Locked Plating Set. This line extension is to add additional styles of plates based on the plates in the SPS Small Fragment Set and the SPS Basic Fragment Set.

AI/ML Overview

The provided document is a 510(k) summary for the Stryker® Plating System. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving device performance against specific acceptance criteria through a clinical study in the way an AI/ML device submission would.

Therefore, many of the requested points related to acceptance criteria, specific studies, sample sizes, and ground truth establishment (which are common for AI/ML device evaluations) are not applicable or explicitly stated in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Implied by Substantial Equivalence)
Design: The new components are similar in design to the predicate systems.	The additional styles of plates are based on the existing SPS Small Fragment Set and SPS Basic Fragment Set.
Intended Use: The new components do not alter the intended use of the predicate systems.	The indications for the subject plates and accessories are the same as their cleared predicates.
Performance: The new components perform similarly to the predicate systems.	The document asserts "substantial equivalence... in respect to design, intended use, performance and operational principle as internal fixation components." No specific performance metrics or studies proving this are detailed, as equivalence is often established through design comparison, materials, and (sometimes) mechanical bench testing for orthopedic implants, which are not included here.
Operational Principle: The new components function on the same operational principle as the predicate systems.	The document asserts "substantial equivalence... in respect to design, intended use, performance and operational principle as internal fixation components."

Explanation: For a 510(k) submission, the "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. This means the new device is as safe and effective as the predicate. The "reported device performance" is essentially the claim that the new device meets the equivalence standard in areas like design, intended use, performance, and operational principle. Specific quantitative performance metrics are usually not required for this type of submission unless a significant change that impacts safety or effectiveness is introduced, necessitating new testing.

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

Not applicable/Not provided. This document does not describe a clinical study with a "test set" in the context of analytical or clinical performance evaluations for an AI/ML device. The submission is for a physical medical device (bone plates and screws). The "sample size" here refers to the number of new plate styles being added to an existing system.

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

Not applicable/Not provided. This is not relevant for a 510(k) for a bone plating system. Ground truth establishment with experts is a concept often applied to AI/ML clinical evaluations, not for demonstrating substantial equivalence of orthopedic implants.

4. Adjudication Method for the Test Set

Not applicable/Not provided. This concept is not applicable to this type of device submission.

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/Not provided. This is irrelevant as the device is a physical bone plating system, not an AI/ML diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable/Not provided. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

Not applicable/Not provided. The concept of "ground truth" as typically discussed in AI/ML device evaluations (e.g., pathology, outcomes data, expert consensus) does not apply directly here. For a bone plating system, the "truth" is established through design specifications, material properties, biocompatibility, and mechanical testing (though the details of such testing are not in this summary). Substantial equivalence is the primary "truth" being established in this document.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device is not an AI/ML system that requires a "training set."

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

Not applicable/Not provided. This device is not an AI/ML system that requires a "training set" or corresponding ground truth.

Summary

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Kolo798

Summary of Safety and Effectiveness Stryker® Plating System Line Extension

Proprietary Name:	Stryker® Plating System
Common Name:	Bone Plate System
Classification Name and Reference:	Single/Multiple Component Metallic BoneFixation Appliances and Accessories, 21 CFR§888.3030
Proposed Regulatory Class:	Smooth or Threaded Metallic Bone FixationFastener, 21 CFR §888.3040Class II
Device Product Code:	87 HRS: Plate, Fixation, Bone87 HWC: Screw, Fixation, Bone
For Information contact:	Vivian Kelly, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5581Fax: (201) 831-6038

Date Summary Prepared:

March 23, 2006

Description:

Intended Use

The modifications do not alter the intended use of the predicate systems as cleared in their respective premarket notifications. The indications for the subject plates are provided below.

Indications

The indications for use for the predicate plates are provided below. The subject plates and subject accessories have the same indications as cleared their predicates.

SPS Small Fragment Set The Stryker Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following:

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Cloverleaf plate: proximal humerus, distal tibia Calcaneal plate: calcaneus Reconstructive plate: humerus, pelvis

Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone.

SPS Basic Fragment Set The Basic Fragment Set is intended for use in long bone fracture fixation.

Reconstruction plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis.

T-plates, T-buttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.

Substantial Equivalence:

These additional components are substantially equivalent to their predicate systems from the Stryker® Plating System in respect to design, intended use, performance and operational principle as internal fixation components.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The text is in all caps and is in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2006

Howmedica Osteonics Corporation c/o Ms. Vivian Kelly Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K060798

Trade/Device Name: Stryker® 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, HWC Dated: March 23, 2006 Received: March 24, 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

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Page 2 - Ms. Vivian Kelly

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. 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,

Mark N. Melkerson

Mark N. Melk Director Division of General, Restorative and Neurological Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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K 060798

Indications for Use

510(k) Number (if known):

Device Name: Stryker® Plating System

Indications for Use:

SPS Small Fragment Set

The Stryker® Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following:

One third tubular plate: fibula, metatarsals, metacarpals Fibular plate: fibula Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle Oblique T-plate: distal radius T-plate: distal radius, calcaneus, lateral clavicle Cloverleaf plate: proximal humerus, distal tibia Calcaneal plate: calcaneus Reconstructive plate: humerus, pelvis

Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone.

SPS Basic Fragment Set

The Basic Fragment Set is intended for use in long bone fracture fixation. Reconstruction plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis. T-plates, T-buttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.

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

e of Device Evaluation (ODE) Concurrence of CI

Page 1 of 1

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

510(k) Number_ Ko60798

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.