PERI-LOC Periarticular Locked Plating System B-Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC contoured B-Plates and Screws are indicated for partial articular fractures of the distal fibula, distal tibia, and proximal tibia. PERI-LOC Locking Tubular Plates are indicated for fracture fixation of the tibia, fibula, femur, metacarpals, humerus, ulna, radius, calcaneus, and clavicle.

Components in the PERI-LOC® Periarticular Locked Plating System are for single use only.

Device Description

PERI-LOC* Periarticular Locked Plating System - B-Plates are line additions to the PERI-LOC* Periarticular Locked Plating System cleared under K033669. Like the predicate devices listed below, the subject components include various sizes of contoured and straight, locking bone plates and locking/non-locking bone screws made from stainless steel. PERI-LOC B-Plate locking bone plates and locking/non-locking bone screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.

AI/ML Overview

The provided text describes a 510(k) summary for the PERI-LOC® Periarticular Locked Plating System - B-Plate Locking Bone Plates and Locking/Non-locking Bone Screws. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study or standalone algorithm performance.

Therefore, the following information about acceptance criteria and studies is not available in the provided text:

A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance criteria for the device itself. The focus is on demonstrating equivalence to existing devices.
Sample size used for the test set and the data provenance: No test set is described, as the evaluation is based on comparison to predicate devices, not on a new performance study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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: This is a medical device for bone plating, not an AI or imaging diagnostic device. MRMC studies are not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no new performance study generating "ground truth" data is described.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

What the document does state about the device's "study" and "criteria":

The "study" in this context is the 510(k) substantial equivalence submission process. The "acceptance criteria" are implicitly met by demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices.

The document explicitly states:

Substantial Equivalence Information: "When compared to the predicate devices listed below, substantial equivalence is based on similarities in design features, overall indications for use, and material composition."
Predicate Devices:
- PERI-LOC Periarticular Locked Plating System K033669
- Smith & Nephew Bone Plate System (TC-100 Plating and Screw System) K993106

Essentially, the device "meets acceptance criteria" by being sufficiently similar in its technological characteristics, intended use, and materials to devices already cleared by the FDA, without requiring new clinical performance data.

Summary

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510(k) Summary of Safety and Effectiveness SEP 1 5 2006 PERI-LOC° Periarticular Locked Plating System B-Plate Locking Bone Plates and Locking/Non-Locking Bone Screws

Submitted By:	Smith & Nephew, Inc., Orthopaedic Division1450 Brooks RoadMemphis, TN 38116
Date:	July 31, 2006
Contact Person:	David Henley, Senior Regulatory Affairs SpecialistTel: (901) 399-6487 Fax: (901) 398-5146
Proprietary Name:	PERI-LOC° Periarticular Locked Plating System -B-Plate Locking Bone Plates and Screws
Common Name:	Bone Plates and Bone Screws
Classification Name and Reference:	21 CFR 888.3030, single/multiple component metallicbone fixation appliances and accessories - Class II21 CFR 888.3040, smooth or threaded metallic bonefixation fastener - Class II
Device Product Code and Panel Code:	HRS, HWC / Orthopedics / 87

Device Description:

Intended Use:

PERI-LOC Periarticular Locked Plating System B-Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC contoured B-Plates and Screws are indicated for partial articular fractures of the distal tibia, and proximal tibia. PERI-LOC*Locking Tubular Plates are indicated for fracture fixation of the tibia, fibula, femur, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.

Technological Characteristics:

Components comprising PERI-LOC* Periarticular Locked Plating System - B-Plates are similar to legally marketed devices listed below in that they share similar indications for use, are manufactured from similar materials and incorporate similar technological characteristics.

· Substantial Equivalence Information:

When compared to the predicate devices listed below, substantial equivalence is based on similarities in design features, overall indications for use, and material composition.

PERI-LOC Periarticular Locked Plating System K033669 .
Smith & Nephew Bone Plate System (TC-100 Plating and Screw System) K993106 ●

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized representation of three human figures, possibly representing health, family, and community.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 2006

Smith & Nephew, Inc. % Mr. David Henley Senior Regulatory Affairs Specialist Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116

Re: K062216

Trade/Device Name: PERI-LOC® Periarticular Locked Plating System – B-Plate Locking Bone Plates and Locking/Non-locking Bone Screws 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: July 31, 2006 Received: August 1, 2006

Dear Mr. Henley:

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 – Mr. David Henley

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.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbareßnern

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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Premarket Notification Indications for Use Statement

KO62216 510(k) Number (if known): _

Device Name: PERI-LOC° Periarticular Locked Plating System -B-Plate Locking Bone Plates and Locking/Non-locking Bone Screws

Indications for Use:

Components in the PERI-LOC® Periarticular Locked Plating System are for single use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X = ========================================================================================================================================================================== (Part 21 CFR 801.109)

AND/OR

Over-the-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jarlane Mullin

Division of General, Restorative, and Neurological Devices

510(k) Number K063716

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.