The PERI-LOC Periarticular Locked Plating System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bones plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.

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

Device Description

Volar Distal Radius Locking Plates for the Upper Extremity manufactured from ASTM F139 material are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K051735 and K061352. Like the predicate devices listed below, the subject components include various sizes of contoured locking bone plates and locking/non-locking bone screws made from stainless steel. PERI-LOC™ locking bone plates and 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 – Volar Distal Radius Locking Plate for the Upper Extremity – ASTM F139 Material Change. This is a medical device submission, and the content focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study demonstrating performance against specific acceptance criteria for a new AI or diagnostic algorithm.

Therefore, many of the requested categories for AI/diagnostic studies, such as acceptance criteria, reported device performance, sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of submission.

The document primarily addresses the following aspects:

Device Description: It describes the Volar Distal Radius Locking Plates as line additions to an existing system, made from ASTM F139 material, and incorporating a screw-to-plate locking feature.
Intended Use: Specifies that the system is for adult patients with osteopenic bone and is indicated for fixation of various bone fractures.
Technological Characteristics: States that the device is similar to legally marketed devices in terms of indications, materials, and technological characteristics.
Substantial Equivalence Information: Compares the device to several predicate devices based on design features, indications, and material composition.

Key points from the document regarding the device's assessment:

No specific acceptance criteria for a new performance metric are listed. The approval is based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices. This means the new device is considered as safe and effective as the predicate devices, without needing to prove new performance thresholds.
No explicit study proving specific performance metrics is included. The 510(k) summary relies on comparison to predicate devices, implying that the established performance and safety of the predicates serve as the benchmark.
No sample sizes for test sets, data provenance, expert numbers, adjudication, MRMC studies, or standalone performance are mentioned. These are typically associated with studies evaluating diagnostic or AI-driven devices, which this orthopedic implant is not.
The "ground truth" for this type of device is implicitly the clinical performance and history of the predicate devices. Its substantial equivalence implies it should perform similarly in a clinical setting.
No training set or ground truth establishment for a training set is relevant as this is not an AI/machine learning device.

In summary, based on the provided text, the device approval is based on substantial equivalence, not on meeting specific quantitative acceptance criteria through a performance study. The document does not contain the information required to populate the requested table or answer the specific questions about an AI/diagnostic study.

Summary

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510(k) Summary of Safety and Effectiveness

PERI-LOC™ Periarticular Locked Plating System

Volar Distal Radius Locking Plate for the Upper Extremity - ASTM F139 Material Change

Submitted By:	Smith & Nephew, Inc.,Orthopaedic Division1450 Brooks RoadMemphis, TN 38116	JUN 1 8 2008
Date:	February 13, 2008
Contact Person:	Laura Sejnowski, Regulatory Affairs SpecialistTel: (901) 399-5349 Fax: (901) 399-1557
Proprietary Name:	PERI-LOC™ Periarticular Locked Plating System -Volar Distal Radius Locking Plate for the Upper ExtremityASTM F139 Material Change
Common Name:	Bone Plates and Bone Screws
Classification Name and Reference:	21 CFR 888.3030, single/multiple component metallic bonefixation appliances and accessories - Class II
Device Product Code and Panel Code:	HRS, HWC / Orthopedics / 87

Device Description:

Intended Use:

The PERI-LOC™ Periarticular Locked Plating System can be used for adult patients with osteopenic bone. PERI-LOC™ bone plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, and clavicle.

Technological Characteristics:

PERI-LOC™ Volar Distal Radius Plates manufactured from ASTM F139 material 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 for the Upper Extremity - K051735
. PERI-LOC™ Periarticular Locked Plating System for the Upper Extremity Device Modifications – K061352
. Smith & Nephew Locked Plating System (PERI-LOC™ Periarticular Locked Plating System) – K033669
. PERI-LOC™ Periarticular Locked Plating System VLP Plates/Screws – K071563

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. % Orthopaedic Division Ms. Laura Sejnowski Regulatory Affairs Specialist 1450 Brooks Road Memphis, TN 38116

JUN 1 8 2008

Re: K081106 Trade/Device Name: Peri-Loc™ Periarticular Locked Plating System - Volar Distal Radius Locking Plate for the Upper Extremity 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: May 15, 2008 Received: May 19, 2008

Dear Ms. Sejnowski:

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. Laura Sejnowski

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

Mark M. Milliman

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

510(k) Number (if known): ___ K 0 8 || 0 6

PERI-LOC™ Periarticular Locked Plating System -Device Name: Volar Distal Radius Locking Plate for the Upper Extremity - ASTM F139 Material Change

Indications for Use:

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

Prescription Use × AND/OR (Part 21 CFR 801.109)

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)

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Division of General, Restorative, and Neurological Devices

510(k) Number K091106

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.