The PERI-LOC™ Periarticular Locked Plating System can be used for adult and pediatric patients, as well as 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, calcaneus, and clavicle.

Device Description

The subject devices are design modifications to PERI-LOC™ Periarticular Locked Plating System devices previously cleared under K033669, K051735 and K061352. Like the predicate devices listed below, the subject components include various sizes of contoured, locking bone plates made from stainless steel. PERI-LOC™ locking bone plates 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 is a 510(k) summary for a medical device (PERI-LOC™ Locking Bone Plates). It describes design modifications to an existing device and asserts substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for assessing performance.

Therefore, I cannot populate the requested table or answer most of the questions based on the provided input.

Here's a breakdown of what can be inferred:

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

Not available in the provided text. The document focuses on demonstrating substantial equivalence through design modifications, material composition, and intended use, rather than presenting new performance data against specific acceptance criteria.

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

Not available in the provided text. No performance testing data is presented.

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 available in the provided text. No performance testing data is presented.

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

Not available in the provided text. No performance testing data is presented.

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 available in the provided text. This device is a mechanical bone plate system, not an AI-assisted diagnostic tool.

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

Not applicable / Not available in the provided text. This device is a mechanical bone plate system, not an algorithm.

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

Not available in the provided text. No performance testing data is presented. The "ground truth" for this type of device would typically involve mechanical testing (e.g., fatigue, static strength) and biocompatibility, but no such details are provided for this specific submission beyond asserting similarity to predicates.

8. The sample size for the training set

Not applicable / Not available in the provided text. This is not an AI device, so there is no "training set."

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

Not applicable / Not available in the provided text. This is not an AI device, so there is no "training set" or its associated ground truth establishment.

Summary of what the document does provide:

The document describes design modifications to existing PERI-LOC™ Periarticular Locked Plating System devices. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (K033669, K051735, and K061352) based on:

Identical indications for use.
Identical material (stainless steel).
Very similar technological design characteristics.

The modifications are described as minor (e.g., removal of tunnels, chamfers, tabs, or slots) and do not appear to fundamentally change the intended mechanical function or safety profile in a way that would necessitate new, extensive clinical or performance studies for this 510(k) submission. The FDA clearance letter confirms the substantial equivalence determination.

Summary

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K092015 · 510(k) Summary of Safety and Effectiveness PERI-LOC™ Locking Bone Plates

July 2, 2009

JUL 30 2009

Submitted By:

Smith & Nephew, Inc. Orthopaedic Reconstruction and Trauma Division 1450 Brooks Road Memphis, TN 38116

Contact Person:

Date:

Proprietary Name:

Common Name:

Classification Name and Reference:

David Henley, Regulatory Affairs Project Manager Fax: (901) 398-5146 Tel: (901) 399-6487

PERI-LOC™ Periarticular Locked Plating System Locking Bone Plates for Lower & Upper Extremity

Bone Plates and Bone Screws

21 CFR 888.3030, single/multiple component metallic bone fixation appliances and accessories - Class II

Device Product Code and Panel Code:

HRS / Orthopedics / 87

Device Description:

Design modifications include the following changes to PERI-LOC™ locking bone plates:

· Removal of tunnels (undercuts) from bottom-side of 3.5/4.5mm Lateral Proximal Tibia, 4.5mm Lateral Distal Femur, 2.5mm Volar Distal Radius Locking Bone Plates and 3.5mm Medial Distal Tibia Locking Bone Plates
Removal of the 76° chamfer from around the top, entry point of the locking screw holes from the 4.5mm Lateral Proximal Tibia and 4.5mm Lateral Distal Femur Locking Bone Plates
Removal of the tab for screw hole extension from the outer edge of the flared head section of the 3.5mm Medial Distal Tibia Locking Bone Plates.
· Removal of the slot (i.e. alignment slot) from the plate shaft (just below the plate head) on the 2.5mm Volar Distal Radius Locking Bone Plates and the 3.5mm Proximal Humerus Locking Bone Plates and replace the slot feature with a locking screw hole.

Intended Use:

The PERI-LOC™ Periarticular Locked Plating System can be used for adult and pediatric patients, as well as 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, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.

Technological Characteristics:

Components comprising PERI-LOC™ Locking Bone Plates for the Lower/Upper Extremity are very similar to legally marketed devices listed below in that they share identical indications for use (compared to K033669, K051735 and K061352), are manufactured from identical material, and incorporate very similar technological design characteristics.

Substantial Equivalence Information:

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

· Smith & Nephew Locked Plating System (PERI-LOC™ Periarticular Locked Plating System) K033669
· PERI-LOC™ Periarticular Locked Plating System for the Upper Extremity K051735 and K061352

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

111- 8 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. % Mr. David Henley Regulatory Affairs Project Manager 1450 Brooks Road Memphis, Tennessee 38116

Re: K092015

Trade/Device Name: PERI-LOCTM Periarticular Locked 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: July 2, 2009 Received: July 6, 2009

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 - Mr. David Henley

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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Chabari Buchind

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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Premarket Notification Indications for Use Statement

510(k) Number (if known):

PERI-LOC™ Periarticular Locked Plating System Device Name:

Indications for Use:

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

Prescription Use X (Per 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)

Sonita
(Division Sign off) for mxm

(Division Sign-Of Division of Surgical, Orthoped and Restorative Devices

510(k) Number K092015

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.