PERI-LOC™ Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC™ Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions; basiltranscervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.

Device Description

The subject PERI-LOC™ Periarticular Locked Plating System – Proximal Femur Locking Bone Plates manufactured from titanium material have undergone a design modification when compared to devices cleared under K072818. Like the predicate devices include various lengths of contoured, locking bone plates made from titanium material. PERI-LOC™ Proximal Femur 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 the PERI-LOC™ Periarticular Locked Plating System - Proximal Femur Locking Bone Plates. It describes a medical device, specifically bone plates, and discusses its substantial equivalence to previously cleared devices.

However, the document does not contain information about acceptance criteria or a study that uses terms like sensitivity, specificity, or any form of diagnostic performance metrics typically associated with AI/ML device evaluations. The study mentioned is a "pre-clinical bench testing" focused on "Construct fatigue testing of bone plate (and screw) constructs." This is a mechanical engineering test, not a clinical study involving human or image data.

Therefore, I cannot populate the requested table and answer the study-related questions (2-9) because the provided text describes a hardware medical device (bone plates) and its mechanical testing for substantial equivalence, not an AI/ML-based diagnostic or assistive device that would have such performance criteria and studies.

Here's a breakdown of why this information is not available in the provided text:

Acceptance Criteria & Device Performance (Table 1): The document doesn't define acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy). The "performance" mentioned relates to mechanical properties (fatigue testing), not clinical diagnostic outcomes.
Sample Size (Test Set) & Data Provenance (Question 2): Not applicable. The "test set" for a mechanical fatigue test would involve physical constructs, not a dataset of patient information.
Number of Experts & Qualifications (Question 3): Not applicable. This relates to establishing ground truth for clinical diagnoses, which is not what this document describes.
Adjudication Method (Question 4): Not applicable.
Multi-Reader Multi-Case (MRMC) Study (Question 5): Not applicable. This is completely irrelevant to a bone plate's mechanical performance.
Standalone Performance (Question 6): Not applicable. "Algorithm only" performance refers to AI, which is absent here.
Type of Ground Truth (Question 7): Not applicable. For mechanical testing, the "ground truth" would be the physical properties measured in a lab.
Sample Size for Training Set (Question 8): Not applicable. This is not an AI/ML device.
Ground Truth for Training Set (Question 9): Not applicable.

In summary, the provided document describes a traditional medical device (bone plates) and its mechanical testing for regulatory clearance based on substantial equivalence, not an AI/ML diagnostic device.

Summary

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510(k) Summary of Safety and Effectiveness

K112406 (pg1/2)

PERI-LOC™ Periarticular Locked Plating System Proximal Femur Locking Bone Plates

NOV 1 4 2011

Submitted By:	Smith & Nephew, Inc.Orthopaedic Division1450 Brooks RoadMemphis, TN 38116
Date:	August 19, 2011
Contact Person:	David Henley, Regulatory Affairs Project ManagerTel: (901) 399-6487 Fax: (901) 566-7079
Proprietary Name:	PERI-LOC ™ Periarticular Locked Plating System -Proximal Femur Locking Bone Plates
Common Name:	Bone Plates
Classification Name and Reference:	21 CFR 888.3030, single/multiple component metallicbone fixation appliances and accessories - Class II
Device Product Code and Panel Code:	HRS / Orthopedics / 87

Device Description:

Device Type	Devices Available With theFollowing Number ofIndividual Locking ScrewHoles Per Plate
PERI-LOC 4.5mm Lateral Proximal Femur Locking Plate, LH	2, 4, 6, 9, 12, 15 or 18
PERI-LOC 4.5mm Lateral Proximal Femur Locking Plate, RH	2, 4, 6, 9, 12, 15 or 18

Intended Use:

PERI-LOC™ Periarticular Locked Plating System Proximal Femur Bone Plates and Bone Screws can be used for adult patients as well as patients with osteopenic bone. PERI-LOC™ Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions; basiltranscervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.

11,

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Technological Characteristics:

Components comprising PERI-LOC™ Periarticular Locked Plating System - Proximal Femur Locking Bone Plates are similar to legally marketed devices listed below in that they share identical or similar indications for use, are manufactured from titanium material (i.e. devices cleared under K072818). and incorporate identical or similar technological characteristics.

Substantial Equivalence Information:

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

. PERI-LOC™ Proximal Femur Locking Bone Plates (Bone Screws and Cable Accessories) - K072818
. (Smith & Nephew) Trauma Internal Fixation System (TC-100 Blade Plates) - K993289

To further support a determination of substantial equivalence, pre-clinical bench testing was conducted on the subject devices (that have undergone the design modification) in comparison against previously cleared TC-100 Blade Plates described above. The specific type of pre-clinical testing conducted is described as:

Construct fatigue testing of bone plate (and screw) constructs .
O

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features an abstract eagle-like symbol with three lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Smith & Nephew Inc. Orthopaedics Division % David Henly 7135 Goodlet Farms Parkway Cordova, Tennessee 38016

NOV 1 4 2011

Re: K112406

Trade/Device Name: PERI-LOC™ Periarticular Locked Plating System -Proximal Femur Locking Bone Plates 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: August 19, 2011 Received: August 22, 2011

Dear Mr. Henly:

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

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Page 2 - Mr. David Henly

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.

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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Eunel Keith

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):	K112406 (pa 1/1)
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Device Name: PERI-LOC ™ Periarticular Locked Plating System – Proximal Femur Locking Bone Plates

Indications for Use:

PERI-LOC™ Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC™ Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complax nultifragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; sub boitel, femoral neck fractures; and subtrochanteric femur fractures.

Components in the PERI-LOC™ Periarticular Locked Plating System - Proximal Femur Locking Bone Plates are for single use only.

Prescription Use × (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, @ffice of Device Evaluation (ODE)

(Division Sign-Off Division of Surgical Orthopedic, and Restorative Devices

510(k) Number K112406

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.