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

PERI-LOC° Locking Bone Plates and Locking Bone Screws for the Upper Extremity 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 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 is a 510(k) summary for the PERI-LOC® Locking Bone Plates and Locking Bone Screws for the Upper Extremity. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a specific clinical study with acceptance criteria and device performance metrics in the way a diagnostic AI device would.

Therefore, much of the requested information cannot be extracted from this particular document, as it describes a mechanical implant device and not a diagnostic algorithm. Specifically, there is no mention of a "study that proves the device meets acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or accuracy for diagnosis.

However, I can extract the general intent behind the acceptance criteria for a medical device seeking 510(k) clearance, which is substantial equivalence to legally marketed predicate devices.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The acceptance criterion for a 510(k) submission like this is Substantial Equivalence to legally marketed predicate devices. The "reported device performance" is that it is substantially equivalent.

Acceptance Criterion	Reported Device Performance
Substantial Equivalence to Predicate Devices	"When compared to the predicate devices listed below, substantial equivalence is based on similarities in design features, overall indications for use, and material composition." The FDA's letter states: "we have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your became o ready fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to togethy the enactment date of the Medical Device Amendments, or to conninered print to may 20, 1978, in ecordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA)."

Acceptance Criterion

Reported Device Performance

Substantial Equivalence to Predicate Devices

"When compared to the predicate devices listed below, substantial equivalence is based on similarities in design features, overall indications for use, and material composition." The FDA's letter states: "we have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your became o ready fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to togethy the enactment date of the Medical Device Amendments, or to conninered print to may 20, 1978, in ecordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA)."

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

This information is not provided in the document. For a mechanical implant like this, the "test set" would typically refer to mechanical bench testing or sometimes limited animal or cadaveric studies, not clinical data in the sense of patient-derived data for diagnostic performance.

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)

This information is not applicable/relevant for this type of device and submission. Expert consensus for ground truth is typically for diagnostic classification tasks, which this device does not perform.

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

This information is not applicable/relevant for this type of device and submission. Adjudication methods are used to establish ground truth in diagnostic studies.

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

This information is not applicable/relevant. This is a mechanical implant device, not an AI diagnostic system that would assist human readers.

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

This information is not applicable/relevant. This is not an algorithm or AI device.

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

This information is not applicable/relevant in the context of diagnostic ground truth. For a mechanical device, performance is typically evaluated through mechanical testing (e.g., strength, fatigue, torsional stability) and comparison to the predicate, potentially with some in vivo or in vitro biomechanical studies. The document does not detail these specific tests, but infers their comparison to predicate devices.

8. The sample size for the training set

This information is not applicable/relevant. This is not an AI/ML device that requires a training set.

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

This information is not applicable/relevant. This is not an AI/ML device.

Summary

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510(k) Summary of Safety and Effectiveness PERI-LOC° Locking Bone Plates and Locking Bone Screws for the Upper Extremity

Submitted By:	JUL. 1 9 2005Smith & Nephew, Inc., Orthopaedic Division1450 Brooks RoadMemphis, TN 38116
Date:	June 27, 2005
Contact Person:	David Henley, Senior Regulatory Affairs SpecialistTel: (901) 399-6487 Fax: (901) 398-5146
Proprietary Name:	PERI-LOC® Locking Bone Plates and LockingBone Screws for the Upper Extremity
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, KTT, LXT / Orthopedics / 87

Device Description:

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, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.

Technological Characteristics:

Components comprising PERI-LOC* Locking Bone Plates and Locking Bone Screws for the Upper Extremity 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 .
Synthes LCP Proximal Humerus Plates K041860 .
Synthes 3.5mm LCP Distal Humerus System K033995 .
Synthes Small Fragment DCL System K000684 .
Howmedica Osteonics Numelock II Polyaxial Locking System K041709 .
Acumed, Inc. Congruent Bone Plate System K012655 .
Hand Innovations, Inc. Distal Volar Radius Anatomical Plate System K050932 .

Page 1 of 1

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Image /page/1/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-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the symbol.

JUL 19 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051735 . Kool 753
Trade/Device Name: PERI-LOC® Periarticular Locked Plating System Regulation Number: 21 CFR 888.3030, 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HRS, HWC, KTT, LXT Dated: June 27, 2005 Received: July 6, 2005

Dear Mr. Henley:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became o ready fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to togethy the enactment date of the Medical Device Amendments, or to conninered print to may 20, 1978, in ecordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetic Free (110) was the device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device is classified (600 world) als. Existing major regulations affecting your device can may be subject to such additions, 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 I least of advised that I Drivisation that your device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must or any I ederal bather 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 OF IT in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quality by tights (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. David Henley

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to ough finding of substantial equivalence of your device to a legally prematics notification: "The Pressification 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 If you desire spochile at (240) 276-0120. Also, please note the regulation entitled, Connact the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Evelyn Chen

Miriam C. Provost, Ph.D. Acting 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):	K051735
---------------------------	---------

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 _ × (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)

Earle Orr

K051735

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.