The PERI-LOC™ Bone Plating and Screw 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 PERI-LOC™ Bone Plating and Screw System represents titanium versions of stainless steel PERI-LOC™ Periarticular Locked Plating System bone plates and bone screws previously cleared under K082516, K061352, K051735, and K033669. Like the predicate devices, the PERI-LOC™ Bone Plating and Screw System devices feature various lengths of straight and contoured locking bone plates: locking and non-locking bone screws, washers, plus a screw adapter accessory. Bone plates in the PER/-LOC™ Bone Plating and Screw System feature a screw to-plate locking feature, which forms a locked, fixed-angle construct to aid in maintaining fracture reduction.

AI/ML Overview

The provided text is a 510(k) summary for the PERI-LOC™ Bone Plating and Screw System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) pathway is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies to prove performance against specific acceptance criteria like those outlined in your request. While the device's technological characteristics are mentioned as being similar to predicate devices, there's no discussion of quantitative performance metrics, study designs, sample sizes, or ground truth establishment.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The document focuses on regulatory approval through substantial equivalence, not on a detailed performance study with defined acceptance criteria.

Here's what I can infer or explicitly state based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Not specified in the document. The 510(k) primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new performance acceptance criteria for a novel device.	Not specified in the document. The document states that the new device has "similar technological characteristics" and "similarities in design features and overall indications for use" to predicate devices, implying comparable performance without providing specific metrics.

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

Sample size for test set: Not applicable and not mentioned in the document. The 510(k) submission does not describe a performance test set.
Data provenance: Not applicable. No performance 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 applicable. The document does not describe a study involving ground truth establishment by experts.

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

Not applicable. No test set or adjudication process is described.

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. This device is a bone plating and screw system, not an AI-based diagnostic tool for which MRMC studies are typically performed.

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

Not applicable. This device is a mechanical implant, not an algorithm.

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

Not applicable. The document does not reference performance studies that would require ground truth. The substantial equivalence argument relies on the established safety and effectiveness of predicate devices.

8. The sample size for the training set

Not applicable. This submission doesn't describe an algorithm or a training set.

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

Not applicable. This submission doesn't describe an algorithm or a training set.

Summary of what the document does communicate regarding evidence for substantial equivalence:

The "study" referenced in a 510(k) context is often the comparison to legally marketed predicate devices. The device's safety and effectiveness are supported by demonstrating that it has:

Similar intended use.
Similar technological characteristics (e.g., made of titanium like some predicate devices, screw-to-plate locking feature).
No new questions of safety or effectiveness compared to those predicates.

The acceptance criteria for a 510(k) largely revolve around demonstrating this substantial equivalence, which is typically shown through engineering comparisons, material biocompatibility, and sometimes mechanical testing (though specific results of such tests are not detailed in this summary). The document lists several predicate devices (K082516, K072818, K061352, K051735, K033669, K993106, K000682, K000684, K011815) to which the PERI-LOC™ Bone Plating and Screw System is compared. The "study" proving it meets acceptance criteria is the regulatory review finding of substantial equivalence based on the submitted documentation comparing the device to these predicates.

Summary

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510(k) Summary of Safety and Effectiveness PERI-LOC™ Bone Plating and Screw System

Submitted By:

Date:

Contact Person:

Proprietary Name: Common Name:

Classification Name and Reference:

Smith & Nephew, Inc. JAN - 7 2009 1450 Brooks Road Memphis, TN 38116

October 9, 2008

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

PERI-LOC™ Bone Plating and Screw System Bone Plates and Bone Screws

21 CFR 888.3030. single/multiple component metallic bone fixation appliances and accessories - Class II 21 CFR 888.3040, smooth or threaded metallic bone fixation fastener - Class II

Device Product Code and Panel Code:

HRS, HWC, KTT, LXT / Orthopedics / 87

Device Description:

Intended Use:

The PERI-LOC™ Bone Plating and Screw 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, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus and clavicle.

Technological Characteristics:

The PERI-LOC™ Bone Plating and Screw System is similar to legally-marketed devices listed below in that they share similar indications for use 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 and overall indications for use.

PERI-LOC™ Periarticular Locked Plating System Hexalobular Bone Screws (K082516) �
PERI-LOCTM Periarticular Locked Plating System Proximal Femur (K072818) .
PERI-LOC™ Periarticular Locked Plating System Locking Bone Plates & Screws for the Upper . Extremity (K061352)
. PERI-LOC™ Locking Bone Plates and Locking Bone Screws for the Upper Extremity (K051735)
Smith & Nephew Locking Bone Plate System (K033669) .
Smith & Nephew Bone Plate System (K993106) .
Synthes Large Fragment DCL System (K000682) .
Synthes Small Fragment DCL System (K000684) .
. Synthes LCP Proximal Humerus Plate (K011815)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stripes above it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew. Inc. % Mr. David Henley Orthopaedic Division 1450 Brooks Road Memphis. TN 38116

JAN - 7 2009

Re: K083032

Trade/Device Name: PERI-LOC™ Bone Plating and Screw System 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: October 9, 2008

Received: October 10, 2008

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 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

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Page 2 - Mr. David Henley

marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

11 8

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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark A. Milkein

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): K083032

PERI-LOC™ Bone Plating and Screw System Device Name:

Indications for Use:

Components in the PERI-LOC™ Bone Plating and Screw 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)

_ and_, and I'm here to help. How can I assist you today?

(Division Division of General, Restorative. and Neurological Devices

510(k) Number K083032

Page 1 of 1

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.