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

Hexalobular Bone Screws are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K033669, K051735, K061352, and K993106. Like the predicate devices listed below, the subject components include various sizes of locking/non-locking Cortex and partially/fully threaded Cancellous bone screws made from stainless steel that are intended for use with locking bone plates for both the upper and lower extremity. The subject screws are designed for use with the PERI-LOC™ locking bone plates, which incorporate a screw-to-plate locking feature forming a locked, fixed angle construct to aid in holding fracture reduction.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the PERI-LOC™ Periarticular Locked Plating System Hexalobular Bone Screws. These documents are generally used to demonstrate substantial equivalence to a predicate device, rather than to present a study demonstrating the device meets specific acceptance criteria in the way a clinical trial for a new drug or novel medical software would.

Therefore, the requested information about acceptance criteria and a study proving those criteria are met for this type of device submission is largely not applicable in the conventional sense of a clinical performance study. Instead, the "study" is a comparison to a predicate device and a demonstration that the new device shares similar technological characteristics, materials, and intended use as the legally marketed predicate.

Here's a breakdown based on the provided document:

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

Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" are primarily established by the features and performance of the predicate devices. The new device must demonstrate that its technological characteristics (design, materials, intended use) are substantially equivalent to these predicates and do not raise new questions of safety or effectiveness.
Reported Device Performance: The document states that the PERI-LOC™ Hexalobular Bone Screws 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." This inherent similarity to the existing, cleared predicate devices is the "reported performance" for a 510(k) submission. Specific quantitative performance metrics (e.g., tensile strength, fatigue life) would have been part of the full submission, but are not detailed in this summary. However, the summary asserts that these characteristics are comparable.

Acceptance Criteria (Implicit from Predicate Devices)	Reported Device Performance (PERI-LOC™ Hexalobular Bone Screws)
Indications for Use: Fixation of pelvic, small, and long bone fractures in adult patients.	Similar Indications for Use: 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 (adult and pediatric patients, including those with osteopenic bone, extended for this device).
Material Composition: Stainless steel (as per predicate devices).	Similar Material Composition: Made from stainless steel.
Design Features: Locking/non-locking Cortex and partially/fully threaded Cancellous bone screws, designed for use with PERI-LOC™ locking bone plates, forming a locked, fixed angle construct.	Similar Design Features: Various sizes of locking/non-locking Cortex and partially/fully threaded Cancellous bone screws, designed for use with PERI-LOC™ locking bone plates, which incorporate a screw-to-plate locking feature forming a locked, fixed angle construct.
Safety and Effectiveness: Demonstrate substantial equivalence to predicate devices, raising no new safety or effectiveness concerns.	Substantial Equivalence: Based on similarities in design features, overall indications for use, and material composition to listed predicate devices (K051735, K061352, K033669, K993106, K043185).

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

Not applicable in the context of a typical clinical trial. This submission relies on a comparison to existing predicate devices and likely includes in vitro mechanical testing data (which is not detailed in this summary). There is no mention of a "test set" of patients or data provenance in the way one would for an AI/software or drug trial. The "test" is the comparison to the predicate device's established performance and characteristics.

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. There is no "test set" requiring expert ground truth in the context of clinical interpretation for this orthopedic implant. The "ground truth" for showing substantial equivalence for this type of device largely comes from engineering specifications, material standards, and the known clinical performance and regulatory history of the predicate devices.

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

Not applicable. No such adjudication method is mentioned or relevant for this type of medical device submission.

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 submission is for an orthopedic implant (bone screws), not an AI-assisted diagnostic device. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed or is relevant.

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

Not applicable. This is not an algorithm or software device.

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

For this device, the "ground truth" for demonstrating substantial equivalence includes:
- Engineering specifications and material science: Demonstrating the new screws meet established standards for mechanical properties (e.g., strength, fatigue) comparable to the predicates.
- Regulatory precedent: The predicate devices have already been deemed safe and effective by the FDA. The "ground truth" is that devices with similar characteristics have a history of safe and effective use.
- Clinical experience with predicate devices: The established performance and safety profile of the predicate PERI-LOC systems.

8. The sample size for the training set

Not applicable. This device submission does not involve a "training set" in the context of machine learning.

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

Not applicable. As above, no training set for machine learning is involved.

Summary

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K082516 pg 1 et 1

510(k) Summary of Safety and Effectiven PERI-LOC™ Periarticular Locked Plating System Hexalobular Bone Screws

Submitted By:	Smith & Nephew, Inc.,Orthopaedic Division1450 Brooks RoadMemphis, TN 38116	SEP 1 7 2008
Date:	August 28, 2008
Contact Person:	Laura Sejnowski, Regulatory Affairs SpecialistTel: (901) 399-5349 Fax: (901) 399-1557
Proprietary Name:	PERI-LOC™ Periarticular Locked Plating System Hexalobular Bone Screws
Common Name:	Bone Screws
Classification Name and Reference:	21 CFR 888.3040 - Screw, Fixation, Bone - Class II
Device Product Code and Panel Code:	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™ Hexalobular Bone Screws 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
Smith & Nephew Bone Plate System (TC-100 Plate & Screw System) K993106 .
◆ Synthes 3.5mm Cortex Screws - K043185

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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 2008

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

Re: K082516

Trade/Device Name: PERI-LOC™ Periarticular Locked Plating System Hexalobular Bone Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: August 29, 2008 Received: September 2, 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 Foold, Orug, 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misburanding 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 af 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.

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Page 2 - Ms. Laura Sejnowski

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 this, 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 Riometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting 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 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 M. Millican

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):

PERI-LOC™ Periarticular Locked Plating System Device Name: Hexalobular Bone Screws

Indications for Use:

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

Prescription Use × (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)

Del

Division of General, Restorative, and Neurological Dev

510(k) Number K082516

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.