PERI-LOC Locking Hole Inserts and Cable Accessories are intended for use with existing PERI-LOC Periarticular Locked Plating Systems and their cleared indications for use as listed below:

The PERI-LOC Periarticular Locked Plating System including Locking Hole Inserts and Cable Accessories 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.

PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws, Locking Hole Inserts 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, Locking Hole Inserts 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 and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.

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

Device Description

Subject of this premarket notification are PERI-LOC™ Locking Hole Inserts and Cable Accessories. The PERI-LOC Locking Hole Inserts and Cable Accessories are line additions to the PERI-LOC Periaticular Locked Plating System cleared under K033669, K051735, K072818, and K082516. The subject Locking Hole Inserts and Cable Saddles are accessory components that may be used in coniunction with various PERI-LOC locking bone plates for the upper and lower extremities. The subject devices are made from 316L stainless steel.

When compared to the predicate PERI-LOC Screw Hole Plug and Cable Saddles, the subject PERI-LOC Locking Hole Inserts and Cable Saddles have been modified as follows:

Designed to be used independently or in conjunction with one another .
Addition of a Hexalobular drive feature .
Addition of a 3.5mm Locking Hole Insert .

The subject devices are available in the following size ranges:

Device Type	Available Drive Feature
3.5mm Locking Hole Insert	Hex or Hexalobular
4.5mm Locking Hole Insert	Hex or Hexalobular
Short Cable Saddle	Hex or Hexalobular
Tall Cable Saddle	Hex or Hexalobular

AI/ML Overview

The provided document, K100325, describes a 510(k) premarket notification for PERI-LOC™ Locking Hole Inserts and Cable Accessories. This document is a regulatory submission for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical study results.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical integrity and durability for orthopedic fixation applications. (Implied by the device's function as bone fixation accessories and the type of testing performed).	"Pre-clinical testing included four point bend fatigue testing of plate constructs with appropriate accessory devices."
Substantial equivalence to predicate devices (K033669, K051735, K072818, K082516) in terms of design, materials, and intended use.	Device demonstrated substantial equivalence based on similarities in design features and overall indications for use with the listed predicate devices.

Explanation: The document explicitly states "Performance Data" and then details "Pre-clinical testing included four point bend fatigue testing of plate constructs with appropriate accessory devices." It then states that "Substantial equivalence is based on similarities in design features and overall indications for use" with the predicate devices. This implies that the acceptance criteria for these accessory devices revolved around demonstrating sufficient mechanical strength for their intended orthopedic application and proving they are functionally similar to previously cleared devices.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document only mentions "plate constructs" without providing the number of samples tested for the four-point bend fatigue tests.
Data Provenance: Not explicitly stated, but it's a pre-clinical study, meaning it was conducted in a lab setting by the manufacturer (Smith & Nephew, Inc.). It is retrospective in the sense that the testing was completed before the submission to FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a pre-clinical, mechanical performance study, not a study involving human interpretation or clinical outcomes data that would require expert ground truth establishment.

4. Adjudication method for the test set

Not applicable. There was no human interpretation or decision-making in the testing that would require adjudication. The testing involved mechanical measurements.

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 document pertains to a medical device (orthopedic fixation accessories), not an AI/software device that would involve human readers or AI assistance.

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

Not applicable. This is a physical medical device; there is no algorithm involved.

7. The type of ground truth used

For the pre-clinical performance testing, the "ground truth" would be the engineering specifications and industry standards for mechanical strength and fatigue resistance for orthopedic implants. The failure modes and stress limits observed during the four-point bend fatigue testing would be compared against these established benchmarks.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable. As above, there is no training set for this type of device.

Summary

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K100325 (pg 1/2)

510(k) Summary of Safety and Effectiveness PERI-LOC™ Locking Hole Inserts and Cable Accessories

Submitted By:	Smith & Nephew, Inc.,Orthopaedic Division1450 Brooks RoadMemphis, TN 38116
Date:	May 4, 2010MAY - 4 2010
Contact Person:	Laura Medlin, Regulatory Affairs SpecialistTel: (901) 399-5349 Fax: (901) 398-5146
Proprietary Name:	PERI-LOC™ Locking Hole Inserts and CableAccessories
Common Name:	Locking Bone Plate Accessories
Classification Name and Reference:	21 CFR 888.3040, smooth or threaded metallic bonefixation fastener, Class II
Device Classification for Predicate Devices:	21 CFR 888.3040, smooth or threaded metallic bonefixation fastener, Class II
Device Product Code and Panel Code:	Panel: Orthopedics / 87Product Code: HWC

Device Description:

When compared to the predicate PERI-LOC Screw Hole Plug and Cable Saddles, the subject PERI-LOC Locking Hole Inserts and Cable Saddles have been modified as follows:

Designed to be used independently or in conjunction with one another .
Addition of a Hexalobular drive feature .
Addition of a 3.5mm Locking Hole Insert .

The subject devices are available in the following size ranges:

Device Type	Available Drive Feature
3.5mm Locking Hole Insert	Hex or Hexalobular
4.5mm Locking Hole Insert	Hex or Hexalobular
Short Cable Saddle	Hex or Hexalobular
Tall Cable Saddle	Hex or Hexalobular

Intended Use:

PERI-LOC Locking Hole Inserts and Cable Accessories are intended for use with existing PERI-LOC Periarticular Locked Plating Systems and their cleared indications for use as listed below:

The PERI-LOC Periarticular Locked Plating System including Locking Hole Inserts and Cable Accessories 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,

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LOC Proximal Femur Locking Bone Plates, Bone Screws, Locking Hole Inserts 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 and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.

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

Technological Characteristics:

The PERI-LOC Locking Hole Inserts and Cable Accessories are similar to legally marketed devices listed below in that they share similar indications for use, are manufactured from identical material, and incorporate similar technological characteristics.

Performance Data

To further support a determination of substantial equivalence, pre-clinical testing was conducted on the subject devices. Pre-clinical testing included four point bend fatigue testing of plate constructs with appropriate accessory devices.

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.

Smith & Nephew Locking Bone Plate System (PERI-LOC Periarticular Locked Plating System) K033669 .
PERI-LOC Locking Bone Plates and Locking Bone Screws for the Upper Extremity K051735 .
PERI-LOC Periarticular Locked Plating System for the Upper Extremity K061352 ●
PERI-LOC Periarticular Locked Plating System Proximal Femur Plates, Screws, and Cable . Accessories - K072818
PERI-LOC Periarticular Locked Plating System Hexalobular Bone Screws K082516 .

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the symbol.

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

Smith & Nephew Inc. % Laura Medlin 1450 Brooks Rd. Memphis, Tennessee 38116

MAY - 4 2010

Re: K100325

Trade/Device Name: PERI-LOC Locking Hole Inserts and Cable Accessories Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 1, 2010 Received: February 4, 2010

Dear Ms. Medlin:

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, Orve 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 – Ms. Laura Medlin

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 yours,

[signature]

Mark N. Melke 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): _KIOO325(pg 1/1)

Device Name: PERI-LOC™ Locking Hole Inserts and Cable Accessories

Indications for Use:

PERI-LOC Locking Hole Inserts and Cable Accessories are intended for use with existing PERI-LOC Periarticular Locked Plating Systems and their cleared indications for use as listed below:

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

AND/OR Prescription Use (Part 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)

Onetta for mums

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

510(k) Number /Cl00325

Page 1 of 1

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.