Post-traumatic joint contracture which has resulted in loss of range of motion .
Fractures and disease which generally may result in joint contractures or loss of . range of motion and fractures requiring distraction
Open and closed fracture fixation .
Pseudoarthrosis of long bones .
Limb lengthening by epiphyseal or metaphyseal distraction .
Correction of bony or soft tissue deformities ●
Correction of bony or soft tissue defects .
Joint arthrodesis ●
Infected fractures or nonunions .
Components in the Smith & Nephew Circular Fixation System are for single use only.

Device Description

Subject of this Traditional 510(k) premarket notification is the Smith & Nephew Circular Fixation System. The subject device is a multilateral external fixation system that is intended for fracture fixation of long bones and for joint fusions and limb lengthening or deformity corrections which involve cutting of the bone. The Circular Fixation system can also be used with a software component that is designed to be used to assist the physician in adjusting the six struts by creating a patient adjustment schedule. Components of this premarket notification include the following:

Full, half, 2/3 and foot rings manufactured from aluminum material. .
. U-plates manufactured from aluminum material.
Adjustable struts manufactured from aluminum material .
. Drill tip wires manufactured from stainless steel material
Accessory components such as rancho cubes, ring connectors, nuts, bolts and centering . sleeves manufactured from stainless steel material
. Disc clips manufactured from polycarbonate material
Half pin caps manufactured from PVC material
. Web-based software
The Circular Fixation System can also be used with other existing Smith and Nephew, Inc external fixation components.

AI/ML Overview

The Smith & Nephew Circular Fixation System is a medical device designed for external fixation of bones, primarily for fracture fixation, joint fusions, and limb lengthening/deformity corrections. The device includes hardware components (rings, plates, struts, wires, accessories) and a web-based software component to assist physicians in adjusting the struts.

The provided document describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain a study comparing the device's performance against specific acceptance criteria in the format requested. Instead, it focuses on the engineering and software validation aspects to support its "substantial equivalence" claim for 510(k) clearance.

Therefore, many of the requested fields cannot be directly extracted from the provided text. However, based on the information provided, we can infer some details regarding the device's validation.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance Statement
Mechanical Performance	Ability of hardware components to withstand expected in vivo loading without failure. Includes: - Drill Tip Wires: Adequate cutting performance. - Pin Connector Hinge and Post: Ability to withstand maximum tightening torque. - Pin Connector Assembly: Adequate mechanical integrity. - Combo Wire Fixation Bolt: Adequate wire pull-out force and maximum threading torque. - ControlFx Strut: Adequate mechanical evaluation.	"A review of the mechanical data indicates that the hardware components of the Circular Fixation System are capable of withstanding expected in vivo loading without failure." Specific tests performed: - Cutting Performance Evaluation of Drill Tip Wires - Evaluation of the maximum Tightening Torque of the Pin Connector Hinge and the Pin Connector Post - Mechanical Evaluation of the Pin Connector Assembly - Evaluation of the Wire Pull-Out Force and Maximum Threading Torque of the Combo Wire Fixation Bolt - Mechanical Evaluation of the ControlFx Strut "A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices."
Software Performance	Software to perform as intended, specifically in assisting the physician in adjusting the six struts by creating a patient adjustment schedule. Adherence to FDA's guidance document "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," dated January 11, 2002. This implies criteria for: - Installation Qualification (IQ): Correct installation and configuration. - Operational Qualification (OQ): Operation according to specifications. - Performance Qualification (PQ): Consistent performance under anticipated conditions.	"software verification and validation testing was completed in line with FDA's guidance document entitled, 'General Principles of Software Validation; Final Guidance for Industry and FDA Staff,' dated January 11, 2002. The results of the testing indicate that the software will perform as intended." Specific tests performed: - Software Installation Qualification Protocol - Software Operational Qualification Protocol - Software Performance Qualification Protocol "A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices."

Study Details (Based on available information)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not explicitly stated. The document refers to "mechanical data" and "software verification and validation testing." For mechanical tests, the sample size would typically refer to the number of components tested for each specific evaluation (e.g., number of wires, pins, struts). For software, it would relate to the test cases executed. These specific numbers are not provided.
- Data Provenance: The nature of the tests (mechanical and software validation) indicates the data would be laboratory-generated rather than clinical patient data. Therefore, "country of origin" of data is not applicable in the clinical sense. The testing was conducted by Smith & Nephew, Inc. (USA) and evaluated by the FDA (USA). The study is not clinical and therefore not retrospective or prospective in the typical medical device context.
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 for this type of submission. This submission is for hardware and software validation, not for diagnostic or predictive AI with a clinical ground truth. The "ground truth" would be established by engineering specifications and correct software functionality as defined by its design and intended output. Expertise would be in materials science, mechanical engineering, and software engineering/validation rather than clinical diagnosis.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 are used in clinical studies, particularly for diagnostic imaging, where multiple human readers assess cases. This document focuses on direct mechanical and software function testing. The "adjudication" for mechanical tests would be acceptance/rejection based on meeting predefined engineering thresholds. For software, it's about whether the software functions according to its validated protocols.
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:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices." The software component assists the physician but its performance was validated as a standalone component, not in a human-AI team context described by MRMC.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a form of standalone performance evaluation was done for the software. The document mentions "software verification and validation testing," including "Software Installation Qualification Protocol," "Software Operational Qualification Protocol," and "Software Performance Qualification Protocol." These are standard procedures to ensure the software itself (the "algorithm only") functions correctly according to its specifications, independent of human interaction during the test process. Its purpose is to assist a human, but the validation described here is for the software's functional correctness.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For Mechanical Performance: The ground truth is generally based on engineering specifications, material properties, and established biomechanical standards for bone fixation devices. The tests verify that components withstand defined forces, torques, and perform cutting as expected.
- For Software Performance: The ground truth is defined by the software's functional specifications and design documentation. The validation protocols (IQ, OQ, PQ) verify that the software delivers the expected outputs and performs its intended calculations accurately according to its design.
The sample size for the training set:
- Not applicable. The software component described here is likely rule-based or algorithmic for adjustment schedules, rather than a machine learning/AI model that requires a distinct "training set." If there were configurable parameters or specific calculations, these would be based on engineering principles and validated through the performance qualification, not "trained" on data samples.
How the ground truth for the training set was established:
- Not applicable. As a non-ML/AI component in the sense of predictive models, there is no "training set" or corresponding ground truth for training. The software's "ground truth" is its deterministic mathematical and logical function in calculating adjustment schedules, which is verified through testing against expected outcomes for given inputs.

Summary

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We are smith&nephew

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	September 27, 2010
Contact Person and Address:	Shereen Myers, Regulatory Affairs SpecialistT (901) 399-6325 F (901) 566-7075
Name of Device:	Smith & Nephew, Inc. Circular Fixation System
Common Name:	Multilateral Fixators and Accessories
Device Classification Name andReference:	21 CFR 888.3030, Single/multiple component metallic bonefixation appliances and accessories.
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	KTT, OSN

Device Description

Full, half, 2/3 and foot rings manufactured from aluminum material. .
. U-plates manufactured from aluminum material.
Adjustable struts manufactured from aluminum material .
. Drill tip wires manufactured from stainless steel material
Accessory components such as rancho cubes, ring connectors, nuts, bolts and centering . sleeves manufactured from stainless steel material
. Disc clips manufactured from polycarbonate material
Half pin caps manufactured from PVC material �
. Web-based software

The Circular Fixation System can also be used with other existing Smith and Nephew, Inc external fixation components.

Technological Characteristics

A review of the mechanical data indicates that the hardware components of the Circular Fixation System are capable of withstanding expected in vivo loading without failure. In addition, software verification and validation testing was completed in line with FDA's guidance document entitled, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," dated January 11, 2002. The results of the testing indicate that the software will perform as intended. The following mechanical and software testing of the Circular Fixation System was performed:

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. Cutting Performance Evaluation of Drill Tip Wires
Evaluation of the maximum Tightening Torque of the Pin Connector Hinge and the Pin . Connector Post
. Mechanical Evaluation of the Pin Connector Assembly
. Evaluation of the Wire Pull-Out Force and Maximum Threading Torque of the Combo Wire Fixation Bolt
. Mechanical Evaluation of the ControlFx Strut
Software Installation Qualification Protocol ●
Software Operational Qualification Protocol .
. Software Performance Qualification Protocol

A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.

Intended Use

The Smith & Nephew Circular Fixation System is intended to be used for post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions. Components in the Smith & Nephew Circular Fixation System are for single use only.

Substantial Equivalence Information

The substantial equivalence of the Circular Fixation System is based on its similarities in indications for use, design features, operational principles, and materials to the following predicate systems:

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew	Illizarov (Richards) External FixationSystem	K870961	03-19-1987
Smith & Nephew	Illizarov External Fixation System	K962808	08-19-1996
Smith & Nephew	Taylor Spatial Frame	K970748	05-09-1997
Smith & Nephew	External Fixation System	K994143	02-18-2000
Smith & Nephew	Jet-X Bar System Clamps, Bar andPosts	K072212	03-07-2008
Smith & Nephew	VLP Foot Plating, Screw system andAccessories	K090675	06-04-2009

Conclusion

As previously noted, this Traditional Premarket Notification is being submitted to request clearance for the Circular Fixation system. Based on the similarities to the predicate components and a review of the mechanical and software testing performed, the devices are substantially equivalent to above predicate external fixation systems.

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Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers of the bird. The image is in black and white.

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

Smith and Nephew Endoscopy, Inc. % Ms. Shereen Myers Regulatory Affairs Specialist 1450 E Brooks Road -Memphis, TN 38116

SEP 2 7 2010

Re: K093047

Trade/Device Name: Smith & Nephew Circular Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, OSN Dated: August 13, 2010 Received: August 13, 2010

Dear Ms. Myers:

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. Iisting 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

{3}------------------------------------------------

Page 2 - Ms. Shereen Myers

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as settonic device-related adverse events) (21 CFR Pat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r (1580) html (2011) (1) ================================================ If you desire specific advice tor your device of to allothers/ucm II 1589.htm for a go to http://www.lda.gov/About/DA/CentersOft of CDRH's) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH) stocket natifiestion" (21C the Center for Devices and Radional by reference to premarket notification" (21 CFR Pat
note the regulation entitled, "Misbranding by reference to verder the MDP regulation ( note the regulation entitled, "Miscanding of reference wents under the MDR regulation (21 CFR Part 803), please go to

CFR Part 803), please go to Illip.77www.ida.gov.riednetrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may oftain other general information on your respected at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

(800) 038-2041 of (501) 770 7100 er artistics of You/Industry/default.htm.

Sincerely yours,

Mark McMillan

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

K093047

SEP 2 7 2010

510(k) Number (if known): K093047

Device Name: Smith & Nephew Circular Fixation System

Indications for Use:

The Smith & Nephew Circular Fixation system is intended to be used for the following indications:

Post-traumatic joint contracture which has resulted in loss of range of motion .
Fractures and disease which generally may result in joint contractures or loss of . range of motion and fractures requiring distraction
Open and closed fracture fixation .
Pseudoarthrosis of long bones .
Limb lengthening by epiphyseal or metaphyseal distraction .
Correction of bony or soft tissue deformities ●
Correction of bony or soft tissue defects .
Joint arthrodesis ●
Infected fractures or nonunions .

Components in the Smith & Nephew Circular Fixation 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)

Srutu for mxm
(Division Sign Off)

Division of Surgical rthonedic and Restorative Devic

510(k) Number: K093047

4-1

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.