The Smith & Nephew Spatialframe.com software is intended to be used as component of multilateral external fixation systems that are indicated for the following: 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.

Device Description

Subject of this Special 510(k) premarket notification is the Smith & Nephew Spatialframe.com version 4.1 Software. The subject device is a web-based software component of 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 software is designed to be used to assist the physician in adjusting the external fixator frame by creating a patient adjustment schedule. The Spatialframe.com software receives inputs measurements taken by the physician and produces outputs recommending adjustments to the fixator that define a correction path for the deformity.

AI/ML Overview

The provided document describes the Smith & Nephew Spatialframe.com Software version 4.1, a web-based software component for multilateral external fixation systems. It states that software verification and validation testing was completed in line with FDA's guidance document, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," dated January 11, 2002.

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Reported Device Performance (as per submission)
Software Validation	- Software Installation Qualification Protocol completed.- Software Operational Qualification Protocol completed.- Software Performance Qualification Protocol completed.
Functional Performance	"The results of the testing indicate that the software will perform as intended."
Safety and Effectiveness	"A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject device."

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

The document does not specify a sample size for a "test set" in the context of clinical or diagnostic performance. The testing described relates to software validation activities (Installation, Operational, Performance Qualification) rather than evaluation of diagnostic or predictive accuracy on a dataset of patient cases. There is no information provided about data provenance (e.g., country of origin, retrospective or prospective data) because no clinical data or patient datasets were used for performance evaluation in this submission.

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

This information is not applicable as the submission states, "Clinical data was not needed to support the safety and effectiveness of the subject device." The software validation outlined does not involve establishing ground truth from expert consensus on medical cases.

4. Adjudication method for the test set:

This information is not applicable as no test set requiring expert adjudication was used.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device is software designed to assist physicians in adjusting an external fixator frame by creating an adjustment schedule, not a diagnostic AI tool that human readers would interpret.

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

A standalone performance evaluation in the context of diagnostic accuracy was not explicitly described or presented. The software's "performance as intended" refers to its functional operation as a calculation and recommendation tool based on physician inputs, not its ability to standalone diagnose or interpret medical images.

7. The type of ground truth used:

Ground truth in the medical diagnostic sense (e.g., pathology, outcomes data, expert consensus on patient cases) was not used. The "ground truth" for the software's performance was its adherence to specified functional requirements and its ability to correctly process inputs and generate outputs according to its design, as assessed during software qualification protocols.

8. The sample size for the training set:

A training set, in the context of machine learning or AI models, was not mentioned or applicable to this submission. The software described is a rule-based or algorithmic tool for calculating adjustment schedules, not an AI model requiring a training set.

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

This information is not applicable as there was no training set for a machine learning model.

Summary

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K110069(112)

FEB - 8 2011 - We are smith&nephew

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	January 7, 2011
Contact Person and Address:	Shereen Myers, Regulatory Affairs SpecialistT (901) 399-6325 F (901) 566-7075
Name of Device:	Smith & Nephew, Inc. Spatialframe.com Software version 4.1
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

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 following software testing of the Spatialframe.com v4.1 software was performed:

Software Installation Qualification Protocol .
Software Operational Qualification Protocol .
Software Performance Qualification Protocol .

The results of the testing indicate that the software will perform as intended. A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject device. Clinical data was not needed to support the safety and effectiveness of the subject device.

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Intended Use

The Smith & Nephew Spatialframe.com software is intended to be used as a component of multilateral external fixation systems that are indicated for the following: 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 distraction; correction of bony or soft tissue deformilies; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.

Substantial Equivalence Information

The substantial equivalence of the Spatialframe.com Software version 4.1 is based on its similarities in indications for use, design features, and operational principles to the predicate system listed in the table below.

			Table 1: Substantially Equivalent Predicate System
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Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew, Inc.	Circular Fixation System	K093047	09/27/2010

Conclusion

As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the Spatialframe.com Software, version 4.1. Based on the similarities to the predicate component and a review of the validation testing performed, the device is substantially equivalent to above predicate system.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

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. Tennessee 38116

FEB - 8 2011

Re: K110069

Trade/Device Name: Smith & Nephew Spatialframe.com version 4.1 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: January 7. 2011 Received: January 10, 2011

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, 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

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Page 2 - Ms. Shereen Myers

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 (OS) 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

AC. B. n.tc
for

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

510(k) Number (if known): _ K \ | DD 69

Device Name: Smith & Nephew Spatialframe.com version 4.1

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (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)

(Division/Sign-Off) for M. Merkerson

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110069

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.