The Smith & Nephew SURESHOT Targeting System is intended to be an intraoperative image guided localization system. It is a computer assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing intraoperatively obtained electromagnetic tracking data. The Smith & Nephew SURESHOT Targeting System is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.

Device Description

Subject of this premarket notifications to the SURESHOT Targeting System. The modifications to the SURESHOT® Targeting System V2.1 implement the ability to target for humeral nails, along with the former applications with the META, TAN and FAN Nails previously cleared via K100107. Targeting for humeral nail is implemented in the same way as for META/TAN nails.

The SURESHOT® Targeting System is a computer controlled electromagnetic tracking system. It assists the surgeon in locating and positioning screws in an intramedullary nail implant during orthopedic trauma surgery. The link between the sterile surgical area (patient) and the instrument system is provided through an electromagnetic tracking system. Electromagnetic spatial measurement systems determine the location of instruments that are embedded with sensor coils. When the sensor-embedded instrument is placed inside controlled, varying magnetic fields, voltages are induced in the sensor coils. These induced voltages are used by the measurement system to calculate a 3D virtual position of the instrument. Because the magnetic fields are of a low field strength and can safely pass through human tissue, location measurement of an object is possible without the line-of-sight constraints of an optical spatial measurement system that requires a camera.

The SURESHOT® Distal Targeting System software is intended to be used with existing Smith & Nephew platform, instruments and implants. New instrumentation has been developed for the humeral nail application aspect of the software. The devices subject of this premarket notification include:

SURESHOT® Distal Targeting System Software V2.1 .
- Humeral Set Stop .
- Humeral Drill Guide Probe .
- Humeral Hexdriver
- Humeral Drill Sleeve .
- . Humeral AO Drill

No new implants are being cleared via this premarket notification

AI/ML Overview

The provided text describes the Smith & Nephew SURESHOT® Distal Targeting System V2.1, a computer-assisted surgical system, and its premarket notification (K110240). However, it does not contain information about specific acceptance criteria or a dedicated study proving the device meets those criteria in terms of quantitative performance metrics.

Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices by highlighting similarities in:

Indications for Use: The system is an intraoperative image-guided localization system to aid surgeons with drill positioning for screws during intramedullary nail implantation.
Design Features: It's a computer-controlled electromagnetic tracking system. The V2.1 version adds humeral nail targeting capability.
Sterilization Methods and Operational Principles.

The primary method of demonstrating safety and effectiveness for this type of submission (a Special 510(k) for software modification) is through software verification and validation testing, not through a clinical performance study with defined acceptance criteria for accuracy, sensitivity, or specificity.

Therefore, the requested information cannot be fully extracted as a specific clinical study with detailed performance metrics and acceptance criteria, as one was not presented in the provided document for K110240.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Acceptance Criteria (Anticipated for a clinical performance study)	Reported Device Performance (from text)
Not specified in the provided document	Not specified in the provided document

Reasoning: The document states, "Software verification and validation testing was completed... A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject device and the software will perform as intended. Clinical data was not needed to support the safety and effectiveness of the subject device." This indicates that a study with defined performance metrics and acceptance criteria was not part of this 510(k) submission. The FDA clearance letter also supports this by stating the device is "substantially equivalent" to predicates, implying a comparison on design and intended use, rather than a new performance study.

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

Sample Size: Not applicable/Not provided. No clinical test set data was used.
Data Provenance: Not applicable/Not provided.

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)

Number of experts: Not applicable/Not provided.
Qualifications of experts: Not applicable/Not provided.

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

Adjudication method: Not applicable/Not provided.

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

MRMC study: No.
Effect size: Not applicable.

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

Standalone performance: No. The device is described as "an intraoperative image guided localization system" and a "computer assisted orthopedic surgery tool to aid the surgeon," clearly indicating a human-in-the-loop system, not a standalone algorithm. Also, the document explicitly states "Clinical data was not needed to support the safety and effectiveness of the subject device."

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

Type of ground truth: Not applicable/Not provided. The submission relies on software verification and validation to demonstrate proper function, rather than clinical ground truth.

8. The sample size for the training set

Sample Size: Not applicable/Not provided. This device is an electromagnetic tracking system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "software design" mentioned refers to the system's logic and functionality, not a trained model.

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

Ground truth for training set: Not applicable/Not provided.

In summary, the provided submission for K110240 is a Special 510(k) focusing on a software modification (adding humeral nail targeting) to an existing device. It relies on software verification and validation and a demonstration of substantial equivalence to predicate devices, rather than a new clinical study with performance metrics and acceptance criteria. Therefore, most of the requested details related to clinical studies, ground truth establishment, and sample sizes are not present in the document.

Summary

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Kilo240

p. 1/3

Ne are smith&nephew

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	January 26, 2011
Contact Person and Address:	Shereen Myers, Regulatory Affairs SpecialistT (901) 399-6325 F (901) 566-7075
Name of Device:	Smith & Nephew, Inc. SURESHOT® Distal Targeting System V2.1
Common Name:	Computer Assisted Surgery System
Device Classification Name andReference:	21 CFR 882.4560 Stereotaxic Instrument - Class II
Device Class:	Class II
Panel Code:	Neurology/84
Product Code:	OLO

Device Description

SURESHOT® Distal Targeting System Software V2.1 .
- Humeral Set Stop .
- Humeral Drill Guide Probe .
- Humeral Hexdriver �
- Humeral Drill Sleeve .
- . Humeral AO Drill

No new implants are being cleared via this premarket notification

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Image /page/1/Picture/0 description: The image shows handwritten text. The text on the left reads "K110240". To the right of that, the text reads "p. 2/3". The handwriting is in black ink on a white background.

Technological Characteristics

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

Intended Use

The Smith & Nephew SURESHOT® Targeting System is intended to be an intraoperative image guided localization system. It is a computer assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing intraoperatively obtained electromagnetic tracking data. The Smith & Nephew SURESHOTY Targeting System is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.

Substantial Equivalence Information

The substantial equivalence of the SURESHO™ Targeting System software is based on its similarities in indications for use, design features, sterilization methods and operational principles to the predicate systems listed in the following table.

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew	Smith & Nephew PiGalileo Screw TargetingSystem V1.1	K092497	09/11/09
Smith & Nephew	Smith & Nephew SURESHOT® DistalTargeting System v.2.0	K100107	02/23/10
Smith & Nephew	Smith & Nephew SURESHOT® DistalTargeting System v.2.0.2	K102967	11/04/10
Smith & Nephew	Journey CR Knee System	K101499	08/26/10

Table 1: Substantially Equivalent Predicate Systems to SURESHOT® Targeting System

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K110240 p. 3/3

A comparison of the subject device to the predicate devices is described in the following table.

Table 2: Comparison of Substantial Equivalence

Design AspectReviewed	SURESHOT® DistalTargeting Systemv.2.1	PiGalileo ScrewTargeting SystemV1.1	SURESHOTDistalTargetingSystem v.2.0	SURESHOTDistalTargetingSystemv.2.0.2	Journey CR KneeSystem
510(k) Number	K110240	K092497	K100107	K102967	K101499
Manufacturer	Smith & Nephew	Smith & Nephew	Smith &Nephew	Smith &Nephew	Smith & Nephew
SimilarIndications forUse?	Y	Y	Y	Y	N
Intended Use	Intraoperative image guided localization system
Instrumentation	Used to assist surgeon in placing nail implants and for specific use with thedistal targeting software	Total cruciate retaining knee implant systemUsed to assist surgeon in implanting total knee components
SimilarSterilization?	Y	Y	Y	Y	Y
SimilarPackaging?	Y	Y	Y	Y	Y
SimilarMaterials?	Y	Y	Y	Y	N
SoftwareDesign	Provides informationto the surgeon thatis used to placesurgical instrumentsduring surgeryutilizingintraoperativelyobtainedelectromagnetictracking data.Addition of humeralnail application	Provides information to the surgeon that is used toplace surgical instruments during surgery utilizingintraoperatively obtained electromagnetic trackingdata.	N/A

Conclusion

As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the SURESHOT Targeting System software modifications. Based on the similarities to the predicate components and a review of the validation testing performed, the device is substantially equivalent to above predicate systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem features a staff with a serpent entwined around it, and a pair of wings at the top.

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

Smith & Nephew, Inc. % Ms. Shereen Myers 1450 Brooks Road Memphis, Tennessee 38116

APR 1 4 2011

Re: K110240

Trade/Device Name: Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: March 15, 2011 Received: March 16, 2011

. . . . . . . . . . . . . . . .

1000

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 – Ms. Shereen Myers

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.

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.

Sincerely vours.

Ating B. Reta
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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KiiOayo p. 1/

Premarket Notification Indications for Use Statement

510(k) Number (if known):

Device Name: SURESHOT Targeting System V2.1

Indications for Use:

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil K. Dale for mkin
Division Sign bm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110240

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).