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 notification are modifications to the SURESHOT™ Targeting System. The modifications to the SURESHOT™ Targeting System V3.0 include the implementation of the drill depth measurement function, the ability to target for 8.5mm Japanese nails, an updated graphical user interface, updates to the Launcher program, and the addition of new drill sleeves.

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 sensorembedded 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 drill depth measurement application aspect of the software. The devices subject of this premarket notification include:

SURESHOT™ Distal Targeting System Software V3.0 .
SURESHOT™ Trauma Launcher Software V1.1.1 .
SURESHOT™ Drill Depth Inner Drill Sleeves .
SURESHOTTM Drill Depth Outer Screw Sleeve .

No new implants are being cleared via this premarket notification.

AI/ML Overview

This document describes a Special 510(k) Premarket Notification for modifications to the SURESHOT™ Distal Targeting System V3.0. The notification focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a standalone study with acceptance criteria and a detailed validation report.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the modified device (SURESHOT™ Distal Targeting System V3.0). Instead, it relies on demonstrating that the software modifications perform "as intended" and do not introduce new safety or effectiveness issues, aligning with the performance of its predicate devices.

The "Technological Characteristics" section states: "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."

This implies that the acceptance criteria were met through standard software validation processes, which typically involve demonstrating that the software functions according to its specifications and user requirements. However, the exact performance metrics or thresholds are not detailed in this submission. The "reported device performance" is essentially that the device performs equivalently to the predicate devices without introducing new risks.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a clinical or performance study of the modified device. The submission explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject device."

The software validation and verification would have involved various testing scenarios, but these are generally considered engineering tests rather than clinical studies using patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

As no clinical test set is described, there's no mention of experts establishing ground truth for such a set. Software validation typically involves testing by engineers and possibly clinical subject matter experts (e.g., surgeons in a simulated environment) to verify functionality, but this is not equivalent to establishing ground truth for a diagnostic or predictive AI model.

4. Adjudication Method for the Test Set:

Not applicable, as no external test set requiring expert adjudication for ground truth establishment is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not conducted. The document states that "Clinical data was not needed to support the safety and effectiveness of the subject device." The focus was on demonstrating substantial equivalence through software validation and comparison to predicate devices, not on quantifying the improvement of human readers with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

While software verification and validation would involve evaluating the algorithm's performance in a standalone manner (e.g., in a test environment), the document does not present this as a formal "standalone performance study" with specific metrics. The device is a "computer assisted orthopedic surgery tool to aid the surgeon," inherently designed for human-in-the-loop use. The "standalone" evaluation would be part of the general software V&V, ensuring the system calculates and assists correctly.

7. The Type of Ground Truth Used:

For the software validation, the "ground truth" would be the expected output and behavior of the software based on its design specifications and user requirements. This is established through engineering design, mathematical models, and simulated scenarios, not typically through clinical labels like pathology or outcomes data in this context. The accuracy of the electromagnetic tracking system itself would have been validated in previous submissions or as part of the overall system's design, likely against known physical measurements.

8. The Sample Size for the Training Set:

The document does not describe an AI/machine learning training set. This device is a "computer assisted surgery system" that uses electromagnetic tracking, not a system that relies on machine learning or AI models trained on large datasets. Therefore, there is no "training set" in the context of typical AI device submissions.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no AI/machine learning training set is described.

Summary

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We are smith&nephew

Submitted by:	Smith & Nephew, Inc.Advanced Surgical Devices Division1450 East Brooks RoadMemphis, Tennessee 38116	K130748Page 1 of 3
Date of Summary:	March 5, 2013
Contact Person and Address:	Bradley Heil, Regulatory Affairs SpecialistT (901) 399-6339F (901) 566-7831
Name of Device:	Smith & Nephew, Inc. SURESHOT™ Distal Targeting SystemV3.0
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 V3.0 .
SURESHOT™ Trauma Launcher Software V1.1.1 .
SURESHOT™ Drill Depth Inner Drill Sleeves .
SURESHOTTM Drill Depth Outer Screw Sleeve .

No new implants are being cleared via this premarket notification.

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K130748 Page 2 of 3

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

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Substantial Equivalence Information

The substantial equivalence of the SURESHOT™ 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	ClearanceDate
Smith & Nephew	Smith & Nephew PiGalileo ScrewTargeting System V1.1	K092497	09/11/09
Smith & Nephew	Smith & Nephew SURESHOT™Distal Targeting System v.2.0	K100107	02/23/10
Smith & Nephew	Smith & Nephew SURESHOT™Distal Targeting System v.2.0.2	K102967	11/04/10
Smith & Nephew	Smith & Nephew SURESHOT™Distal Targeting System v.2.1	K110240	4/14/11

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

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Design AspectReviewed	SURESHOT™Distal TargetingSystem v.3.0	SURESHOT™Distal TargetingSystem v.2.1	PiGalileo ScrewTargeting SystemV1.1	SURESHOTDistalTargetingSystem v.2.0	SURESHOTDistalTargetingSystemv.2.0.2
510(k)Number		K110240	K092497	K100107	K102967
Manufacturer	Smith & Nephew	Smith & Nephew	Smith & Nephew	Smith &Nephew	Smith &Nephew
SimilarIndicationsfor Use?	Y	Y	Y	Y	Y
Intended Use	Intraoperative image guided localization system
Instrumentation	Used to assist surgeon in placing nail implants and for specific use with the distal targetingsoftware
SimilarSterilization?	Y	Y	Y	Y	Y
SimilarPackaging?	Y	Y	Y	Y	Y
SimilarMaterials?	Y	Y	Y	Y	Y
SoftwareDesign	Providesinformation to thesurgeon that isused to placesurgicalinstrumentsduring surgeryutilizingintraoperativelyobtainedelectromagnetictracking data.Addition of drilldepthmeasurement,Trauma Launcherupdates, GUIupdates, newinstrument andJapan Nailapplication	Providesinformation to thesurgeon that isused to placesurgicalinstrumentsduring surgeryutilizingintraoperativelyobtainedelectromagnetictracking data.Addition ofhumeral nailapplication	Provides information to the surgeon that is usedto place surgical instruments during surgeryutilizing intraoperatively obtainedelectromagnetic tracking data.

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

Conclusion

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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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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of what appears to be an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

August 4, 2013

Smith & Nephew, Inc. % Mr. Bradley Heil 1450 Brooks Road Memphis, Tennessee 38116

Re: K130748

Trade/Device Name: Sureshot Distal Targeting System V3.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: July 01, 2013 Received: July 03, 2013

Dear Mr. Heil:

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 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 of medical

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Page 2 - Mr. Bradley Heil

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/ucm | 1.5809.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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

FOR

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Indications for Use Statement

K130748 510(k) Number (if known):

Device Name: SURESHOT Targeting System V3.0

Indications for 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 SURESHOT Targeting System is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.

Prescription Use (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)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

DSD-DIVISION SIGN-OFF	Joshua C. Nipper
Division of Surgical Devices	-S
510(k) Number:	K130748

一 Page _________________________________________________________________________________________________________________________________________________________________________

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).