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 to include software updates (V4.0) to include the ability to target for the TRIGEN META-TAN Nail (previously cleared in K092748), the ability for on screen rotation using the SURESHOT™ Targeter, additional languages of the graphical user interface (for international users), updates to the graphical user interface, and updates to the Launcher program

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 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. No new instruments or implants are being cleared via this premarket notification.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Smith & Nephew SURESHOT™ Distal Targeting System V4.0. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and a standalone study proving device performance against specific targets.

However, I can extract information related to software validation and verification testing, which serves as the basis for demonstrating the device works as intended.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding device performance metrics (e.g., accuracy in mm, failure rate thresholds). Instead, it states that "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 acceptance criteria are implicitly met if the listed preclinical tests passed, demonstrating that the "software will perform as intended." The reported performance is that "there are no new issues related to the safety and effectiveness of the subject device and the software will perform as intended as compared to the predicate."

Implicit Acceptance Criteria (based on tests performed):

Test Category	Implied Acceptance Criterion	Reported Performance
Software Validation & Verification	Software functions as designed, without introducing new safety or effectiveness issues.	All tests passed; no new safety/effectiveness issues.
Deployment Distal Targeting Software	Software deploys and functions correctly for distal targeting.	Performed as intended.
Workflow and System Settings	Workflow and system settings operate correctly.	Performed as intended.
Tool Connections	Tools connect reliably and are recognized by the system.	Performed as intended.
Sleeve Selection	Sleeve selection functions correctly.	Performed as intended.
Implant Selection	Implant selection functions correctly.	Performed as intended.
Drilling Screen	Drilling screen displays correct information and functionality.	Performed as intended.
Hardware Failure	System handles hardware failures gracefully or as designed.	Performed as intended.
Drill Depth Measurement	Drill depth measurement is accurate (though specific precision not stated).	Performed as intended.
Targeting Calculations (META, TAN/FAN, Humeral, META-TAN, Field Check)	Targeting calculations for various nail types are accurate and reliable.	Performed as intended.
Translations (Chinese, English, French, German, Italian, Japanese, Portuguese, Finnish, Spanish)	Graphical User Interface (GUI) is correctly translated and functional in specified languages.	Performed as intended.
Nail Rotation	Nail rotation functionality operates correctly.	Performed as intended.
View Selection	View selection functionality operates correctly.	Performed as intended.
Customer Validation	(Details not provided, but implies the software meets user needs/expectations).	Performed as intended.
Regression Test	(Details not provided, but implies new changes did not adversely affect existing functionality).	Performed as intended.

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

The document does not specify a "test set" in terms of subject or case count for the preclinical testing. The tests listed are functional and technical software validation tests, typically performed in a controlled environment. Clinical data was explicitly not used or needed to support the safety and effectiveness of the subject device for this 510(k) submission. Therefore, there's no data provenance in the context of clinical studies (e.g., country of origin, retrospective/prospective).

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

Not applicable. The preclinical software tests described do not involve human expert adjudication of medical images or diagnoses to establish a "ground truth." The ground truth for these tests would be the intended software behavior and calculation correctness as defined by engineering specifications.

4. Adjudication Method for the Test Set

Not applicable, as no expert adjudication for medical data is described. The "adjudication" for software testing would be the engineering team verifying that the test results match the expected outcomes.

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

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 device." The submission relies on demonstrating substantial equivalence to a predicate device and software verification/validation.

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

The listed preclinical tests are essentially standalone algorithm/software verification, focusing on the functionality and calculations of the device's software. The device itself (SURESHOT™ Distal Targeting System) is an "intraoperative image guided localization system" and a "computer assisted orthopedic surgery tool to aid the surgeon with drill positioning," implying a human-in-the-loop during actual clinical use. However, the testing described is of the underlying software's performance (e.g., targeting calculations, GUI functionality) in a controlled environment, which can be considered standalone verification of the software components.

7. The Type of Ground Truth Used

For the software validation and verification, the "ground truth" is likely defined by:

Design specifications: The intended behavior, outputs, and calculations as per the software design documents.
Known correct values: For calculations (e.g., "Targeting Calculations META"), the ground truth would be precise, pre-calculated results for a given input.
Previous versions' behavior: For regression testing, the ground truth is the expected behavior of the existing features from prior, cleared versions.

8. The Sample Size for the Training Set

Not applicable. The text describes software updates to an existing system and verification/validation testing. This is not a machine learning model, so there is no training set in the typical sense.

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

Not applicable, as there is no training set for a machine learning model described.

Summary

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Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The text is left-aligned and in a simple font.

April 28, 2017

Smith & Nephew, Inc. Allison Chan Regulatory Affairs Specialist II 1450 East Brooks Road Memphis. Tennessee 38116

Re: K170280

Trade/Device Name: Smith & Nephew SURESHOT™ Distal Targeting System V4.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: January 27, 2017 Received: January 30, 2017

Dear Allison Chan:

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 device

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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Lori A. Wiggins -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.

510(k) Number (if known)	K170280
Device Name	SURESHOT TM Distal Targeting System V4.0
Indications for Use (Describe)	The Smith & Nephew SURESHOT TM 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 TM Targeting System is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.

510(k) Number (if known)

K170280

Device Name

SURESHOT TM Distal Targeting System V4.0

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)	Page 1 of 1	PSC Publishing Services (301) 443-6740	EF
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Image /page/3/Picture/0 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange.

Submitted by:	Smith & Nephew, Inc.Advanced Surgical Devices Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	April 24, 2017
Contact Person and Address:	Allison ChanRegulatory Affairs Specialist IIT 901-399-1098
Name of Device:	Smith & Nephew, Inc. SURESHOT™ DistalTargeting System V4.0Computer Assisted Surgery System
Device Classification Nameand Reference:	21 CFR 888.4560 Stereotaxic Instrument
Device Class:	Class II
Panel Code:	Neurology/84
Product Code:	OLO

Device Description

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Indications for Use

The Smith & Nephew SURESHOT™ Targeting System is intended to be an intraoperative image quided 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.

Comparison to Technological Characteristics with the Predicate Device

Device comparisons described in this premarket notification demonstrated that the proposed SURESHOT™ Targeting System is equivalent to the legally marketed predicate devices cleared in the below table with regard to intended use, indications for use, and performance characteristics.

The subject devices feature characteristics as previously cleared in K130748 with the primary differences being additional software features which include the ability to target for the TRIGEN META-TAN Nail (previously cleared in K092748), the ability for on screen rotation using the SURESHOT™ Targeter, additional languages of the graphical user interface (for international users), updates to the graphical user interface, and updates to the Launcher program

Summary of Pre-Clinical Testing

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. Preclinical testing included the following tests:

12.102 Software Validation and Verification Report .
12.201 Deployment Distal Targeting Software ●
12.301 Workflow and System Settings ●
12.302 Tool Connections
12.303 Sleeve Selection .
12.304 Implant Selection
. 12.305 Drilling Screen
. 12.306 Hardware Failure
. 12.307 Drill Depth Measurement
12.308 Targeting Calculations META ●
12.309 Targeting Calculations TAN/FAN
12.310 Targeting Calculations Humeral
12.311 Targeting Calculations Field Check
12.312 Targeting Calculations META-TAN
. 12.313 Translations Chinese
12.314 Translations English ●
12.315 Translations French ●
12.316 Translations German .

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12.317 Translations Italian ●
. 12.318 Translations Japanese
12.319 Translation Portuquese .
12.320 Translation Finnish
. 12.321 Translation Spanish
. 12.322 Nail Rotation
12.323 View Selection .
12.401 Customer Validation .
12.402 Regression Test .

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 as compared to the predicate. Clinical data was not needed to support the safety and effectiveness of the subject device.

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 & NephewSURESHOT™ Distal TargetingSystem V.3.0	K130748	August 4,2013
Smith &Nephew	Smith & NephewSURESHOT™ Distal Targetingsystem V.2.1	K110240	April 4, 2011
Smith &Nephew	Smith & NephewSURESHOT™ Distal TargetingSystem V.2.0.2	K102967	November 4,2010
Smith &Nephew	Smith & NephewSURESHOT™ Distal TargetingSystem V.2.0	K100107	February 23,2010
Smith &Nephew	Smith & Nephew PiGalileoScrew Targeting System V1.1	K092497	September11, 2009

Table 5.1: Substantially Equivalent Predicate Systems to SURESHOT™ Targeting System

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Design AspectReviewed	SURESHOT™Distal TargetingSystem v.4.0	SURESHOT™Distal TargetingSystem v.3.0 –primarypredicate	SURESHOT™Distal TargetingSystem v.2.1	SURESHOTDistal TargetingSystem v.2.0.2	SURESHOTDistal TargetingSystem v.2.0	PiGalileo ScrewTargetingSystem V1.1
510(k) Number	Subject Device	K130748	K110240	K102967	K100107	K092497
Manufacturer	Smith & Nephew	Smith & Nephew	Smith & Nephew	Smith & Nephew	Smith & Nephew	Smith & Nephew
SimilarIndications forUse?	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 nailimplantation. It provides information to the surgeon that is used to place surgical instruments during surgery utilizingintraoperatively obtained electromagnetic tracking data. The Smith & Nephew SURESHOT ™ Targeting System is indicatedfor long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.
Intended Use	Intraoperative image guided localization system
Instrumentation	Used to assist surgeon in placing nail implants and for specific use with the distal targeting software
SimilarSterilization?	Y	Y	Y	Y	Y	Y
SimilarPackaging?	Y	Y	Y	Y	Y	Y
SimilarMaterials?	Y	Y	Y	Y	Y	Y
SoftwareDesign	Addition of abilityto target forTRIGEN META-	Addition of drilldepthmeasurement,	Addition ofhumeral nailapplication.
Design AspectReviewed	SURESHOT™Distal TargetingSystem v.4.0	SURESHOT™Distal TargetingSystem v.3.0 –primarypredicate	SURESHOT™Distal TargetingSystem v.2.1	SURESHOTDistal TargetingSystem v.2.0.2	SURESHOTDistal TargetingSystem v.2.0	PiGalileo ScrewTargetingSystem V1.1
	(K092748),updates toTraumaLauncherprogram, abilityof on screenimage rotationusing targeter,additionallanguages forthe graphicaluser interface,updates tographical userinterface.	Launcherupdates, GUIupdates, newinstrument andJapan Nailapplication.

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

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Conclusion

The SURESHOT™ Distal Targeting System V4.0 is substantially equivalent to the existing System V3.0 cleared in K130748 in that the indications for these devices are identical and the core technological principals for these devices are also equivalent.

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).