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™ Distal Targeting System V4.0- targeter which has been designed with a reduced size and weight compared to the previous design of the targeter (K092497). The SURESHOT Targeting system targeter is intended to be used the SURESHOT trauma interfaces (K170977, K100107) and software V4.0 (K170280).

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 V4.0 targeter is intended to be used with existing Smith & Nephew software, trauma interface, 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. The submission focuses on modifications to an existing device (targeter) with reduced size and weight, and largely relies on the substantial equivalence to a predicate device (PiGalileo Screw Targeting System V1.1) and pre-clinical testing.

Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them:

Overall Conclusion from the Document:

The document states that "Clinical data was not needed to support the safety and effectiveness of the subject device." This is a crucial piece of information, as it indicates that the FDA's acceptance was primarily based on:

Substantial Equivalence: Demonstrating that the modified device is as safe and effective as a legally marketed predicate device with identical indications for use and equivalent technological principles, despite minor design changes (reduced size/weight).
Pre-clinical Testing (Verification and Validation): Ensuring the device's functionality, electrical safety, electromagnetic compatibility, and software performance meet specified standards.

Therefore, for the SURESHOT Distal Targeting System V4.0 targeter, the "acceptance criteria" are not framed as specific performance metrics derived from a human-in-the-loop or standalone AI study, but rather as successful demonstration of substantial equivalence and compliance with engineering/software V&V standards.

Detailed Breakdown for the SURESHOT Distal Targeting System V4.0:

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

Since no clinical study data with specific performance metrics (like accuracy, sensitivity, specificity, etc., which are common for AI/diagnostic devices) are provided, the "acceptance criteria" are derived from the substantial equivalence and pre-clinical testing mentioned.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from document)	Reported Device Performance/Outcome
Substantial Equivalence	Identical Indications for Use to Predicate Device	The Indications for Use for the SURESHOT Distal Targeting System V4.0 are identical to the PiGalileo Screw Targeting System V1.1 predicate device. Both are intended to be intraoperative image-guided localization systems, computer-assisted orthopedic surgery tools for drill positioning during intramedullary nail implantation, providing information using intraoperatively obtained electromagnetic tracking data for long bone fractures treated with intramedullary nails where stereotactic surgery is appropriate.
	Similar Technological Principles/Operational Principles to Predicate Device	The core technological principles for both the subject device and the predicate device are equivalent. Both are based on electromagnetic tracking technology, determining 3D virtual positions using sensor coils in controlled magnetic fields. The subject device generates the same electromagnetic tracking technology as the existing targeter in the predicate.
	Similar Design (with minor, non-impacting changes)	The subject device features characteristics "as previously cleared in K092497 with the primary differences being the reduced size and weight." This implies the fundamental design remains similar, with only these specific modifications. The document states "Similar Design: Y". The overall weight changed from ~1kg (predicate) to ~750g (subject device).
	Similar Materials, Sterilization, Packaging	The document confirms "Similar Sterilization: Y" and "Similar Packaging: Y", and "Similar Materials: Y".
Pre-clinical Testing	Compliance with Electromagnetic Compatibility (EMC) standards (IEC 60601-1-2:2007 Class A)	"Results of the electromagnetic compatibility and electrical safety validation testing demonstrate the device is found to meet the application performance requirements to those standards."
	Compliance with Electrical Safety standards (IEC 60601-1: 2005 + A1:2012)	"Results of the electromagnetic compatibility and electrical safety validation testing demonstrate the device is found to meet the application performance requirements to those standards."
	Software Verification & Validation (V&V) per FDA Guidance ("General Principles of Software Validation; Final Guidance for Industry and FDA Staff," Jan 11, 2002) including specific functional and performance tests.	"Software verification and validation testing was completed in line with FDA's guidance document..." A list of 24 specific software tests was conducted (e.g., Workflow and System Settings, Tool Connections, Targeting Calculations META/TAN/FAN/Humeral/Field Check, Drill Depth Measurement, Nail Rotation, Translations, Customer Validation, 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." The subject device software (SURSHOT Distal Targeting System V4.0 software (K170280)) is compatible with the system.

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

Test Set Sample Size: Not applicable in the context of clinical data for performance evaluation. The "test set" here refers to the units of the device and associated software/hardware components subjected to engineering and software verification/validation tests. The document doesn't specify the number of physical targeters or software instances used for these tests, but it indicates the tests were conducted successfully.
Data Provenance: The data provenance is from internal Smith & Nephew pre-clinical testing, performed to demonstrate compliance with standards and equivalence. It is not patient or clinical data, thus "country of origin" and "retrospective/prospective" are not relevant in this context.

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

Not applicable. As this approval is based on substantial equivalence and pre-clinical V&V, there was no "ground truth" derived from expert medical review of patient data. The "ground truth" for the engineering tests would be the established engineering specifications and regulatory standards. The experts involved would be engineers, quality assurance personnel, and regulatory affairs specialists within Smith & Nephew who designed, built, tested, and submitted the device. Their qualifications would align with these disciplines.

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

Not applicable. No clinical test set requiring human adjudication of ground truth was conducted. The "adjudication" in this context would be the internal review and sign-off processes for engineering and software validation reports, ensuring tests met predefined acceptance criteria.

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:

No. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject device." Therefore, no MRMC study, or any clinical comparative effectiveness study involving human readers/users, was performed or presented. This device is a surgical tool, not an AI diagnostic/interpretative device the FDA typically reviews with MRMC studies.

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

Not directly applicable in the terms of standalone diagnostic AI performance. However, extensive standalone software validation (algorithm performance) was conducted through the listed "Software verification and validation testing," which included tests like "Targeting Calculations META," "Targeting Calculations TAN/FAN," "Drill Depth Measurement," and "Nail Rotation." These tests verify the accuracy and correctness of the algorithms within the software, independent of a human operator, by comparing computed results against expected outputs based on known inputs or simulations. This is a form of "standalone" evaluation of the software's functional correctness.

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

For the software testing, the "ground truth" was deterministic: it was established through engineered specifications, mathematical models, and simulated inputs that define the expected correct output of the algorithms. For example, for "Targeting Calculations," the ground truth would be the precisely calculated correct target coordinates based on the software's intended geometric and kinematic models. For "Drill Depth Measurement," the ground truth would be the predefined correct depth for a given input. This is not medical expert consensus, pathology, or outcomes data.
For the hardware (EMC, electrical safety), the ground truth was established international and national regulatory standards (e.g., IEC 60601 series).

8. The sample size for the training set:

Not applicable. This device is a surgical targeting system, not an AI/machine learning model that requires a "training set" of data in the typical sense (e.g., for image classification or prediction). The software is deterministic and rule-based, performing calculations and tracking based on predefined engineering principles and algorithms, rather than learning from data.

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

Not applicable, as no training set was used.

Summary

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April 24, 2018

Smith & Nephew, Inc. Brad Sheals Regulatory Affairs Manager 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K180277

Trade/Device Name: Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 23, 2018 Received: March 26, 2018

Dear Brad Sheals:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K180277

Device Name

Smith & Nephew SURESHOT Distal Targeting System V4.0

Indications for Use (Describe)

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 fracted with intramedulary 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)

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Submitted by:	Smith & Nephew, Inc.Advanced Surgical Devices Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	April 20, 2018
Contact Person and Address:	Brad ShealsRegulatory Affairs ManagerT 901-399-6897
Name of Device:	Smith & Nephew, Inc. SURESHOT™ DistalTargeting System V4.0
Common Name:	Computer Assisted Surgery System
Device Classification Nameand Reference:	21 CFR 882.4560 Stereotaxic Instrument
Device Class:	Class II
Panel Code:	Neurology/84
Product Code:	OLO

Device Description

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Indications for Use

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 K092497 with the primary differences being the reduced size and weight.

Summary of Pre-Clinical Testing

Electromagnetic compatibility and electrical safety validation testing has been conducted on the SURESHOT™ Distal Targeting System. The SURESHOT Distal Targeting System V4.0 targeter is used with the trauma interface. The subject device generates the same electromagnetic tracking technology as the existing targeter cleared in PiGalileo Screw Targeting System V1.1. The electromagnetic capability and electrical safety testing that was conducted includes.

IEC 606061-1-2:2007 Class A for Emissions, Immunity for Non Life . Supporting Equipment
IEC 60601-1: 2005 + A1 :2012 Medical Electrical Equipment Part 1: General . Requirements for Safety.

Results of the electromagnetic compatibility and electrical safety validation testing demonstrate the device is found to meet the application performance requirements to those standards.

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

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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 ●
12.317 Translations Italian ●
12.318 Translations Japanese ●
12.319 Translation Portuguese ●
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 V4.0 - targeter 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	PiGalileo Screw TargetingSystem V1.1	K092497	September 11,2009

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

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Design Aspect Reviewed	SURESHOT ™ Distal Targeting SystemV4.0-Targeter	PiGalileo Screw Targeting System V1.1
510(k) Number	Subject device	K092497
Manufacturer	Smith & Nephew	Smith & Nephew
Similar Indications for Use	The Smith & Nephew SURESHOT™Targeting System is intended to be anintraoperative image guided localizationsystem. It is a computer assistedorthopedic surgery tool to aid the surgeonwith drill positioning for screws duringintramedullary nail implantation. Itprovides information to the surgeon that isused to place surgical instruments duringsurgery utilizing intraoperatively obtainedelectromagnetic tracking data. The Smith& Nephew SURESHOT™ TargetingSystem is indicated for long bone fracturestreated with intramedullary nails in whichthe use of stereotactic surgery may beappropriate.	The Smith & Nephew PiGalileo ScrewTargeting System is intended to be anintraoperative image guided localizationsystem. It is a computer assistedorthopedic surgery tool to aid the surgeonwith drill positioning for screws duringintramedullary nail implantation. It providesinformation to the surgeon that is used toplace surgical instruments during surgeryutilizing intraoperatively obtainedelectromagnetic tracking data. The Smith& Nephew PiGalileo Screw TargetingSystem V1.1 is indicated for long bonefractures treated with intramedullary nailsin which the use of stereotactic surgerymay be appropriate.
Intended Use	Intraoperative image guided localization system
Instrumentation	Used to assist surgeon in placing nail implants and for specific use with the distaltargeting software
Similar Sterilization	Y	Y
Similar Packaging	Y	Y
Similar Materialsf the	Y	Y
Similar Design	Y	Y
Overall Weight Targeter	~750g	~1kg

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

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Design Aspect Reviewed	SURESHOT ™ Distal Targeting SystemV4.0-Targeter	PiGalileo Screw Targeting System V1.1
Software Compatibility	SURSHOT Distal Targeting System V4.0software (K170280)	PiGalileo Screw Targeting System V1.1(K092497)

Conclusion

The SURESHOT™ Distal Targeting System V4.0 targeter is substantially equivalent to the existing PiGalleo Screw Targeting System V1.1 handheld field generator (targeter) cleared in K092497 in that the indications for use 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).