The Smith & Nephew PiGalileo Screw 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 PiGalileo Screw Targeting System V 1.1 is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.

Device Description

The PiGalileo Screw 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.

AI/ML Overview

This document, K042497, describes the Smith & Nephew PiGalileo Screw Targeting System V1.1. It is a computer-assisted surgical system designed to aid surgeons in locating and positioning screws during intramedullary nail implantation for long bone fractures.

Unfortunately, the provided text does not contain the specific details required to answer all the questions comprehensively regarding acceptance criteria and a study proving device performance. The document focuses on the device's description, classification, indications for use, and substantial equivalence to a previously cleared device (PiGalileo Screw Targeting System V1.0, K090420). It is a submission for 510(k) clearance, which primarily demonstrates substantial equivalence to a predicate device rather than presenting extensive de novo clinical study results with detailed acceptance criteria and study methodologies.

Therefore, the following information is extracted or noted as unavailable from the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not provided. The document states it assists the surgeon in locating and positioning screws. It does not define specific quantitative acceptance criteria (e.g., accuracy in mm, success rate) or report performance against such criteria.	Not provided. The document describes the function of the system (aiding in drill positioning), but does not quantify its performance outcomes (e.g., screw placement accuracy, reduction in surgical time, improved patient outcomes).

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

Not provided. The document does not describe a specific study or test set used to establish performance for the V1.1 device, beyond claiming substantial equivalence to the V1.0 device.

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)

Not provided. As no specific performance study with a test set is detailed, information on experts used to establish ground truth is absent.

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

Not provided. No details of a test set or its adjudication are mentioned.

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 does not describe a multi-reader multi-case comparative effectiveness study. The device is a "computer assisted orthopedic surgery tool" that provides information to the surgeon, implying human-in-the-loop operation, but no study on improvement from AI assistance is presented.

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

No. The device is described as "assisting the surgeon" and "providing information to the surgeon," indicating it is designed for human-in-the-loop use. Standalone algorithmic performance is not discussed.

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

Not provided. As no specific performance study is detailed, the type of ground truth used is not mentioned.

8. The sample size for the training set

Not provided. The document does not mention any training set size. This device appears to be primarily an electromagnetic tracking system, not one that relies on extensive "training data" in the typical machine learning sense for its core functionality, though it is "computer controlled."

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

Not provided. Since no training set is discussed, the method for establishing ground truth for it is also absent.

Summary of what is present:

The document focuses on demonstrating that the PiGalileo Screw Targeting System V1.1 is substantially equivalent to the predicate device, PiGalileo Screw Targeting System V1.0 (K090420). This typically means that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate, often without requiring new clinical performance studies if the differences are minor and do not raise new questions of safety or effectiveness. The core of this submission is therefore a comparison to a previously cleared device, rather than a detailed report of a new performance study with specific acceptance criteria.

Summary

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K042497 f. lot 1

SEP 1 1 2009

Smith & Nephew, Inc. Summary of Safety and Effectiveness PiGalileo Screw Targeting System V1.1

Contact Person and Address

Date of Summary: 08/12/2009

Regina Holmes Regulatory Affairs Specialist Smith & Nephew Orthopaedics 1450 Brooks Road Memphis, TN 38116 (901) 399-6538

Name of Device: Smith & Nephew PiGalileo Screw Targeting System V1.1 Common Name: Computer Assisted Surgery System

Device Description

Device Classification

21 CFR 882.4560 Stereotaxic Instrument - Class II

Indications for Use

Substantial Equivalence Information

The overall design of the PiGalifeo Screw Targeting System V1.1 is substantially equivalent to the previously cleared device listed below:

Manufacturer	Description	510(k)	Clearance Date
Smith & Nephew, Inc.	PiGalileo Screw Targeting System V1.0	K090420	10/29/08

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

SEP 1 1 2009

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

Smith & Nephew % Ms. Regina Holmes Regulatory Affairs Specialist 1450 East Brooks Road Memphis, Tennessee 38116

Re: K092497

Trade/Device Name: PiGalileo Screw Targeting System V1.1 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instruments Regulatory Class: II Product Code: OLO Dated: August 12, 2009 Received: August 14, 2009

Dear Ms. Holmes:

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 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.

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Page 2 – Ms. Regina Holmes

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.html 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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Indications for Use

510(k) Number (if known):

Device Name: PiGalileo Screw Targeting System V1.1

Indications for Use:

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

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)

Nifre Odu for mxm

(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number.

Page 1 of 1

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).