(40 days)
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.
The SURSHOT 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 provided text describes the Smith & Nephew SURESHOT Targeting System, a computer-assisted surgery system designed to aid surgeons in locating and positioning screws during intramedullary nail implantation. However, the document is a 510(k) summary and FDA clearance letter, which does not contain details about specific acceptance criteria or a study proving that the device meets those criteria.
Typically, 510(k) submissions demonstrate substantial equivalence to a predicate device. While this process involves testing, the detailed study design, acceptance criteria, and specific performance results are often summarized or referenced rather than fully detailed in the publicly available 510(k) summary.
Therefore, I cannot provide the requested table and study details directly from the given text. The document focuses on regulatory clearance based on substantial equivalence, not a detailed technical performance study against acceptance criteria.
To answer your request, I would need a different type of document, such as a validation report or a detailed performance study report from Smith & Nephew.
Based on the information not present in the document, here's what I can state:
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A table of acceptance criteria and the reported device performance: Not provided in the document. The document states the device is "substantially equivalent" to previously cleared devices (e.g., PiGalileo Screw Targeting System V1.1, K092497). This implies that its performance is expected to be comparable, but specific numerical acceptance criteria and direct performance metrics are not listed.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided in the document.
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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 in the document.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided in the document.
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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: Not provided in the document. This device is a targeting system (computer-assisted surgery tool) for drill positioning, not an AI-assisted diagnostic imaging system that would typically involve human "readers" or an MRMC study in this context. Its function is to guide physical placement, not to interpret images in a diagnostic sense for human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not provided in the document. The device description clearly states it "assists the surgeon" and is an "intraoperative image guided localization system" and a "computer assisted orthopedic surgery tool to aid the surgeon." This implies a human-in-the-loop system, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided in the document. For a targeting system, ground truth would likely involve physical accuracy measurements (e.g., how close the drill path is to the intended target based on a physical measurement or post-operative imaging).
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The sample size for the training set: Not applicable/Not provided in the document. This device is described as an "electromagnetic tracking system" and a "computer controlled" system for guidance. It's likely a rule-based or algorithm-driven system based on electromagnetic physics and geometry, rather than a machine learning model that requires a distinct "training set" in the common AI sense.
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How the ground truth for the training set was established: Not applicable/Not provided in the document. (See point 8).
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JC/00107
Smith & Nephew, Inc. Summary of Safety and Effectiveness SURESHOT Targeting System
Date of Summary: January 8, 2010
Contact Person and Address
Regina Holmes Regulatory Affairs Specialist Smith & Nephew Orthopaedics 1450 Brooks Road Memphis, TN 38116 (901) 399-6538
FEB 2 3 2010
Name of Device: Smith & Nephew SURESHOT Targeting System V2.0 Common Name: Computer Assisted Surgery System
Device Description
The SURSHOT 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 colls. 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 ine-of-sight constraints of an optical spatial measurement system that requires a camera.
Device Classification
21 CFR 882.4560 Stereotaxic Instrument - Class II
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 intramedulary nalls in which the use of stereotactic surgery may be appropriate.
Substantial Equivalence Information
The overall design of the SURSHOT Targeting System is substantially equivalent to the previously cleared devices listed below:
| Manufacturer | Description | 510(k) | Clearance Date |
|---|---|---|---|
| Smith & Nephew, Inc. | PiGalileo Screw Targeting System V1.1 | K092497 | 09/11/09 |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized image of an eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
FEB 2 3 2010
Smith & Nephew, Inc. % Ms. Regina Holmes, PMP Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
Re: K100107
Trade/Device Name: SURESHOT Targeting System V2.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: February 15, 2010 Received: February 16, 2010
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. 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
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Page 2 - Ms. Regina Holmes, PMP
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 yours,
llt.htm.
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): K100107
Device Name: SURESHOT Targeting System
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 utflizing 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 _ X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Devic uation (ODE)
Page 1 of 1
",
Office Evaluation (ODE)
(Division Si} = Off) Division of tongical, Orthopedic, and Restorative Devices
510(k) Number
§ 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).