(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).
§ 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).