(28 days)
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.
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.
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.
§ 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).