(98 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 1.0 is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.
The PiGalieo Screw Targeting System is a computer controlled electromagnetic tracking system. It assists the surgeon in mo roallist below harged 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 wn roduced 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 does not contain detailed information about acceptance criteria and a specific study proving the device meets them. The document is a 510(k) summary for the Smith & Nephew PiGalileo Screw Targeting System V1.0, which focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a standalone performance study with defined acceptance criteria.
However, based on the information provided, here's what can be extracted and inferred regarding performance and the study context:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria or a direct performance table for the PiGalileo Screw Targeting System V1.0. It primarily relies on demonstrating equivalence to the predicate device, the PiGalileo Navigation System (4th Generation) (K080875), and other electromagnetic tracking technology systems.
The closest we can come to "performance" in this document is the description of the device's function: "It assists the surgeon in mo roallist below harged in an intramedullary nail implant during orthopedic trauma surgery." and "It provides information to the surgeon that is used to place surgical instruments during n urgery utilizing intraoperatively obtained electromagnetic tracking data."
2. Sample Size Used for the Test Set and Data Provenance:
No specific test set or sample size for performance evaluation is mentioned in this 510(k) summary. The document does not describe a study involving a particular set of cases or data. The focus is on demonstrating substantial equivalence by comparing the design and indications for use to existing cleared devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. Since no specific performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set:
Not applicable, as no test set or study requiring adjudication is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned in the provided text. The document focuses on regulatory clearance through substantial equivalence, not a comparative efficacy trial.
6. Standalone (Algorithm Only) Performance Study:
No standalone performance study is explicitly described. The document indicates the system "assists the surgeon," implying a human-in-the-loop system. The data provided focuses on the device's functionality rather than a purely algorithmic performance evaluation.
7. Type of Ground Truth Used:
Not applicable, as no specific performance study requiring ground truth establishment is described. The "ground truth" implicitly relies on the established safety and effectiveness of the predicate devices.
8. Sample Size for the Training Set:
Not applicable. The document does not describe the development or training of an AI algorithm, but rather a computer-assisted surgical system using electromagnetic tracking. Therefore, there's no mention of a training set or its size.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set mentioned for an AI algorithm.
Summary of what can be extracted from the document regarding performance (with caveats):
While a formal "acceptance criteria" table is not present, the underlying implied acceptance is that the new device performs at least as safely and effectively as its predicate devices. The "study" proving this, in the context of a 510(k) submission, is primarily a comparison to predicate devices to establish substantial equivalence based on:
- Overall design: The PiGalileo Screw Targeting System is described as a "computer controlled electromagnetic tracking system" that "assists the surgeon" with drill positioning. This is compared to the predicate, "PiGalileo Navigation System (4th Generation)," and other "Predicate Electromagnetic Tracking Technology Systems."
- Indications for use/intended use: The new device's indications for use are carefully laid out and are considered "substantially equivalent" to those of the predicate devices. This implies that the device is expected to achieve similar surgical guidance outcomes for long bone fractures treated with intramedullary nails.
In essence, the "study" is a regulatory assessment of similarity to legally marketed devices, rather than a clinical performance trial designed to meet specific quantitative performance metrics.
§ 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).