(109 days)
The PiGalileo 4th Generation System is intended for use as a stereotaxic instrument to assist in the positioning of total knee and total hip replacement components intra-operatively. The system is a computer controlled image guided system equipped with a three-dimensional tracking sub-system. The PiGalileo System is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, as such instruments are precisely positioned relative to these axes by displaying their locations. This allows for accurate positioning of instruments used for total knee and total hip replacement surgery and provides intraoperative measurements of bone alignment.
The PiGalileo 4th Generation System is a software-controlled electromechanical sterotaxic device for computer aided navigation of PiGalileo surgical instruments with the purpose of assisting the surgeon in optimally positioning knee and hip prostheses during total knee and hip arthroplasties. The subject device incorporates new hardware components as well as new platform system software. The PiGalileo 4th Generation System allows for existing knee applications to run on the new platform system.
The provided document is a 510(k) summary for the PiGalileo 4th Generation System, a stereotaxic instrument for computer-aided navigation during total knee and hip arthroplasties. However, it does not contain specific acceptance criteria, details of a study proving device performance against such criteria, sample sizes, expert qualifications, or ground truth establishment methods for an AI/algorithm-based device.
The document primarily focuses on:
- Device Description: What the device is and its purpose.
- Device Classification: Its regulatory classification.
- Indications for Use: What the device is intended to be used for.
- Substantial Equivalence Information: Comparing it to previously cleared predicate devices (PLUS Orthopedics AG's PiGalileo Total Knee Replacement (TKR) System K061362 and PiGalileo Total Hip Replacement (THR) System K070731). This is the key element for 510(k) clearance, demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Since this device is a stereotaxic instrument and not an AI/algorithm system that processes data for diagnostic or prognostic purposes, the questions regarding acceptance criteria and study designs typically associated with AI/ML-based medical devices (like MRMC, standalone performance, training/test set details, and ground truth methodologies) are not applicable or addressed in this type of 510(k) submission.
Therefore, I cannot extract the requested information from the provided text. The document is about a hardware and software system for surgical navigation, not an AI model requiring a performance study against specific accuracy or precision metrics for a diagnostic task.
§ 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).