(119 days)
The ExactechGPS® System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.
TKA Pro software application is specifically indicated for Total Knee Arthroplasty.
The ExactechGPS System proposed in this submission is a modification of the ExactechGPS System cleared per 510(k) #K213877.
The ExactechGPS System is an image-guided surgery, or navigation, system intended to be used during orthopedic surgical procedures to intraoperatively assist surgeons during arthroplasty. The ExactechGPS System enables surgeons to acquire intraoperative data by computing and displaying information such as distances, angles, and placement of prosthetic components in order to identify and characterize bone cuts necessary to achieve surgical goals.
The ExactechGPS System works with ExactechGPS hardware trackers that communicate intraoperative data to the ExactechGPS hardware station to provide surgeons with real-time information on the positions of patient anatomical structures and instrumentation used to prepare bone during stereotaxic surgery.
The proposed modifications do not change the ExactechGPS System general intended use, general design features, or basic fundamental scientific technology.
This FDA 510(k) clearance letter and summary primarily address mechanical and electrical modifications to an existing device, the ExactechGPS® System. It focuses on demonstrating that these hardware changes do not significantly alter the performance of the device for its intended use in stereotaxic surgery for total knee arthroplasty (TKA).
Therefore, the document does not contain the detailed information typically found in acceptance criteria and study designs for Artificial Intelligence/Machine Learning (AI/ML) based medical devices. The performance data section lists general function tests, electrical safety, EMC compatibility, photobiological safety, and sterilization validation, which are standard for hardware modifications, not AI/ML algorithm validation.
Based on the provided text, I cannot extract the information required for a study proving an AI/ML device meets acceptance criteria. The document pertains to a hardware modification of a surgical navigation system, not an AI/ML component or software that analyzes data for diagnostic or prognostic purposes, which would necessitate the criteria you've outlined.
Specifically, the document states:
- "Based on test bench testing, the proposed changes do not alter significantly the performances of the devices and the way it is used."
- "The proposed ExactechGPS system have the same general features and dimensions, with the same technology and performances."
- "The redesigned electronic card only resolves obsolescence issues with no impact on user, global performances and safety."
This indicates that the focus of the submission was to show non-inferiority or equivalence of the modified hardware to its predicate, rather than to prove a new performance claim for an AI/ML component.
Therefore, I cannot fulfill your request to provide:
- A table of acceptance criteria and reported device performance (in the context of AI/ML).
- Sample sizes for a test set or training set (for AI/ML).
- Details on experts, adjudication methods, MRMC studies, or standalone performance (for AI/ML).
- Ground truth establishment methods (for AI/ML).
The provided text deals with the ExactechGPS® System, which is a surgical navigation system (stereotaxic instrument). The submission is for hardware modifications to an existing cleared device, primarily to address obsolescence of sub-components (optical localizer, tablet, wireless feature). The core claim is that these hardware changes do not alter the fundamental performance or intended use of the device.
The "TKA Pro software application" is mentioned as being compatible with the modified system, but the document does not describe any AI/ML components within this software application or any studies validating AI/ML performance. The performance data listed (electrical safety, EMC, etc.) are typical for hardware evaluations, not AI/ML model validation.
In summary, this document is a 510(k) clearance for hardware modifications to a surgical navigation system, not an AI/ML device, and thus does not contain the information requested about AI/ML acceptance criteria or an AI/ML study.
§ 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).