(251 days)
The Exactech GPS is intended for use during stereotaxic 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) #K152764.
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 camera component that communicates with trackers is compliant with EN 62471 (Photobiological safety testing).
The proposed modifications do not change the ExactechGPS System general intended use, general design features, or basic fundamental scientific technology.
The provided document does not contain details about specific acceptance criteria, reported device performance metrics, or a study that evaluates these metrics for the ExactechGPS System. The document focuses on regulatory approval (510(k) clearance) for a modified version of an existing device, highlighting changes to hardware and software, and confirming its substantial equivalence to a predicate device based on general functionality, safety, and electromagnetic compatibility testing.
Therefore, I cannot provide the requested table, sample sizes, ground truth information, or details about MRMC studies.
Here's an overview of what is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not available in the provided text. The document states that "Based on test bench testing, the proposed changes do not alter significantly the performances of the devices and the way it is used," and lists general testing categories like "General Functions tests to ensure design is fully verified and validated." However, specific quantitative acceptance criteria or reported performance figures are not detailed.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not available in the provided text. The document mentions "test bench testing" but does not specify the sample size or the provenance of any data used for testing device performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not available in the provided text. Ground truth establishment is not discussed.
4. Adjudication Method for the Test Set:
This information is not available in the provided text. Adjudication methods are not discussed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
This information is not available in the provided text. There is no mention of an MRMC study or any comparison of human readers with or without AI assistance. The device in question ("ExactechGPS System") is an image-guided surgery system, not a diagnostic AI tool for image interpretation by human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The document describes the ExactechGPS System as an "image-guided surgery, or navigation, system intended to be used during orthopedic surgical procedures to intraoperatively assist surgeons." This implies a human-in-the-loop system, where the device provides information to assist a surgeon. There is no mention of a standalone algorithm-only performance evaluation, as the device's function inherently involves human interaction during surgery.
7. Type of Ground Truth Used:
This information is not available in the provided text. The document refers to "General Functions tests to ensure design is fully verified and validated," but it does not specify how accuracy or performance was verified against a "ground truth" (e.g., pathology, outcomes data, or expert consensus).
8. Sample Size for the Training Set:
This information is not available in the provided text. The document does not mention a training set, as it describes a modification to an existing navigation system rather than a new AI model requiring a training phase in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
This information is not available in the provided text, as no training set is mentioned.
§ 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).