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The ExactechGPS is intended for use during preoperative planning and during orthopedic surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures provided that the requred anatomical landmarks can be identified on the patient's preoperative CT scan.

The ExactechGPS Total Ankle Case Manager Application is specifically indicated for creating Total Ankle Navigation cases, uploading CT scans for reconstruction, download the reconstruction and export the reconstructed case to the Total Ankle Navigation Application.

The ExactechGPS Total Ankle Navigation is specifically indicated for Total Ankle Arthroplasty using the Vantage ankle system to aid the surgeon in locating anatomical structures and aligning the tibial and talar components with the anatomical structures.

The ExactechGPS Total Ankle Application proposed by Blue Ortho in this submission is new clinical software application.

The ExactechGPS Total Ankle Application (TAA) system is intended to be used during stereotaxic surqical procedures to aid the surgeons in locating anatomical structures and aligning the endoprosthesis with the patient bony anatomy provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan.

The ExactechGPS Total Ankle Application is an Image Guided Surgery, or Navigation, system designed to guide surgeons during the preparation of the tibia and talar bones as part of a total ankle arthroplasty procedure. The ExactechGPS Total Ankle Application requires patient CT-scan data to undergo segmentation prior to being imported into the software, as part of reconstructing the bone model.

It encompasses two software applications:

• The ExactechGPS Total Ankle Case Manager Application is specifically indicated for creating Total Ankle Navigation cases, uploading CT scans for reconstruction, download the reconstruction and export the reconstructed case to the Total Ankle Navigation Application.
• -The ExactechGPS Total Ankle Navigation Application is specifically indicated for Total Ankle Arthroplasty using the Vantage ankle system to aid the surgeon in locating anatomical structures and aligning the tibial and talar components with the anatomical structures.

The ExactechGPS Total Ankle Navigation is working on the Blue Ortho ExactechGPS System cleared per 510(k) #K213877. The system is composed of ExactechGPS Trackers, which are rigidly fixed to the patient bony anatomy, and other components (ExactechGPS Station and ExactechGPS camera) that are not in contact with the patient.

The provided text is a 510(k) FDA clearance letter and a summary of safety and effectiveness for a medical device (ExactechGPS® Total Ankle Application). While it discusses indications for use, device description, and comparison to a predicate device, it explicitly states, "This submission includes or references the following non-clinical testing: Software verification testing to ensure all design outputs meet all specified requirements; Software validation to ensure software specifications conform to user needs and intended uses."

Crucially, the document does NOT contain detailed performance data to establish acceptance criteria or describe a specific study proving the device meets those criteria with statistical rigor, using a defined test set, expert ground truth, or adjudication methods. It mentions "non-clinical testing" for software verification and validation, but these are general statements about software development processes, not specific clinical or even simulated performance studies with quantitative results against defined acceptance criteria.

Therefore, I cannot fulfill your request for the following information based on the provided text:

• A table of acceptance criteria and the reported device performance: The document does not define specific performance acceptance criteria beyond general software quality statements, nor does it report quantitative performance.
• Sample size used for the test set and the data provenance: No test set or data provenance is detailed.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on ground truth establishment or experts is provided.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available.
• 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: This is a navigation system, not an AI-assisted diagnostic tool. An MRMC study would be irrelevant. The document does not describe any human-in-the-loop performance studies or comparative effectiveness studies.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document describes a surgical navigation system, which inherently involves human interaction. There's no mention of a "standalone" algorithm performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth definition is provided.
• The sample size for the training set: No training set or machine learning model is explicitly described as part of the performance evaluation. The device uses patient CT-scan data for reconstruction, but this is not delineated as a "training set" in the context of AI model development that would typically require such detail.
• How the ground truth for the training set was established: Not applicable, as no training set for an AI model is described.

In summary, the provided document is a regulatory approval letter and a summary of the device's characteristics and intended use, not a detailed study report on device performance against specific, quantifiable acceptance criteria. It states that safety and effectiveness are supported by "non-clinical testing" for software verification and validation, but these are high-level statements without the specifics requested in your prompt.

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