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The ONEFIT Hip Planner software is indicated for assisting healthcare professionals in preoperative planning of hip replacement surgery. The software allows for overlaying of 3D/2D implant models on radiological images and 3D reconstruction of bone, and includes tools for performing measurements on the image and 3D model of bones and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.

The ONEFIT Hip Planner software allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. ONEFIT Hip Planner is accessible on any computer via ONEFIT Management System that provides secure interface through authentication mechanisms, web accessible authentication servers and access for authorized users through secure protocols to web server.

The provided document is a 510(k) summary for the ONEFIT Hip Planner, which is a pre-operative planning software for hip replacement surgery. It establishes substantial equivalence to a predicate device, TraumaCAD Release 2.0 (K073714). The performance data section in this document is very brief and does not contain the detailed information requested in your prompt.

Specifically, the document states:

• "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'"

This statement indicates that testing was performed, but it does not provide any specific details regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Whether an MRMC comparative effectiveness study was done, or any effect size for human readers with and without AI assistance.
6. Whether a standalone performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Therefore, based solely on the provided text, it is not possible to answer your questions in detail. The document confirms that some performance data demonstrations were done to support the claim of substantial equivalence to the predicate device, but the specifics of these studies are not part of this 510(k) summary. Further information would typically be found in the full 510(k) submission, which is not included here.

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