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The SixFix™ Hexapod and Deformity Analysis and Correction Software (DACS) are intended to be used for posttraumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudo-arthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.

The SixFix™ Hexapod Fixator is a multilateral circular external fixation system. The system includes the following external fixator elements: rings, footplates, arches, struts, threaded rods, wires, external fixation accessories, and software. All of the elements are provided non-sterile and are for single use only.

The system is designed such that gradually adjusting the lengths of the struts in relation to one another alters the orientation of the rings and, consequently, the bone segments connected to the rings by half-pins and wires during the treatment period in order to achieve the patient's treatment goals.

The Deformity Analysis and Correction Software is an optional software component and is used to assist the physician in calculating the lengths of the struts connecting the rings to manipulate the bone fragments. The software receives inputs from the physician and allows the physician to visualize the moving bone position. The program computes the strut lengths necessary to implement any desired translation and/or rotation required by the surgeon.

The provided text describes the SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) but does not detail specific acceptance criteria or a study that rigorously proves the device meets those criteria with quantitative performance metrics.

Instead, the document highlights:

• Substantial Equivalence: The primary assertion is that the SixFix™ Hexapod Fixator and DACS are "substantially equivalent" to predicate devices (Taylor Spatial Frame, Deformity Analysis and Correction Software (DASC), and Ilizarov External Fixation Wires). This means it performs as well as or better than legally marketed predicate devices without raising new questions of safety or effectiveness.
• Performance Data Overview: It mentions that "Static and dynamic mechanical testing were performed" and "Software verification and validation testing were conducted." However, it does not provide the results of these tests in terms of specific acceptance criteria.

Therefore, an answer using the requested format would mostly consist of "Not Provided" or "N/A" for many fields, as the document does not contain the level of detail asked for in the prompt regarding a specific study proving quantifiable acceptance criteria.

Here's an attempt to answer based on the given text, with the understanding that much information is missing:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance
Not provided in the document. The text refers to "static and dynamic mechanical testing" and "software verification and validation testing" but does not specify sample sizes for these tests or the provenance of any data used (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. The document focuses on substantial equivalence based on mechanical and software testing, not on clinical performance evaluated against expert ground truth for interpretation or diagnosis.

4. Adjudication method for the test set
Not applicable/Not provided. No clinical test set or expert adjudication process is described in the provided text.

5. 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
Not applicable/Not provided. This document does not describe an MRMC study. The DACS is software to assist the physician in calculating strut lengths and visualizing bone position, not for diagnostic interpretation by human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
While the DACS is a standalone software component in terms of its execution, the performance demonstration focuses on its functional equivalence to a predicate software and its role in assisting a physician. No specific "standalone performance" study (e.g., accuracy of calculations compared to a gold standard without human input as part of the evaluation) is detailed with quantifiable results. The text states, "The DACS matches the functions performed by the predicate DACS."

7. The type of ground truth used
For the mechanical testing, the ground truth would likely be established engineering standards or validated predicate device performance data.
For the software testing, the ground truth would be the expected output or behavior according to the software requirements specification and comparison to the predicate software's known functionality.
Specific details are not provided.

8. The sample size for the training set
Not applicable/Not provided. The document describes software verification and validation, not a machine learning model that would require a "training set" in the conventional sense.

9. How the ground truth for the training set was established
Not applicable/Not provided. As no training set for a machine learning model is mentioned, this information is not relevant to the provided text.

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