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The Taylor Spatial Frame (TSF) external fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The TSF is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.

The TSF is intended for fixation of fractures of long bones including intracapsular, intertrochanteric, supracondylar. or condylar. It is also used for joint fusions and limb lengthening or deformity corrections which involve cutting of the bone.

The TSF is not intended for use in the spine, and it does not claim dynamization benefits or MRI compatibility.

The TSF consists of full or partial rings coupled by six telescopic struts which terminate at each end by articulating ball joints. The components of the Tavlor Special Frame External Fixator are intended to be used with pins, wires and washers of the Ilizarov External Fixator System. The half-pins, wires and washers of the Ilizarov system are inserted into the affected limb. The wires are tensioned and attached to the TSF ring of the TSF frame using an Ilization bolt. Half-pin fixation is occasionally used instead of wires. An adjustable half-pin clamp allows for the insertion of the half-pins or femoral screws. A universal joint may be used in cases where movement is necessary. Rancho cubes are available for half-pins combined with TSF rings.

The devices are for single use. Cementless or cement fixation is not applicable to this device. These devices have not been submitted to the FDA for identical or different intended uses.

A software program is included with the surgical technique. To template or guide the device, a software program is used to assist the surgeon and is equivalent to performing manual calculations to obtain the numbers necessary to adjust the 6 telescopic struts and apply the TSF external fixation device.

This document describes a physical medical device (Taylor Spatial Frame External Fixation System) and its accompanying software for surgical planning, not an AI/ML powered medical device. Therefore, many of the requested categories for acceptance criteria and study design (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable.

However, based on the provided text, we can infer some aspects related to the software's functionality and its role.

Here's an analysis addressing the applicable points:

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

Since this is a physical device with accompanying software for calculations, formal performance metrics like sensitivity, specificity, or AUC are not presented in this summary. The acceptance criteria for the software would likely revolve around its accuracy in calculations and equivalence to manual methods.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable for an AI/ML driven device. The "software program" here is described as a calculator equivalent to manual methods, not an algorithm processing data like images or patient records. There is no mention of a "test set" in the context of data validation for the software.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable for an AI/ML driven device. The "ground truth" for this calculation software is the correct mathematical outcome, which would be verified by engineering principles or comparison to expert manual calculations. The document does not describe a process involving experts to establish a "ground truth" for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable for an AI/ML driven device. This concept typically applies to the resolution of discrepancies in expert labeling or assessment of an AI's output.

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. This study design is for evaluating human performance with and without AI assistance for tasks like diagnosis or detection. The software described aids in mechanical adjustments, not diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Partially applicable/Inferable: The software's "standalone" performance would be its ability to accurately produce the necessary adjustment numbers. The statement "equivalent to performing manual calculations" implies that the software performs these calculations reliably on its own, independent of further human calculation validation post-software output. It acts as a calculator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Inferred based on software function: The ground truth for this software would be mathematical correctness of the calculations required to adjust the struts. This implies verification against established mathematical formulas or manual calculations performed by qualified engineers or surgeons.

8. The sample size for the training set

• Not applicable for an AI/ML driven device. This software is rule-based or formula-based, not an AI/ML model that requires training data.

9. How the ground truth for the training set was established

• Not applicable for an AI/ML driven device. As it's not an AI/ML model, there is no "training set" or ground truth establishment in that context. The "ground truth" for its development would be the accurate mathematical principles and formulas for calculating strut adjustments.

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