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The KMedic External Fixation Devices are non-sterile, single-use, external fixation devices intended to be used for unilateral external fixation in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

KMedic External Fixation Devices consist of various fixation pins and wires for use in unilateral external fixation. The various lengths, sizes and end configurations are offered to accommodate various patient anatomies, injuries and/or conditions, and physician preference. All KMedic external fixation devices included in this submission are manufactured of medical grade stainless steel. All KMedic external fixation devices included in this submission will be offered in a non-sterile condition. The following KMedic External Fixation Devices are included in this submission: Kirschner Wires, Steinmann Pins, Schanz Pins, Cerclage Wires.

I am sorry, but based on the provided document, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. This document is a 510(k) Pre-market Notification for the KMedic External Fixation Devices, which primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices.

The document includes:

• Device description and intended use: This section describes the KMedic External Fixation Devices and their intended medical applications.
• Comparison to predicate devices: The submission asserts that the KMedic devices are substantially equivalent in design and materials to previously marketed devices.
• FDA clearance letter: This letter confirms the FDA's finding of substantial equivalence, allowing the device to be marketed.

However, it does not contain the following information you requested, which would typically be found in a performance study or validation report:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, or adjudication methods for any test set.
• Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Information on ground truth types or how ground truth was established for training or test sets.
• Sample size for a training set.

The 510(k) pathway for medical device clearance in the US relies on demonstrating substantial equivalence to a predicate device rather than requiring extensive clinical trials and performance studies as might be needed for a PMA (Pre-Market Approval) or for a device incorporating AI.

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