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The Stealth Fusion System and its accessory components are intended to be used on adults or pediatric patients as required and are intended to be used for ankle and foot joints fusion; to stabilize fractures of foot bones; (open and closed); post-traumatic 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; pseudoarthrosis or non-union of foot bones; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue foot defects; joint arthrodesis; and management of comminuted intra-articular foot bone fractures.

The Stealth Fusion System is an orthopedic device indicated for the use of bone fusion and other bone abnormalities and deformities. As with most external fixation devices, the standard Stealth Fusion System fixator assembly consists of three basic types of elements: 1) bone anchorage elements, 2) bridge elements, and 3) connection elements. The Stealth Fusion System design allows freedom of pin placement, ease of assembly and stable fixation of bone fragments with the possibility of axial loading of the lower extremity and immediate range of motion of all adjacent joints.

I am sorry, but the document provided does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. This document is a 510(k) summary for a medical device (Stealth Fusion System), which primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance study results.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Information on experts used to establish ground truth.
• Adjudication methods.
• Results from multi-reader multi-case (MRMC) comparative effectiveness studies.
• Results from standalone performance studies.
• Details on the type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

The document mainly describes the device, its intended use, technological characteristics, and states its substantial equivalence to predicate devices based on similar design, materials, and intended use. Performance data, if collected, would typically be summarized in a more detailed technical report which is not part of this 510(k) summary.

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