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ZPS One-Third Tubular Plates, T-Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloverleaf and Spoon Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:

• comminuted fractures
• supracondylar fractures
• extra-articular fractures
• fractures in osteopenic bone
• nonunions
• malunions
  Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet.
  ZPS Calcaneal plates are indicated for temporary internal fixation of ostectomies and fractures of the calcaneus. ZPS and Forte Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

The ZPS System is a non-locking, stainless steel plate and screw system. Plate shapes vary to address varying patient bone sizes and injury fragment sizes. Plates incorporate a spherical sliding slope plate hole design to achieve the compression required to treat bone fractures. The plates are used with a variety of screws for temporary fixation to the bone.

This document is an FDA 510(k) premarket notification for the Zimmer Plates and Screws System (ZPS). It is a regulatory document and does not contain information about a study proving device acceptance criteria in the context of AI/software performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on material, design, and mechanical performance, which is typical for hardware medical devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set specifics, as these concepts are not applicable to this document.

The document primarily states:

• Device Name: Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS
• Indications for Use: Temporary internal fixation and stabilization of various osteotomies and fractures (e.g., comminuted, supracondylar, extra-articular, osteopenic bone, nonunions, malunions). Smaller plates for hands and feet, calcaneal plates for calcaneus.
• Comparison to Predicate Device: Similar in intended use, basic shape, compatible diameters, materials, and performance characteristics.
• Performance Data:
  • Non-Clinical Performance: Biocompatibility testing (per ISO 10993-1 and 21 CFR § 58) and beam bending cross-sectional analyses showing similar mechanical performance to predicate devices.
  • Clinical Performance: "Clinical data and conclusions were not needed for these devices." This indicates that for this type of medical device (fixation plates and screws), the FDA often relies on non-clinical performance data and substantial equivalence to already approved predicate devices, rather than new clinical trials demonstrating "acceptance criteria" in the way one might for diagnostic or AI-driven devices.

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