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The Synthes Sacral Bar System is intended for fixation of fractures of the posterior pelvis, in areas of the posterior superior iliac spine and posterior inferior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.

The Synthes Sacral Bar System consists of a threaded bar, washers, and nuts. The bars are fully threaded. One end of the bar has a trocar point to guide the bar through pre-drilled holes. The bars are available in lengths ranging from 120 to 260 mm, in 10 mm increments. The washers that are used with this system are oval shaped and are designed to slide freely along the bars. Both rounded and straight nuts are provided with this system; the rounded nuts mate with the washers to create compression, while the straight nuts are then added to wedge against the rounded nuts to maintain compression.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance as it relates to a medical device's analytical or clinical performance (e.g. sensitivity, specificity, accuracy).

The document is a 510(k) premarket notification from the FDA for the Synthes Sacral Bar System, dated August 24, 2000. It primarily focuses on the substantial equivalence of the device to predicate devices for marketing purposes.

Here's what the document does include:

• Device Name: Synthes Sacral Bar System
• Intended Use: Fixation of fractures of the posterior pelvis, in areas of the posterior superior iliac spine and posterior inferior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.
• Material: Implant quality stainless steel.
• Predicate Devices: Zimmer Threaded Sacral Rod, Synthes Threaded Bolt.
• Regulatory Class: II, Product Code: JDW.

However, the document does not include:

• A table of acceptance criteria (e.g., sensitivity, specificity, accuracy metrics).
• Reported device performance against such criteria.
• Details of any study (clinical or analytical) that would demonstrate performance such as sample size, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for training or testing sets.

The FDA's 510(k) process for devices like this typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through mechanical testing, biocompatibility, and sometimes limited clinical data, but not usually in the context of diagnostic performance metrics like those requested in your prompt. The standard approval for devices like bone fixation systems does not require performance metrics relating to AI.

Therefore, I cannot fulfill your request with the information provided.

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