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The Synthes Low-Profile Wrist Fixator is intended for stabilization of fractures of the distal radius.

The Synthes Low-Profile Wrist Fixator consists of frame elements that form a construct intended to treat fractures of the distal radius. The Low-Profile Wrist Fixator provides stabilization of fractures via pins (Schanz screws) inserted proximally and distally to a fracture and connected by an external bridging frame consisting of two Low-Profile Wrist Fixator Clamps - MR Safe, a carbon fiber rod and two protective end caps. The Low-Profile Wrist Fixator is available as a complete sterile assembly.

The provided document describes a medical device, the Synthes (USA) Low-Profile Wrist Fixator, and its clearance through the 510(k) premarket notification process. This process is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific performance acceptance criteria through clinical studies.

Therefore, the document does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm-only) performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Explanation:

The 510(k) submission primarily focuses on demonstrating that the "Synthes (USA) Low-Profile Wrist Fixator" is substantially equivalent to existing, legally marketed predicate devices (Orthofix Penning Wrist Fixator, Synthes (USA) Articulating Distal Radius System, Synthes (USA) 4.0 mm Adjustable Clamp for Distal Radius). Substantial equivalence is typically established by comparing device characteristics such as intended use, technological characteristics, and performance data without requiring new clinical trials if the device is similar enough to predicates.

The document states: "Documentation is provided which demonstrates that the Synthes (USA) Low-Profile Wrist Fixator is substantially equivalent to other legally marketed devices." It also mentions "The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice requirements... labeling, and prohibitions against misbranding and adulteration." This indicates regulatory clearance based on equivalence and adherence to general controls, not on a study proving a novel device meets specific performance acceptance criteria as would be required for innovative devices or those requiring a PMA.

In essence, the 510(k) process is about demonstrating safety and effectiveness by showing similarity to an already approved device, not by independently proving performance against predefined acceptance criteria for a novel device.

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