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Synthes RIA System is intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis; and to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects. These procedures include spinal fusion, joint arthrodesis, total joint replacement, fracture repair, nonunion, maxillofacial reconstruction, and tumor removal.

Synthes RIA System is a flexible reaming device that consists of a series of disposable tube assemblies, disposable reamer heads, tube assemblies, drive shaft seals and reusable drive shafts. The device is designed for expedited reaming of the medullary canal in preparation for internal fixation. The RIA System is also designed to harvest bone and bone marrow. The free-rotating reamer head attaches to the distal end of the tube assembly. Ports in the manifold of the tube assembly allow simultaneous irrigation and aspiration through the tube assembly during the reaming process. Irrigating fluid is passed through the cannula of the drive shaft and reamer head and aspiration is drawn through ports of the retainer and aspiration tube. The RIA System is available in various lengths and diameters.

The provided text is a 510(k) summary for the Synthes (USA) Reamer Irrigator Aspirator (RIA) System and a letter from the FDA regarding its substantial equivalence. This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance in terms of diagnostic accuracy or effectiveness metrics.

The 510(k) process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring a detailed clinical performance study with specific acceptance criteria and performance metrics like sensitivity, specificity, or reader studies.

Therefore, I cannot provide the requested information from the given input. The document confirms that the device is substantially equivalent to existing devices and outlines its intended use, but does not include:

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

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