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(Fine Gold) a. K-Piston For bridging the stapes in case of otosclerosis, also for bridging defects of the ossicular chain between manubrium mallei and vestibulum (malleovestibulopexy).
ANGULAR Piston (Gold with Titanium Bands) b. For bridging the stapes of otosclerosis, specifically for surgical revisions in patients with shortenend incudal process and for primary procedures when this anatomical condition is present.

• K-Piston Like many of the SE devices, the K-Piston is shaped like a. a bishop's crosier. Its outstanding feature is the slightly laterally displaced, wide golden band. The bent end allows overclosure and, thus, extremely secure fastening, around long process of incus.
  b. ANGULAR Piston
  An angled gold wire with two titanium bands, which are connected to the shorter leg. Specifically designed in cases of extreme arrosion of long incudal process.
  Both devices are manufactured of fine gold (99.99%).

This document is a 510(k) summary for the KURZ K-Piston and ANGULAR Piston partial ossicular replacement prostheses. It describes the devices and asserts their substantial equivalence to predicate devices already on the market. This document does NOT describe a study that uses acceptance criteria to prove a device meets those criteria, nor does it contain information about AI/algorithm performance.

Therefore, I cannot provide the requested information. This document focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, which is a regulatory pathway that doesn't typically involve new clinical studies with defined acceptance criteria for device performance in the same way an AI/algorithm submission would.

The document indicates that the devices are substantially equivalent in size and design to FDA-approved devices manufactured by Smith & Nephew Richards and XOMED. This is the primary "proof" for this type of submission.

Specifically, the document includes:

• Identificaiton of Predicate Devices [807.92(a)(3)]: States that "KURZ pistons are substantially equivalent in size and design to FDA-approved devices manufactured by Smith & Nephew Richards, Bartlett, TN, and XOMED, Jacksonville, FL, (which also markets TREACE devices). These devices have been found substantially equivalent through the 510(k) premarket notification process."
• Information Bearing on the Safety and Effectiveness: States, "The KURZ K-Piston and ANGULAR Piston partial ossicular replacement prostheses have the same intended use as predicate devices. There are no additional characteristics known that should adversely affect the safety and effectiveness of these implants."

The only "testing" mentioned is:

• MRI Environment: "Testing in a 0.5 Tesla nuclear magnetic resonance tomograph has revealed no implant movement and no adverse tissue effects attributable to MRIgenerated heating. The image quality may be impeded or blurred in direct vicinity of the implant. To date, no report of hearing loss or other adverse effect has come to the attention of the manufacturer." This is a safety test, not a performance study comparing the device against acceptance criteria for clinical outcomes.

In conclusion, the categories of information requested (acceptance criteria table, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types, training set size and ground truth establishment) are not applicable to the content provided in this 510(k) summary for a physical medical implant.

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