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The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.

The CONQUEST FN system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. The subject premarket notification describes additional sizes of the bone plates to the Smith & Nephew CONQUEST FN system. The subject devices are manufactured from the same implant-grade stainless steel (316L) and designed for singleuse. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.

This document, K193029, is a 510(k) premarket notification for a medical device called CONQUEST FN, specifically an additional size of the bone plate (CONQUEST FN 3 Hole Small Stature Plate). The FDA letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain information about studies involving AI or human readers, expert ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies. The acceptance criteria discussed refer to engineering and biocompatibility testing for a physical implant, not an AI/software device.

Therefore, I cannot provide a response filling in the requested information about AI device acceptance criteria and performance studies. The document describes a traditional medical device (metallic bone fixation appliance) and its mechanical and material testing.

The "Summary of Pre-Clinical Testing" section discusses:

• Construct Fatigue Testing: This is a mechanical test to assess the device's durability under repeated stress.
• Bacterial Endotoxin Testing: This is a biocompatibility test to ensure the device is safe from endotoxin contamination.

The acceptance criteria for these tests are described in terms of meeting specific standards and showing similar stability to the predicate device.

If your request was based on the assumption that this document detailed an AI/software device, please note that it does not.

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