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Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the mid-foot, metatarsals and phalanges of the foot.

The 34mm SCARF Thread-Head Screw is a threaded bone fixation screw that is 3.0mm in diameter and 34mm in length. It is made of thanium alloy and is cannulated with a threaded head. This screw is an extension of the product line for the SCARF Thread-Head Screw.

This document is a 510(k) premarket notification for a medical device (34mm SCARF Thread-Head Screw), which focuses on establishing substantial equivalence to existing devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria, as these are typically part of a different type of submission (e.g., a De Novo submission or a PMA).

Here's why and what information is available:

• 510(k) Premarket Notification Purpose: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This often relies on comparing design, materials, indications for use, and technological characteristics, rather than extensive new performance studies against predefined acceptance criteria.
• Missing Information: The provided text explicitly lacks the following information that would be necessary to answer the prompt:
  • A table of acceptance criteria and reported device performance.
  • Details of a study conducted to demonstrate performance against specific criteria.
  • Sample sizes, data provenance, expert qualifications, or adjudication methods for a performance study.
  • Information about MRMC or standalone performance studies.
  • Details about ground truth establishment or training sets.

What the document does implicitly convey about "acceptance":

The "acceptance" in a 510(k) context refers to the FDA's "substantial equivalence" determination. The letter from the FDA confirms:

• "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
• "This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."

In summary, based solely on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and performance studies because the document is a 510(k) summary focused on substantial equivalence, not a detailed performance study report.

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