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This device is used in the general management of fractures and reconstructive surgery.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Helical Compression Anchor System, Cannulated, Model 7.3mm". This document does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

The letter confirms that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It outlines regulatory requirements and provides contact information for further assistance.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them based on the provided text. This information would typically be found in the 510(k) submission itself, not in the FDA's decision letter.

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This device is used in the general management of fractures and reconstructive surgery.

Not Found

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "Helical Compression Anchor System, Cannulated, Version 2." It primarily states that the device has been found substantially equivalent to a legally marketed predicate device for the stated indications for use.

The document does not include:

1. A table of acceptance criteria or reported device performance.
2. Details about sample sizes, data provenance, or types of studies conducted (e.g., test set, ground truth experts, adjudication methods, MRMC studies, standalone performance).
3. Information on the training set or how its ground truth was established.

The "Indications for Use Statement" only provides the general purpose of the device: "This device is used in the general management of fractures and reconstructive surgery." This is an intended use statement, not a list of performance acceptance criteria.

Ask a specific question about this device