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The device is intended to be used for internal fracture fixation of small and large bones. It is to be used in combination with 3.5mm diameter and 4.5 mm diameter stainless steel cortical bone screws.

It is not intended for use in the attachment of screws or other devices to the posterior elements of the cervical, thoracic or lumbar spine.

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I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for "The Answer Screw Supplementation System." It primarily addresses the regulatory approval of the device based on substantial equivalence to a predicate device.

The document does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Details about a study proving the device meets acceptance criteria.
• Sample size used for a test set, data provenance, number of experts, adjudication method for a test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Information about standalone algorithm performance.
• Type of ground truth used.
• Sample size for a training set or how its ground truth was established.

The letter focuses on:

• Correcting information about the sponsor.
• Stating that the device is substantially equivalent to legally marketed predicate devices.
• Indicating the regulatory class (Class II) and product code (HWC).
• Outlining general controls and other applicable regulations.
• Defining the intended use: "internal fracture fixation of small and large bones. It is to be used in combination with 3.5mm diameter and 4.5 mm diameter stainless steel cortical bone screws. It is not intended for use in the attachment of screws or other devices to the posterior elements of the cervical, thoracic or lumbar spine."

To provide the information you requested, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed engineering specification document.

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