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The Skelite™ Resorbable Cement Restrictor is intended to be used in orthopaedic surgeries, such as those involving the femoral and tibia canals in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.

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The provided document is a 510(k) clearance letter from the FDA for the Skelite™ Resorbable Cement Restrictor. It does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.

This letter is a regulatory document stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It includes:

• Trade/Device Name: Skelite™ Resorbable Cement Restrictor
• Regulation Number and Name: 21 CFR 878.3300, Surgical mesh
• Regulatory Class: II
• Product Code: JDK
• Date of Clearance: November 21, 2005
• Intended Use: Orthopaedic surgeries involving femoral and tibia canals in hip stem and total knee replacement.
• Limitations: Specifically states "THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. WARNING: THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED."

To answer your request about acceptance criteria and the supporting study, you would need to refer to the original 510(k) submission (K051836) itself, which is not provided here. The 510(k) submission would contain the detailed information on testing, performance data, and how the manufacturer demonstrated substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information from the given document as it is outside the scope of this regulatory clearance letter.

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The Skellite™ Synthetic Resorbable Bone Void Filler is indicated only for bony voids on I he Skence - Bynthone reability of the bony structure. Skelite "" is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, be gently paokid into belly veats may be surgically created osseous defects or osseous spine, and pervisy. Theose coloring to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. The product can be mixed with bone marrow.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (SKELITE™ Synthetic Resorbable Bone Void Filler). This letter does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

Therefore, I cannot provide the detailed response you're looking for based on this document.

Ask a specific question about this device