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• a. Repair of long bone fractures due to trauma or reconstruction;
• b. Reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy;
• c. Sternotomy closure; and
• d. Sublaminar and Intrafacet wiring of the spinal column.

Not Found

The provided text is a U.S. FDA 510(k) clearance letter for the "Iso-Elastic Cerclage System (1mm and 2mm cable diameter)". It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. The letter is a regulatory approval, not a scientific study report.

Therefore, I cannot provide the requested table and information based on the given text. The text only specifies:

• Trade/Device Name: Iso-Elastic Cerclage System (1mm and 2mm cable diameter)
• Regulation Number: 21 CFR 888.3010
• Regulation Name: Smooth or threaded metallic bone fixation fasteners
• Regulatory Class: Class II
• Product Code: JDQ
• Indications For Use:
  • Repair of long bone fractures due to trauma or reconstruction;
  • Reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy;
  • Sternotomy closure; and
  • Sublaminar and Intrafacet wiring of the spinal column.

To address your query, you would need a clinical study report or a performance data summary for the device, which is not present in this regulatory clearance letter.

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• Repair of long bone fractures due to trauma or reconstruction; a.
• reattachment of the greater trochanter in total hip arthroplasty, surface replacement b. arthroplasty, or other procedures involving trochanteric osteotomy;
• c. sternotomy closure; and
• d. sublaminar and intrafacet wiring of the spinal column.

Not Found

I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the Kinamed Iso-Elastic Cerclage System, stating that the device is substantially equivalent to legally marketed predicate devices.

This type of document primarily confirms that the device can be marketed. It does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes for test sets, data provenance, or study types (retrospective/prospective).
• Information on the number or qualifications of experts for ground truth establishment, or adjudication methods.
• Any multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes for AI assistance.
• Confirmation of standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• The sample size for the training set or how its ground truth was established.

These details would typically be found in the 510(k) submission itself or in a separate clinical study report, which is not part of this FDA clearance letter.

Ask a specific question about this device