(270 days)
- 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.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.