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K Number
K102834
Device Name
ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)
Manufacturer
KINAMED INCORPORATED
Date Cleared
2011-01-12

(105 days)

Product Code
JDQ
Regulation Number
888.3010
Type
Special
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • 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.
Device Description

Not Found

AI/ML Overview

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.

§ 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.