(74 days)
Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.
Vanguard Reprocessed External Fixation Devices are previously used non-invasive orthopedic devices that have been cleaned, inspected, tested, and packaged by Vanguard Medical Concepts, Inc. External fixation device systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casting or other means of internal fixation. External fixation elements consist of components such as straight and curved rods, rod-to-rod, and rod-to-pin couplings and clamps, rings and ring segments, ring-to-rod, and ring-to-pin clamps. These components are provided in bulk, packaged in nylon pouches, non-sterile, with instructions for steam sterilization by the health care facility.
The provided text describes a 510(k) summary for VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES but does not contain acceptance criteria for device performance nor any study details that prove the device meets such criteria.
The document primarily focuses on:
- Identification of the device: Vanguard Reprocessed External Fixation Devices, along with its classification, common name, and product code.
- Predicate devices: Listing of original equipment manufacturers (OEM) and third-party reprocessors for comparison.
- Indications for Use and Contra-indications: Specifies the medical conditions the device is intended to treat and situations where it should not be used.
- Device Description: Detailed explanation of the components of external fixation systems (rods, couplings, rings, clamps) and their materials.
- Technological Characteristics: States that the reprocessed devices are "essentially identical" to OEM devices and perform the same.
- Test Data (mentioned, but not detailed): A generic statement that "Cleaning, packaging, and performance testing demonstrate that the reprocessed devices perform as intended and are safe and effective." However, no specific acceptance criteria or results from these tests are provided.
- Conclusion: A declaration of substantial equivalence to predicate devices based on the information provided.
Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, sample sizes, ground truth details, or specific study information because this information is not present in the provided document.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.