(67 days)
The CONCISE™ Compression Hip Screw System is indicated for stable and unstable fractures in which a stable medial buttress can be reconstructed for fractures of the proximal femur including:
- Intertrochanteric fractures .
- Subtrochanteric fractures .
- Basilar neck fractures .
- Selected trochanteric non-unions
The CONCISE™ Compression Hip Screw System (Sterile) consists of lag screws, cortical bone screws, compression screws, and compression bone plates. Each component is available in a range of sizes to fit varying anatomical requirements.
The provided text describes a medical device, the CONCISE™ Compression Hip Screw System (Sterile), and its 510(k) submission to the FDA. However, the document does not contain information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any comparative effectiveness studies as typically found in a clinical study report.
The document is a notification from the FDA confirming the device's substantial equivalence to a predicate device, allowing it to be marketed. It details the device's intended use and materials but does not present data from any performance or clinical study.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance study details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This information would typically be found in a separate clinical or performance study report, which is not part of the provided text.
§ 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.