(57 days)
Both devices mentioned above are intended to stabilize fractures of the tibia. Indications include, but are not limited to, open and closed tibial shaft fractures, certain pre- and post-isthmic fractures, tibial malunions and tibial non-unions.
Synthes Titanium Cannulated Tibial Nail (Ti CTN) is compared to Synthes Ti-6Al-7Nb Unreamed Tibial Nail and is an extension to Synthes Titanium Tibial Nail System.
The Synthes Ti CTN is available in sizes ranging from 11 mm in diameter and in lengths ranging from 255 mm to 420 mm. The nail has a cannulated tube with a bend in the sagittal plane which facilitates insertion into the tibia. There are four locking holes proximally and three locking holes distally. All of the locking holes accept 4.9 mm Titanium Locking Bolts.
The devices will be provided both sterile. The non-sterile devices must be sterilized prior to use. The following sterilization parameters are recommended:
| Method | Cycle | Time | Temperature |
|---|---|---|---|
| Steam | Pre-Vacuum | 6 minutes | 132°C - 135°C |
| Steam | Gravity Displacement | 15 minutes | 132°C - 135°C |
The provided text describes a medical device, the Synthes Titanium Cannulated Tibial Nail (Ti CTN), and its intended use. However, it does not contain any information regarding acceptance criteria, device performance studies, or details relevant to AI/algorithm performance. The document is a "Summary of Safety and Effectiveness Information" (K962047) from 1996, which predates the widespread application of AI in medical devices and focuses on comparing the new device to existing Synthes products and specifying its physical characteristics and sterilization parameters.
Therefore, I cannot provide the requested information. The text does not include:
- A table of acceptance criteria and reported device performance.
- Sample size for test set or data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.