(93 days)
The intended use for the 450mm it's is as a temporary ant to aid in the healing of lor fractures. I for children abo 110 130 ow 65 The 100mm Nancy Nail™ for small long bone with a long diaphysis. as carpal or tarsal bone
The I fancy Nail™ is a titanium alloy pin, available in two lengths: 450mm and 100mm The 450mm is available in five diameters: 2.0, 2.5, 3.0, 3.5, 4.0. The 100mm has a diameter of 1mm
The provided document does not contain information about acceptance criteria or a study that proves the device meets such criteria. It is a summary of safety and effectiveness for a medical device (Nancy Nail™ intramedullary elastic nail) under the K960642 submission. The document primarily focuses on:
- Manufacturer and Sponsor Identification: Contact details and registration numbers.
- Proprietary and Common Name: Nancy Nail™ (Intramedullary Elastic Nail).
- Classification: FDA classification as a Class II metallic bone fixation fastener (21 CFR Section 888.3040), specifically a flexible, metallic bone fixation pin.
- Intended Use: Temporary aid in healing long bone fractures for children (450mm nail for patients 110-130 lbs, under 65 inches; 100mm nail for small long bones like carpal or tarsal bones).
- Description: Titanium alloy pin available in two lengths (450mm and 100mm) and various diameters.
- Predicate Devices: Kirschner's Wire & Steinman Pin, Howmedica's Rush Nail.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader studies, as this information is not present in the provided text.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.