(71 days)
The Gotfried PH (Physiological Hip) Nail is intended for fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric), subtrochanteric, and base of neck fractures of the proximal femur.
The Gotfried PH (Physiological Hip) Nail is an intramedullary nail which utilizes two proximal dynamic femoral neck screws and two distal locking bolts.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Gotfried PH (Physiological Hip) Nail) and primarily discusses its intended use, comparison to predicate devices, and the FDA's clearance.
The text does not contain any details on:
- Acceptance criteria for performance metrics.
- Performance data from a study.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for any set was established.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.