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The Gotfried PH (Physiological Hip) Nail is intended for fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric), subtrochanteric, subcapital (intra capsular), 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 up to two distal locking bolts.

This 510(k) summary (K083648) describes a medical device, "The Gotfried PH (Physiological Hip) Nail," which is an intramedullary nail for hip fracture fixation. However, the provided document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include information on software performance.

The document is a standard 510(k) summary for a Class II medical device (Intramedullary fixation rod). It primarily focuses on:

• Identification of the device and its submitter.
• Classification of the device and its predicate devices.
• Description of the device: An intramedullary nail with two proximal dynamic femoral neck screws and up to two distal locking bolts, made of stainless steel.
• Intended Use: Fractured bone stabilization, fixation, and management of specific types of proximal femur fractures (trochanteric, subtrochanteric, subcapital, and base of neck).
• Comparison to predicate devices: States that it is "substantially equivalent" in technology, construction, materials, and orthopedic design principles. It explicitly mentions its dimensions and tolerances are within the range of previously cleared devices.

Therefore, I cannot provide the requested table and information about acceptance criteria and study details because the provided text does not contain this information. This type of information (performance studies, acceptance criteria for software, sample sizes, ground truth) is typically found in the more detailed sections of a 510(k) submission, not usually in the publicly available 510(k) summary document itself, especially for a hardware device like an intramedullary nail. The substantial equivalence argument for this device relies on its similarity to existing, legally marketed predicate devices, rather than on new performance studies with specific acceptance criteria that would be relevant for software or AI.

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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.

Ask a specific question about this device