(61 days)
Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.
Synthes Lateral Entry Femoral Nail System is composed of cannulated femoral nails, solid 6.5 mm recon locking screws and cannulated end caps. Recon locking screws, as well as Synthes commercially available 5.0 mm and 6.0 mm locking screws, are used to secure the nail in the bone.
The provided text is a 510(k) summary for the Synthes (USA) Lateral Entry Femoral Nail System. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, this document describes a medical device (intramedullary fixation rod), not an AI/ML powered device, and therefore does not contain information typically found in a study proving an AI/ML device meets acceptance criteria.
Specifically, the document does not provide information on:
- Acceptance criteria for an AI/ML device: As it's a physical device, the acceptance criteria would relate to mechanical properties, biocompatibility, and manufacturing quality, not performance metrics like accuracy, sensitivity, or specificity.
- A study proving an AI/ML device meets acceptance criteria: The 510(k) process for this type of device relies on demonstrating substantial equivalence to legally marketed predicate devices, often through mechanical testing, material characterization, and comparison of design features and indications for use, rather than a clinical study evaluating AI performance.
Therefore, I cannot populate the requested table and answer the study-specific questions for an AI/ML device based on the provided text. The document's purpose is to establish "substantial equivalence" of a medical implant to existing devices for market clearance, not to evaluate the performance of an AI/ML algorithm.
§ 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.