(67 days)
Intended Use: The ACE® A/R Humeral Nail is a single use device intended for fixation of humeral fractures.
Indications for Use: The ACE® Antegrade Retrograde Humeral Nail System is indicated for open and closed fracture patterns, humeral shaft fractures, fractures of the proximal and distal metaphysis, comminuted fractures of the humerus with small medullary canals, fracture non-unions and mal-unions, pathological fractures, floating elbow.
The ACE® Antegrade Retrograde (A/R) Humeral Nail System includes an intramedullary nail, cancellous and cortical screws, and end caps and is intended for the firsting of humeral fractures. The nail is available in diameters of 7, 8, and 9 millimaters and lengths of 200-300mm, in 20mm increments. The nail incorporates anterior/posterior and lateral/medial screw holes, distal and proximal bends, a distal locking screw postcho may be inserted antegrade as well as retrograde.
The provided text describes a 510(k) Summary for the DePuy ACE® Antegrade Retrograde Humeral Nail System. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with acceptance criteria. As such, the document does not contain the information requested regarding acceptance criteria, a study that proves the device meets them, or details about sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The "Basis of Substantial Equivalence" section explicitly states:
"Based on the same intended use, indications for use, design features, materials, and sterilization processes, DePuy ACE® believes that the subject Antegrade Rotrograde Humeral Nail System is substantially equivalent to the previously cleared DePuy ACE® AIM Humeral Nail System (K934643) and the Howmedica Osteonics Corp T2™ Humeral Nail System (K011529)."
This indicates that the submission relies on demonstrating similarity to already approved devices rather than presenting novel performance data against pre-defined acceptance criteria for the new device.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.
§ 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.