(75 days)
The Excia Hip System is intended to replace a hip joint. The device is intended for: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis Patients suffering from disability due previous fusion. Patients with acute femoral neck fractures. The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or with or with of u CaP®.
The Excia 36mm Ceramic Head is manufactured from ceramic (Al2O3) and conforms to ISO 6474. The 36mm diameter head is offered in three different head lengths (-3.5 mm, 0 mm, and +3.5mm). These ceramic heads allow the surgeon further option to meet the patient's needs.
The provided text does not contain information about acceptance criteria for a device, nor does it describe a study proving the device meets particular acceptance criteria. Instead, it is a 510(k) summary for a medical device (Excia Total Hip System 36mm Ceramic Head), which focuses on establishing substantial equivalence to previously cleared devices.
The text details:
- Device Identification: Trade Name, Common Name, Classification Name, Product Code.
- Substantial Equivalence: It states that the device is a line extension and substantially equivalent to other cleared devices (K042344, K060918).
- Device Description: Material (Al2O3 ceramic), size (36mm diameter), and head lengths.
- Indications for Use: Detailed list of conditions for which the Excia Hip System is intended.
- Technological Characteristics: Comparison to predicate devices, stating similar shapes, sizes, and materials.
- Performance Data: This section mentions that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable." It then lists several other specific guidance documents for orthopedic implants that were followed for testing. However, it does not present specific performance data, acceptance criteria, or the results of those tests. It only indicates that relevant guidance documents were followed.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, training set details) from the provided text, as this type of information is typically found in detailed study reports or performance data sections which are not included here. The document primarily serves as a declaration of substantial equivalence based on adherence to established guidelines and previous device clearances.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.