(327 days)
The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip joint.
The device is intended for:
- skeletally mature individuals undergoing primary surgery for total hip replacement
- 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 to previous fusion
- patients with acute femoral neck fractures
The Metha® Hip System is a modular system which consists of two components: the stem and the neck. Each component is available in various sizes. The conical shaped stem is manufactured from titanium alloy. The proximal area of the femoral stem is plasma sprayed (Plasmapore®) with a secondary coating of Calcium Phosphate (u-CaP®). This stem is designed for cementless use only.
The modular cone adapter option allows the user to choose a combination of stem, neck, and head component to appropriately fit the individual patient. The modular cone adapter is manufactured from CoCr29MO.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.
The document is a 510(k) summary for the Metha® Hip System, which is a physical medical device (a hip implant). The "performance data" section refers to physical and mechanical testing conducted according to various guidance documents for orthopedic implants, not a clinical study involving AI or machine learning.
Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria, study details, sample sizes, expert involvement, or adjudication methods, as these concepts are not present in the provided text for this specific device.
The "PERFORMANCE DATA" section explicitly states:
"All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the;
- 'Guidance Document for Testing Orthopedic Implants with Modified 事 Metallic Surfaces Apposing Bone or Bone Cement',
- 'Guidance for Industry on the Testing of Metallic Plasma Sprayed 事 Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements'.
- 'Guidance Document for Testing Non-articulating, "Mechanically Locked" . . Modular Implant Components',
- 'Draft Guidance for Femoral Stem Prostheses', 事
- 'Draft Guidance for Calcium Phosphate (Ca-P) Coating' was completed 業 where applicable."
This clearly indicates a focus on physical, mechanical, and material performance testing for a hip implant, not on the performance of a software or AI/ML device.
§ 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.