(69 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 without u-CaP®.
The Excia M and ML femoral stem are available in one design. The femoral stem is manufactured from TI with a plasma spray coating (Plasmapore) with U-CaP®. The Excia M and ML femoral stem will be offered in an 8/10 or 12/14 taper. This component is intended for uncemented use.
The provided text is a 510(k) summary for the Excia Total Hip System M and ML Femoral Stem. It describes the device, its intended use, and substantial equivalence to predicate devices. However, the document does not include specific acceptance criteria, performance metrics, or details about a study designed to prove the device meets those criteria.
Instead, the "Performance Data" section states 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- "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable."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 lists several other guidance documents for orthopedic implant testing that were followed.
This indicates that the device underwent a battery of standardized tests required by the FDA for orthopedic implants. However, the document does not present:
- A table of specific acceptance criteria (e.g., minimum fatigue strength, maximum wear rate).
- Any reported device performance against such specific criteria.
- Details about a clinical study with human subjects or a comparison to AI.
Therefore, I cannot provide the requested information for the following points based only on the provided text:
- A table of acceptance criteria and the reported device performance: Not explicitly stated.
- Sample size used for the test set and the data provenance: Not mentioned. The testing refers to physical/mechanical performance rather than clinical data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is related to mechanical testing, not expert-adjudicated clinical data.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical implant, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as the testing described is mechanical.
- The sample size for the training set: Not applicable. This is not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided text:
The document indicates that the Excia Total Hip System M and ML Femoral Stem met necessary performance data requirements by undergoing various mechanical and material tests in accordance with FDA guidance documents for orthopedic devices. However, it does not specify the exact performance metrics or acceptance criteria for those tests, nor does it describe any studies involving human subjects, AI systems, or expert consensus adjudication. This 510(k) emphasizes substantial equivalence based on material, design, and indications for use, supported by adherence to recognized testing standards for physical implants.
§ 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.