(52 days)
The Excia Hip System is intended to replace a hip joint. The device is intended for: Patients suffering from severe hip and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necosis 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 Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo. The other femoral stem is for uncemented fixation and manufactured from Ti with Ti plasma spray.
The Excia femoral component is available in two designs. One is manufactured from Ti with a plasma spray coating (Plasmapore). This component is intended for uncemented use. The other femoral component is manufactured from CoCrMo and is intended for cemented use. Both femoral components have a 12/14 trunnion. The ceramic heads are available in head diameters of 28mm, and 36mm in three neck lengths each. They are for use only with the Ti alloy cementless stems. The cemented or cementless femoral stems may be used with the CoCrMo head that was cleared in BiContact (K040191). The acetabular insert is UHMWPE and is available in a 36mm symmetrical design. The 12/14 femoral component and ceramic head are in conjunction with Plasmacup (K042344) for total hip arthroplasty.
The provided text is a 510(k) summary for the Excia Total Hip System with a 12/14 Trunnion and Ceramic Head. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain any information about acceptance criteria or a study proving the device meets specific performance metrics in the way your request describes (e.g., using a test set, ground truth, expert review, or MRMC studies).
Instead, the performance data section 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"All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable.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 Metallic Surfaces Apposing Bone or Bone Cement',
- 'Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements',
- 'Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular Implant Components',
- 'Draft Guidance Document for Testing Acetabular Cup Prostheses',
- 'Points to Consider for Femoral Stem Prostheses',
- 'Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems and
- 'Data Requirements for Ultrahigh Molecular Weight Poletheylene (UHMWPE) Used in Orthopedic Devices' was completed where applicable."
This indicates that various guidance documents were followed for testing, but it does not provide:
- Specific acceptance criteria values.
- Reported device performance values against those criteria.
- Details of a study involving a test set, experts, ground truth, or statistical analysis (like sensitivity/specificity, AUC typical for AI/diagnostic devices).
- Any mention of AI, human readers, or comparative effectiveness studies (MRMC).
The document is a regulatory submission for a medical device (hip implant) whose clearance is based on substantial equivalence to existing devices, supported by adherence to various mechanical and material testing standards rather than a clinical performance study as one might expect for a diagnostic or AI-driven device.
Therefore, I cannot populate the table or answer most of your specific questions based on the provided text. The questions seem to be geared towards an AI/software device evaluation, which is not what this 510(k) document describes.
If this were an AI/software device, the information would typically include:
1. Table of Acceptance Criteria and Reported Device Performance:
Not available in the provided text.
2. Sample size used for the test set and data provenance:
Not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and qualifications:
Not available in the provided text.
4. Adjudication method for the test set:
Not available in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size:
Not applicable, as this is not an AI/diagnostic device described with MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/diagnostic algorithm.
7. The type of ground truth used:
Not applicable, as the evaluation here is based on mechanical/material testing against standards, not diagnostic truth.
8. The sample size for the training set:
Not applicable, as there is no "training set" for this type of device evaluation.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" for this type of device evaluation.
§ 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.