(30 days)
The BiContact Hip System with u-CaP® (prosthesis, hip, semi-constrained, metal/polymer, porous uncemented) 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 eptiphysis
- Patients suffering from disability due to previous fusion
- Patients with acute femoral neck fractures
The BiContact Hip System with u-CaP® is available in one design. The femoral stem is manufactured from Ti with a Ti plasma spray coating (Plasmapore®) and a layer of Calcium Phosphate. This component is intended for uncemented use. A CoCrMo femoral head is available. The acetabular cup is manufactured solely of UHMWPE.
The provided text is a 510(k) summary for the BiContact Hip System with u-CaP®, which is a medical device. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than proving the device meets specific acceptance criteria through a clinical study with reported performance metrics.
Therefore, many of the requested details related to acceptance criteria, specific performance statistics, expert adjudication, stand-alone performance, and training/test set ground truth establishment cannot be found in this document. This is common for 510(k) submissions, which often rely on bench testing and comparison to predicates for clearance.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document in the format of a table with specific acceptance criteria and corresponding reported performance values (e.g., accuracy, sensitivity, specificity, mechanical strength tolerances). The document states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable," and lists several other guidance documents. This implies that the device met the requirements outlined in those guidances, but the specific metrics and their acceptance ranges are not detailed here.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document details various "Performance Data" which are likely results from bench testing (mechanical, material, coating properties) rather than a clinical "test set" with human data. The provenance of any such data is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. As the submission focuses on substantial equivalence based on technical characteristics and bench testing, there is no mention of a "ground truth" established by human experts in the context of device performance in a clinical scenario.
4. Adjudication Method for the Test Set
This information is not provided. There is no indication of a clinical "test set" or any adjudication process involving expert assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not provided, and it is highly unlikely such a study was performed or required for a 510(k) submission for this type of orthopedic implant. MRMC studies are typically associated with diagnostic imaging devices where human interpretation is a key factor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the device is a physical orthopedic implant (hip system), not a software algorithm with standalone performance metrics.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance would primarily be established through engineering specifications, material science testing, and adherence to relevant industry standards and guidance documents (as listed in the "Performance Data" section). For example, the "ground truth" for coating adherence might be defined by a specific load or cycling test failure threshold. There is no mention of pathology, expert consensus, or outcomes data being directly used as "ground truth" for the clearance in this document.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical orthopedic implant. There is no concept of a "training set" in the context of an algorithm for this product type.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
Summary of available information from the document:
- The document describes the intended use of the BiContact Hip System with u-CaP® to replace a hip joint in patients with various conditions like arthritis, avascular necrosis, congenital hip dysplasia, previous fusion, and acute femoral neck fractures.
- The device is a Class II medical device.
- Performance data refers to various required testing per established guidance documents for orthopedic devices, metallic surfaces, plasma-sprayed coatings, modular implant components, femoral stem prostheses, and calcium phosphate coatings. The specific results of these tests (e.g., acceptance criteria values and observed performance values) are not detailed in this summary.
- The device claims substantial equivalence to four predicate devices: BiContact Hip System (K040191), Accolade-TMZF Plus HA Hip System (K023102), Taperloc Porous Femoral Stem & Ha Taperloc Porous (K020963), and Corail (K953111). This substantial equivalence is the primary basis for its clearance, rather than a novel clinical effectiveness study.
§ 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.