(83 days)
In total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
This device is for cemented use only.
The Cemented EXTEND™ Hip Stem is a monolithic design femoral component. The stem is cast cobalt chrome alloy (ASTM F-75). The stem is available straight with standard or reduced flare, or bowed with a calcar platform. It is designed for use with bone cement.
This document is a 510(k) summary for the Cemented EXTEND™ Hip Stem. It describes the device, its intended use, and indicates that it "demonstrates acceptable fatigue strength." However, it does not provide detailed acceptance criteria or a study summary as typically found in comprehensive device performance reports.
Based on the provided text, here’s what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (specific quantitative fatigue strength thresholds are not provided in this summary) | "The EXTEND™ Hip System demonstrates acceptable fatigue strength." (Qualitative statement) |
2. Sample Size for the Test Set and the Data Provenance
This information is not provided in the 510(k) summary. It only broadly mentions "Testing."
- Sample Size for Test Set: Not provided.
- Data Provenance: Not provided (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable here. The device testing appears to be mechanical (fatigue strength) rather than involving expert assessment of images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable as the testing described is mechanical, not involving human interpretation or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not applicable for this type of mechanical device. This kind of study is typically used for diagnostic devices that involve human interpretation (e.g., radiologists reading images).
6. Standalone Performance Study
The statement "The EXTEND™ Hip System demonstrates acceptable fatigue strength" implies a standalone performance test was conducted on the device itself without human interaction. However, the details of this study (methodology, specific results, statistical analysis) are not provided in this summary.
7. Type of Ground Truth Used
The "ground truth" for fatigue strength testing would be established by engineering standards and testing protocols (e.g., ASTM standards for medical implants). It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic device would be.
8. Sample Size for the Training Set
This information is not provided as this is not a machine learning or AI-based device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as this is not an AI/ML device.
In summary:
The provided 510(k) summary states that the Cemented EXTEND™ Hip Stem has "acceptable fatigue strength." However, it lacks the detailed information requested regarding specific acceptance criteria, study methodologies, sample sizes, and expert involvement that would typically be found in a comprehensive study report for a device. This document serves as a regulatory summary, not a scientific publication detailing the full device validation study.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.