(112 days)
The metal backed acetabular component is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
The metal shell is fabricated from wrought/forged or cast Ti-6A1-4V. The outside surface of the shell is plasma sprayed to provide a roughened surface for enhanced press-fit fixation.
The metal shell is hemispherical in shape and is available with screw holes. The screw holes are for the use of cancellous bone screws for secondary fixation.
The poly liners are manufactured from ultra high molecular weight polyethylene and are available in a neutral and 10° hooded design. The hooded design is intended for those patients prone to subluxation because of soft tissue laxity.
This document is a 510(k) Pre-market Notification summary for a medical device, specifically a metal-backed acetabular component for total hip arthroplasty. It is not a study report detailing clinical performance or AI algorithm validation. Therefore, most of the requested information regarding acceptance criteria, study design, and AI performance is not applicable to this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document primarily focuses on mechanical performance for a physical medical device, not a diagnostic or AI-powered device. Therefore, the "acceptance criteria" relate to engineering specifications rather than clinical accuracy metrics like sensitivity or specificity.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Attachment strength of liners to shell | "All results are sufficient for in-vivo loading." |
Explanation: The document states that testing was performed on "attachment strength of liners to shell." The reported "performance" is a qualitative statement that these results were "sufficient for in-vivo loading," implying they met an internal engineering standard for durability and secure fit within the human body. There are no specific numerical thresholds or metrics provided for these criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. This document refers to engineering tests on the device's components, not clinical trials with patient data.
- Data Provenance: Not applicable. The "tests" mentioned are likely in-vitro mechanical tests conducted in a laboratory setting, not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. Ground truth for clinical outcomes or diagnostic accuracy is not relevant here. The "truth" in this context is whether the mechanical properties meet engineering specifications.
- Qualifications of Experts: Not applicable. The "experts" would be mechanical engineers or materials scientists conducting the tests, but their specific qualifications are not mentioned as a part of a clinical ground truth establishment process.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept is relevant for clinical studies where expert consensus is needed to determine a diagnosis or outcome. For mechanical testing, the "adjudication" is typically adherence to predefined engineering test protocols and specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No. This is a pre-market notification for a physical implantable device, not an AI algorithm. MRMC studies are used to assess the effectiveness of diagnostic tools, often involving AI, when interpreted by multiple human readers.
6. If a Standalone (Algorithm Only) Performance Study was Done
- Standalone Study: No. This document describes a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Engineering specifications and mechanical test standards (implicit). For example, the "ground truth" for liner attachment strength would be a predefined force or torque threshold that the device must withstand without failure, as determined by internal engineering requirements or relevant ISO/ASTM standards. It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document is not describing an AI/ML device, so there is no training set. If it refers to manufacturing process development, that information is not provided.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable.
In summary: This document is a regulatory submission for a physical medical device's pre-market clearance. It focuses on the device's design, materials, intended use, and mechanical testing results to demonstrate safety and effectiveness for its intended physical function. It does not contain information related to AI performance, clinical trials with human subjects for diagnostic accuracy, or data sets for machine learning.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.