(131 days)
The LINEAGE® A-CLASS™ Poly Liner is indicated for use 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; and,
- revision procedures where other treatments or devices have failed
The design features of the LINEAGE® A-CLASS™ Poly Liner are summarized below:
- Ultra High Molecular Weight Polyethylene (UHMWPE) .
- Oura High Morecular Wolferal lip assembly to lock the liner into the actabular . shell
- Offered with 0° and 15° overhangs .
Here's an analysis of the provided text to extract the acceptance criteria and study information for the LINEAGE® A-CLASS™ Poly Liner:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Exhibit significantly less wear than traditional LINEAGE® Liners. | The LINEAGE® A-CLASS™ Poly Liner exhibits 94% less wear than traditional LINEAGE® Liners based on a hip wear simulator test. The average amount of wear at 5 million cycles for the test device (LINEAGE® A-CLASS™ Poly Liner) was 424.7 mg less than that of the control device (LINEAGE® Poly Liner). |
| Material is Ultra High Molecular Weight Polyethylene (UHMWPE). | Confirmed: The device material is Ultra High Molecular Weight Polyethylene (UHMWPE). |
| Design features include a peripheral lip assembly. | Confirmed: Includes a peripheral lip assembly to lock the liner into the acetabular shell. |
| Offered with 0° and 15° overhangs. | Confirmed: Offered with 0° and 15° overhangs. |
| Substantially equivalent in indications for use to predicate. | Confirmed: The indications for use of the LINEAGE® A-CLASS™ Poly Liner are identical to the indications for use of the currently marketed LINEAGE® poly liner. |
| Substantially equivalent in material to predicate. | Confirmed: The material used to manufacture the LINEAGE® A-CLASS™ Poly Liner is substantially equivalent to that which is used to manufacture the currently marketed LINEAGE® poly liner. |
| Fundamental scientific technology not changed relative to predicate. | Confirmed: The fundamental scientific technology of the modified device has not changed relative to the predicate device. |
| Safe and effective for intended use. | This is an overall regulatory acceptance. The document states: "The safety and effectiveness of the LINEAGE® A-Class Poly Liner are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." The wear test data serves as key evidence for improved effectiveness (reduced wear) compared to the predicate device. |
Study that Proves the Device Meets Acceptance Criteria:
The primary study mentioned is a hip wear simulator test conducted to demonstrate reduced wear.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): Not explicitly stated as a "sample size" in the conventional sense for a human study. For the hip wear simulator test:
- The test involved the LINEAGE® A-CLASS™ Poly Liner (test device) and the LINEAGE® Poly Liner (control device). The number of individual liners tested concurrently is not specified, but it implies at least one of each type.
- Both devices were 28 mm inner diameter acetabular liners.
- Both were tested for 5 million cycles.
- Data Provenance: This was an in vitro (laboratory) study using hip simulators manufactured by Shore Western Manufacturing, Inc. It's not human data (retrospective or prospective), nor is a country of origin specified beyond the company location in the US (Wright Medical Technology, Inc., Arlington, Tennessee).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable: This was an in vitro mechanical wear test. There were no human experts establishing ground truth for a "test set" in the context of clinical or diagnostic performance. The "ground truth" was established by the wear measurement methodology of the hip simulator.
4. Adjudication Method for the Test Set:
- Not Applicable: There was no human adjudication process involved in this mechanical wear test. The wear was measured directly by the hip simulator and recorded.
5. 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 document describes a medical device (hip liner), not an AI diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers is not relevant and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable: This is a physical medical device, not an algorithm. The wear test describes the standalone performance of the liner in a simulated environment.
7. The Type of Ground Truth Used:
- Direct Measurement of Wear: The ground truth for the wear claim was the quantifiable mass loss (mg) measured directly from the liners after 5 million cycles in the hip simulator.
8. The Sample Size for the Training Set:
- Not Applicable / Not explicitly stated: This is a physical device being compared to a predicate, not an AI model requiring a training set. The "design features" and "material" can be considered "learned" or "developed" from prior engineering knowledge and testing of UHMWPE, but there isn't a "training set" in the machine learning sense. The wear test itself compares two physical products.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable: As there's no "training set" for an AI model, this question is not relevant to the provided documentation.
§ 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.