(118 days)
The Escalade Acetabular Cup System is intended for the replacement of the natural articular surface of the hip joint in a total hip replacement surgery. Total hip arthroplasty is intended to provide increased patient mobility and to decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants.
The Escalade Acetabular Cup System is indicated for use in total hip arthroplasty procedures where the means of cup fixation is uncemented, biological fixation. The Escalade Acetabular Cup System is compatible with the Ovation Hip Stem System (indicated for uncemented, biological fixation of the stem) and the Encompass Hip Stem System (indicated for both cemented and uncemented, biological fixation of the stem).
Total hip arthroplasty is indicated for the following conditions:
- Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
- Previously failed hip surgery.
- Fractures of the femoral neck or head.
- Avascular necrosis of the femoral head.
- Congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.
The Escalade Acetabular Cup System is a modular system intended for the replacement of the natural articular surface of the hip joint in a total hip replacement surgery. The system consists of acetabular shells, liners, bone screws, apical screw hole cover, and femoral heads.
Acetabular shells are hemispherical in shape and are designed for press-fit, cementless surgical applications. The shells are machined from titanium alloy (Ti-6Al-4V ELI) and are plasma spray coated (Ti-CP) for biological fixation. Escalade liners are manufactured from extensively cross-linked UHMWPE and are available in neutral face and 10° hooded options. Liners are configured for use with femoral head diameters ranging from 26mm to 40mm. The Ø6.5mm cancellous bone screws and the apical screw hole cover are manufactured from titanium alloy (Ti-6Al-4V ELI). The 36mm and 40mm diameter femoral heads made of cobalt chromium alloy (Co-28Cr-6Mo) are being added to the currently offered femoral head sizes in conjunction with this system.
The provided text does not describe acceptance criteria for a diagnostic device or a study related to its performance in a clinical setting. Instead, it is a 510(k) summary for a medical device called the "Escalade Acetabular Cup System," which is a hip implant.
The "study" referenced in the document is an in-vitro hip simulator study conducted to support a marketing claim about the wear reduction of the Escalade Acetabular Liners, not a diagnostic device's performance study based on expert interpretation or comparison with ground truth.
Therefore, I cannot provide the requested information in the format of acceptance criteria for a diagnostic device's performance because the document describes an orthopedic implant, not a diagnostic tool.
However, I can extract information about the in-vitro wear test if that is helpful:
1. Table of Acceptance Criteria and Reported Device Performance (for wear performance in in-vitro study):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reduced wear compared to predicate device (TriPlus UHMWPE liners) | Escalade Acetabular Liners reduce wear by 88% compared to previously cleared TriPlus UHMWPE liners when used with CoCrMo femoral heads. |
Steady state wear rates:
- Escalade 36mm and 40mm ID liners: 1.5 ± 0.6 mg/MC (millions of cycles)
- TriPlus control 32mm ID liners: 12.8 ± 1.6 mg/MC |
| Acceptable absolute wear rate | Average total wear for 5 million cycles: - Escalade 40mm liners: 6.6 mg
- Escalade 36mm liners: 6.7 mg
- TriPlus 32mm control liners: 67.9 mg |
Note: The document explicitly states: "Reduced wear claims are based upon the results of in-vitro hip wear simulator tests which have not been shown to quantitatively predict clinical wear performance. Also, a reduction in total polyethylene wear volume or wear rate alone may not result in an improved clinical outcome as wear particle size and morphology are also critical factors in the evaluation of the potential for wear mediated osteolysis and associated aseptic implant loosening. Particle size and morphology were not evaluated as part of this wear claim." This highlights that the in-vitro wear performance is not directly translatable to clinical outcome or clinical "acceptance criteria."
Regarding the other requested information, it is not applicable or not provided in the document for a diagnostic device context:
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Sample size used for the test set and the data provenance:
- The "test set" in this context refers to the liners tested in the in-vitro hip simulator. The document mentions "Escalade 36mm ID liners for a 52mm OD shell, Escalade 40mm ID liners for a 56mm OD shell, and TriPlus 32mm ID liners for a 52mm OD shell as a control." It does not specify the exact number of each type of liner tested.
- Data Provenance: The study was an "in-vitro hip simulator study," indicating it was conducted in a laboratory setting, not with human patient data from a specific country.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was an in-vitro mechanical wear test, not a diagnostic study requiring expert ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 is an orthopedic implant, not an AI-powered diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the wear test was the measured mass loss (wear rate) of the liners after a specified number of cycles in the hip simulator, determined by weighing.
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The sample size for the training set: Not applicable. There is no "training set" as this is not a machine learning/AI study.
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How the ground truth for the training set was established: Not applicable.
§ 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.