(269 days)
The POLARCUP® Dual Mobility System is indicated for:
- Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or . rheumatoid arthritis.
- Fracture or avascular necrosis of the femoral head .
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
- . All forms of osteoarthritis
- . Patients with hips at risk of dislocation
- Femoral neck fracture or proximal fracture to hip joint .
The POLARCUP® Dual Mobility System is intended for single use only and depending on its version is to be implanted either with or without bone cement.
The POLARCUP Dual Mobility System consists of a metal shell and plastic liner (or insert). The inside of the metal shell is polished, and the outside of the plastic liner is able to articulate against this polished surface. This dual mobility design results in higher intra-prosthetic stability to address the treatment of patients with a high risk of dislocation (especially for elderly patients) or patients with recurrent dislocation. The subject device is identical to the previously cleared POLARCUP® Dual Mobility System with the exception of an increase in the size range and the addition of Highly Crosslinked Polyethylene Liners.
Here's the analysis of the provided text regarding the acceptance criteria and study for the POLARCUP® Dual Mobility System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, K110135, is a 510(k) premarket notification for a medical device. For such devices, "acceptance criteria" and "device performance" are typically established through bench testing and comparison to predicate devices rather than clinical study outcomes with specific metrics like sensitivity or specificity.
Therefore, the "acceptance criteria" here relate to demonstrating substantial equivalence through mechanical testing and material characterization, and the "reported device performance" is the conclusion that these tests met the requirements for substantial equivalence.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance |
|---|---|---|
| Mechanical Data | Capable of withstanding expected in vivo loading without failure (as demonstrated through various mechanical tests). | "A review of the mechanical data indicates that the POLARCUP® Dual Mobility System is capable of withstanding expected in vivo loading without failure." |
| Overall Design | Substantially equivalent to commercially available predicate devices. | "The overall design... for the POLARCUP® Dual Mobility System are substantially equivalent to the commercially available predicate devices identified." The specific changes (increase in size range, addition of highly crosslinked polyethylene liners) did not alter substantial equivalence due to testing. |
| Materials | Substantially equivalent to commercially available predicate devices. | "The overall design, materials... for the POLARCUP® Dual Mobility System are substantially equivalent to the commercially available predicate devices identified." |
| Indications for Use | Substantially equivalent to commercially available predicate devices. | "The overall design, materials, and indications for use for the POLARCUP® Dual Mobility System are substantially equivalent to the commercially available predicate devices identified." |
| Specific Testing | Wear, coating characterization, range of motion, stress analysis, and fatigue properties deemed acceptable for substantial equivalence. | "Wear Testing, Coating Characterization, Range of Motion Testing, Stress Analysis and Fatigue Properties were evaluated for the determination of substantial equivalence." (Implies results were acceptable). |
| Safety and Effectiveness | Demonstrated to be safe and effective for its intended use, based on substantial equivalence to predicate devices (as determined by the FDA). | FDA's 510(k) clearance indicates that the device is "substantially equivalent... to legally marketed predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
This is a physical medical device (implantable hip component), not a diagnostic algorithm or software. Therefore, the concept of a "test set" and "data provenance" in the context of clinical images or patient data does not apply in the same way.
- Sample Size for Test Set: Not applicable in the traditional sense of patient data. The "test set" would refer to the number of devices or components used in mechanical and material testing. The document does not specify the exact number of units tested for each mechanical evaluation (Wear Testing, Coating Characterization, Range of Motion Testing, Stress Analysis, and Fatigue Properties).
- Data Provenance: The data comes from in vitro mechanical and material testing conducted by Smith & Nephew, Inc. There is no information regarding country of origin for the data or whether it's retrospective or prospective, as these terms are relevant for clinical studies, not bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in this context would be scientifically established standards for material and mechanical performance testing, as well as regulatory standards for demonstrating substantial equivalence. The document does not mention the use of experts to establish a "ground truth" for the test data itself. The interpretation and assessment of the test results would be conducted by qualified engineers and regulatory affairs personnel within Smith & Nephew, and ultimately reviewed by FDA experts.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations of clinical data, particularly in diagnostic studies. This document describes a submission for a physical implant, where performance is assessed through objective mechanical and material tests.
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 is not an AI-assisted diagnostic device, nor is it a device that involves human "readers" interpreting clinical cases. Therefore, an MRMC study is irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The Type of Ground Truth Used
The "ground truth" in this context is based on established engineering and material science principles and regulatory standards for mechanical and material performance of hip prosthetic components. This includes:
- Industry standards for wear testing (e.g., ISO standards for orthopedic implants).
- Material property specifications for titanium alloys, polyethylene, and porous coatings.
- Biomechanical principles for stress analysis and fatigue life.
- The performance characteristics of the predicate devices (K070278 POLARCUP Dual Mobility System and K083116 VERSAFIT Double Mobility System) against which the subject device is being compared for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device submission.
§ 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.