(142 days)
The ConforMIS BeneFIT Hip System is indicated for use in skeletally mature individuals undergoing total hip replacement due to:
- · A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
- · Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, manageable by other techniques.
- Revision procedures for failed previous hip surgery (excluding situations where hardware is present). . The ConforMS BeneFIT Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.
The Conformis BeneFIT Hip System is an uncemented, primary total hip replacement composed of femoral and acetabular components. All components are provided sterile. The femoral component consists of a standard monoblock femoral stem body and neck, which mates with a standard femoral head. The stem and neck are manufactured as one piece and hence are not modular. The proximal neck surface with a 12/14 taper is highly polished and transitions to hydroxyapatite coating in the main stem body and is indicated for uncemented press fit fixation only. The femoral head is designed to connect to the femoral stem neck. All femoral heads are polished and have a 12/14 taper to match the femoral stem. The femoral heads are available in either cobalt chromium alloy (CoCr) or ceramic (Biolox® Delta). The acetabular component consists of a standard size shell in 1mm increments with standard screw hole placement, a mating polyethylene liner, and cancellous screws. The acetabular component is designed for uncemented use; initial implant fixation is achieved through press-fit design. The 6.5mm diameter cancellous screws with low profile head fits through the acetabular shell screw holes and is driven using a 3.5mm hex drive recess. The acetabular component has matching circumferential scallops on the shell and liner that rotationally secure the liner in the shell and allow for dialing the liner in a desired orientation. The liner is provided with an impactor made of a biocompatible nylon material.
The ConforMIS BeneFIT Hip System is a medical device and its acceptance criteria are established through non-clinical laboratory testing. This is a hip implant system, not a software or AI-driven device, so the typical AI/software performance metrics, ground truth establishment, and expert adjudication as described in your prompt are not applicable.
Here's an overview of the acceptance criteria and the study as described in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Femoral Stem Fatigue Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Femoral Neck Fatigue Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Femoral Taper-CoCr Head Junction Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Femoral Taper-Ceramic Head Junction Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Acetabular Liner-Cup Disassembly Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Acetabular Liner Impingement Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Wear Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Acetabular Bone Screw Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| HA Coating Microstructure Characterization | Demonstrated acceptable performance; substantially equivalent to predicates. |
| HA Coating Static Fatigue Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| HA Coating Shear Fatigue | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Range of Motion Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Chemical and Mechanical Characterization of iPoly XE | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Cadaveric Evaluation | Demonstrated acceptable performance; substantially equivalent to predicates. |
Note: The document states "Test results demonstrated that the device can be considered substantially equivalent to the predicate devices for the specified intended use." This implies that the device met pre-defined performance thresholds, typically based on industry standards and comparison to the predicate devices, for each of these tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes for each non-clinical test. Clinical trials (human test subjects) for hip implants involve sample sizes that depend on the study design (e.g., pilot studies, pivotal studies), but this document focuses on non-clinical testing for 510(k) clearance, which typically involves mechanical testing of device samples.
- Data Provenance: The data is generated from non-clinical laboratory testing conducted by ConforMIS, Inc. or its designated testing facilities. There is no information about country of origin of data in the sense of patient data, nor is it retrospective or prospective in a clinical study context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This is not applicable to the non-clinical laboratory testing described. The "ground truth" for the performance of a mechanical device like a hip implant is established by meeting predefined engineering specifications, adherence to ISO standards (e.g., for fatigue, wear), and demonstrating equivalence to predicate devices, rather than through expert consensus on interpreting patient data.
4. Adjudication Method for the Test Set
- Not applicable. As this is non-clinical mechanical testing, there is no "adjudication method" in the sense of reconciling human expert opinions on cases. Test results are typically evaluated against pre-defined engineering criteria and scientific principles.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- Not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI algorithms where human interpretation plays a role. This document concerns a physical implant and its mechanical properties.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device, in the context of non-clinical testing, is compliance with established engineering standards (e.g., ISO standards for orthopedic implants), predefined performance specifications, and demonstrated substantial equivalence to legally marketed predicate devices. This includes meeting specified thresholds for properties like fatigue strength, wear resistance, and component integrity.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a "training set." The design and manufacturing processes are refined through engineering, material science, and iterative testing, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the reasons stated in point 8.
§ 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.