(162 days)
BI-MENTUM™ Dual Mobility System is indicated for total hip replacement, which includes:
- Osteoarthritis
- Femoral neck fracture
- Dislocation risk
- Osteonecrosis of the femoral head
- Revision procedures where other treatments or devices have failed and if bone reconstruction so permits
BI-MENTUM™ PressFit Cup, BI-MENTUM™ Plus Cup and BI-MENTUM™ Revision Cup are intended for press-fit use and BI-MENTUMTM Cemented Cup is indicated for cemented use.
The BI-MENTUM™ dual mobility system is composed of a metallic shell fixed in the acetabulum and a polyethylene liner.
Cemented metallic shell: BI-MENTUM™ Cemented Cup: the cemented metallic shell is made of stainless steel according to ISO 5832- 1. The outer surface is sandblasted and presents macro-volumes to augment contact between the implant and the cement. The inner surface is highly polished.
Cementless metallic shell: The cementless metallic shell is made of stainless steel according to ISO 5832-1 and is coated with a CP titanium and hydroxyapatite plasma spray (double layer coating) on the outer surface and is highly polished on the inner surface.
Three cementless metal-backs are available:
- BI-MENTUM™ PressFit Cup: this version is available without the pegs and screw, and is a press fit only.
- BI-MENTUM™ Plus Cup: it has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium).
- BI-MENTUM™ Revision Cup: it has 5 fixation points (2 divergent pegs towards the pubis and ischium, cortical screws through 2 flanges towards the ilium and 1 foramen hook).
Liner: The liner is made of Ultra-High-Molecular-Weight Polyethylene according to ISO 5834-2. The liner is mobile (free) in the metallic shell and retained on the prosthetic femoral head. Liners can be used with Ø22,2 or 28 mm prosthetic femoral heads.
Pegs and cortical screws: When applicable, primary fixation can be reinforced by impacted pegs and self-tapping cortical screws made of stainless steel according to ISO 5832-1.
The provided text details the 510(k) summary for the BI-MENTUM™ dual mobility system, claiming substantial equivalence to a previously cleared device, the NOVAE® Dual Mobility Acetabular Cup (K111572). The document outlines non-clinical testing performed to support this claim.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Head Insertion On Force | Not explicitly stated in the provided text, but implied as "acceptance criteria was met". | Acceptance criteria was met. |
| Head Pull-Out Testing | Not explicitly stated in the provided text, but implied as "acceptance criteria was met". | Acceptance criteria was met. |
| Range of Motion Analysis | Not explicitly stated in the provided text, but implied as "acceptance criteria was met". | Acceptance criteria was met. |
| Wear Analysis | Not explicitly stated in the provided text, but implied as "acceptance criteria was met". | Acceptance criteria was met. |
Note: The specific numerical or qualitative acceptance criteria for these tests are not provided in the submitted text. The document only states that the acceptance criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
The provided text only mentions "new cup/head + stem assembly were validated" and lists non-clinical tests. It does not specify sample sizes for these tests, nor does it provide information on data provenance (e.g., country of origin, retrospective or prospective) as these were non-clinical, in-vitro tests, not studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The tests performed were non-clinical mechanical and wear studies, not studies requiring expert interpretation of medical images or patient data for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable, as no expert-based ground truth establishment or adjudication was involved in these non-clinical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC comparative effectiveness study was conducted. The evaluation was based on non-clinical testing and substantial equivalence to a predicate device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical medical implant (hip prosthesis components), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" would be the established engineering and biomechanical standards and specifications for hip prostheses. This would involve:
- Physical measurements and material properties: Conforming to ISO standards like ISO 5832-1 (stainless steel), ISO 5834-2 (UHMWPE).
- Biomechanical performance metrics: Such as those for head insertion/pull-out force, range of motion, and wear, as defined by relevant ISO standards or industry best practices for similar devices.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not an AI/ML algorithm 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 a physical implant device.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.