(93 days)
The MDMIM liner and X30 Acetabular Inserts are a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. These devices are intended to be used only with currently available Howmedica Osteonics 22.2 mm and 28 mm diameter femoral heads.
The indications for use for total hip arthroplasty include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed;
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Dislocation risks
The MDM™ liners are intended for cementless use only.
The Modular Dual Mobility (MDM™) liner is a highly polished cobalt chrome liner that features a Trident® locking mechanism. This feature will allow for compatibility with other acetabular cups containing the same locking mechanism. A Duration® or X3® polyethylene insert will articulate within the MDM™ liner. The additional X3® Acetabular Inserts are intended to accommodate the size range of the MDM™ liner device.
This 510(k) summary describes the Modular Dual Mobility (MDM™) Liner and X3® Acetabular Insert, which are components for artificial hip replacement. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, and expert involvement is not present in the provided text.
Here is an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Mechanical Performance | Disassembly force evaluation (ASTM F1820-03) | Performed, demonstrating "equivalence of the subject device compared to its predicate devices." |
| Push-out strength (ASTM F1820-03) | Performed, demonstrating "equivalence of the subject device compared to its predicate devices." | |
| Lever-out force testing | Performed, demonstrating "equivalence of the subject device compared to its predicate devices." | |
| Pull-out force testing | Performed, demonstrating "equivalence of the subject device compared to its predicate devices." | |
| Biomechanical Performance | Range of motion | Engineering analysis performed. |
| Jump distance | Engineering analysis performed. | |
| Fretting wear | Engineering analysis performed. | |
| Material Compatibility | Not explicitly stated as a criterion, but inherent in the choice of materials (Cobalt Chrome, X3® polyethylene). | Implied to be acceptable through substantial equivalence to predicate devices. |
| Biocompatibility | Not explicitly stated as a criterion, but a standard requirement for implantable devices. | Implied to be acceptable through substantial equivalence to predicate devices. |
Missing Information: The document states that testing was performed to "demonstrate equivalence" to predicate devices. However, it does not provide specific acceptance values (e.g., minimum push-out strength in Newtons) or the exact quantitative results achieved by the MDM™ Liner and X3® Acetabular Insert for the mechanical or biomechanical tests. The K103233 does not contain a formal "Clinical Study" section with detailed performance results against pre-defined acceptance criteria for the new device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned. The document primarily refers to "testing" and "engineering analysis" to demonstrate equivalence rather than a specific clinical or performance test set with a defined sample size. These tests are typically benchtop mechanical tests on a limited number of device samples.
- Data Provenance: Not explicitly stated. For benchtop mechanical testing, the "provenance" would typically refer to the manufacturing batch or lot of the devices tested. It is not clinical data, so country of origin of patient data or retrospective/prospective status is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This information is relevant for studies involving human data and expert review (e.g., image interpretation, clinical outcome assessment). The provided document describes engineering and mechanical tests aimed at demonstrating equivalence to predicate devices, not clinical performance assessed by experts.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple experts when establishing ground truth in studies involving human assessment. This is not relevant to the engineering and mechanical tests described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- Not Applicable. This device is a hip implant component. The provided documentation does not involve Artificial Intelligence (AI) or human readers interpreting data. Therefore, an MRMC study and AI assistance effect size are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Not Applicable. This question pertains to AI algorithm performance. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the mechanical and engineering tests described would be the established scientific and engineering principles, material properties, and the performance characteristics of the predicate devices as defined by their own testing and regulatory clearance. For example, for push-out strength, the "ground truth" is a measurable force value, and the new device's performance is compared against that of the predicate to demonstrate equivalence.
8. The Sample Size for the Training Set
- Not Applicable. This information is relevant for AI models, which require training data. This device is a physical implant.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This information is relevant for AI models.
In summary: The provided 510(k) summary for the Modular Dual Mobility (MDM™) Liner and X3® Acetabular Insert focuses on demonstrating substantial equivalence through benchtop engineering and mechanical testing against a set of predicate devices. It does not provide detailed quantitative acceptance criteria or specific performance data in the context of a clinical study or a study directly addressing human performance or AI. Therefore, much of the requested information, which is typically found in clinical trial reports or AI/CADe system submissions, is not contained within this document.
§ 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.