(30 days)
Intended Use: The PROFEMUR® Hip System Modular Necks are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed
Modular necks can be used during either cemented or uncemented femoral and acetabular arthroplasty.
The subject modular femoral necks, manufactured from cobalt chrome alloy, were cleared for use in K091423 with metal femoral heads, but lacked testing for direct assembly to ceramic femoral heads. This 510(k) notification consists of the mechanical testing that allows for the clearance for use of the subject necks with the 28mm, 32mm, and 36mm alumina ceramic femoral heads previously cleared in K893685, and removal of this previous contraindication (K091423), except for with the 28mm Long ceramic head.
The provided document describes the PROFEMUR® Hip System Modular Necks and its clearance for use with ceramic femoral heads. However, it does not describe an acceptance criteria table or a study in the context of device performance against clinical or diagnostic metrics (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on mechanical testing to demonstrate substantial equivalence to previously cleared predicate devices under existing FDA guidance and industry standards. Therefore, most of the requested information regarding acceptance criteria for device performance based on diagnostic/clinical metrics, sample sizes for test/training sets, expert involvement, and MRMC studies, is not applicable or cannot be extracted from this particular 510(k) summary.
Here's a breakdown of what can be extracted based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are framed within the context of mechanical testing standards rather than diagnostic accuracy or clinical efficacy. The "device performance" reported is its ability to meet these specified mechanical properties.
| Acceptance Criteria (Mechanical Testing Standard) | Reported Device Performance (PROFEMUR® Hip System Modular Necks) |
|---|---|
| Pre-fatigue burst strength: Exceed minimum values specified by FDA in the Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems - 1/10/95. | Mean and minimum pre-fatigue burst strength testing results exceeded minimum values specified. |
| Post-fatigue burst strength (per ASTM F2009): Greater than identical currently marketed ceramic femoral heads assembled to a titanium neck cone. | Mean post-fatigue burst strength greater than that of the identical currently marketed ceramic femoral heads assembled to a titanium neck cone. |
| Axial static distraction force (ASTM F2009): Greater than identical currently marketed ceramic femoral heads assembled to a titanium neck cone. | Mean axial static distraction force greater than that of the identical currently marketed ceramic femoral heads assembled to a titanium neck cone. |
| Fretting: Harder identical taper junctions less fretting than softer identical junctions. | Harder identical taper junctions demonstrated less fretting than softer identical junctions. |
| Fatigue resistance (per ISO 7206-6): Resistance to fatigue failure. | Lower hardness identical junctions demonstrated resistance to fatigue failure. |
| Total Fretting wear: Less than published metal-on-metal articulating wear results. | Total Fretting wear for proximal and distal junctions less than that of published metal-on-metal articulating wear results. |
| Compressive burst testing (per ASTM 2345-03): Meet requirements for static and cyclic fatigue strength of ceramic modular femoral heads. | Met requirements per static, fatigue, and post-fatigue compressive burst testing of 28mm alumina ceramic heads. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated as a number of devices tested. The document refers to "testing" and "results" collectively for various components (neccs, heads, junctions) under specific standards. For example, it mentions "28mm alumina ceramic heads" being tested. The specific number of units tested per mechanical stress point is not provided.
- Data Provenance: The "study" (mechanical testing) was conducted in-house by Wright Medical Technology, Inc. No information regarding country of origin of data in a geographical sense. It is by nature "prospective" in the sense that the tests were performed specifically for this 510(k) submission, simulating real-world forces.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a mechanical device test, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method for the test set
Not applicable. This is a mechanical device test, not a diagnostic device involving human interpretation.
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 a mechanical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the mechanical tests would be the established industry standards and FDA guidance documents that define acceptable mechanical performance limits (e.g., minimum burst strength, maximum fretting wear). The device demonstrated its "truth" by meeting or exceeding these predetermined numerical and qualitative benchmarks.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set for this type of 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.