(198 days)
The 2 Piece Modular Revision Stem Components are intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.
The 2 Piece Modular Hip Stem is a modular system comprised of a proximal body, distal stem, and locking bolt. These three individual components utilizing a modular junction are assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal stem. This system is designed so that all proximal components will be able to mate with all distal components, thus affording optimal flexibility.
This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.
The 2 Piece Modular Hip Stem components will be fabricated from Titanium (Ti6A1-4V) Alloy. The Cone, Broached, and Milled body components as well as the Porous Stems will be offered with plasma spray or plasma spray and hydroxylapatite coatings.
The provided document is a 510(k) summary for a medical device, the "2 Piece Modular Hip Stem." It details the device's description, intended use, and substantial equivalence to predicate devices, but it does not describe an AI/ML powered device or a study involving human readers or expert consensus.
Therefore, many of the requested categories are not applicable to the information contained in this document.
Here's a breakdown of the relevant information from the document regarding acceptance criteria and the study:
Acceptance Criteria and Device Performance
| Acceptance Criteria (from the document) | Reported Device Performance (from the document) |
|---|---|
| Mechanical Strength/Fatigue Strength | Proximal and Distal Regions of Bodies and Stems: Verified using finite element techniques. |
| Proximal Body Strength | Testing conducted consistent with applicable ISO standards for neck and stem strength. |
| Taper Region Stresses (effect of taper length) | Investigated using finite element techniques. |
| Strength of the Junction in Torsion | Physical testing of the taper was undertaken to confirm. |
| Effect of PureFix® HA coating on fatigue strength | Application of PureFix® HA coating has no effect on the fatigue strength of the shot peened and plasma sprayed coating on the Ti-6Al-4V ELI Alloy. |
| Substantial Equivalence (Intended Use, Materials, Design, Operational Principles) | The device is deemed substantially equivalent to the following predicate devices: Type 3 Femoral Components (K983404), Partnership Revision Femoral Component (K972893), Meridian Titanium Femoral Stems (K972228), and the Citation TMZF HA Femoral Stem (K993768). This is the primary "acceptance criterion" for 510(k) clearance, and the body of the submission inherently argues that this has been met by comparing the new device to established predicates. |
Study Details:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not describe a "test set" in the context of clinical data or human evaluation. The testing described pertains to mechanical engineering analysis (finite element techniques and physical testing) of the device components. No information is provided regarding the provenance of this testing data (e.g., country of origin). -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The study is a mechanical engineering evaluation of the device's physical properties, not a study requiring expert clinical review or ground truth establishment in a medical imaging context. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human readers or clinical adjudication. -
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 document is for a physical medical implant (hip stem), not an AI-powered diagnostic device, and no MRMC study was conducted. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm. -
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For the mechanical testing, the "ground truth" would be established by engineering standards (e.g., ISO standards for neck and stem strength) and the results of various physical and computational tests (finite element analysis, physical torsion testing). There is no "expert consensus," "pathology," or "outcomes data" in the traditional sense for this type of evaluation. -
The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set. The mechanical analyses and tests were performed on the device itself or its design specifications. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.