(103 days)
The Alpine Hip Stem is intended for use in total hip replacement surgery or hemi-arthroplasty. Hip arthroplasty is intended to provide increased patient mobility and decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants.
This device is intended for use in total hip arthroplasty or hemi-arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
- Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis
- Previously failed hip surgery
- Proximal femoral neck fractures or dislocation
- Idiopathic avascular necrosis of femoral head
- Non-union of proximal femoral neck fractures
- Treatment of fractures that are unmanageable using other forms of therapy
- Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis
The Alpine Hip Stem is a single-piece, conical tapered femoral hip prostheses, designed for single, cementless use. The stem has a neck with a 12/14 trunnion for modular attachment to femoral heads.
The Alpine Hip Stem is manufactured from titanium alloy (per ASTM F136, Ti-6Al-4V ELI) and device fixation is achieved via press-fit in the medullary canal, which maximizes contact between the stem and bone. The proximal portion is plasma sprayed with titanium alloy (per ASTM F1580).
This document describes the premarket notification (510(k)) for the Alpine Hip Stem. The acceptance criteria and the study that proves the device meets the acceptance criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance (Summary of Results) |
|---|---|
| ISO 7206-6:2013 (Fatigue Testing) | Performance was considered acceptable, allowing for substantial equivalence to predicate devices. |
| ISO 7206-4:2010 (Distal Fatigue) | Performance was considered acceptable, allowing for substantial equivalence to predicate devices. |
| ISO 21535:2007 (Range of Motion) | Performance was considered acceptable, allowing for substantial equivalence to predicate devices. |
| Plasma Spray Coating Testing | Mechanical properties and microstructure analysis were performed with acceptable results. |
| Substantial Equivalence Basis | Proven to be substantially equivalent to predicate devices based on similarities in intended use, overall design, materials, manufacturing methods, packaging, mechanical performance, and sterilization. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical studies with human subjects or a defined dataset for AI/algorithm performance. The testing performed was non-clinical (mechanical and material testing). Therefore:
- Sample size for the test set: Not applicable in the context of traditional clinical or AI algorithm testing. The sample sizes would refer to the number of hip stems or components tested for each mechanical and material property. These specific numbers are not provided in the summary but are typically defined by the relevant ISO standards.
- Data provenance: Not applicable in the context of a "test set" from human data. The data originates from laboratory testing of the device and its components.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device is a mechanical implant, and its performance is evaluated against engineering and biological standards, not through expert consensus on medical image interpretation or clinical outcomes of a "test set" established by experts.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical "test set" requiring adjudication by medical experts. The non-clinical testing involved laboratory measurements and analysis against established engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states, "No clinical studies were performed." Therefore, an MRMC comparative effectiveness study was not conducted as this is a new mechanical device being cleared through substantial equivalence to existing devices, not an AI or diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The Alpine Hip Stem is a physical medical device (hip prosthesis), not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.
7. Type of Ground Truth Used
The "ground truth" for this device's performance evaluation lies in established engineering and scientific standards for hip prostheses, including:
- ISO 7206 series: Specifically, ISO 7206-6:2013 (fatigue testing) and ISO 7206-4:2010 (distal fatigue).
- ISO 21535:2007: Range of motion analysis.
- ASTM F136 and F1580: Standards for titanium alloy materials and plasma spray coatings.
- Predicate device characteristics: The "ground truth" for substantial equivalence is the safety and effectiveness of the legally marketed predicate devices (Ovation™ Hip Stem (K062775), Global Taper Tapered Hip System (K963509), and Novation 12/14 Press-Fit Femoral Stem (K042842)).
8. Sample Size for the Training Set
Not applicable. This is a physical medical device undergoing mechanical and material testing, not an AI or machine learning model 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 an AI model, the concept of establishing ground truth for it does not apply.
§ 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.