(481 days)
The Prime Acetabular Cup System is 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
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non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
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inflammatory degenerative joint disease such as rheumatoid arthritis;
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- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed.
Shells with BIOFOAM® coating are intended only for uncemented arthroplasty.
MicroPort is introducing the Prime BIOFOAM® Multi-Hole Shells as a line extension of its existing Prime Acetabular System (K170444, K171181, K180798, and K181598). The subject implants are single use only, are provided sterile, and are to be implanted only by orthopedic specialists in an operating room setting. Associated instrumentation is reusable, provided nonsterile, and are to be used only by orthopedic specialists in an operating room setting.
The Prime BIOFOAM® Multi-Hole Shell includes 10, 12, or 14 screw hole variations. The subject acetabular shells can be used with existing MicroPort devices listed in Section G, Table 3 to form a complete total hip system.
- Multi-Hole Acetabular Shells
- Material: Ti alloy conforming to ASTM F620 O
- Coating: Commercially Pure Ti Foam conforming to ASTM F67 O (BIOFOAM®)
- Outer diameters: 42mm to 68mm with 2 mm increments O
- Variants: 10, 12, or 14 screw holes O
- Sterilized using Gamma Radiation O
This FDA 510(k) summary (K201157) is for the Prime BIOFOAM® Multi-Hole Shells, an acetabular shell used in total hip arthroplasty. The document asserts substantial equivalence to existing predicate devices based on design features, materials, and nonclinical bench testing.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide numerical performance results against such criteria. Instead, it relies on demonstrating equivalence to predicate devices through design similarity and standard mechanical testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Frictional Torque/Pinch Load (ISO 7206-2, ISO 7206-12) | Bench testing performed. Results support substantial equivalence to predicate devices. |
| Finite Element Analysis (ASTM F3090) | Performed. Results support substantial equivalence to predicate devices. |
| Long-Term Shell Fatigue (ASTM F1820, ASTM F2068, ASTM F3090) | Bench testing performed. Results support substantial equivalence to predicate devices. |
| Material/Design Equivalence: | |
| Material (Ti alloy, Commercially Pure Ti Foam) | Identical to predicate devices. |
| Sterilization Method (Gamma Radiation) | Identical to predicate devices. |
| Intended Use and Indications for Use | Identical to predicate devices. |
| MRI Safety: | |
| MR Conditionality (Field Interactions, Artifacts, RF Heating) per ASTM F2052, ASTM F2119, ASTM F2503, ASTM F2182 | Predicate nonclinical test results leveraged via equivalency rationale. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "bench testing was performed" for mechanical tests, but doesn't quantify the number of units tested. For MR conditionality, predicate test results were leveraged, so no new test set was used for the subject device in this regard.
- Data Provenance: The document implies the mechanical bench testing was conducted by MicroPort Orthopedics Inc. The general provenance is regulatory submission data. The studies are non-clinical (bench) studies, not human subject studies, so concepts like "country of origin of the data" or "retrospective/prospective" do not directly apply in the same way they would for clinical trials. The data is generated ex vivo.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the studies described are non-clinical bench tests. "Ground truth" in this context typically refers to clinical diagnosis or outcomes for human subjects. For mechanical and material testing, the "ground truth" is defined by the physical properties measured against established standards (e.g., ISO, ASTM).
4. Adjudication Method for the Test Set
This section is not applicable as the studies described are non-clinical bench tests. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where expert consensus is needed to establish ground truth from patient data.
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
This section is not applicable. The device described is a physical orthopedic implant (acetabular shell), not an AI/software device that assists human readers in interpreting medical images. Therefore, an MRMC study is outside the scope of this device's evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The device is an orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is established by:
- Standardized Test Methods: Adherence to recognized international and national standards such as ISO 7206 series and ASTM F series (F620, F67, F3090, F1820, F2068, F2052, F2119, F2503, F2182). These standards define how performance characteristics (like fatigue, frictional torque, material properties) are measured and evaluated.
- Material Specifications: Compliance with ASTM standards for material composition (e.g., ASTM F620 for Ti alloy, ASTM F67 for Commercially Pure Ti Foam).
8. The Sample Size for the Training Set
This section is not applicable. As a physical orthopedic implant (not an AI/ML device), there is no "training set" in the context of machine learning. The design and manufacturing process are subject to engineering design principles and quality control, not algorithmic training.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as point 8.
§ 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.