(210 days)
This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- · 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 function deformity; .
- · Revision procedures where other treatments or devices have failed; and
- · Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The U2 Acetabular Cup and Femoal Head are designated as an acetabular component and femoral head and are to be used with United U1 hip stem (K994078) and U2 hip stem (K003237) of total hip replacement. It is a modular type of product system. The U2 Acetabular Cup has ten sizes of options, hemispherical design, porous-coated surface on the metallic shell, clustered bone screw holes, spherical screw holes for variable screw locking angle, PMMA cement plug, easy snap-in and take out mechanism, 12 options for angle adjustment, minimum 6.9 mm thickness of UHMWPE liner. The metallic shell is produced from cast Co-Cr-Mo alloy (ASTM F75). The plastic liner is machined from extruded UHMWPE bars (ISO 5834/I). The U2 28 mm femoral head is aimed to providing more choice for orthopaedic surgeon to perform total hip arthroplasty. The taper angle of 28 mm femoral head is identical with U1 26. mm femoral head (K994078). Therefore, U2 28 mm femoral head can be used wath our Ul and U2 hip stems. The U2 28 mm femoral head is available in -3, +0, +5, and +10 mm of neck length.
The provided text describes a 510(k) premarket notification for the U2 Acetabular Cup and Femoral Head, and therefore it is a submission to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria through clinical trials or software validation.
Here's an analysis of what is and isn't present in the document based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present "acceptance criteria" in the typical sense of a clinical study (i.e., specific sensitivity, specificity, accuracy targets). Instead, it presents test results for biomechanical properties and states that the device is substantially equivalent to a predicate device.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Static Tensile Strength (Porous Coating) | Substantially equivalent to predicate device (K994078) | 27 MPa |
| Static Shear Strength (Porous Coating) | Substantially equivalent to predicate device (K994078) | 67 MPa |
| Porosity (Porous Coating) | Substantially equivalent to predicate device (K994078) | 30 to 70 percent |
| Pore Size (Porous Coating) | Substantially equivalent to predicate device (K994078) | 100 to 1000 microns |
| Thickness (Porous Coating) | Substantially equivalent to predicate device (K994078) | 500 to 1500 microns |
| Range of Motion (U2 Acetabular Cup) | Substantially equivalent to predicate device (U1 Hip System K994078) | U2 Acetabular Cup is substantial equivalent to U1 Hip System (K994078) |
| Locking Mechanism (Push-out Test) | Compared with U1 Hip System (K994078) | Integrity is substantial equivalent |
| Locking Mechanism (Lever-out Test) | Compared with U1 Hip System (K994078) | Integrity is substantial equivalent |
| Locking Mechanism (Torque-out Test) | Compared with U1 Hip System (K994078) | Integrity is substantial equivalent |
Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. The performance metrics presented are compared against the predicate device or industry standards to support this claim.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" in terms of patient data or clinical samples. The testing described (static tensile/shear strength, porosity, range of motion, biomechanical tests) refers to physical testing of the device components. The number of units tested for each biomechanical or material property is not provided.
- Data Provenance: The testing appears to be laboratory-based physical/mechanical testing of the device components. It is not patient data. The manufacturer is located in Hsinchu, Taiwan, suggesting the testing was likely conducted by or for the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable as the study described is physical product testing, not an assessment requiring expert adjudication of "ground truth" using imaging or clinical data.
4. Adjudication Method for the Test Set
This is not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. The document describes physical and biomechanical testing of the device, not a comparative effectiveness study involving human readers or AI.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical medical implant (hip prosthesis components), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to engineering specifications, material science standards (e.g., ASTM F75 for Co-Cr-Mo alloy, ISO 5834/I for UHMWPE), and the performance characteristics of the predicate device (UNITED U1 Hip Prosthesis K994078). The physical properties and biomechanical performance of the U2 Acetabular Cup and Femoral Head were measured and compared against these established benchmarks.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical implant, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable.
§ 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.