(102 days)
The Precision Casting Solutions Total Hip System implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- · Rheumatoid arthritis or traumatic arthritis
- · Correction of functional deformity
- · Non-union femoral neck fracture
- Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.
The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.
The present 510k submission is for a non-cemented primary hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral Head, acetabular poly liner, and acetabular metal (or shell) components. The femoral head component articulates within the poly acetabular component. The poly acetabular component snaps into the metal acetabular component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion.
The femoral stem component is made from forged Ti 6AL 4V, with a Ti plasma spray coating. The uni-polar femoral head component is made from CoCr, or BIOLOX® delta ceramic, in 28, 32, and 36 mm sizes.
The acetabular poly liner component is made of standard UHMWPE polyethylene in both hooded and non-hooded options. The acetabular poly liner component is offerent inner and outer diameter combinations to accept various size uni-polar femoral heads and acetabular metal components.
The acetabular metal (or shell) component is made from forged Ti 6AL 4V with a Ti porous coating. It is available in nohole, cluster-hole, and revision multi-hole styles.
The provided text describes a 510(k) premarket notification for the "Precision Casting Solutions Total Hip System." This document establishes substantial equivalence to a predicate device, the "Progressive Orthopaedic Total Hip System," based on identical design, materials, indications for use, and a reliance on preclinical performance testing previously conducted for the predicate device.
Therefore, the acceptance criteria and the study that proves the device meets the acceptance criteria are not directly reported as a standalone study for the Precision Casting Solutions Total Hip System. Instead, the substantial equivalence relies on the performance testing of the predicate device.
Here's the breakdown of the requested information based on the provided text, recognizing that it refers to the predicate device's testing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for each test. Instead, it states that "the results confirm that all components of the Precision Casting Solutions Total Hip System exhibit the appropriate mechanical characteristics for total hip joint replacement and is substantially equivalent to the predicate devices." This implies that the performance of the predicate device in these tests met the necessary mechanical characteristics.
| Test Type | Reported Performance (for Predicate Device) |
|---|---|
| Fatigue Performance Test for Stem | Appropriate mechanical characteristics |
| Fatigue Performance Test for the Neck Portion of the Stem | Appropriate mechanical characteristics |
| Disassembly Force Test for Neck Taper/Femoral Head Interface | Appropriate mechanical characteristics |
| Range of Motion Test for Total Hip System | Appropriate mechanical characteristics |
| Burst Strength Test for Ceramic Femoral Heads (Static Compression) | Appropriate mechanical characteristics |
| Cyclic Fatigue Test for Ceramic Femoral Heads (Cyclic Compression) | Appropriate mechanical characteristics |
| Post-Cyclic Fatigue Burst Test for Ceramic Femoral Heads (Static Compression) | Appropriate mechanical characteristics |
| Pull-Off Test for Ceramic Femoral Heads | Appropriate mechanical characteristics |
| Rotational Stability Test for Ceramic Femoral Heads | Appropriate mechanical characteristics |
| Torsional Properties Test for Bone Screws | Appropriate mechanical characteristics |
| Driving Torque Test for Bone Screws | Appropriate mechanical characteristics |
| Axial Pull-Out Strength Test for Bone Screws | Appropriate mechanical characteristics |
| Lever-Out Test for Acetabular Shell/Liner Assembly | Appropriate mechanical characteristics |
| Torque-Out Test for Acetabular Shell/Liner Assembly | Appropriate mechanical characteristics |
| Push-In Test for Acetabular Shell/Liner Assembly | Appropriate mechanical characteristics |
| Push-Out Test for Acetabular Shell/Liner Assembly | Appropriate mechanical characteristics |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes (e.g., number of stems, heads, etc.) used for each individual performance test of the predicate device. It also does not mention the data provenance beyond stating that the tests were "preclinical."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the studies described are preclinical mechanical and material performance tests, not clinical evaluations requiring expert interpretation of results for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical studies involving expert assessments, not in preclinical mechanical testing.
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 is not applicable. The device is a total hip replacement system, and the studies mentioned are preclinical mechanical tests, not an AI-assisted diagnostic device.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the established mechanical and material properties required for a total hip replacement system to function safely and effectively. This is determined by engineering standards, biomechanical principles, and regulatory requirements (e.g., ISO standards for implants) that define "appropriate mechanical characteristics."
8. The sample size for the training set
This is not applicable. The described studies are preclinical mechanical tests, not machine learning or AI models with training sets.
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.