(100 days)
The Progressive Orthopaedic Total Hip System implant components are 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 4part total hip replacement system including 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 offered with different 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 no-hole, cluster-hole, and revision multi-hole styles.
The provided document is a 510(k) summary for a medical device called "The Progressive Orthopaedic Total Hip System". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for performance as would typically be seen for AI/Software as a Medical Device (SaMD).
Therefore, the information requested for AI/SaMD performance studies is largely not applicable to this submission. This document details non-clinical laboratory testing to prove mechanical and material equivalence.
However, I can extract the relevant information from the document as it pertains to the type of acceptance criteria and the testing done to meet regulatory requirements for this specific device.
Acceptance Criteria and Device Performance (Not applicable in the typical AI/SaMD sense as this is a mechanical prosthesis):
The document states that "All devices met the required performance specifications for testing and are considered equivalent to the predicate devices." The acceptance criteria are implicitly tied to the performance of the predicate device and established standards for hip prostheses, but specific numerical thresholds are not detailed in this summary.
Here's a table based on the non-clinical tests performed:
| Test Performed | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Fatigue Performance Test for Progressive Orthopaedic Stem | Meet established standards for hip stem fatigue and predicate | Met required performance specifications |
| Fatigue Performance Test for the Neck Portion of the Stem | Meet established standards for neck fatigue and predicate | Met required performance specifications |
| Disassembly Force Test for Neck Taper/Femoral Head Interface | Meet established standards for interface integrity and predicate | Met required performance specifications |
| Range of Motion Test for Total Hip System | Achieve functional range of motion and predicate | Met required performance specifications |
| Burst Strength Test for Ceramic Femoral Heads (Static) | Withstand static compression forces and predicate | Met required performance specifications |
| Cyclic Fatigue Test for Ceramic Femoral Heads (Cyclic) | Withstand cyclic compression forces and predicate | Met required performance specifications |
| Post-Cyclic Fatigue Burst Test for Ceramic Femoral Heads (Static) | Withstand static compression after cyclic loading and predicate | Met required performance specifications |
| Pull-Off Test for Ceramic Femoral Heads | Demonstrate adequate pull-off strength and predicate | Met required performance specifications |
| Rotational Stability Test for Ceramic Femoral Heads | Demonstrate adequate rotational stability and predicate | Met required performance specifications |
| Torsional Properties Test for Bone Screws | Meet established standards for screw torsion and predicate | Met required performance specifications |
| Driving Torque Test for Bone Screws | Meet established standards for screw driving torque and predicate | Met required performance specifications |
| Axial Pull-Out Strength Test for Bone Screws | Meet established standards for screw pull-out and predicate | Met required performance specifications |
| Lever-Out Test for Acetabular Shell/Liner Assembly | Demonstrate resistance to lever-out forces and predicate | Met required performance specifications |
| Torque-Out Test for Acetabular Shell/Liner Assembly | Demonstrate resistance to torque-out and predicate | Met required performance specifications |
| Push-In Test for Acetabular Shell/Liner Assembly | Demonstrate appropriate push-in forces and predicate | Met required performance specifications |
| Push-Out Test for Acetabular Shell/Liner Assembly | Demonstrate appropriate push-out forces and predicate | Met required performance specifications |
Additional Information (Specific to AI/SaMD, but N/A for this device):
- Sample size used for the test set and the data provenance: Not applicable. This device is a mechanical prosthesis, not a software device relying on a test set of data. The "samples" would be the physical devices or components tested in the lab.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by physical measurements and engineering standards, not expert consensus on data.
- Adjudication method for the test set: Not applicable.
- 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 is not an AI-assisted diagnostic or therapeutic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, ground truth is based on established engineering standards (e.g., ISO standards for implant testing), material specifications, and performance data from the legally marketed predicate device (NovoSource NovoHip Total Hip System).
- The sample size for the training set: Not applicable. This device is not developed using machine learning that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided document:
The Progressive Orthopaedic Total Hip System underwent a series of non-clinical, in-vitro laboratory tests, including fatigue, strength, stability, and disassembly tests for its various components (stem, femoral head, acetabular shell/liner, bone screws). The acceptance criteria were implicitly defined by relevant engineering standards for orthopedic implants and by demonstrating equivalence to the predicate device, NovoSource NovoHip Total Hip System (K132158). The document states that all devices met the required performance specifications for testing, leading to the conclusion that the device is substantially equivalent to the predicate. No clinical testing was required for this 510(k) submission.
§ 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.