(28 days)
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis , and avascular necrosis.
- Rheumatoid Arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications
The purpose of this Special 510(k) is to expand the Provident Hip System with a line extension to the existing Provident Hip Stems. The new stems are to be marketed as the Provident II Hip Stems and feature a shortened stem.
This is a medical device submission for a Hip Stem, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, expert involvement, MRMC studies, standalone performance, ground truth, and training set specifics for an AI/ML device are not applicable.
The submission is for the Provident II Hip Stem, a physical medical device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering analyses and tests conducted to demonstrate the substantial equivalence of the Provident II Hip Stems to predicate devices.
Here's the relevant information that can be extracted:
1. Acceptance Criteria and Device Performance (as related to substantial equivalence to predicate devices):
| Acceptance Criteria (Implied by equivalence to predicate) | Reported Device Performance |
|---|---|
| Equivalent intended use | Stated as equivalent to predicate. |
| Equivalent materials | Stated as equivalent to predicate. |
| Equivalent design | Stated as equivalent to predicate (new Provident II has shortened stem length, but an engineering analysis demonstrates similar performance to predicate). |
| Equivalent range of available sizes | Stated as equivalent to predicate. |
| Equivalent method of fixation | Stated as equivalent to predicate. |
| Equivalent performance characteristics | "An engineering analysis was performed on both the modified and predicate stems. All results demonstrate that the modified device performs similarly to the predicate device." |
| Meeting pyrogen limit specifications | "Limulus Amebocyte Lysate (LAL) testing has been performed to establish that the device meets pyrogen limit specifications." |
2. Sample size used for the test set and the data provenance: Not applicable to this type of device submission. The "test set" here would refer to the physical hip stems undergoing engineering analysis and LAL testing, not a dataset in the AI/ML sense. Data provenance refers to the origin of the materials and manufacturing, not a clinical data source.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood in AI/ML is not relevant here. The evaluation relies on engineering principles and regulatory standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is a physical orthopedic implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical orthopedic implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the engineering analysis, the "ground truth" is established by recognized engineering standards and comparison to the performance of the legally marketed predicate devices, as demonstrated through testing and simulation. For pyrogen testing, the ground truth is established by the LAL assay and compliance with established pyrogen limits.
8. The sample size for the training set: Not applicable (this is not an AI/ML device).
9. How the ground truth for the training set was established: Not applicable (this is not an AI/ML device).
§ 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.