(63 days)
The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cup are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity Congenital dislocation Revision procedures where other treatments or devices have failed Femoral neck and trochanteric fractures of the proximal femur
Non hooded (0 deg neutral) and Hooded (10 deg) +4mm offsets for use with 28, 32, 36, 40mm Apex Modular heads.
The provided text describes a 510(k) summary for the Interface Acetabular System, Acetabular Insert. The documentation primarily focuses on the device's design, materials, indications for use, and a comparison to predicate devices, along with non-clinical testing.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ROM analysis per ISO-21535-2007 | All samples tested met the acceptance criteria. |
| Extreme artificial aging per ASTM F2003-02 | All samples tested met the acceptance criteria. |
| Push-out & Lever-out Test | All samples tested met the acceptance criteria. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document does not specify the exact number of samples used for each non-clinical test (ROM analysis, artificial aging, push-out & lever-out). It only states "All samples tested."
- Data Provenance: Not applicable in the context of this device and testing. The tests are in vitro mechanical/material tests, not data derived from human subjects or clinical settings based on a specific country of origin or retrospective/prospective nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the document explicitly states, "No clinical studies were performed." The "ground truth" for the non-clinical tests would be the performance standards defined in the ASTM and ISO standards, which are engineering specifications, not expert medical consensus.
4. Adjudication method for the test set:
- This information is not applicable as there were no clinical studies involving human readers or subjective interpretations of data that would require an adjudication method. The testing involved objective physical measurements against established engineering standards.
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:
- No, an MRMC comparative effectiveness study was not done. This is a medical device (hip insert), not an AI diagnostic or image analysis tool. The document explicitly states, "No clinical studies were performed."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This device is a mechanical implant, not an algorithm.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" was established by engineering performance standards specified by ASTM F2003-02 (extreme artificial aging) and ISO-21535-2007 (ROM analysis), along with industry-standard "Push-out & Lever-out Test" criteria.
8. The sample size for the training set:
- This information is not applicable as no clinical studies or AI/machine learning models were involved in the evaluation of this device.
9. How the ground truth for the training set was established:
- This information is not applicable as no clinical studies or AI/machine learning models were involved.
§ 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.