(90 days)
This device is indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant. This device is intended for either cemented or noncemented use.
The Zimmer Trabecular Metal Modular Acetabular System is a modular acetabular cup system intended to replace a hip joint and designed to achieve fixation to bone either with or without the use of bone cement. The system consists of a shell and liner. The shell substrate is made from Tivanium Ti-6Al-4V Alloy. The outer porous material, which is metallurgically bonded to the shell substrate, is made of Trabecular Metal. The Trabecular Metal material has an elliptical outer diameter and a hemispherical inner diameter to allow hemisphere to hemisphere bonding between the Trabecular Metal and the Tivanium substrate. Three porous acetabular shell designs are available: one with screw holes, one with cluster screw holes and one without screw holes. The shells range in diameter from 38 to 80 mm in 2mm increments. The screw holes permit the use of Tivanium Allov screws to provide immediate fixation and security. Screws are available in 4.5 and 6.5mm diameters with varying lengths. The shell incorporates a threaded polar hole to attach the cup positioner.
The provided document is a 510(k) summary for a medical device, the Zimmer Trabecular Metal Modular Acetabular System. It describes the device, its intended use, and its comparison to predicate devices. Crucially, it states:
"Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."
This means that a study proving the device meets specific acceptance criteria based on human or AI performance was not performed for this 510(k) submission. The clearance was based on substantial equivalence to predicate devices and non-clinical performance testing.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
Here's what can be extracted from the document regarding the non-clinical performance:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Integrity of Trabecular Metal/Tivanium alloy interface under physiological loads | "the results demonstrated that the interface will maintain its integrity under physiological loads." |
2. Sample sized used for the test set and the data provenance: Not applicable, as no clinical or AI-based performance study was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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: No MRMC study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical performance, the ground truth was based on "applicable FDA Guidance Documents and ASTM Standards" for material integrity.
8. The sample size for the training set: Not applicable, as no algorithm was trained. The assessment was based on substantial equivalence and non-clinical engineering tests.
9. How the ground truth for the training set was established: 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.