(161 days)
The Trabecular Metal Modular System when used with a Trilogy® Neutral, Elevated, Offset or Oblique Liner 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.
The Trabecular Metal Modular System when used with a Trilogy Longevity® Constrained Liner is indicated for primary or revision total hip arthorplasties where is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered.
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 biological fixation to bone without the use of bone cement; or, it may also be for cemented fixation. The system consists of a shell and polyethylene liner. The shell substrate is made from TivaniumTM Ti-6Al-4V Alloy. The outer porous material, which is metallurgically bonded to the shell substrate, is made of Trabecular Metal.
Three porous acetabular shell designs are available: one with multiple screw holes, one with cluster screw holes and one without screw holes. The shells range in diameter from 38 to 80mm in 2mm increments. The screw holes permit the use of Tivanium Ti-6Al-4V Alloy screws for immediate fixation and security. The shell incorporates a threaded polar hole to attach the cup positioner.
The provided documentation is a 510(k) premarket notification for a medical device, specifically the Zimmer Trabecular Metal™ Modular Acetabular System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel performance or efficacy through extensive clinical trials. Therefore, the information typically requested for AI/software-as-a-medical-device performance (like precision, recall, expert consensus, training/test set details, MRMC studies) is generally not present in this kind of filing.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for an AI/software device. Instead, the "acceptance criteria" for this implant are implicitly met by demonstrating substantial equivalence to predicate devices. The reported "performance" is that the device "met performance requirements and is as safe and effective as its predicate."
| Acceptance Criteria (Implicit from 510(k)) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The device was determined to be substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and similar technological/geometric features, and performs as safely and effectively. |
| Compliance with FDA Guidance Document | The device's non-clinical testing was provided, including the information outlined in the FDA "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, 4/28/94;" |
| Device Design and Geometry | An evaluation of the device design and geometry demonstrated that the Zimmer Trabecular Metal Modular Acetabular System met performance requirements. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not applicable in the context of an AI/software performance study. The "test set" here refers to the physical device and its components undergoing non-clinical bench testing. The document does not specify a "sample size" for these non-clinical tests (e.g., number of implants tested).
- Data Provenance: Not applicable. The "data" refers to non-clinical testing results obtained from the manufactured device, not patient data from a specific country or retrospective/prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts & Qualifications: Not applicable. Ground truth, in the context of AI, usually refers to labeled data for diagnostic tasks. For a physical orthopedic implant, "ground truth" is established through engineering specifications, material science standards, and established biomechanical testing protocols, not by expert interpretation of images or clinical cases. The "experts" would be the engineers and scientists who performed and interpreted the non-clinical tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI algorithm validation to resolve discrepancies in expert labeling or diagnoses. This filing for an implant relies on objective non-clinical test results.
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:
- MRMC Comparative Effectiveness Study: No. This is not an AI/software device, so an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The "ground truth" for this device's performance is based on engineering specifications, material science data, and established biomechanical testing standards and protocols (e.g., those referenced in the FDA Guidance Document for Orthopedic Implants). The device is deemed to perform adequately if it meets these defined engineering and material requirements.
8. The sample size for the training set:
- Sample Size (Training Set): Not applicable. This is not an AI/software device that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. This is not an AI/software device.
In summary: K093561 is a 510(k) premarket notification for a physical medical device (hip implant). The regulatory pathway for such devices focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices through non-clinical performance testing (bench testing, material characterization, design evaluation) rather than clinical studies or AI algorithm validation. Therefore, most of the requested information pertaining to AI/software performance metrics, ground truth establishment for datasets, and multi-reader studies is not relevant to this specific filing.
§ 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.