(214 days)
The system is indicated for primary or revision surgery in skeletally mature individuals 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 system is intended for use either with or without bone cement in total hip arthroplasty.
The Longevity IT Highly Crosslinked Polyethylene Elevated Liners are intended to be used with either Continuum or Trilogy IT Acetabular components in Total Hip Arthroplasty.
The Continuum and Trilogy IT Acetabular Systems are modular acetabular cup systems intended to replace a hip joint and designed to achieve fixation to bone either with or without bone cement. The systems consist of porous coated shells, optional dome and screw hole plugs
The subject devices are line extensions to the previously cleared predicate systems to add 42mm OD shells and additional 22mm, 32mm, and 36mm ID elevated liners. The subject 32mm and 36mm liners are identical to the previously cleared devices; no changes have been made except for the additional sizes. The subject 22mm liner has been modified to include a poly-relief ring above the scallops. The subject 42mm shells have been modified so that they will not accept the option screw hole plugs.
The provided document describes a 510(k) premarket notification for a medical device (hip prosthesis components) and as such, it does not detail acceptance criteria and a study in the same way one would for a diagnostic AI device. Instead, it outlines non-clinical performance testing to demonstrate substantial equivalence to predicate devices.
Here's an interpretation based on the document, addressing the requested points where applicable, and noting when the information is not present for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria alongside performance metrics in the format typically seen for AI device validation. Instead, it states that "the observed test results exceeded all acceptance criteria." The acceptance criteria would likely be defined by relevant ISO standards or internal Zimmer specifications for mechanical and wear performance of orthopedic implants.
| Performance Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Wear Performance Analysis | (Implicitly: Meet/exceed predicate or defined standard) | Functioned as intended and exceeded all acceptance criteria. |
| Anatomic Fatigue Test | (Implicitly: Meet/exceed predicate or defined standard) | Functioned as intended and exceeded all acceptance criteria. |
| Durability and Backside Wear Analysis | (Implicitly: Meet/exceed predicate or defined standard) | Functioned as intended and exceeded all acceptance criteria. |
| Lever-Out Strength Test | (Implicitly: Meet/exceed predicate or defined standard) | Functioned as intended and exceeded all acceptance criteria. |
| Push-Out Strength Test | (Implicitly: Meet/exceed predicate or defined standard) | Functioned as intended and exceeded all acceptance criteria. |
| Torque-Out Strength Test | (Implicitly: Meet/exceed predicate or defined standard) | Functioned as intended and exceeded all acceptance criteria. |
| Compatibility in the MR Environment Test | (Implicitly: Meet/exceed predicate or defined standard) | Functioned as intended and exceeded all acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample sizes (number of devices, test repetitions) for each non-clinical test. This information would typically be detailed in the full test reports, not in this summary document.
- Data Provenance: The data is from non-clinical (laboratory) testing conducted by Zimmer, Inc. or its contracted labs. It is not human subject data from a specific country or retrospective/prospective in the medical sense.
3. Number of Experts and Qualifications for Ground Truth of Test Set
This requirement is not applicable to this type of non-clinical device submission. Ground truth for mechanical and wear testing is typically established through engineering and metrology standards, not expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical data (e.g., image interpretation), not for non-clinical mechanical testing.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a non-clinical evaluation of medical device components (hip prosthesis). MRMC studies are relevant for diagnostic AI devices assessing human reader performance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is not an AI algorithm. The performance described is "standalone" in the sense that the device components were tested in a controlled laboratory environment without human interaction during the test itself, but it's not an "algorithm-only" evaluation.
7. Type of Ground Truth Used
The ground truth for this device's performance relies on:
- Engineering specifications and design requirements.
- Industry standards (e.g., ISO standards for orthopedic implants).
- Performance data of legally marketed predicate devices, which serve as the benchmark for substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device 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.