(90 days)
The Foundation® Porous Coated Flared Rim Acetabular Cup is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necresis or family and fracture, and revision arthromasty where hone loss is minimal. This system includes a metal-backed sineli and modular polyethylene liner and is to be used press-fit. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
The Foundation® Porqus Coated Flared Rim Acetabular Cup is fabricated from wrought/forged Ti-6Al-4V that conforms to ASTM F136. The outside surfaces are coated with commercially pure titanium beads (ASTM F67) for the purpose of providing a porous surface for enhanced press-fit fixation.
The flared shells are available with and without screw holes. It is hemispherical in shape and is available in sizes 44mm - 70mm.
Based on the provided text, here's an analysis of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Sufficient attachment strength of liners to shell for in-vivo loading | "All results are sufficient for in-vivo loading." |
| Substantial equivalence to predicate device(s) | Device deemed "substantially equivalent" to predicate devices. |
Important Note: The provided text is a 510(k) summary for a medical device (an acetabular cup for hip replacement). For this type of submission, the "acceptance criteria" are not typically presented as explicit, quantitative targets in the same way they might be for a software or AI product. Instead, the primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device. This is achieved through a combination of design similarity, material similarity, and performance testing that shows the new device performs as safely and effectively as the predicate. The specific performance test mentioned is "attachment strength of liners to shell."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text only mentions "Test Results: Testing on this device included attachment strength of liners to shell." It does not specify the number of samples tested for attachment strength.
- Data Provenance: Not specified. It's highly probable this testing was conducted in a laboratory setting by the manufacturer (Encore Orthopedics, Inc.), rather than using patient-derived data in the sense of a clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable/not stated. The "ground truth" for mechanical testing, such as attachment strength, is determined by physical measurements and engineering standards, not by expert consensus or interpretation of data in the way it would be for a diagnostic AI. The "sufficiency" for in-vivo loading would likely be based on established biomechanical thresholds or comparison to predicate device performance.
- Qualifications of Experts: Not applicable/not stated.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not stated. As this is a mechanical performance test, there isn't an "adjudication" process in the typical sense of resolving disagreements among human reviewers of qualitative data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This device is a mechanical implant, not a diagnostic imaging device or an AI algorithm that assists human readers. Therefore, an MRMC study is not relevant to its evaluation.
- Effect size of how much human readers improve with AI vs. without AI assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes, in a sense. The "attachment strength" testing is a standalone evaluation of the device's mechanical integrity without human interaction (beyond the setup and execution of the test). However, this isn't "algorithm only" performance as the device is a physical product, not a software algorithm.
7. Type of Ground Truth Used
- Ground Truth Type: Engineering/Biomechanical performance standards and physical measurements. The "sufficiency for in-vivo loading" and "substantial equivalence" are the ultimate measures against which the device's performance is judged.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a physical product, not an AI algorithm that requires a "training set." Its development involves engineering design, material selection, and manufacturing processes, followed by performance testing.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. (See explanation for point 8).
§ 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.