(90 days)
The Foundation® Porous Coated Hemispherical 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 necrosis of femoral neck fracture, and revision arthroplasty where bone loss is minimal. This system includes a metal-backed shell 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® Porous Coated Hemispherical Acetabular Cup is fabricated from wrought/forged Ti-6A1-4V 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 hemispherical shells are available with and without screw holes. It is hemispherical in shape and is available in sizes 44mm - 70mm.
This is a 510(k) summary for a medical device (hip implant), not an AI/ML predictive device. Therefore, much of the requested information regarding AI/ML study design and performance metrics is not applicable.
Here's an interpretation of the provided text in the context of device approval, focusing on what is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was tested) | Reported Device Performance (Result) |
|---|---|
| Attachment strength of liners to shell | All results are sufficient for in-vivo loading. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Testing on this device included attachment strength of liners to shell," but does not give the number of samples tested.
- Data Provenance: Not specified, but implied to be laboratory testing conducted by Encore Orthopedics®, Inc. (the manufacturer). This is a physical device test, not data from patients or a specific country.
- Retrospective/Prospective: Not applicable, as this refers to a physical device test.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. The ground truth for the "attachment strength of liners to shell" would be based on engineering specifications and physical testing methods, not expert human interpretation.
4. Adjudication Method for the Test Set
- Not applicable. This refers to the process of resolving disagreements among experts during ground truth establishment, which isn't relevant for a physical engineering test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not an AI/ML device, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
- Engineering Specifications/Physical Measurement Standards: For the "attachment strength of liners to shell," the ground truth would be based on predefined engineering requirements for material strength and adhesion, measured through physical testing.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML algorithm that requires a training set. If 'training set' were broadly interpreted as design iterations or preliminary tests, the size is not specified.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set in the context of AI/ML. For a physical device, development uses engineering principles and material science.
Summary of the Device Approval in the Provided Text:
The provided documents are a 510(k) premarket notification for a medical device (Foundation® Porous Coated Hemispherical Acetabular Cup), which is a hip implant. The approval process for such devices primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical efficacy or AI/ML performance studies.
The "Test Results" section indicates that "Testing on this device included attachment strength of liners to shell. All results are sufficient for in-vivo loading." This statement represents the critical acceptance criterion and the device's performance in meeting it. The FDA's letter states that they have reviewed the 510(k) notification and determined the device is "substantially equivalent" to predicate devices for its stated indications for use. This means the device's design, materials, and (limited) performance data presented were deemed comparable to devices already on the market.
§ 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.