(163 days)
The Inter-Op Durasul Acetabular Components and CoCr Femoral Heads are intended for use in treatment of the following:
- joint destruction resulting from degenerative, posttraumatic or Advanced 1. rheumatoid arthritis.
- Fracture or avascular necrosis of the femoral head. 2.
- Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, 3. hemiarthroplasty and total hip replacement.
The Sulzer Orthopedics Inter-Op Durasul Acetabular Inserts were originally cleared via 510(k) K983509. The purpose of the present submission is to gain notice of substantial equivalence for line additions to these previously cleared insert components and corresponding metallic heads. More specifically, this includes decreased thicknesses (down to 5mm) of the previously cleared Inter-Op Durasul Standard Acetabular Insert design for use with 28, 32, 38mm and 46mm CoCr femoral heads.
The provided submission K993259 is for line additions to previously cleared acetabular inserts and femoral heads for hip arthroplasty. The submission focuses on demonstrating substantial equivalence rather than presenting an AI-based device, therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What needs to be demonstrated) | Reported Device Performance (What was found) |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- --|
| Performance as intended | "Wear, contact stress, fatigue, and locking mechanism integrity testing all indicated that these line additions would perform as intended and similar to legally marketed products." |
| Similar to legally marketed products (Predicate device K983509) | The Inter-Op Durasul Standard Acetabular insert is substantially equivalent and identical in intended use, function, material and general overall design to those products cleared under K983509. These are modular components that are manufactured from the same Durasul crosslinked polyethylene, interface with the same Inter-Op Acetabular Shells and metallic heads and are used to resurface the acetabulum during total hip arthroplasty in the same indications. The main difference is the decreased polyethylene insert thickness (down to 5mm) and increase in diameter of the corresponding head sizes that will be offered. Wear, contact stress, fatigue, and locking mechanism integrity testing all indicated that these line additions would perform as intended and similar to legally marketed products. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of number of devices tested. The text refers to "in vitro wear tests," "contact stress," "fatigue," and "locking mechanism integrity testing." These are likely conducted on a defined number of physical samples according to industry standards, but the exact count is not given here.
- Data Provenance: The tests are described as "in vitro," meaning they were conducted in a laboratory setting, not with human or animal subjects. The origin of the data is internal to the manufacturer, Sulzer Orthopedics Inc. It is prospective testing designed to evaluate the new designs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This submission is for medical device components (hip implants), not an AI device or diagnostic tool requiring ground truth established by experts interpreting outputs. The "truth" is based on engineering performance specifications determined by the manufacturer and accepted by the FDA for substantial equivalence.
4. Adjudication Method for the Test Set
- Not applicable. As this is not an AI or diagnostic device, there is no need for expert adjudication of results. The performance is measured against engineering specifications.
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?
- Not applicable. This is not an AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an AI device.
7. The Type of Ground Truth Used
- Engineering Performance Specifications: The ground truth for this device is based on established engineering performance specifications for hip implant components, including thresholds for wear, contact stress, fatigue life, and the integrity of the locking mechanism. These are typically defined by international standards (e.g., ISO) and internal company specifications derived from predicate device performance. The FDA's acceptance of "substantial equivalence" implies that these tests demonstrate performance similar to legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI device that requires a training set or associated ground truth.
§ 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.