(71 days)
The Osteonics® Secur-Fit™-AD Generation II Acetabular Components are single-use devices. The shells are intended for cemented or cementless fixation within the prepared acetabulum. The Osteonics® Secur-Fit™-AD Generation II Acetabular Component System is compatible with any appropriately selected Osteonics hip stem/femoral head combination.
Indications:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
The Osteonics® Secur-Fit™-AD Generation II Acetabular Component System consists of single-use devices. Each Osteonics® Secur-Fit™-AD Generation II Acetabular Component consists of two pieces: an Osteonics® Secur-Fit™-AD Generation II Acetabular Shell and an Osteonics® Generation II Cup Insert. The metal shell is intended for cementless fixation within the prepared acetabulum.
The Osteonics® Secur-Fit™-AD Generation II Acetabular Shells are characterized by the following features:
- A basic dual radius design.
- The predicate interior geometry which allows a mating polyethylene insert size to be used with more than one shell size.
- A variety of screw hole patterns, including dome hole and peripheral screw holes.
- A dome hole which is compatible with the optional, currently marketed Osteonics® Acetabular Dome Hole Plugs.
- Circumferential normalizations.
- A wide range of sizes.
- Osteonics' AD coating.
- Compatibility with the Generation II Cup Insert.
The Osteonics® Generation II Cup Inserts are characterized by the following features:
- A wireless locking mechanism which utilizes a continuous ridge which locks into a groove on the interior of the mating shell.
- A hemispherical geometry which is designed to maximize liner conformity to mating shell.
- Increased indexability through mating of barbs on shell with scalloped areas on insert.
This is a 510(k) premarket notification for a medical device (Osteonics® Secur-Fit™-AD Generation II Acetabular Component System), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study design for AI/ML performance is not applicable. The document discusses mechanical testing for demonstrating substantial equivalence to predicate devices, but no performance metrics for AI/ML algorithms are presented.
Here's a breakdown of why an AI/ML-focused response is not possible:
- Device Type: The device is an acetabular component system, which is a physical implant used in hip replacement surgery. It is explicit "single-use devices".
- Submission Date: The submission date is October 5, 1998, long before the widespread use and regulatory pathways for AI/ML in medical devices were established.
- Performance Data Section: The "Performance Data" section states, "The performance characteristics of the "AD" coatings have been presented in predicate 510(k) submissions. Mechanical testing of the subject shell/insert locking mechanism and fatigue performance is provided in this submission and demonstrate substantial equivalence to the predicate devices." This clearly refers to physical and mechanical properties, not algorithmic performance.
Therefore, I cannot provide the requested information about acceptance criteria, study details, expert involvement, or ground truth for an AI/ML device, as this document pertains to a traditional medical implant.
§ 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.