(87 days)
This device is a femoral component of a total hip system. Its substantial equivalence is based on an equivalence in labeling, design and materials to several legally marketed devices including: P.C.A.® E-Series Hip System (Howmedica); Straight Stem Femoral Component (Howmedica) and the Anatomic Hip (Zimmer). All of the named devices are intended for use in the primary and secondary reconstruction of the head and neck portion of the femur. For the specific indication of primary non-inflammatory degenerative joint disease, the Howmedica® Asymmetric Stem Femoral Component is substantially equivalent to the P.C.A.® E-Series Hip and the Howmedica® Straight Stem Femoral Component. Relative indications and contraindications for use are the same for all of the named devices.
This device is a femoral component of a total hip system. The Howmedica® Asymmetric Stem Femoral Component is manufactured from forged cobalt-chromium-molybdenum (Vitallium®) alloy which is similar to the material used in the P.C.A.® E-Series Hip and the Howmedica® Straight Stem Femoral Component. Each of the named equivalent hip stems, as well as the Howmedica® Asymmetric Stem Femoral Component, share certain design features as follows: anatomic design (P.C.A. E-Series and Zimmer Anatomic Hips); circumferential porous coating (P.C.A.® E-Series Hip, Howmedica® Straight Stem Femoral Component and the Zimmer Anatomic Hip); collared and collarless versions (P.C.A.® E-Series Hip, Howmedica® Straight Stem Femoral Component and the Zimmer Anatomic Hip) and distal split (Howmedica® Straight Stem Femoral Component and the Zimmer Anatomic Hip .
This document describes a medical device, the Howmedica® Asymmetric Stem Femoral Component, and its substantial equivalence to other legally marketed devices. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of device performance metrics typically reported for AI/ML-enabled devices (e.g., sensitivity, specificity, AUC).
Instead, the provided text focuses on:
- Device Description: A femoral component of a total hip system.
- Substantial Equivalence: Comparing its labeling, design, and materials to existing devices (P.C.A.® E-Series Hip System, Howmedica® Straight Stem Femoral Component, and Zimmer Anatomic Hip).
- Indication for Use: Primary non-inflammatory degenerative joint disease.
- Materials: Forged cobalt-chromium-molybdenum (Vitallium®) alloy.
- Design Features: Anatomic design, circumferential porous coating, collared and collarless versions, distal split.
- Mechanical Testing: A finite element analysis indicating the "endurance load exceeds the Semlitsch minimum of 630 lbs." This is a mechanical performance metric, not an AI/ML-related performance metric.
Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The prompt asks for information typically found in AI/ML performance studies, which is not applicable to this traditional 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.