(27 days)
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection of the hip; and correction of deformity.
The ANTHOLOGY AFIT Hip Stem is for single use only. The ANTHOLOGY AFIT Hip Stem is intended for cementless use.
Subject of this Special premarket notification is the addition of a new stem design to the Smith & Nephew ANTHOLOGY™ Hip System. The ANTHOLOGY Hip System currently consists of the ANTHOLOGY Hip Stems cleared via premarket notification K052792. The proposed devices are ANTHOLOGY™ AFIT Hip Stems, new hip stems that will be marketed as part of the ANTHOLOGY Hip System.
The ANTHOLOGY AFIT Hip Stem represents minor design modifications when compared to the predicate ANTHOLOGY Hip Stem cleared via K052792. The ANTHOLOGY AFIT Hip Stem is manufactured from Titanium alloy (Ti-6Al-4V) per ASTM F1472. The proximal body is both porous-coated per ASTM F67 and hydroxyapatite-coated, the middle section is grit-blasted, and the distal end is glassbeaded. The ANTHOLOGY AFIT Hip Stem will be available in a size range of 3 to 14, in both a high and standard neck offset with a 12/14 taper.
This looks like a 510(k) premarket notification for a hip stem, which is a medical device. Based on the provided text, this document does not describe a study involving an AI/Machine Learning device or a diagnostic device that would have a test set, ground truth established by experts, or performance metrics like accuracy, sensitivity, or specificity.
The document discusses substantial equivalence for a physical hip implant (ANTHOLOGY™ AFIT Hip Stem) based on its similarity to a previously cleared predicate device (ANTHOLOGY Hip Stem cleared via K052792) and mechanical testing.
Therefore, I cannot extract the information required to populate the fields related to acceptance criteria and performance of an AI/ML device, as this type of study was not performed or described in this document. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices." and "A review of the existing ANTHOLOGY Hip Stem testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices."
Summary of what can be inferred from the document regarding the device's acceptance (though not an AI study):
The acceptance criteria for this device appear to be based on demonstrating substantial equivalence to a predicate device already on the market (Smith & Nephew, Inc. ANTHOLOGY Hip Stem, K052792). This includes demonstrating similarity in:
- Function
- Intended Use
- Indications for Use
- Material Composition
- Overall Design (with minor modifications demonstrated not to raise new safety/effectiveness issues)
The device performance is assessed through "existing mechanical testing performed" and a "Limulus Amebocyte Lysate (LAL) test" to determine pyrogen limit.
Therefore, the table and other points cannot be filled as requested because the document does not describe the kind of study you're asking about.
§ 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.