(30 days)
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No
The provided text describes a hip stem made of metal alloys for surgical implantation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a hip stem used in primary and revision surgeries to rehabilitate hips damaged by trauma or disease, which is a therapeutic purpose.
No
The document describes a hip stem, which is an implant used for rehabilitating damaged hips, not for diagnosing conditions.
No
The device description explicitly states the device is a "HA Global Taper (GT) Tapered Hip Stem" made of "metal alloys" and is intended for surgical implantation. This is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the HA Global Taper (GT) Tapered Hip Stem is a hip implant made of metal alloys, intended for surgical implantation to rehabilitate damaged hips.
- Intended Use: The intended use describes the surgical procedures and conditions for which the hip stem is used, all of which involve direct intervention within the body, not testing of samples outside the body.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The HA Global Taper (GT) Tapered Hip Stem is made of metal alloys. The components are indicated for uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for rehabilitating hips damaged as a result of trauma, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications also include inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis; femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
Product codes
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Device Description
The HA Global Taper (GT) Tapered Hip Stem is made of metal alloys. The devices are for single use. Cementless fixation is available with these devices. The components have the same function as other hip systems designed for cementless fixation.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hips, femoral neck, proximal femur
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analysis results were acceptable and the components should perform as well as other hip systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
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Summary of Safety and Effectiveness
FEB 2 8 1997 Smith & Nephew Orthopaedics
HA Global Taper (GT) Tapered Hip Stem
The HA Global Taper (GT) Tapered Hip Stem is made of metal alloys. The components are indicated for uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for rehabilitating hips damaged as a result of trauma, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications also include inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis; femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The devices are for single use. Cementless fixation is available with these devices. The components have the same function as other hip systems designed for cementless fixation.
Analysis results were acceptable and the components should perform as well as other hip systems.
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CONFIDENTIAL page 14