(29 days)
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No
The summary describes a hip stem component made of metal alloys for surgical implantation. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The focus is on the material and design of the physical implant.
Yes
The device is indicated for rehabilitating hips damaged by trauma or disease, which is a therapeutic purpose.
No
The provided text describes a hip stem device (GT Spectron) which is an implant used in hip replacement surgery. Its purpose is treatment and rehabilitation, not to diagnose a condition.
No
The device description explicitly states the device components are made of metal alloys, indicating it is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant (hip stem components) used to replace damaged hip joints. This is a therapeutic device, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and materials of the hip stem, which is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis. IVDs are designed to perform tests on these types of samples.
Therefore, the GT Spectron Hip Stem is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The hip stem components of the GT Spectron are made of metal alloys. The components are indicated for cemented and 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 (NID/D) 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 Global Taper (GT) Spectron Hip Stems have a new taper.
The hip stem components of the GT Spectron are made of metal alloys. The devices are for single use. Cement fixation is available with these devices. The Spectron Hip Stems have the same function as other hip stems designed for cemented and 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
Hip, 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
Analysis results were acceptable and the components of the GT Spectron Hip should perform as well as other hip stems.
Key Metrics
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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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§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Exhibit 5
Summary of Safety and Effectiveness
FEB 28 1997
Smith & Nephew Orthopaedics
Global Taper Spectron Hip Stem
The Global Taper (GT) Spectron Hip Stems have a new taper.
The hip stem components of the GT Spectron are made of metal alloys. The components are indicated for cemented and 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 (NID/D) 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. Cement fixation is available with these devices. The Spectron Hip Stems have the same function as other hip stems designed for cemented and cementless fixation.
Analysis results were acceptable and the components of the GT Spectron Hip should perform as well as other hip stems.