(76 days)
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No
The summary describes a mechanical implant with modifications to its outer geometry, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an acetabular component for total hip arthroplasty, indicating it is intended to treat conditions such as osteoarthritis and avascular necrosis, which makes it a therapeutic device.
No
Explanation: The device described is an acetabular cup (a component of a total hip arthroplasty), which is an implant used for treatment. It does not perform any diagnostic function.
No
The device description clearly describes a physical implant (acetabular shell) with specific geometric features and material properties, indicating it is a hardware device, 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 medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is an "Acetabular Component" (a hip implant) used in surgical procedures for total hip arthroplasty. It is a physical implant placed within the body.
- Intended Use: The intended uses are all related to surgical treatment of hip conditions, not the analysis of biological samples.
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 indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post-traumatic arthritis; avascular necrosis; femoral neck fractures; osteomyelitis; fracture-dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection.
Product codes
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Device Description
The outer diameter of The Reflection Dual Dimension Shell has been modified to include an area with a larger diameter. This feature is a peripheral enhancement to the rim of the cup for improved press fit stability. The shell will be available in a no holed version (one apex hole for shell insertion) and a 3-holed version for some adjunctive screw fixations. In addition to the similarities to the previous Reflection Acetabular Component, The Dual Dimension Shell is similar to several shells currently marketed by other companies. The DePuy Duraloc and the Osteonics PSL shells. Since this modification is only to the outer geometry and the internal geometry and the locking mechanism remain the same as the previous Reflection Acetabular Component.
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
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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
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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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§ 888.3358 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.
0
MAR 27 1996
K960096 Smith & Nephew Richards Inc. Reflection Dual Dimension Shell [510(k) Notification] Summary of Safety and Effectiveness
Intended Use
The indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post-traumatic arthritis; avascular necrosis; femoral neck fractures; osteomyelitis; fracture-dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection.
Modifications that do not significantly affect safety and effectiveness.
The outer diameter of The Reflection Dual Dimension Shell has been modified to include an area with a larger diameter. This feature is a peripheral enhancement to the rim of the cup for improved press fit stability. The shell will be available in a no holed version (one apex hole for shell insertion) and a 3-holed version for some adjunctive screw fixations. In addition to the similarities to the previous Reflection Acetabular Component, The Dual Dimension Shell is similar to several shells currently marketed by other companies. The DePuy Duraloc and the Osteonics PSL shells. Since this modification is only to the outer geometry and the internal geometry and the locking mechanism remain the same as the previous Reflection Acetabular Component.
Materials
The acetabular shell is Titanium 4 Vanadium Alloy (ISO 5832/III) with a coating of commercial pure (C.P.) titanium beads (ASTM F67).
Substantial Equivalence Information
The legally marketed devices with which the subject device is to be compared for the determination of substantially equivalency.
| Features | Reflection D.D. | Osteonics PSL | DePuy Duraloc |
|---|---|---|---|
| Shell Material | Titanium | Titanium | Titanium |
| Porous Surface | Sintered Beads (rough surface) | Sintered Beads (smooth surface) | Sintered Beads (rough surface) |
| Shell Geometry | Low Profile (-2mm) with | ||
| peripheral build-up | Low Profile (-1mm) with | ||
| peripheral build-up | Low Profile (-3mm) | ||
| Shell Options | No holes, Three holes | No holes, Five holes | No holes, 3 holes, 3 |
| spikes, 12 holes | |||
| Adjunctive | |||
| Fixation | Screws | Screws | Screws and fixed spikes |
| Liner Overhang | Neutral and 20 degree | Neutral, 10, and 20 | |
| degree | Neutral, 10, and 15 | ||
| degree | |||
| Polished Inner | |||
| Surface | Yes | No | Yes (Sector Cup only) |
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