(112 days)
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No
The description focuses on the materials and mechanical design of a hip implant, with no mention of AI or ML capabilities.
Yes
The device is described as an acetabular component for total hip arthroplasty, intended to relieve hip pain and restore hip motion, which are therapeutic actions.
No
The device described is a metal-backed acetabular component intended for total hip arthroplasty, which is a treatment for hip conditions, not a tool for diagnosing them. Its purpose is to aid the surgeon in relieving pain and restoring motion, not to identify or characterize diseases.
No
The device description clearly details physical components made of metal and polyethylene, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a metal backed acetabular component for total hip arthroplasty. This is a surgical implant used to replace a damaged hip joint.
- Device Description: The description details the materials and design of a physical implant (metal shell and poly liners).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The metal backed acetabular component is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Product codes
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Device Description
The metal shell is fabricated from wrought/forged or cast Ti-6A1-4V. The outside surface of the shell is plasma sprayed to provide a roughened surface for enhanced press-fit fixation.
The metal shell is hemispherical in shape and is available with screw holes. The screw holes are for the use of cancellous bone screws for secondary fixation.
The poly liners are manufactured from ultra high molecular weight polyethylene and are available in a neutral and 10° hooded design. The hooded design is intended for those patients prone to subluxation because of soft tissue laxity.
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
Indicated Patient Age Range
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Intended User / Care Setting
surgeon
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
Testing on this device included attachment strength of liners to shell. All results are sufficient for in-vivo loading.
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
Summary of Safety and Effectiveness
Encore Orthopedics®, Inc. 8900 Shoal Creek Blvd. Suite 300 Austin, TX 78759 (512) 206-1437 Ashley M. Bock
JAN 27 1997
Trade Name: Metal Backed Acetabular Component
Common Name: Metal backed acetabular component
Classification Name: Hip joint metal/polymer semi-constrained uncemented prosthesis per 21 CFR 888.3358
Description: The metal shell is fabricated from wrought/forged or cast Ti-6A1-4V. The outside surface of the shell is plasma sprayed to provide a roughened surface for enhanced press-fit fixation.
The metal shell is hemispherical in shape and is available with screw holes. The screw holes are for the use of cancellous bone screws for secondary fixation.
The poly liners are manufactured from ultra high molecular weight polyethylene and are available in a neutral and 10° hooded design. The hooded design is intended for those patients prone to subluxation because of soft tissue laxity.
Intended Use: The metal backed acetabular component is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Comparable Features to Predicate Device(s): The spherical shape, titanium substrate, indexability of liners in shell and bone screw holes are features that are comparable to other devices in commercial distribution. The outside surface of the shell is plasma sprayed to provide a roughened surface for enhanced fixation. The Encore® metal backed acetabular component flares at the rim to enhance the press-fit fixation, with a straight line rather than a change in radius .
Test Results: Testing on this device included attachment strength of liners to shell. All results are sufficient for in-vivo loading.