(120 days)
The Ovation™ Hip Stem is used in uncemented total hip replacement in cases of:
- Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
- Previously failed surgery.
- Proximal femoral neck fractures or dislocation.
- Idiopathic avascular necrosis of the femoral head.
- Non-union of proximal femoral neck fractures.
- Treatment of fractures that are unmanageable using other forms of therapy.
- Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.
The Ovation™ Hip Stem is a one-piece, tapered prosthesis, designed for single, uncemented use. Device fixation is achieved by an optimal press-fit in the medullary canal. The stem will be available in a variety of sizes to accommodate the majority of patients encountered with lengths of 110-165mm, horizontal offsets of 33-47mm, vertical offsets of 27-36mm, and neck angles of 127° and 132°. The stem is manufactured from Titanium Alloy (ASTM F-136, Ti-6A1-4V ELI) and the proximal portion of the stem is plasma sprayed with titanium alloy (ASTM F-1580). The finished stem is passivated per ASTM F-86.
This is a 510(k) summary for a hip stem, which is a physical medical device, not an AI/ML device. Therefore, the typical acceptance criteria and study design for AI/ML devices (like those focusing on performance metrics such as sensitivity, specificity, or AUC based on expert ground truth) are not applicable here.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's a breakdown of the relevant information provided:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: For non-AI/ML medical devices like this hip stem, the "acceptance criteria" revolve around demonstrating substantial equivalence to legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The specific criteria are often related to materials, design features, and mechanical performance as evaluated through engineering analysis and mechanical testing.
- Reported Device Performance:
- Material: Manufactured from Titanium Alloy (ASTM F-136, Ti-6A1-4V ELI); proximal portion plasma sprayed with titanium alloy (ASTM F-1580); finished stem passivated per ASTM F-86.
- Design: One-piece, tapered prosthesis, designed for single, uncemented use with optimal press-fit. Available in various sizes (lengths: 110-165mm, horizontal offsets: 33-47mm, vertical offsets: 27-36mm, neck angles: 127° and 132°).
- Performance (demonstrated through testing): "Engineering analysis and mechanical testing has demonstrated equivalence between the Ovation™ Hip Stem and the predicate devices." (Detailed results of these tests, such as fatigue strength, torsional stability, etc., are typically found in the full 510(k) submission, but only this summary statement is provided here.)
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. This device is a physical implant, and the assessment is based on engineering principles and mechanical testing, not a "test set" of patient data or images.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. "Ground truth" in the context of AI/ML or image analysis does not apply to this device. Material and mechanical properties are established through standardized testing procedures and industry specifications, not expert consensus on medical images.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no concept of "adjudication" for a physical device's mechanical or material properties.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a physical hip stem, not an AI/ML diagnostic or assistive tool. Clinical testing was explicitly stated as "None provided" in the 510(k) summary.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no algorithm for this device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this type of device is based on established engineering standards and material specifications (e.g., ASTM F-136 for Titanium Alloy, ASTM F-1580 for plasma spray, ASTM F-86 for passivation) and comparative mechanical testing against predicate devices. The equivalence is demonstrated through meeting these specified physical and mechanical properties.
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The sample size for the training set
- Not applicable. This is a physical device, not an AI/ML model that requires a training set.
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How the ground truth for the training set was established
- Not applicable. No training set is used for this type of device.
§ 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.