(187 days)
The Ovation 10/12 Hip Stem is intended for use in a total hip replacement surgery. Total hip arthroplasty is intended to provide increased patient mobility and to decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants.
The Ovation 10/12 Hip Stem is indicated for use in uncemented total hip arthroplasty procedures in cases of:
- Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
- Previously failed hip surgery.
- Proximal femoral neck fractures or dislocation.
- Idiopathic avascular necrosis of 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 10/12 Hip Stem is a one-piece press-fit tapered femoral stem, designed for single, uncemented use. The system consists of a variety of sizes to accommodate the majority of patients encountered, lengths (98-142mm), horizontal offsets (34-49mm), vertical offsets (29-36mm), resection angle of 130°, and neck angle of 132°.
The Ovation 10/12 Hip Stem has a rectangular cross-section and provides stability through a 3point fixation. The femoral stem is manufactured from Titanium Alloy (ASTM F-136, Ti-6Al-4V ELI). The proximal portion of the stem is plasma-sprayed with titanium alloy (ASTM F-1580).
The provided text describes the regulatory clearance for the Ovation 10/12 Hip Stem, which is a medical device (hip prosthesis), not an AI/ML clinical decision support tool. Therefore, much of the requested information (e.g., sample sizes for test/training sets, adjudication methods, MRMC studies, ground truth establishment by experts, AI performance metrics) is not applicable to this type of device and is not present in the document.
The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, manufacturing, intended use, and most importantly, mechanical performance through physical testing.
Here's a breakdown of the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| ODEV Protocol/Report Number | ISO Standard(s) | Test Type | Acceptance Criteria (Implied by "Pass") | Test Results (Pass/Fail) |
|---|---|---|---|---|
| P-10-0017 | ISO 7206-6:1992(E) | Proximal Fatigue | Met requirements of ISO 7206-6:1992(E) | Pass |
| P-13-0065 | ISO 7206-4:2010(E) | Distal Fatigue | Met requirements of ISO 7206-4:2010(E) | Pass |
| R-13-0062A | ISO 21535:2007(E) | Range of Motion | Met requirements of ISO 21535:2007(E) | Pass |
Note: For physical devices, "acceptance criteria" are typically defined by the performance requirements outlined in the referenced ISO standards. A "Pass" result indicates that the device met these criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document specifies "Size 1 Ovation 10/12 Hip Stem EXT (100-1001)" for the fatigue tests. This indicates that a specific size/model of the hip stem was tested. The exact number of samples tested for each fatigue and range of motion test is not explicitly stated, but it would typically involve a small number of physical prototypes (e.g., n=3 or n=5) to demonstrate compliance with the mechanical standards.
- Data Provenance: The data comes from internal testing conducted by Ortho Development Corporation, likely in a laboratory setting according to the specified ISO standards. It is not patient data (retrospective or prospective) from a country of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a physical device. "Ground truth" in the context of AI/ML models (e.g., image annotation by radiologists) does not apply here. The "ground truth" for mechanical testing is adherence to the specified ISO standard requirements under laboratory conditions.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3. Testing is conducted according to a standard protocol, and results are objectively measured.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is a physical orthopedic implant. MRMC studies are relevant for diagnostic devices or AI tools that assist human interpretation.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an algorithm. The mechanical tests (fatigue, range of motion) are standalone performance evaluations of the device itself.
7. The Type of Ground Truth Used
- Mechanical Performance Standards. The "ground truth" is defined by the performance parameters and acceptance limits specified in the referenced ISO standards (ISO 7206-6, ISO 7206-4, ISO 21535). These are objective, quantifiable criteria for the physical properties of the implant.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical device, not a machine learning model that requires a training set. The design of the device is based on engineering principles and existing knowledge of hip prostheses, not on "training data."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
§ 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.