(104 days)
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
- Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
- Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
Exactech Tapered Wedge Femoral Stem is a collarless, press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The overall design goal of the Exactech Tapered Wedge Femoral Stem is to emphasize medial/lateral fixation of the device and axial/rotational stability when implanted in the femoral/medullary canal.
Manufactured from titanium alloy, the subject stem is available in 17 sizes with two lateral offsets offered for each size and two surface finish options (commercially pure titanium, and hydroxylapatite over commercially pure titanium) for the press-fit region of the device. Together, there are 68 total femoral stem configurations available to accommodate patients' various anatomical needs. Regardless of configuration, all Tapered Wedge Femoral Stems feature a polished neck region and bead blast (satin) surface finish on the distal region of the femoral stem. Exactech Tapered Wedge Femoral Stems are intended for press-fit applications. With respect to devicecompatibility with other Exactech manufactured products, Tapered Wedge Femoral Stem is designed to be used with the following 12/14 femoral heads and AcuMatch bipolar components.
The proposed femoral stems are intended to mate with the following modular 12/14 femoral heads:
- Exactech Cobalt Chromium Alloy Femoral Heads (K041906, K121392)
- Exactech Ziramic Zirconia Femoral Heads (K050398, K060107)
- Exactech BIOLOX® forte Alumina Femoral Heads (K032964, K051682)
- Exactech BioloxDelta and BioloxOption Femoral Heads and Adapters (K103012, K121392)
- Exactech AcuMatch L-series Unipolar endoprosthesis (K010081)
The proposed femoral stems are intended to mate with the following bipolar components:
- Exactech AcuMatch L-Series Bipolar Endoprosthesis (K013211)
The Exactech Tapered Wedge Femoral Stem is accompanied by a complete instrumentation set including trial and broach/rasp system to assist surgeons in implantation of the device.
The provided document describes the Exactech® Tapered Wedge Femoral Stem, a medical device for hip replacement surgeries. As such, it does not contain information about software or AI-powered devices, and therefore many of the questions regarding acceptance criteria and studies are not applicable in the context of AI.
However, I can extract information related to the device's performance based on the provided text, focusing on the available non-clinical testing.
Here's a breakdown of the requested information, adjusted for a physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative "acceptance criteria" for each test with corresponding "reported device performance" in a typical table format that would be seen for a diagnostic algorithm. Instead, it states that the device "conforms to recognized performance standards for total hip replacement devices" and that specific tests were performed "to demonstrate that the Exactech Tapered Wedge Femoral Stem performs as intended and is substantially equivalent to the identified predicate devices."
Therefore, the "acceptance criteria" are implied to be meeting the requirements of the referenced standards and a successful demonstration of substantial equivalence. The "reported device performance" is the successful completion of these tests.
| Test Type | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Literature Review | Consistent with performance of similar femoral prostheses. | Successful completion of review, supporting substantial equivalence. |
| Template Studies | Demonstrated acceptable outcomes/characteristics. | Successful completion of studies, supporting substantial equivalence. |
| Range of Motion Testing (per ISO 21535) | Meets specified range of motion requirements per the standard. | Successful completion, demonstrating compliance with ISO 21535. |
| Distally Fixed Fatigue Testing (worst case per FDA guidance) | Withstands fatigue loads as per FDA guidance for worst-case scenarios. | Successful completion, demonstrating fatigue resistance per FDA guidance. |
| Femoral Neck Fatigue Testing (worst case per FDA guidance) | Withstands fatigue loads as per FDA guidance for worst-case scenarios. | Successful completion, demonstrating fatigue resistance per FDA guidance. |
| Femoral Head Modular Junction Burst Testing (per ISO 7206-10 and ASTM F2009-00) | Withstands burst pressure as per ISO 7206-10 and ASTM F2009-00. | Successful completion, demonstrating burst strength per standards. |
| Femoral Head Modular Junction Fatigue Testing (per ISO 7206-10 and ASTM F2009-00) | Withstands fatigue loads as per ISO 7206-10 and ASTM F2009-00. | Successful completion, demonstrating fatigue resistance per standards. |
| Femoral Head Modular Junction Axial Pull-off Testing (per ISO 7206-10 and ASTM F2009-00) | Withstands axial pull-off forces as per ISO 7206-10 and ASTM F2009-00. | Successful completion, demonstrating pull-off strength per standards. |
| Cadaveric Evaluation | Demonstrates proper implantation, fit, and function in a cadaveric model. | Successful completion, validating device performance in a cadaveric setting. |
| Microstructural Characterization & Mechanical Testing (dual coating) | Meets specified material and mechanical properties for the coating. | Successful completion, confirming coating properties. |
| Biocompatibility Testing (colorants) | Demonstrates biocompatibility of instrument colorants. | Successful completion, confirming biocompatibility. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for any of the individual tests. The document refers to "worst case" testing for fatigue tests, implying a representative sample, but specific numbers are not given.
- Data Provenance: The studies are primarily non-clinical tests (mechanical testing, cadaveric evaluation, material characterization). No patient data is mentioned in detail regarding provenance (country of origin, retrospective/prospective). The "Clinical Literature Review" would be based on existing published literature, which could involve diverse geographies and study types.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the studies described are mostly non-clinical engineering and material science tests. Ground truth in this context would refer to established engineering standards (e.g., ISO, ASTM, FDA guidance) and successful physical demonstration, rather than expert interpretation of medical images or patient outcomes. For the "Cadaveric evaluation," it can be inferred that medical professionals (likely surgeons) would be involved for the evaluation, but their number and specific qualifications are not mentioned.
4. Adjudication Method for the Test Set
This question is not applicable to the non-clinical tests described. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human interpretation or subjective assessments.
5. 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
This question is not applicable as the document describes a physical medical device, not an AI or software device involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the document describes a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is defined by:
- Recognized performance standards (e.g., ISO 21535, ISO 7206-10, ASTM F2009-00)
- FDA guidance documents for specific tests (e.g., fatigue testing)
- Material specifications and biocompatibility standards
- Successful physical outcomes in laboratory and cadaveric settings.
8. The Sample Size for the Training Set
This question is not applicable as the document describes a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.