(26 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.
Addition of 36 mm outside diameter size femoral head components in three different head lengths (-3.5, 0 +3.5 mm)
The provided text describes a 510(k) Special Modification for the Exactech AcuMatch 12/14 Press-Fit Femoral Stems, specifically the addition of 36mm outside diameter size femoral head components. This is a submission for a medical device and not for a software or AI-driven device. Therefore, the traditional "acceptance criteria" and "study" framework as it applies to software performance (such as sensitivity, specificity, or reader studies) is not applicable here.
Instead, the "acceptance criteria" for this device modification are related to its mechanical performance and substantial equivalence to existing predicate devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Adequacy for In Vivo Use: The modified device (36mm femoral heads) must demonstrate performance adequate for its intended use in the human body. | "Testing and engineering evaluations were conducted to verify that the performance of the new Exactech AcuMatch 12/14 Press-Fit Femoral Stem components would be adequate for anticipated in vivo use." |
| Material Equivalence/Compatibility: The materials and design should maintain safety and effectiveness. | The device is an "Alumina Femoral Head," implying ceramic material, consistent with common hip prosthesis materials. The modification is an addition of a size, not a fundamental design change influencing material. |
| Substantial Equivalence: The modified device must be substantially equivalent to a legally marketed predicate device. | "Based on successful results we conclude that the proposed devices are substantially equivalent to Exactech's predicate femoral stems." Specifically claimed substantially equivalent to "Exactech 12/14 Alumina Femoral Heads" (K032964). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data or patient samples as it is not a clinical study of a diagnostic device. The "testing" refers to empirical (mechanical/engineering) testing and engineering analyses. The sample size for these tests (e.g., number of femoral heads tested for fatigue) is not provided. Similarly, no data provenance (country, retrospective/prospective) is relevant or mentioned, as this is pre-market device testing, not a clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable. "Ground truth" in this context would implicitly refer to the established engineering standards and biomechanical principles used to design and evaluate orthopedic implants. The "experts" involved would be the engineering team at Exactech, potentially external consultants, and regulatory reviewers at the FDA. Their specific number or qualifications for establishing biomechanical "ground truth" are not mentioned, but it's implicit that they possess relevant engineering and medical device expertise.
4. Adjudication Method for the Test Set
This concept is not applicable for mechanical testing. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of clinical data or images. For device performance testing, the results are typically quantitative and objective measurements against predefined engineering specifications.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, not for a physical orthopedic implant modification.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This concept is specific to AI/software performance.
7. The Type of Ground Truth Used
The "ground truth" for this device modification is based on:
- Engineering Analyses: Biomechanical principles, material science, and established orthopedic design standards.
- Empirical Testing Data: Results from mechanical tests (e.g., fatigue, static strength, wear) designed to simulate in vivo conditions and evaluate the integrity and durability of the implant components.
- Predicate Device Performance: The established safety and effectiveness of the existing Exactech 12/14 Alumina Femoral Heads (K032964) serves as a benchmark and "ground truth" for substantial equivalence.
8. The Sample Size for the Training Set
This concept is not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable.
§ 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.