(30 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. ● Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
- Femoral heads and endoprostheses are intended for use in cemented and . press-fit applications.
The proposed Novation Cemented Plus femoral stem is a modification to the existing Novation Cemented femoral stem devices previously cleared in K052787. The proposed stem has the same general design features (collar, cement groove, and "cobra" flange) as the predicate stem. but incorporates a more trapezoidal distal geometry. Additionally, the proposed device includes 5 additional sizes (standard offset Size 10, standard and extended offset Size 12 and 14) to the scope. The proposed stems mate with previously cleared 12/14 CoCr (#K041906), Zirconia ceramic (#K060107), and Alumina ceramic (#K032964 and #K051682) femoral heads.
The provided text describes a 510(k) submission for the Exactech® Novation® Cemented Plus Femoral Stems, focusing on its substantial equivalence to a predicate device. This type of submission is for medical devices and does not involve AI or machine learning. Therefore, the concepts of "acceptance criteria," "study proving the device meets acceptance criteria," "sample sizes," "ground truth," "MRMC studies," or "standalone performance" as they relate to AI/ML device evaluation are not applicable to this document.
The document primarily demonstrates that the modified femoral stem (the new device) is substantially equivalent to a previously cleared device (the predicate device) based on design features, indications for use, materials, shelf life, packaging, and sterilization processes.
Here's how the information provided aligns with what would be in an AI/ML context, if it were applicable, but noting its absence:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable for this type of device. For a traditional medical device like a femoral stem, "acceptance criteria" relate to engineering performance (e.g., strength, fatigue life, biocompatibility) rather than diagnostic accuracy or sensitivity/specificity of an algorithm. The reported "performance" is that it demonstrates substantial equivalence to the predicate device through "engineering studies."
| Acceptance Criteria (Not explicitly stated as such for AI/ML) | Reported Device Performance (Focus on Substantial Equivalence) |
|---|---|
| (Hypothetical: Device meets specific engineering benchmarks) | Results of engineering studies demonstrate substantial equivalence to the cleared predicate device. The device has the same indications for use, design features, materials, shelf life, and sterilization processes as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. There is no "test set" in the context of an AI/ML algorithm being evaluated. The evaluation relies on "engineering studies" of the physical implant. The document does not specify the sample size of these engineering studies or their provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. No "ground truth" establishment in the AI/ML sense is needed for this type of device. The evaluation of a femoral stem is based on engineering principles and regulatory compliance, not expert consensus on image interpretation or similar tasks.
4. Adjudication Method for the Test Set:
- Not applicable. No adjudication method is used as there is no "test set" of AI/ML outputs to adjudicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, not applicable. MRMC studies are specific to evaluating human reader performance with and without AI assistance for diagnostic tasks. This device is a physical implant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done:
- No, not applicable. This concept belongs to AI/ML device evaluation. The "device" here is a physical product, not an algorithm.
7. The Type of Ground Truth Used:
- Not applicable in the AI/ML context. For this device, the "ground truth" (if analogies must be drawn) would be established engineering standards, material science principles, and clinical safety/efficacy data from the predicate device that inform the modified device's design and testing. The document states "Results of engineering studies" as the basis for substantial equivalence.
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. Again, no AI/ML training set is involved.
In summary, the provided text pertains to a regulatory submission for a physical medical device (a femoral stem) under the 510(k) pathway, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. The criteria and study types relevant to evaluating AI/ML models are not found or necessary in this document.
§ 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.