(85 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 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.
The Alteon Monobloc Revision Femoral Stem is a distally tapered, press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The Alteon Monobloc Revision Stem system is intended to treat typical Total Hip Arthroplasty primary and revision cases. Compared to predicate Alteon Monobloc Revision Stems implants, proposed Alteon Monobloc Revision Stem line extension implants offer a longer stem length option, a reduced neck offset option, and options for intermediately sized stem diameters to accommodate an array of patient anatomies.
This document describes the Exactech® Alteon® Monobloc Revision Stem and its line extensions. It is a 510(k) premarket notification, indicating that the device is being submitted for clearance based on its substantial equivalence to a predicate device, not through a study proving it meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. This submission focuses on comparing the new device to a previously cleared device (K150066) to demonstrate substantial equivalence based on design, materials, and non-clinical testing, rather than a clinical study evaluating diagnostic performance.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
This document does not specify general "acceptance criteria" in the way one would for a diagnostic or AI device's performance (e.g., sensitivity, specificity, accuracy thresholds). Instead, the "acceptance criteria" revolve around demonstrating substantial equivalence to the predicate device through non-clinical testing.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Non-Clinical Testing) |
|---|---|
| Fatigue Performance: Must perform comparably to the predicate device and meet relevant engineering standards for fatigue strength. | Fatigue testing was performed to demonstrate that the Exactech Alteon Monobloc Revision Stem line extensions perform as intended and are substantially equivalent to the identified predicate devices. (No specific numerical results or thresholds are provided in this summary.) |
| Range of Motion: Must allow for a comparable range of motion to the predicate device. | Range of motion analysis was performed. (No specific numerical results are provided in this summary.) |
| Pyrogenicity: Must meet recommended limits for pyrogens for devices labeled as sterile. | Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72 to ensure the proposed Alteon Monobloc Revision Stem line extension components meet recommended limits per FDA's Guidance Document. (No specific numerical results are provided in this summary.) |
| Design Features and Geometry: Must be identical or acceptably similar where differences are justified and not affecting safety or effectiveness. | Both the proposed and predicate devices are identical per: The Indications for Use, The intended use, Design features and geometry, Materials and surface finishes, Implantation methods, Compatibility. (Note: The line extensions offer longer stem lengths, reduced neck offsets, and intermediately sized stem diameters, which are considered variations within existing design principles and are justified by the "array of patient anatomies" they accommodate, not presenting a new risk). |
| Materials and Surface Finishes: Must be identical or acceptably similar. | Both the proposed and predicate devices are identical per: Materials and surface finishes. |
| Intended Use and Indications for Use: Must be identical. | Both the proposed and predicate devices are identical per: The Indications for Use, The intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This document does not refer to a "test set" in the context of clinical data or AI performance evaluation. The "testing" refers to non-clinical, bench-top engineering tests (fatigue, range of motion, pyrogenicity). The sample sizes for these engineering tests are not specified in this summary.
- Data Provenance: Not applicable as no clinical data or patient-specific data is involved in this summary for demonstrating substantial equivalence. The data comes from internal laboratory testing.
3. 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" usually refers to a definitive diagnosis or outcome for clinical data. This submission is based on non-clinical engineering testing, not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept applies to clinical data review by experts, not to non-clinical engineering tests.
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
- Not applicable. This device is an orthopedic implant, not a diagnostic imaging device or an AI-powered tool. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission are the accepted engineering standards for performance and material properties (e.g., USP , USP , ANSI/AAMI ST72 for pyrogen testing, and general industry standards for fatigue strength and range of motion for hip implants). This is not clinical ground truth.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set ground truth."
§ 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.