(15 days)
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, 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. Exactech Hip Systems are also potentially indicated for revision of failed previous reconstruction's where sufficient bone stock is present.
The Exactech MCS - HA Porous Coated Total Hip System is made of similar materials and is of a similar design to prostheses that were on the market before May 28, 1976. Additionally, this Porous Coated Total Hip System is of similar design to other components on the market that have been determined to be equivalent to devices on the market prior to May 28, 1976.
The Exactech MCS - HA Total Hip System's acceptance criteria and the study proving its performance are based on demonstrating substantial equivalence to predicate devices, primarily through material integrity and sterilization testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test Description | Reported Device Performance | Comparator/Predicate Data (if available) |
|---|---|---|---|
| Material Integrity | Interfacial shear strength (uncoated sintered bead surface) | In excess of 27 N/sq.mm | Data meets or exceeds predicate data (K921113, K921114) |
| Material Integrity | HA coating tensile strength (porous coated Ti alloy) | Approximately 55 MPa | - |
| Material Integrity | HA shear strength on solid substrates (Ti-6A1-4V and Co-Cr-Mo) | 36.6-44.8 MPa (5300-6500 psi) | - |
| Material Integrity | HA shear strength on porous coated substrates (Ti-6A1-4V and Co-Cr-Mo) | 34.5-40.7 MPa (5000-5900 psi) | - |
| Material Integrity | HA shear fatigue strength (on Ti-6A1-4V at 10 million cycles) | 13.8 MPa (2000 psi) | - |
| Sterilization | Sterility Assurance Level (SAL) | 10⁻⁴ | - |
Note: The primary acceptance criterion here is substantial equivalence to legally marketed predicate devices, meaning the new device performs as safely and effectively as a device already on the market. The specific values reported for material integrity are considered acceptable because they either meet or exceed predicate device data or are within acceptable ranges for such materials in this application.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Material Integrity (Interfacial Shear Strength): 10 coating samples were tested.
- Material Integrity (HA Coating Tensile/Shear/Fatigue Strength): Specific sample sizes for each of these tests are not explicitly stated in the provided text. However, the data is presented as definitive values (e.g., "approximately 55 MPa"), suggesting testing was conducted to establish these properties.
- Data Provenance: The data appears to be retrospective laboratory testing on manufactured components. There's no mention of clinical data or human subject studies for this 510(k) submission regarding the acceptance criteria. The tests were performed on device components, not on patient data. No country of origin for the data is specified, but the submission is to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable in the context of this 510(k) submission. The "ground truth" for material integrity and sterilization is established through standardized engineering and laboratory testing protocols, not through expert consensus on interpretation of images or clinical outcomes. The performance is measured against objective physical and chemical properties and established sterilization standards.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation studies where expert review is needed to resolve discrepancies. For bench testing of material properties, the results are objectively measured and reported.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging devices where AI assists in interpretation. This 510(k) pertains to a total hip system, which is an implantable medical device, and its evaluation focuses on material properties and bio-compatibility, not diagnostic accuracy.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone performance study of an algorithm was done. This 510(k) does not involve an AI algorithm or software device. The product is a physical hip implant system.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Physical and Mechanical Material Properties: Direct measurements of characteristics like interfacial shear strength, tensile strength, shear strength, and fatigue strength of the device's materials and coatings.
- Sterilization Standards: Demonstration of achieving a specified Sterility Assurance Level (SAL) according to recognized guidelines (e.g., AAMI Guideline for gamma radiation sterilization).
- Predicate Device Performance: The underlying "ground truth" for substantial equivalence is the established safety and effectiveness of the legally marketed predicate devices. The new device's performance must meet or exceed these benchmarks.
8. Sample Size for the Training Set
This section is not applicable. There is no "training set" as this 510(k) does not involve a machine learning or AI model that requires training data. The device is a physical product, and its design and manufacturing processes are validated through engineering tests.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as above; there is no training set.
§ 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.