(176 days)
The UNIVATION® Unicompartmental Knee System is indicated for cemented use only in patients undergoing surgery for a severely painful and/or disabled joint damaged as a result of osteoarthritis, traumatic arthritis, or a failed previous implant when only one condyle of the knee (medial) is affected.
The UNIVATION® Unicompartmental Knee System is a prosthesis that replaces only one compartment of the knee condyle which consists of a femoral, tibial and meniscal components that are available in a wide range of sizes. The UNIVATION® Unicompartmental Knee System components are medial unicondylar knee replacements for either the right or left knee. The femoral and tibial components are manufactured from CoCrMo, the meniscal components are manufactured from UHMWPE. The femoral and tibial components are available with either a PMMA (polymethylmethacrylate) or ZrN (Zirconium nitride) coating. All components are sterile and for single use only.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
The provided document describes a UNIVATION® Unicompartmental Knee System, which is a medical device, and the information is from a 510(k) summary, likely for FDA clearance. This type of document focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving efficacy or diagnostic accuracy through clinical studies in the way an AI or diagnostic device would.
Therefore, many of the requested categories for acceptance criteria and study details (especially those related to AI, human readers, ground truth establishment, training sets, etc.) are not applicable to this type of device and its submission.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Equivalence | Same fundamental scientific technology and materials as the predicate device (K081293). | The fundamental scientific technology and materials for UNIVATION® Unicompartmental Knee System remain the same as the predicate (K081293). (Femoral and tibial components: CoCrMo; Meniscal components: UHMWPE. Coatings: PMMA or ZrN). |
| Indications for Use Equivalence | Indications for use are equivalent to the predicate device. | The indications for use remain unchanged and are equivalent to the predicate. (Indicated for cemented use in patients with severely painful/disabled joint due to osteoarthritis, traumatic arthritis, or failed previous implant, when only one medial condyle is affected). |
| Design Modification Risk Assessment & Performance (Femur) | Bone interface geometry evaluation for design modifications of the femur component (at posterior fin and distal teeth) to ensure performance similar to the legally marketed predicate. Tested according to ISO 14879-1:2000 for 5 million load cycles. | Customized endurance testing based on ISO 14879-1:2000 for 5 million load cycles was conducted. The results for the modified femur component were found to be similar to the legally marketed UNIVATION® Unicompartmental Knee System. |
| Design Modification Risk Assessment & Performance (Tibia) | Bone interface geometry evaluation for design modifications of the tibia component (at posterior fin and distal teeth) to ensure performance similar to the legally marketed predicate. Tested according to ASTM F1800-07 for 10 million load cycles. | Customized endurance testing based on ASTM F1800-07 for 10 million load cycles was conducted. The results for the modified tibia component were found to be similar to the legally marketed UNIVATION® Unicompartmental Knee System. |
| Sterility | All components are sterile. | Stated in device description: "All components are sterile and for single use only." (No specific test data provided in this summary, but this is a general requirement for such devices). |
| Single Use | All components are for single use only. | Stated in device description: "All components are sterile and for single use only." (No specific test data provided in this summary, but this is a general requirement for such devices). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable/Specified. For this type of orthopedic implant, "test set" typically refers to the physical samples of the modified components used in the mechanical/endurance testing, not a dataset of patient images or clinical outcomes. The document states "customized endurance testing" was used, implying a certain number of physical components were tested, but the exact count is not provided.
- Data Provenance: Not applicable in the context of clinical/patient data. The "data" here comes from mechanical/endurance laboratory testing of the device components.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. "Ground truth" in this context is established by the physical properties and performance metrics defined by the ISO and ASTM standards (e.g., deflection, fatigue life, failure modes). Experts (engineers, materials scientists) are involved in designing and conducting the tests, but it's not a "consensus-based ground truth" on clinical observations.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of clinical data (e.g., radiology images). This submission relies on objective mechanical engineering performance testing against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, not applicable. MRMC studies are used for diagnostic imaging devices to assess how AI affects human reader performance. This device is an orthopedic implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, not applicable. This device is an implant, not an algorithm.
7. The Type of Ground Truth Used
- Mechanical Performance Standards. The "ground truth" for the performance of the modified components is their ability to withstand defined stress/load cycles (5 million cycles for femur, 10 million cycles for tibia) without failure or exhibiting similar performance characteristics to the predicate device, as specified by ISO 14879-1:2000 and ASTM F1800-07 standards.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of an AI algorithm for this device submission.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See #8)
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study conducted was a mechanical/endurance testing program focused on the design modifications made to the femur and tibia components of the UNIVATION® Unicompartmental Knee System.
- Purpose: To evaluate the bone interface geometry of the modified components and demonstrate that their performance characteristics are similar to the previously cleared predicate device (K081293). This was done to address potential risks identified in a risk analysis of the design changes.
- Methodology:
- Femur Component: Customized endurance testing based on ISO 14879-1:2000.
- Tibia Component: Customized endurance testing based on ASTM F1800-07.
- Test Duration/Cycles:
- Femur: 5 million load cycles.
- Tibia: 10 million load cycles.
- Results: "The results were found to be similar to the legally marketed UNIVATION® Unicompartmental Knee System." This indicates that the modified components performed equivalently to the predicate under the specified mechanical stress tests, thus meeting the key acceptance criteria for demonstrating substantial equivalence for the design changes.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.