(29 days)
The EVOLUTION® MP Adaptive CS Insert is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® Total Knee System is for cemented use only.
The purpose of this submission is to introduce a new EVOLUTION® Adaptive CS Tibial Insert that allows use of a femoral component from the EVOLUTION® Total Knee System with a tibial base from the ADVANCE® Knee System. The design features of the EVOLUTION® Adaptive CS Insert are summarized below:
. Tibial inserts manufactured from UHMWPE
. Available in 11 sizes, left and right
. Tibial insert thickness: 10 - 20mm
The EVOLUTION® Adaptive CS Insert was evaluated via mechanical testing and engineering analyses; including static stability, contact area, and range of motion testing. A review of these results indicates that the subject device is equivalent to predicate devices and is capable of withstanding expected in vivo loading without failure.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
The provided text, a 510(k) summary for the EVOLUTION® MP Adaptive CS Insert, describes a medical device, specifically a tibial insert for a knee replacement system. It does not describe an AI/ML powered device, an imaging device, or anything that would involve performance metrics like sensitivity, specificity, or AUC, or a study with human readers or ground truth established by experts/pathology.
Instead, the "acceptance criteria" and "study" are related to mechanical and engineering performance to demonstrate substantial equivalence to predicate devices.
Therefore, many of the requested fields are not applicable to this type of device and study.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent indications for use to predicate devices | "The indications for use of the EVOLUTION® Adaptive CS Insert are identical to the previously cleared predicate devices." |
| Substantially equivalent design features and materials to predicate devices | "The design features and materials of the subject devices are substantially equivalent to those of the predicate devices." |
| Fundamental scientific technology unchanged from predicate devices | "The fundamental scientific technology of the modified devices has not changed relative to the predicate devices." |
| Capable of withstanding expected in vivo loading without failure | "A review of these results indicates that the subject device is equivalent to predicate devices and is capable of withstanding expected in vivo loading without failure." (Based on mechanical testing and engineering analyses) |
| Acceptable static stability | Evaluated via mechanical testing and engineering analyses |
| Acceptable contact area | Evaluated via mechanical testing and engineering analyses |
| Acceptable range of motion | Evaluated via mechanical testing and engineering analyses |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a "sample size" in the context of typical clinical or AI/imaging studies. The "test set" here refers to the tested components of the device. The document mentions the insert is "Available in 11 sizes, left and right," implying these variations would be considered in testing.
- Data Provenance: The testing was conducted internally by Wright Medical Technology, Inc. (manufacturer). It's an engineering and mechanical evaluation, not a clinical study involving human patients or existing medical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is an engineering/mechanical evaluation of a physical device, not an AI/imaging study requiring expert ground truth or diagnoses.
4. Adjudication Method for the Test Set
- Not Applicable. No expert adjudication process like 2+1 or 3+1 is mentioned or relevant for this type of device testing. The "adjudication" is based on engineering principles and comparison to predicate device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. This is not an AI/imaging device. No MRMC study involving human readers was conducted.
6. If a Standalone Study Was Done
- Yes, in concept. The "study" (mechanical testing and engineering analyses) evaluates the device itself (the EVOLUTION® MP Adaptive CS Insert) in a standalone fashion to determine if it meets physical performance criteria and is substantially equivalent to predicate devices. It's not "standalone" in the AI sense of algorithm-only performance, but rather the device's inherent mechanical properties.
7. The Type of Ground Truth Used
- The "ground truth" here is the established mechanical performance characteristics and design parameters of the predicate devices, as well as the engineering specifications and test methods (e.g., for static stability, contact area, range of motion) that are deemed acceptable for such implants. The performance of the subject device is compared against these benchmarks.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.