(454 days)
Joint replacement is indicated for patients suffering from disability due to:
- degenerative, post-traumatic or rheumatoid arthritis; .
- . avascular necrosis of the femoral condyle;
- . post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
- . moderate valgus, varus or flexion deformities;
This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended to be used with the 3DKnee System for cemented or uncemented applications.
The Highly Cross-Linked Vitamin E UHMWPE (HXL VE) Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) powder that is blended with pure liquid pharmaceutical grade alpha-tocopheral, compression molded and then highly cross-linked. The tibial inserts are available in 9 sizes (2- 12) and 5 thicknesses (9-19) and are provided in right and left orientations. The HXL VE Tibial Insert design is identical to the 3DKnee Tibial Insert cleared via K020114. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle. The baseplate attachment mechanism is the same as the previously cleared 3DKnee System inserts.
The provided document is a 510(k) summary for a medical device called "Highly Cross-Linked Vitamin E UHMWPE Tibial Insert." This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study to prove acceptance criteria for a new, innovative device with unique performance claims.
Therefore, many of the requested elements for a study proving acceptance criteria (like sample size for a test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets) are not applicable to this type of regulatory submission. This document describes a device approval based on non-clinical testing demonstrating similarity to existing devices.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This report does not define specific discrete "acceptance criteria" in the way a performance study for an AI algorithm or a novel diagnostic might. Instead, it relies on demonstrating that the new device's material properties, design, and indications for use are substantially equivalent to legally marketed predicate devices. The "reported device performance" is the outcome of various non-clinical tests showing these equivalencies.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Material Characterization | Comparable to predicate devices (E-Poly Tibial Bearings, K080528) | All testing demonstrated substantial equivalence. |
| (Tensile, Small Punch, Izod Impact, Crack Prog) | ||
| Physical and Chemical Characterization | Comparable to predicate devices (E-Poly Tibial Bearings, K080528) | All testing demonstrated substantial equivalence. |
| (Oxidation Index, Compressive Modulus, etc.) | ||
| Tibial Insert Peel-out Strength | Comparable to predicate devices | All testing demonstrated substantial equivalence. |
| Wear Testing | Comparable to predicate devices | All testing demonstrated substantial equivalence. |
| Biocompatibility | Comparable to predicate devices | All testing demonstrated substantial equivalence. |
| Design (size, thickness, configuration, dim.) | Identical to 3DKnee Tibial Insert (K020114) | Design is identical to the 3DKnee Tibial Insert (K020114). |
| Indications for Use | Equivalent to 3DKnee Tibial Insert (K020114) | Indications for Use are equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This was non-clinical testing of materials and device components, not a clinical study on patient data. The "sample size" would refer to the number of physical samples tested for each material or mechanical property. This specific number is not provided in the summary but would be detailed in the full test reports.
- Data Provenance: Not applicable in the context of clinical data. The data originates from laboratory testing. It is neither retrospective nor prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth, in the context of this device, would be established by validated engineering and scientific testing standards and methodologies, not by expert medical consensus on clinical cases.
4. Adjudication Method for the Test Set
Not applicable. There's no clinical test set requiring adjudication in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This is a non-clinical submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Not applicable. This is a physical medical device (an orthopedic implant), not an algorithm or AI system.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is based on:
- Established material science properties.
- Validated mechanical testing standards (e.g., for wear, strength, fatigue).
- Chemical quantification methods.
- Biocompatibility standards.
- Direct comparison of design specifications to the predicate device.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI or machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" for this device.
§ 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.