(96 days)
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthrilis, or degenerative arthritis; failed osteotomies, unicompartment, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Journey II Total Knee system components are indicated for use only with cement and are single use devices.
Subject of this Traditional Premarket Notification are the Journey II Deep Dished articular inserts. The Journey II Deep Dished articular insert is a cruciate stabilizing tibial insert that is intended to be used with the Journey II BCS (K111711) and Journey BCS (K042515) knee systems when the posterior cruciate ligament (PCL) is sacrificed and an insert with a post is not a viable option for the patient. Components of this premarket notification include:
- Cruciate substituting (deep dished) articular inserts which will initially be available in sizes 1-2, . 3-4, 5-6, and 7-8 in right and left designs. Journey II Deep Dished inserts will be offered in 9-21 mm thicknesses and manufactured from cross-linked polyethylene (7.5 Mrad XLPE) material and conventional non-cross-linked Ultra-High Molecular Weight Polyethylene (UHMWPE) material.
- . Cruciate substituting (deep dished) articular insert trial implants manufactured from Radel.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Journey II Deep Dished Articular Inserts:
Acceptance Criteria and Device Performance
The provided document describes the Journey II Deep Dished Articular Insert as a cruciate stabilizing tibial insert. The acceptance criteria are indirectly established through mechanical testing designed to demonstrate the device's capability to withstand "expected in vivo loading without failure."
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Withstand expected in vivo loading without failure | "Capable of withstanding expected in vivo loading without failure." |
| Demonstrate proper tibiofemoral contact area | Tibiofemoral Contact Area Analysis performed |
| Demonstrate sufficient tibiofemoral constraint | Tibiofemoral Constraint Testing performed |
| Ensure no new issues related to safety and effectiveness compared to predicates | "A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices." |
Note: The document does not explicitly state quantitative acceptance criteria (e.g., minimum load capacity, specific contact area values, or constraint ranges). Instead, it refers to the performance by indicating that the device "is capable of" meeting the implicit criteria.
Study Details
The document refers to mechanical testing that was performed to support the substantial equivalence of the new device to previously cleared predicate devices.
1. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes (number of inserts tested) for the mechanical tests.
The data provenance is not explicitly stated as originating from a specific country or being retrospective/prospective. However, as this is a 510(k) submission to the U.S. FDA, the testing was likely conducted in accordance with recognized U.S. or international standards for medical device testing.
2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the described studies are mechanical bench tests, not clinical studies involving human subject data or expert assessment for ground truth.
3. Adjudication Method for the Test Set
This information is not applicable for mechanical bench tests.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed, nor is it applicable. The submission focuses on the mechanical properties and substantial equivalence to predicate devices, not on the improvement of human reader performance with or without AI assistance.
5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study was not performed, nor is it applicable. The device is a physical knee implant component, not an algorithm or AI-powered system meant for diagnostic or assistive purposes.
6. Type of Ground Truth Used
The "ground truth" for the mechanical tests would be the physical measurements and observations derived directly from the laboratory testing (e.g., force-displacement curves, contact area measurements, failure modes). This is an objective, empirically derived ground truth based on engineering principles, not expert consensus, pathology, or outcomes data in a clinical sense.
7. Sample Size for the Training Set
This information is not applicable. The device is a physical product, not an AI or machine learning model that requires a training set.
8. How the Ground Truth for the Training Set Was Established
This information is not applicable as no training set was used.
§ 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.