(29 days)
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, 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.
The Journey II XR tibial baseplate and inserts were previously cleared for market via premarket notification K141471. Subject of this premarket notification are minor modifications to the insert locking mechanism on the tibial baseplate and insert.
The Journey II XR components are available in medial and lateral cross-linked polyethylene articular inserts which will be available in left and right hand and titanium alloy (Ti-6Al-4V) tibial bases which will be available in left and right hand
The Journey II XR Knee system will use existing Journey II CR femoral components and existing patella components compatible with the Journey II CR femoral as well as device specific instruments.
This document is a 510(k) premarket notification for the "Journey II XR Knee System." It details the submission by Smith & Nephew, Inc. for minor modifications to an existing device.
Here's an analysis of the provided text in response to your questions:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets. Instead, it describes the types of verification testing conducted to demonstrate equivalence to a predicate device. The "reported device performance" is a general statement that the device is equivalent to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance equivalent to predicate devices with no new safety/effectiveness issues related to: | "A review of the results indicates that the Journey II XR tibial baseplate and inserts are equivalent to the existing, legally marketed predicate devices with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices." |
| - Component Interlock Strength of the Tibial Insert Locking Mechanism | (Demonstrated to be equivalent) |
| - Fatigue Strength Testing Of The Tibial Metal Base Tray, Cement And Polyethylene Insert Construct | (Demonstrated to be equivalent) |
| - Tibial Base Fatigue Testing- FEA | (Demonstrated to be equivalent) |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for the mechanical verification tests.
The data provenance is not explicitly stated as in country of origin, nor whether it was retrospective or prospective. Given it's mechanical testing for a medical device submission, it would be laboratory-generated data, likely conducted by or for Smith & Nephew.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this document. The "ground truth" here is established through mechanical engineering principles and testing protocols, not by medical experts interpreting data like in a diagnostic study.
4. Adjudication method for the test set
This is not applicable. There's no mention of an adjudication method as would be used in a study involving expert interpretation or consensus. The assessment is based on the results of the mechanical tests themselves.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a knee implant, which is a physical device, not an AI-powered diagnostic tool requiring human reader studies. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This is a physical knee implant, not an algorithm or AI system.
7. The type of ground truth used
For this device, the "ground truth" for demonstrating performance is based on mechanical engineering standards and test results, confirming that the modified device's mechanical properties (interlock strength, fatigue strength) are equivalent to those of the predicate device.
8. The sample size for the training set
This is not applicable. There is no training set mentioned or implied for this submission. The evaluation is based on mechanical testing of the physical device.
9. How the ground truth for the training set was established
This is not applicable as there is no training set.
§ 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.