(86 days)
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthrilis; failed osteotomies, unicompartmental replacement, or total knee replacement.
Smith & Nephew, Inc. Journey CR Knee System components are indicated for use only with cement and are single use devices.
Subject of this Abbreviated 510(k) premarket notification is the Journey. CR Knee System. The subject device is a cruciate retaining (CR) total knee system which is designed to provide the potential ability for greater flexion to those patients who have the anatomic capability to allow a greater flexion range. Components of this premarket notification include the following components:
- Cruciate retaining femoral components available in sizes 1-10 in right and left designs in . OXINIUM material.
- Cruciate retaining femoral components available in sizes 1-9 in right and left designs in cobalt chrome material
- Cruciate retaining articular inserts available in sizes 1-2, 3-4, 5-6, and 7-8 in right and left . designs. Journey CR articular inserts will be offered in 9-21mm thicknesses (9, 10, 11, 13, 15, 18, 21) and manufactured from UHMWPE.
The Journey CR Knee system will use existing cemented Journey tibial tray and patellar components currently used with the Journey BCS Knee System (K042515) and may also be used with existing patellar components of the Genesis II Knee System (K951987).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew Journey CR Knee System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) submission for the Smith & Nephew Journey CR Knee System (K101499) does not explicitly list quantitative "acceptance criteria" in the way a diagnostic AI device would. Instead, it refers to a "review of the mechanical data indicates that the Journey CR Knee System is capable of withstanding expected in vivo loading without failure" and that "a review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices."
The "performance" is demonstrated through various mechanical tests, implicitly aiming to show the device is as safe and effective as its predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Withstanding expected in vivo loading without failure. | Mechanical testing of the Journey CR Knee system was performed on: |
- Journey CR femoral lugs (mechanical testing, removal torque, push-out and torque to failure)
- Journey CR tibial insert locking mechanism (static testing)
- Tibiofemoral contact area analysis
- Tibiofemoral constraint testing
- Patellofemoral contact area analysis
- Patellofemoral lateral subluxation
Conclusion: "a review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices." |
| Substantial equivalence to predicate devices in safety and effectiveness. | The submission states that "The substantial equivalence of the Journey CR Knee System is based on its similarities in indications for use, design features, operational principles, and material composition to the predicate systems listed in the table." This is supported by the mechanical testing results, which are deemed sufficient to show no new issues. |
2. Sample Size Used for the Test Set and Data Provenance
This is a medical device (knee implant), not a diagnostic AI algorithm. Therefore, the concept of a "test set" with clinical data provenance does not directly apply in the same way. The evaluation relies on mechanical testing of the device components.
- Sample Size for Test Set: Not specified in terms of number of patient cases. The testing was performed on physical components of the Journey CR Knee System. The document implies a sufficient number of samples were tested to gain confidence in the mechanical properties, but the exact number isn't stated.
- Data Provenance: The "data" comes from in vitro mechanical tests conducted on the physical device components. There is no mention of country of origin for clinical data, as clinical data was not required for this submission. The study is in vitro (bench testing) rather than retrospective or prospective clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Again, this is a mechanical device, not an AI diagnostic. Therefore, the concept of "ground truth" derived from expert consensus on patient data is not applicable. The "ground truth" for mechanical testing is established by engineering standards and validated testing protocols. The experts involved would be qualified engineers and test technicians in a laboratory setting, but their number and specific qualifications are not detailed in this regulatory document.
4. Adjudication Method for the Test Set
Not applicable, as this is a mechanical device undergoing bench testing, not a clinical study involving human readers or expert consensus on medical images. The "adjudication" is implicitly done by the engineers and regulatory affairs personnel reviewing the raw mechanical test data against established engineering principles and relevant standards.
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
Not applicable. This is a knee prosthesis, not an AI diagnostic system. There were no human readers or AI involved in the evaluation of this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop) performance study was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device evaluation is based on mechanical engineering principles, established material properties, and standardized mechanical testing protocols designed to simulate in vivo loading conditions. The performance is compared against known characteristics of predicate devices that have a history of safe and effective use.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. There is no AI model with a training set. The "design" and "development" of the device would involve engineering iterations, but these are not referred to as a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI model or training set, this question is not relevant. The "ground truth" for engineering design would be based on biomechanical principles, clinical requirements for knee function, material science, and the performance characteristics of existing, successful knee implants.
§ 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.