(90 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.
Subject of this Abbreviated Premarket Notification are the Journey II Knee system. This 510(k) was prepared in accordance with the Agency's, "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses," dated April 1993. The subject device is a cruciate retaining (CR) total knee system which provides the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. Components of this premarket notification include the following components: Cruciate retaining femoral components which will initially be available in sizes 1-10 in right and left designs in OXINIUM material. Cruciate retaining femoral components which will initially be available in sizes 1-9 in right and left designs in cobalt chrome material Cruciate retaining 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 CR articular inserts will be offered in 9-21 mm thicknesses and manufactured from cross-linked polyethylene or UHMWPE. The Journey II CR Knee system will use existing cemented Journey tibial tray and patellar components currently used with the Journey BCS Knee System (K042515), Journey II Deep Dished articular insert components (K113482), and existing patellar components of the Genesis II Knee System (K951987)
The provided text describes a 510(k) premarket notification for the "Journey II CR Knee System." The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than conducting a de novo study against explicit acceptance criteria for device performance. Therefore, the information requested regarding acceptance criteria, performance metrics, sample sizes for test and training sets, expert involvement, and ground truth establishment, as typically found in studies for novel algorithms or AI devices, is not applicable in this context.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This submission is based on demonstrating substantial equivalence to predicate devices, not on meeting specific, predefined performance acceptance criteria for a novel device. The "performance" assessment here is a comparison of design and mechanical characteristics to existing products.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No human or animal test sets are mentioned. The "testing" referred to is mechanical testing of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No test set with ground truth established by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set requiring expert adjudication for ground truth is mentioned.
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 mechanical device submission, not an AI/software device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a mechanical device submission, not an AI/software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. For a mechanical device submission demonstrating substantial equivalence, the "ground truth" is typically the established performance and safety profiles of the predicate devices and the results of various mechanical tests performed on the new device (e.g., patellofemoral contact area, tibiofemoral constraint). The document states: "A review of the mechanical data indicates that the Journey II CR Knee System is capable of withstanding expected in vivo loading without failure."
8. The sample size for the training set
- Not Applicable. This is a mechanical device submission, not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not Applicable. This is a mechanical device submission, not a machine learning or AI device.
Summary of the Study and "Acceptance Criteria" (in the context of a 510(k) for a mechanical device):
The "study" conducted for the Journey II CR Knee System was primarily a mechanical testing and comparison study to demonstrate substantial equivalence to previously cleared predicate devices. The "acceptance criteria" are implied by the regulatory requirements for substantial equivalence, meaning the device must be as safe and effective as a legally marketed predicate device.
Device Performance Measures (Mechanical Testing):
The document explicitly states that the following mechanical testing was performed to demonstrate the device's capability of withstanding expected in vivo loading:
- Patellofemoral Contact Area Analysis
- Tibiofemoral Contact Area Analysis
- Patellofemoral Resistance to Lateral Subluxation
- Tibiofemoral Constraint Testing
The report concludes: "A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices."
Table of "Acceptance Criteria" (Substantial Equivalence Aspects) and Reported Device "Performance" (Comparison):
| Design Aspect Reviewed | Acceptance Criteria (Implied by Predicate) | Journey II CR Knee System Performance (Comparison to Predicate) |
|---|---|---|
| Indications for Use | Must be similar to predicate devices. | Similar to predicate (rheumatoid, post-traumatic, osteoarthritis, degenerative arthritis; failed osteotomies, unicompartmental replacement, total knee replacement; primary/revision surgery where cruciate ligaments are incompetent and collaterals intact; cemented use only; single use). |
| Insert Locking Mechanism | Must have a similar mechanism to predicate devices. | Similar ("Y" in comparison table). |
| Sterilization Method | Must be similar to predicate devices. | Similar ("Y" in comparison table). |
| Material | Must use clinically accepted materials, similar to predicates. | Femoral - OXNIUM and CoCr; Insert - XLPE and UHMWPE (similar to K111711, K101499 uses UHMWPE for insert). |
| Manufacturing Process | Must be similar to predicate devices to ensure similar quality/performance. | Similar ("Y" in comparison table). |
| Mechanical Performance (In Vivo Loading) | Must be capable of withstanding expected in vivo loading without failure. | Testing performed for: Patellofemoral Contact Area Analysis, Tibiofemoral Contact Area Analysis, Patellofemoral Resistance to Lateral Subluxation, Tibiofemoral Constraint Testing. "No new issues related to the safety and effectiveness" found. |
Missing Information & Key Points:
- No specific numerical acceptance criteria for the mechanical tests are provided in the document. The conclusion is a qualitative statement of "no new issues." This is typical for a 510(k) where the primary goal is to show similarity to an already cleared device, implying that if the new device performs within the established range of the predicate, it is deemed acceptable.
- No clinical data was required or presented to support the safety and effectiveness, as explicitly stated in the document ("Clinical data was not needed to support the safely and effectiveness of the subject devices"). This reinforces that the submission relies on substantial equivalence through material and design similarity, and mechanical testing.
§ 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.