(74 days)
The Journey Unicondylar Tibial Baseplates are indicated for restoring either compartment of a knee that has been affected by the following:
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and
- Treatment of fractures that are unmanageable using other techniques.
The implants are labeled for single use only. The tibial baseplates are designed to be implanted using bone cement.
New unicondylar metal tibial baseplates have been designed and developed by Smith & Nephew Orthopaedics. In keeping with the design philosophy of the predicate Genesis Unicondylar Tibial Baseplates (K912735), the subject devices share the same design features such as:
- Shape (footprint)
- Size Offering (6 sizes with each size being offered in a RM/LL or LM/RL configuration)
- Cement Grooves
- Keel on Distal Surface
Given that the newly designed Journey tibial baseplates contain the same shape (footprint) and locking mechanism as the existing Journey Unicondylar Tibial Baseplates, the subject devices are intended to inter-lock with the currently marketed Journey Unicondylar UHMWPe Articular Inserts (K061011) in order to form a unicondylar tibial construct to replace either the medial or lateral tibial compartment of the knee.
Here's a breakdown of the acceptance criteria and study information for the Smith & Nephew Journey Unicondylar Tibial Baseplates, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from FDA Guidance) | Reported Device Performance (Journey Unicondylar Tibial Baseplates) |
|---|---|
| Performance requirements outlined in FDA's Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses, dated April 1993. | Met performance requirements. |
| Specific Mechanical Testing: | |
| - Unsupported Baseplate Fatigue Testing | Demonstrated performance capabilities. |
| - Fully Supported Fatigue/Cement Adhesion Testing | Demonstrated performance capabilities. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes mechanical testing, not a clinical study on human subjects. Therefore, the concept of a "test set" in the context of human data or a "sample size" for patients is not applicable here. The testing was conducted on prototype devices.
- Test Set (for mechanical testing): Not explicitly stated, but it would involve multiple samples of the tibial baseplates for each type of fatigue testing.
- Data Provenance: The testing was performed internally by Smith & Nephew Orthopaedics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable to the provided document. The "ground truth" for mechanical testing is based on established engineering standards and physical phenomena, not expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to resolving disagreements among multiple human reviewers in clinical studies, which is not relevant to mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical knee prosthesis, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering standards and physical testing outcomes (e.g., ability to withstand specified loads and cycles without failure, cement adhesion strength). It is not based on expert consensus, pathology, or outcomes data in the medical sense, as no clinical studies were performed.
8. The Sample Size for the Training Set
This question is not applicable, as this is neither an AI/algorithm-based device nor a clinical study that would involve a training set of patient data.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the reasons outlined in point 8.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.