(119 days)
The TGS Unicompartmental Knee Arthroplasty System is intended for arthroplasty of either condyle of a knee with the following indications:
- Non-inflammatory degenerative joint disease including post-traumatic arthritis and osteoarthritis.
- Failed previous implant.
- Correctable deformity.
- All TGS® UKA System implants are intended for cemented use only.
Components of this system are designed for single use and to be used as a system.
The TGS® UKA System is composed of unicompartmental femoral components and unicompartmental tibial components. These components may be used in various combinations to create a single unicompartmental femorotibial replacement for either the medial or lateral side of the knee. TGS® UK A System components include individually packaged femoral components made of cobalt-chromium allov and all-poly tibial components of ultra-high molecular weight polyethylene with radiographic markers. The femoral components are available in 6 symmetrical sizes for medial or lateral application in right or left knees. The tibial components are available in two sets of 6 sizes; one set for right-medial or leftlateral tibial plateau, and one set for right-lateral or left-medial tibial plateau. Each tibial component size is available in 5 thicknesses with cither flat or contoured articular surface, and with either two contoured pegs or anterior-posterior (A/P) keel cement/bone fixation features.
The provided text is a 510(k) summary for the TGS® Unicompartmental Knee Arthroplasty System (TGS® UKA System). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies of the device itself.
Therefore, many of the requested categories about acceptance criteria, device performance, and study details are not applicable or not provided in this type of submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document for the TGS® UKA System. The submission relies on substantial equivalence to predicate devices, implying performance similar to those devices. | Not specified in this document for the TGS® UKA System. Performance is inferred to be similar to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for the test set: Not applicable. No clinical "test set" was used for the TGS® UKA System to prove performance directly. The submission relies on non-clinical testing and substantial equivalence to predicates.
- Data provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. No ground truth establishment by experts was needed for the TGS® UKA System as no clinical study to demonstrate performance against specific criteria was performed.
4. Adjudication Method for the Test Set
- Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No.
- Effect size: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This is a medical device (knee implant), not an algorithm or AI.
7. Type of Ground Truth Used
- Not applicable.
8. Sample Size for the Training Set
- Not applicable, as this is not an AI/ML device and no "training set" was used in the context of this submission. The "training" for substantial equivalence comes from the existing knowledge and performance of the predicate devices.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
Summary of Device Acceptance and Study as per K090024:
- Acceptance Criteria for Regulatory Approval: The primary acceptance criterion for the TGS® UKA System in this 510(k) submission was to demonstrate substantial equivalence to legally marketed predicate devices (K010810 DePuy Orthopaedics Preservation Unicondylar Knee Prosthesis and K012591 Wright Medical Technology ADVANCE® Unicondylar Knee System).
- Study Proving Acceptance:
- The submission states, "The safety and effectiveness of TGS® UKA System are adequately supported by the substantial equivalence information, materials data, and testing results provided within this premarket notification."
- Non-Clinical Testing: "Engineering analysis was performed to demonstrate that the TGS® UKA System implant components presented no new risks and are substantially equivalent to the predicate devices." This likely included mechanical testing, material characterization, and design comparisons. Specific tests (e.g., fatigue, wear) are implied but not detailed in this summary.
- Clinical Testing: "Clinical testing was not necessary to demonstrate substantial equivalence between the subject TGS® UKA System implant components and the predicate devices." This is a key statement indicating the reliance on non-clinical data and comparison to predicates.
In essence, the "study" proving the device met "acceptance criteria" here was a comprehensive comparison of its indications for use, principles of operation, materials, sizes, type of interface, fixation, packaging, and sterility to two already cleared predicate devices, along with engineering analysis, to establish substantial equivalence.
§ 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.