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The TGS® Unicompartmental Knee Arthroplasty System is intended for arthroplasty of either condyle of a knee with the following indications:

1. Non-inflammatory degenerative joint disease including post-traumatic arthritis and osteoarthritis.
2. Failed previous implant.
3. Correctable deformity.
4. All TGS® UKA System implants are intended for cemented use only.
5. Components of this system are designed for single use and to be used as a system.

TGS® Unicompartmental Knee Arthroplasty Modular Tibia System (Modular Tibia) is designed to be used with the TGS® Unicompartmental Knee Arthroplasty System (K090024). The Modular Tibia is designed as a two piece construction including a tibial baseplate and a (poly) tibial insert. The tibial baseplate is composed of titanium alloy and is provided in six sizes. The tibial baseplate is indicated for cemented use only. The tibial insert is composed of ultra-high molecular weight polyethylene and is provided in six sizes corresponding to each metal baseplate size. Each tibial insert size is provided in four thicknesses. The tibial insert assembles to a corresponding tibial baseplate with a snap-fit lock mechanism. The Modular Tibia is provided in right and left configurations for use in the medial or lateral tibiofemoral compartment of the knee. The Modular Tibia is packaged sterile with each tibial baseplate and each tibial insert packaged individually.

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a quantitative manner for performance metrics. Instead, it demonstrates substantial equivalence to predicate devices based on various characteristics, implying that if the device is substantially equivalent, it meets the necessary performance for market clearance. The comparison table below highlights the key characteristics reviewed.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify a "test set" in the context of clinical or large-scale performance testing with human data. The assessment for this device appears to rely on non-clinical bench testing and engineering analysis comparing it to predicate devices. Therefore, the concept of a "test set" with a specific sample size for device performance against ground truth (as might be seen in diagnostic AI) is not applicable here.
• Data Provenance: The data provenance is from non-clinical bench testing and engineering analysis conducted by Alexandria Research Technologies, LLC as part of its premarket notification to the FDA. The country of origin for the data generation would be the USA (Plymouth, Minnesota), where the company is located. The nature of the data is prospective in the sense that the tests were conducted specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth

• This submission does not involve human expert adjudication for establishing ground truth as it is a medical device for knee arthroplasty, not a diagnostic or AI algorithm. The "ground truth" equivalent would be established engineering principles, material science standards, and performance characteristics of legally marketed predicate devices.

4. Adjudication Method

• Not applicable as there is no human adjudication process described for establishing "ground truth" to evaluate a diagnostic device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC comparative effectiveness study is not mentioned as this device is a physical implant, not a diagnostic tool where human readers interact with AI.

6. Standalone Performance (Algorithm Only)

• Not applicable as this device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

• The "ground truth" for this submission is based on engineering and materials standards, mechanical testing results, and the established safety and effectiveness of legally marketed predicate devices. The goal was to demonstrate substantial equivalence to these predicates, meaning the device performs as intended and presents no new risks.

8. Sample Size for the Training Set

• Not applicable. There is no AI or algorithm involved that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable.

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The TGS Unicompartmental Knee Arthroplasty System is intended for arthroplasty of either condyle of a knee with the following indications:

1. Non-inflammatory degenerative joint disease including post-traumatic arthritis and osteoarthritis.
2. Failed previous implant.
3. Correctable deformity.
4. 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

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.

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