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510(k) Data Aggregation
(84 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.
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.
| Feature / Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (TGS® UKA Modular Tibia System) |
|---|---|---|
| Tibial Insert Material | UHMWPE | UHMWPE |
| Tibial Insert Interface | Anterior/Posterior or Medial/Lateral snap fit | Anterior/Posterior snap fit |
| Tibial Insert Thickness | Similar range to predicates | 8, 9, 10 & 11 mm |
| Tibial Insert Sizes | Similar range to predicates | 40, 44, 48, 52, 56, 60mm A/P |
| Tibial Baseplate Material | Titanium or CoCr | Titanium |
| Tibial Baseplate Fixation | Double contoured pegs, keel, cement pockets | 1) Double contoured pegs, 2) Single A/P keel. Contact surface has cement pockets. Cement fixation. |
| Tibial Baseplate Thickness | 2mm | 2mm |
| Sterilization Method | Ethylene Oxide or Gamma Sterilization | Ethylene Oxide Sterilization |
| Packaging | Double Barrier Thermoform Trays with Tyvek Lids or similar | Sterile devices are packaged in Double Barrier Thermoform Trays (PETG) with Tyvek Lids |
| Indications for Use | Consistent with predicate devices | Non-inflammatory degenerative joint disease, failed previous implant, correctable deformity, cemented use only, single use as a system. |
| Bench Testing | No new risks compared to predicates | Modular component interlock, strength & fatigue properties, range of motion & contact area/stress demonstrated to present no new risks. |
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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