(492 days)
This device is indicated for use as a total knee replacement for the relief of pain and significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis. This device is also intended for the revision of knee prostheses.
The HLS Kneetec is intended for cemented use only.
The HLS Kneetec prosthesis is intended for use as a semi-constrained replacement system. The HLS Kneetec cemented prosthesis with fixed tibial insert consists of three components intended to be used with bone cement: the femoral implant, the tibial implant and the patella. The tibial implant consists of two components: tibial insert and tibial tray, the tibial insert is clipsed on the tibial tray can be extended by a stem. The patella of the joint may be preserved or resurfaced with the patellar implant shared by all ranges of the HLS Kneetec prostheses.
The present device modification submission consists of the addition of a new prosthesis named HLS Kneetec to the HLS Knee range. The HLS Kneetec prosthesis is an evolution of the HLS Noetos System, CE marked in Europe since 1996 and cleared in the USA since 2001 (K013906). The HLS Kneetec prosthesis keeps HLS Noetos benefits and improves the compliance with patient's anatomy, with a new design to provide better bone coverage and greater interchangeability between sizes. The HLS Kneetec System completes the Tornier HLS range of knee implants.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Contact Area Stress / Pressure Test | The contact area stress and contact pressure between the new HLS Kneetec size 2 and the predicate HLS Noetos size 1 (K013906- Equivalent size) must be equivalent. | No significant difference between HLS Kneetec size 2 and predicate HLS Noetos size 1 (K013906); contact area stress/pressure is equivalent. |
| Constraint Test (ASTM F1223) | Load displacement curves must be equivalent to the predicate device HLS Noetos (K013906). | No significant difference between HLS Kneetec size 2 and predicate HLS Noetos size 1 (K013906); frame of load displacement curves is equivalent. |
| Tibial Tray Fatigue Test (ASTM F1800:2007 & NF ISO 14879-1:2000) | The fixed tibial tray tested must resist 10 million cycles without any damages. | Five fixed tibial trays resisted 10 million cycles under maximum load of 237daN without any damage or ruptures. Therefore, the new tibial tray is conformed to the standards. |
| Patella Tracking Comparative Study | The contact area and trajectories must be equivalent to the predicate device HLS Noetos (K013906). | For HLS Kneetec and predicate HLS Noetos (K013906), the principle is the same; patella tracking is steady when moving the quadriceps in each position. Therefore, the designs are equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes physical tests conducted on the device components, not a study involving human subjects or data from patients. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) as they relate to clinical studies are not applicable here.
- Contact Area Stress / Pressure Test: HLS Kneetec size 2 (worst-case component) and HLS Noetos size 1 (equivalent size) were compared.
- Constraint Test: HLS Kneetec size 2 (worst-case component) and HLS Noetos size 1 (equivalent size) were compared.
- Tibial Tray Fatigue Test: Five fixed tibial trays of the HLS Kneetec were tested.
- Patella Tracking Comparative Study: HLS Kneetec size 2 (worst-case component) and HLS Noetos size 1 (marketed predicate device, equivalent size) were compared.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the studies were non-clinical engineering tests (e.g., mechanical load tests, material comparisons). The "ground truth" was established based on engineering standards and direct physical measurements, not expert clinical interpretation.
4. Adjudication Method for the Test Set
Not applicable. As described above, these were non-clinical engineering tests, not studies requiring human adjudication of results. The results were based on direct physical measurements and compliance with established engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study was not done as this clearance is for a physical medical device (knee prosthesis) based on non-clinical testing for substantial equivalence to predicate devices, not for an AI/algorithm-based diagnostic or assistive system. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not relevant or measurable in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. A standalone algorithm performance study was not done. The device is a physical knee prosthesis, and the evaluations performed were non-clinical engineering tests to demonstrate substantial equivalence.
7. The Type of Ground Truth Used
The "ground truth" for these non-clinical tests was based on:
- Engineering Standards: Adherence to established mechanical testing standards (e.g., ASTM F1223, ASTM F1800:2007, NF ISO 14879-1:2000).
- Direct Physical Measurement and Observation: Measurement of contact pressure, load displacement curves, and observation of damages after fatigue testing.
- Comparative Performance to Predicate Devices: The performance of the new device was compared directly to that of the legally marketed predicate devices, with equivalence to the predicate serving as the "ground truth" for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. No "training set" in the context of machine learning or AI was used, as this is a physical medical device undergoing non-clinical engineering tests.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there was no training set for an AI/algorithm, there was no ground truth for a training set to be established.
§ 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.