(34 days)
The Lospa Total Knee Replacement System is intended for use in total knee arthroplasty surgery for the following indications:
- Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis;
- Post-traumatic loss of knee joint configuration and function;
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures . can be returned to adequate function and stability;
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of . previous arthroplasty procedure.
The LOSPA Total Knee Replacement System is intended for cemented use only.
The LOSPA TKR System specification inclusions are components of "LOSPA Total Knee System" cleared under K110404 & K121037 which consists of Femoral Components, Tibial Base plate, Tibial Insert, Patellar Components and Instrumentation -LOSPA Total Knee Instrumentation for use with the system implant components.
The acceptance criteria and study proving they are met are described below based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
The document states, "Performance testing - Bench, was not required since engineering analysis showed that the inclusion of additional specification did not change the worst case configuration tested in both K110404 & K121037." This implies that the acceptance criteria for the new specifications (additional sizes of femoral components, tibial base plates, and patellar components) were met by demonstrating that they do not worsen the performance of the previously cleared predicate devices. The "reported device performance" is essentially that the new components maintain the same safety and effectiveness as the predicate devices, as determined by engineering analysis rather than new physical performance testing.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| The inclusion of additional specifications (new sizes of femoral components, tibial base plates, and patellar components) does not change the worst-case configuration performance for the LOSPA TKR System compared to previously cleared predicate devices (K110404 & K121037). | Engineering analysis demonstrated that the inclusion of additional specifications did not change the worst-case configuration tested in K110404 & K121047. The technological characteristics are similar to predicate devices, and no new issues of safety or efficacy are raised. |
2. Sample Size Used for the Test Set and Data Provenance:
No explicit "test set" in the traditional sense of a clinical or bench performance test with a specific sample size is mentioned for this 510(k) submission. The decision was based on engineering analysis and comparison to predicate devices. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) related to a test set is not applicable here as no new performance data was generated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. As described, no new performance testing with a "test set" requiring ground truth establishment by experts was conducted for this specific submission. The assessment was based on engineering analysis and leveraging existing performance data from predicate devices.
4. Adjudication Method for the Test Set:
Not applicable. There was no "test set" in the traditional sense that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document explicitly states that "Performance testing - Bench, was not required." Therefore, no MRMC study, or any clinical study, was conducted to compare human reader performance with or without AI assistance, as AI is not mentioned as a component of this device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No. The device is a total knee replacement system, which is a physical implant, not a software algorithm. Therefore, "standalone algorithm-only performance" is not applicable.
7. Type of Ground Truth Used:
The "ground truth" for proving the acceptance criteria was established through engineering analysis, essentially demonstrating that the design principles and materials of the new component sizes are consistent with and do not negatively impact the established safety and efficacy of the predicate devices. This relies on the established performance and safety profiles of the predicate devices and the understanding of material properties (ASTM standards) and manufacturing processes.
8. Sample Size for the Training Set:
Not applicable. The device is a physical knee replacement system, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for this device, the establishment of ground truth for such a set is not relevant.
§ 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.