(81 days)
The Madison Knee System is intended for total knee replacement. Madison Knee components are for use in total knee arthroplasty to relieve pain and restore knee functions such as: painful, disabling joint disease of the knee resulting from degenerative arthritis , theumatoid arthritis; and revision of previous unsuccessful knee replacement or other procedure. These components are indicated for cemented fixation only.
The Madison Total Knee System is a modular knee system consisting of a femoral component, tibial insert, tibial baseplate, tibial stem extensions, and a patella. The system components are designed to be Cruciate-Retaining and Ultra-Congruent. The femoral component and tibial baseplate are manufactured from Cobalt Chrome and are to be implanted with cement. The tibial stem extensions are manufactured from titanium alloy, and the tibial insert and patella components are manufactured from UHMWPE. All implant components are provided sterile.
The provided document is a 510(k) summary for the Madison Total Knee System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of diagnostic accuracy or performance against a predefined clinical threshold.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this type of regulatory submission, which primarily relies on non-clinical testing and comparison to an established predicate device.
Here's an attempt to answer based on the provided text, highlighting where information is absent or not relevant to the typical understanding of acceptance criteria for diagnostic devices:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in the sense of predefined thresholds for clinical performance (e.g., accuracy, sensitivity, specificity) for a diagnostic AI device. Instead, it describes non-clinical testing performed to demonstrate safety and effectiveness for a knee implant, primarily focused on mechanical properties and material characteristics. The reported "performance" is that the device passed these tests, indicating compliance with the relevant ASTM standards and demonstrating functionality.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Material Properties: | |
| UHMWPE Characterization (ASTM F648) | Met standard requirements |
| Mechanical Performance: | |
| Range of Motion (Tibiofemoral, ASTM F2083) | Met standard requirements |
| Constraint (Tibiofemoral, ASTM F1223) | Met standard requirements |
| Contact Area/Stress (Tibiofemoral) | Acceptable performance |
| Component Interlock Strength | Acceptable performance |
| Range of Motion/Constraint (Patellofemoral, ASTM F1223) | Met standard requirements |
| Contact Area/Stress (Patellofemoral) | Acceptable performance |
| Tibial Baseplate Cantilever Fatigue (ASTM F1800) | Met standard requirements |
| Sterilization & Biocompatibility: | |
| Bacterial Endotoxin Testing | Acceptable levels |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided for the non-clinical tests. The tests were performed on "test units representative of finished devices," implying laboratory testing of physical samples rather than data from human subjects. Therefore, provenance like country of origin or retrospective/prospective data collection is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the testing described is non-clinical, focusing on mechanical and material properties of an implant, not interpretive diagnostic performance requiring expert adjudication of ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as it pertains to expert consensus for diagnostic ground truth, which is not relevant to the non-clinical testing of a knee implant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices, not for a knee implant. The document explicitly states: "Clinical data were not needed to support the safety and effectiveness of the subject device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a knee implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" would be established by the specified ASTM standards and engineering principles that define acceptable material properties and mechanical performance. There is no biological or diagnostic ground truth (like expert consensus or pathology) involved.
8. The sample size for the training set
This information is not applicable. As a physical implant, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for a machine learning model.
§ 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.