(83 days)
The Scorpio® X3™ UHMWPE Cruciate Retaining and Posterior Stabilized tibial inserts and the Scorpio X3™ UHMWPE all polyethylene patcllar components are intended to be used with cemented or cementless Scorpio femoral components, cemented or ccmcntless Series 7000 tibial tray components and cemented Scorpio® tibial tray components in primary or revision total knee arthroplasty. The all polyethylene Scorpio 6 X3™ UHMWPE patellar components are intended for implantation with bone cement only.
The Scorpio® X3™ Total Stabilizer tibial inserts are intended to be used with the cemented Scorpio TS femoral components and the cemented Scorpio or Series 7000 tibial trays in primary or revision total knec arthroplasty.
The Scorpio® Knee System components are for use in total knee atthroplasty as a result of:
- Painful, disabling joint disease of the knee resulting from degencrative athritis, 후 rheumatoid arthritis or post-traumatic 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.
- Revision of previous unsuccessful knee replacement or other procedure. ●
Additional indications for Posterior Stabilized Components:
- Ligamentous instability requiring implant bearing surface geometries with ● increased constraint.
- Absent or non-functioning posterior cruciate ligament. .
Additional indications for Total Stabilized (TS) Components:
- Severe anteroposterior and medial/lateral instability of the knee. .
The device includes tibial and patellar components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the proximal tibia and patclla. The modification to the device subject of this premarket notification is the sequentially crosslinking and annealing of the UHMWPE material by a proprietary process. Tibial inserts will be made in Cruciate Retaining, Posterior Stabilized and Total Stabilizing designs. Patellar components will be made in Medialized Dome, Concentric Dome, Universal Dome, Recessed and Inset designs
The provided text does NOT describe acceptance criteria for a device, nor does it detail a study proving the device meets said criteria in the way typically associated with AI/ML device performance (e.g., sensitivity, specificity, AUC).
Instead, the document is a 510(k) summary for a medical device (Scorpio® X3™ UHMWPE Tibial Inserts and Patellar Components) seeking substantial equivalence to predicate devices. The "Summary of Data" section describes types of tests performed to establish equivalence, but not specific performance metrics or acceptance criteria as would be presented for an AI/ML diagnostic.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test/training sets) are not applicable or cannot be extracted from this document as they pertain to a different type of device assessment.
Here's an analysis based on the information available in the provided text, while making it clear where information relevant to AI/ML device assessment is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present acceptance criteria or reported device performance in the form of specific metrics (like sensitivity, specificity, or accuracy) against predefined thresholds, which is common for AI/ML diagnostic tools. Instead, it states that "Testing and analysis includes material properties characterization, wear testing, disassembly force evaluation, multi-axis fatigue testing, patella shear testing and finite element modeling of contact stresses" to demonstrate "equivalence of the subject products to the predicate devices."
The acceptance criteria are implicitly met by demonstrating "substantial equivalence" through these engineering tests, rather than clinical performance metrics. The document does not provide the specific numerical results or thresholds for these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Equivalence to predicate devices in material properties, wear resistance, disassembly force, fatigue strength, patella shear, and contact stresses. | Testing and analysis performed on material properties, wear, disassembly force, multi-axis fatigue, patella shear, and finite element modeling of contact stresses. (Specific results not detailed in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of an AI/ML algorithm evaluation. The testing described refers to engineering performance tests of the physical device components. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in the context of expert consensus for a test set is specific to diagnostic or interpretive AI/ML devices. This document refers to the physical properties and performance of an orthopedic implant.
4. Adjudication Method for the Test Set
Not applicable. As noted above, there is no "test set" in the AI/ML sense described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI/ML assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation would be the validated engineering standards, material specifications, and performance characteristics established for orthopedic implants, and in particular, for the predicate devices. This is assessed through physical and mechanical testing, not expert consensus, pathology, or outcomes data in the typical sense used for AI/ML.
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML model that requires a "training set" for this device's evaluation.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML model, there is no training set or ground truth in this context.
§ 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.