(101 days)
The Scorpio -Flex Posterior Stabilized Tibial Insert components are for use in total knee arthroplasty for painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; post-traumatic loss of knee joint configuration and function; moderate varus, valgus or flexion deformity in with the ligamentous structures can be returned to adequate function and stability; and/or revision of previous unsuccessful knee replacement or other procedure, ligamentous instability requiring implant bearing surface geometries with increased constraint; and absent or non-functioning posterior cruciate ligament.
This submission is intended to address a design modification to the Scorpio® Flex Posterior Stabilized Tibial Insert components. The tibial insert components have been redesigned to provide for improved hyperextension. There has been no change to the intended use of the device.
This document describes a Special 510(k) Premarket Notification for a design modification to the Scorpio®-Flex Posterior Stabilized Tibial Insert Components. The modification aims to improve hyperextension. The submission focuses on demonstrating substantial equivalence to a predicate device through testing and analysis.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a table format. However, it indicates that the device meets implied acceptance criteria through a comparison to a predicate device and specific tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device in Intended Use and Basic Design Concept | "The subject components share the same intended use and basic design concept as that of the predicate devices." |
| Demonstrates Equivalence in Performance | "A risk analysis, testing and analysis have been performed to demonstrate equivalence of the subject device to the predicate device." |
| Satisfactorily Addresses Range of Constraint | "The testing includes range of constraint testing... The results demonstrate equivalence." |
| Satisfactorily Addresses Tibial Insert Post Stress | "...analysis of tibial insert post stress... The results demonstrate equivalence." |
| Satisfactorily Addresses Contact Stress/Area | "...contact stress/area analysis. The results demonstrate equivalence." |
2. Sample size used for the test set and the data provenance
The document does not specify details about "test sets" in the context of clinical or image-based studies. The testing described (range of constraint, tibial insert post stress, contact stress/area analysis) appears to be bench testing or engineering analysis, not human subject data. Therefore, questions regarding data provenance (country of origin, retrospective/prospective) are not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for the engineering performance tests would be defined by established biomechanical principles and design specifications, not by expert human interpretation of data from a test set as would be the case for a diagnostic device.
4. Adjudication method for the test set
Not applicable. There is no mention of human-adjudicated data for this type of device modification.
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
Not applicable. This is a knee implant component, not a diagnostic device involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm and does not have standalone performance in that sense. The performance is determined by its mechanical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the engineering tests, the "ground truth" would be the established mechanical properties, design specifications, and biomechanical standards for knee implant components, and the comparison to the performance characteristics of the predicate device.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. The design modification is based on engineering principles and testing.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.