(90 days)
The Scorpio® Knec System components are for use in total knee arthroplasty as a result of:
- 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 which the ligamentous structures can be . returned to adequate function and stability;
- Revision of previous unsuccessful knee replacement or other procedure; .
- Ligamentous instability requiring implant bearing surface geometries with increased . constraint;
- Absent or non-functioning posterior cruciate ligament. .
These components are single use only and are intended for implantation with bone cement.
The device includes the tibial insert components of a total knee system. These components are used for the replacement of the bearing surface of the proximal tibia to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.
The provided document is a 510(k) Premarket Notification for the Scorpio® Knee System - Tibial Inserts. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials for efficacy from scratch. Therefore, the information requested, particularly regarding "AI" and "human readers," is not directly applicable to this document, as it pertains to a mechanical orthopedic implant, not a diagnostic or AI-driven system.
Based on the provided information, here's an analysis of the acceptance criteria and the study that proves the device meets them, keeping in mind the context of a 510(k) submission for a mechanical orthopedic implant:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test Performed | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Range of constraint testing | "The results demonstrate equivalence." |
| Tibial insert post stress analysis | "The results demonstrate equivalence." | |
| Contact stress/area analysis | "The results demonstrate equivalence." | |
| Biocompatibility | Not explicitly detailed, but assumed to be equivalent to predicate | Not explicitly detailed |
| Material Properties | Not explicitly detailed, but implied by equivalence to predicate | Not explicitly detailed |
Note: For a 510(k) submission, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device. The performance data provided is typically to support this claim, rather than setting and meeting independent performance targets for a novel device type.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the mechanical tests (range of constraint, post stress, contact stress/area analysis). However, these types of tests for orthopedic implants typically involve a reasonable number of samples to establish statistical significance for engineering metrics. The data provenance is internal to the manufacturer (Howmedica Osteonics Corp.), indicating these were laboratory/bench tests focusing on the physical properties of the device, rather than human subject data. These would be considered prospective tests (i.e., designed and executed to evaluate the specific design modifications).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This concept is not directly applicable here. For mechanical engineering tests of an implant, the "ground truth" is typically established by engineering standards, validated testing methodologies, and objective physical measurements. The "experts" involved would be engineering professionals conducting and interpreting these mechanical tests, not medical professionals establishing a clinical "ground truth."
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies or image-reading scenarios where there's subjectivity and a need to resolve discrepancies between human readers. For the mechanical tests performed, the "results demonstrate equivalence" suggests objective measurements were taken and compared against established benchmarks or the predicate device's performance, without a subjective adjudication process.
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 a mechanical orthopedic implant, not an AI-driven diagnostic or assistive technology. Therefore, no MRMC study or AI-related improvement analysis would have been performed or is relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. As this is a mechanical implant, there is no "algorithm only" performance or "human-in-the-loop" concept relevant to its function.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed (range of constraint, tibial insert post stress, contact stress/area analysis) would be based on engineering specifications, validated mechanical testing methodologies, and the established performance characteristics of the predicate device. The goal was to prove the redesigned components perform equivalently to the existing, legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of mechanical testing for a 510(k) submission of a orthopedic implant. Training sets are relevant for machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set."
§ 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.