(44 days)
The Scorpio® Knce 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 adcquate 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 cenient.
This submission is intended to address a design modification to the Scorpio Total Knee System Posterior Stabilized tibial insert component. The tibial insert components were redesigned to provide for improved hyperextension.
The provided document is a 510(k) summary for a design modification to a knee implant (Scorpio® Total Knee System Posterior Stabilized Tibial Insert Components). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance against specific acceptance criteria for AI/ML devices or clinical studies. Therefore, much of the requested information (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) is not applicable or available in this document.
Here's an attempt to answer the questions based only on the provided text, recognizing its limitations for AI/ML-focused inquiries:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstration of Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Maintain same intended use | Shares same intended use as predicate device. |
| Maintain basic design concept | Shares basic design concept as predicate device. |
| Testing/Analysis: | Results: |
| Risk analysis performed | Performed; demonstrates equivalence. |
| Range of constraint testing | Performed; demonstrates equivalence. |
| Analysis of tibial insert post stress | Performed; demonstrates equivalence. |
| Contact stress/area analysis | Performed; demonstrates equivalence. |
2. Sample sized used for the test set and the data provenance
Not applicable. This document describes a mechanical device modification and its testing for substantial equivalence, not an AI/ML algorithm evaluated on a data test set. The tests conducted appear to be engineering/biomechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for AI/ML performance evaluation is not relevant here. The "ground truth" for this device's performance would be established through engineering analysis and physical testing.
4. Adjudication method for the test set
Not applicable.
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, not an AI diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a knee implant.
7. The type of ground truth used
For the engineering tests mentioned (range of constraint, post stress, contact stress/area), the "ground truth" would be established through biomechanical testing and engineering analysis comparing the modified device's performance to the predicate device and established safety/performance standards for knee implants.
8. The sample size for the training set
Not applicable. This document does not describe an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.