(112 days)
The Scorpio® Total Knee System components are for use in total knee arthroplasty to relieve pain and restore knee function for indications such as: 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. Additional indications for the posterior stabilized components include: ligamentous instability requiring implant bearing surface geometries with increased constraint; absent or non-functioning posterior cruciate ligament. These products are intended to achieve fixation with and without the use of bone cement.
The device includes femoral, 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 distal femur, proximal tibia and patella 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 text describes the Scorpio® Total Knee System and its substantial equivalence to a predicate device, focusing on its proposed modification for use without bone cement. It details the testing performed to demonstrate this equivalence, rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested elements for an AI/device performance study are not applicable or cannot be extracted from this document.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a typical "device performance study" sense. Instead, it refers to demonstrating "equivalence to the predicate devices" and meeting "the requirements of this document" (referring to the Class II Special Controls Guidance Document).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to predicate devices. | Demonstrated through testing. |
| Meet requirements of Class II Special Controls Guidance Document (January 16, 2003). | The results demonstrate that the Scorpio® Total Knee System meets these requirements. |
| Porous coating characterization within acceptable limits. | Testing performed and results contributed to meeting requirements. |
| Baseplate fatigue performance within acceptable limits. | Testing performed and results contributed to meeting requirements. |
| Contact area / stress analyses within acceptable limits. | Testing performed and results contributed to meeting requirements. |
| Range of motion / constraint within acceptable limits. | Testing performed and results contributed to meeting requirements. |
| Locking mechanism performance within acceptable limits. | Testing performed and results contributed to meeting requirements. |
| UHMWPE material properties within acceptable limits. | Testing performed and results contributed to meeting requirements. |
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 applicable to the provided document, as it describes a series of engineering and materials tests rather than a clinical study involving human subjects or data sets in the context of an AI/diagnostic device. The "tests" here refer to mechanical and material evaluations, not a test set of data for an algorithm.
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. The "ground truth" for the device's mechanical and material performance was established through standardized engineering tests and material characterization, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable, as the evaluation involved engineering tests, not human reader adjudication of data.
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
This information is not applicable. The document does not describe a clinical study of diagnostic performance, nor does it involve an AI component for human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The document describes the evaluation of a physical medical device (a knee implant), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the established scientific and engineering principles, material specifications, and performance requirements outlined in the FDA's Class II Special Controls Guidance Document for knee prostheses. This would include measurable physical properties, mechanical strength, durability under simulated physiological conditions, and material biocompatibility, confirmed through specific laboratory testing.
8. The sample size for the training set
This information is not applicable. The document does not describe the development or evaluation of an AI algorithm, and therefore there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set for an AI algorithm, there is no ground truth to be established in this context.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.