(105 days)
The GMK knee prosthesis is designed for cemented use in total knee arthroplasty. if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis.
- · Avascular necrosis of femoral condvle.
- · Post traumatic loss of joint configuration.
· Primary implantation failure.
Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.
In case a GMK Revision tibial tray is used, an extension stem must be implanted.
The GMK Sphere Total Knee System allows for medial-pivot rotation of the knee joint. The GMK Sphere Extension is a line extension to the GMK Sphere Total Knee System and is comprised of the following implants:
- . Femoral Component Left and Right, Sizes 1+ to 6+ (intermediate sizes) Co-Cr-Mo (ISO 5832-4)
- Tibial Insert Fixed Flex, Left and Right, Sizes 1-6, 11mm and 13mm . (intermediate sizes)
UHMWPE (ISO 5834 -2) Type 1, Ti6Al4V (ISO 5232-3)
The following components of the GMK Sphere have been previously cleared under the K121416 predicate device:
- · Femoral Component Left and Right, Sizes 1-7 Co-Cr-Mo (ISO 5832-4)
- Tibial tray fixed cemented Left and Right, 4 intermediate sizes . Co-Cr-Mo (ISO 5832-4)
- Tibial Insert Fixed Flex and Congruent, Left and Right, Sizes 1-6, 10mm-20mm . UHMWPE (ISO 5834 -2) Type 1, Ti6AI4V (ISO 5232-3)
The following components of the GMK Sphere have been previously cleared under the Medacta GMK Total Knee System, which is the primary predicate to K121416 GMK Sphere:
The provided document is a 510(k) summary for a medical device (GMK Sphere Extension) and focuses on demonstrating substantial equivalence to predicate devices, not on proving device performance against acceptance criteria in the context of an AI/ML study.
Therefore, many of the requested sections about AI/ML study details (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as it does not describe such a study.
However, I can extract the information related to the performance testing described in the document, which pertains to the mechanical and material performance of the device rather than an AI's diagnostic performance.
Here's the information extracted from the provided text, focusing on the mechanical performance testing described for the device:
1. A table of acceptance criteria and the reported device performance
| Test/Evaluation Area | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Risk Analysis | Identify any new risks associated with the change (addition of GMK Sphere Extension components). | Risk analysis conducted, and based on this, "design verification was conducted to written protocols with pre-defined acceptance criteria." The document states the GMK Sphere Extension is "not worst case" compared to the predicate device in several categories. |
| Design Verification | Protocols and pre-defined acceptance criteria based on standards, FDA guidance, and comparison to the predicate device system. The GMK Sphere Extension should perform comparably to or better than the worst-case predicate device in terms of fatigue, wear, constraints, clipping system, and range of motion. | The GMK Sphere Extension was compared to the worst-case predicate device in terms of fatigue, wear, constraints, clipping system, and range of motion. It was determined that the GMK Sphere Extension is "not worst case." |
| Overall Conclusion (Equivalence) | Substantial equivalence to predicate devices based on indications for use, design features, materials, and performance testing. | "The GMK Sphere Extension can be considered as substantially equivalent to its predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (N/A): This document describes a 510(k) submission for a physical medical device (knee implant components) and its mechanical/material performance testing. It does not involve a "test set" of data in the context of AI/ML or a clinical study with human subjects. The testing was likely conducted in a lab environment.
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)
- Not Applicable (N/A): This information does not apply to the type of performance testing described (mechanical and material attributes of an implant).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable (N/A): This information does not apply to the type of performance testing described.
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 (N/A): This type of study is irrelevant for the mechanical and material testing of a knee implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A): This concept applies to AI/ML algorithms, not to the mechanical performance of a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this type of device is the established mechanical and material performance standards (e.g., ISO, FDA guidance documents) and the performance characteristics of the predicate device. The GMK Sphere Extension device was tested to ensure it met these engineering standards and performed comparably to, or better than, the "worst-case predicate device."
8. The sample size for the training set
- Not Applicable (N/A): This pertains to AI/ML models, not the mechanical testing of an implant.
9. How the ground truth for the training set was established
- Not Applicable (N/A): This pertains to AI/ML models, not the mechanical testing of an implant.
§ 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.