(87 days)
The GMK Total Knee System 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, traumatoid arthritis, rheumatoid arthritis.
- Avascular necrosis of femoral condyle.
- · Post traumatic loss of joint configuration.
- · Primary implantation failure.
GMK Sphere can be implanted using a kinematic alignment approach. When a kinematic alignment approach is utilized, this knee replacement system is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatoid arthritis or polyarthritis.
- · Collagen disorders, and/or avascular necrosis of the femoral condyle.
- · Moderate valgus, varus, or flexion deformities.
- Cemented tibial wedges 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 the case of a semi-constrained liner is being used, an extension stem must be implanted both on the femoral components. In the case a GMK Revision tibial tray is being used, an extension stem must be implanted.
The GMK Total Knee System - TiNbN Coating is a line extension to the GMK Total Knee System to provide a larger product offering. The subject devices are marketed as individually packaged femoral and tibial components, designed for cemented use in total knee arthroplasty procedures where there is evidence of sufficient sound bone to seat and support for the implants. GMK Total Knee System - TiNbN Coating includes the following implants:
- o GMK Femoral Component, Standard and Posterior Stabilized, Left and Right, Sizes from 0 to 7
- . GMK Femoral Component Narrow, Standard and Posterior Stabilized, Left and Right, Sizes from 1 to 7
- GMK-Sphere Femoral Component, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ . (intermediate sizes)
- 0 Tibial tray fixed cemented. Left and Right, Sizes from 1 to 6 plus 4 intermediate sizes.
The GMK Total Knee System - TiNbN Coating implants, both Femoral Components and Tibial Tray, are manufactured from cobalt-chromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery - Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Alloy with Titanium Nitride (TiNbN) coating. The GMK Total Knee System -TiNbN Coating: Fixed Tibial Tray Plug is manufactured from Type 1 Ultra High Molecular Weight Polyethylene (UHMWPE) per ISO 5834-2: 2019 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene -Part 2: Moulded Forms.
This document is a 510(k) premarket notification for the "GMK Total Knee System - TiNbN Coating." It is a submission to the FDA for a medical device, which is typically a hardware product. The document describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
Based on the provided text, the device is a knee replacement system (GMK Total Knee System - TiNbN Coating). The information in the document does not relate to an AI/ML powered device, nor does it describe studies with acceptance criteria relevant to AI/ML device performance or human reader improvements with AI assistance. It focuses on the physical and material properties, and biological safety of a traditional medical implant.
Therefore, many of the requested categories for AI/ML device performance are not applicable or cannot be answered from the provided text.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device (knee implant) and not an AI/ML powered one, the acceptance criteria are based on mechanical properties, biological safety, and design equivalence rather than algorithmic performance metrics like sensitivity, specificity, or AUC.
| Acceptance Criteria (from implied tests) | Reported Device Performance |
|---|---|
| Performance Testing: | |
| Modular Tapered Connection Evaluation | Passed Medacta Test Protocol IL 07.09.517 rev.0 and Medacta Test Report A.2, and Endolab Test Report 167.181121.20.87 Rev.0 |
| Wear Test (3 Mode) | Passed Medacta Test Protocol IL 07.09.513 Rev. 2 and Medacta O Test Report A.3 and Element Test Reports 00812-010290-1 and 00812-010290-3 |
| Coating Characterization | Performed according to ISO 11885 |
| Mechanical resistance of femoral component under physiological static and dynamic loads | Previously conducted on predicate devices (K090988, K120790, K121416, K12232, K140826, K142069) and reviewed. |
| Mechanical resistance of tibial tray under physiological static and dynamic loads | Previously conducted on predicate devices (K090988, K120790, K121416, K12232, K140826, K142069) and reviewed. |
| Connection of tibial tray with tibial insert | Previously conducted on predicate devices (K090988, K120790, K121416, K12232, K140826, K142069) and reviewed. |
| Pyrogenicity: | |
| Bacterial Endotoxin Test (LAL test) | Conducted according to European Pharmacopoeia §2.6.14 (equivalent to USP chapter ) |
| Pyrogen test | Conducted according to USP chapter |
| Biocompatibility: | |
| Assessment and testing | Performed as per ISO 10993 series and FDA Biocompatibility Guidance document. |
The study proving the device meets the acceptance criteria is the series of non-clinical performance tests listed above, as well as pyrogenicity and biocompatibility assessments. These studies demonstrate that the TiNbN coated components perform equivalently to the uncoated predicate device and meet relevant safety standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "testing was conducted according to written protocols" for the performance, pyrogenicity, and biocompatibility assessments. It refers to specific test reports and standards (e.g., Medacta Test Report A.2, Element Test Reports 00812-010290-1 and 00812-010290-3). These tests are typically performed on a limited number of device samples in a laboratory setting, not on patient data or clinical populations.
- Sample Size: Not explicitly stated for each test, but implied to be a representative number of physical device components for mechanical, wear, and material testing.
- Data Provenance: The tests are explicitly referred to as "Non-Clinical Studies" and are laboratory-based. The companies involved (Medacta, Endolab, Element) might indicate the origin of the testing facilities, but specific "country of origin of data" in the sense of patient data is not applicable. The studies are prospective in the sense that the tests were specifically designed and performed to validate the new device.
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 question is not applicable. For a physical device like a knee implant, "ground truth" is established by direct measurement of physical properties (e.g., strength, wear, material composition) using validated scientific methods and instruments, not by expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are used for interpreting clinical or imaging data, especially for AI/ML devices, to establish a consensus ground truth. For mechanical and biological testing of a physical implant, the "truth" is determined by the results of the laboratory tests against predefined specifications.
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
No. This is a physical knee implant, not an imaging device or an AI/ML system that assists human readers. Therefore, an MRMC study is not relevant and was not conducted. The document explicitly states: "No clinical studies were conducted."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical knee implant. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on:
- Standardized Test Results: Compliance with established international standards (e.g., ISO 5832-4, ISO 5834-2, ISO 11885, ISO 10993 series) and specific internal test protocols for mechanical properties (wear, strength of connections, resistance under loads).
- Material Characterization: Verification of material composition and coating properties.
- Biological Safety Standards: Adherence to established standards for biocompatibility and pyrogenicity (e.g., European Pharmacopoeia, USP chapters).
8. The sample size for the training set
This question is not applicable. There is no "training set" for a physical medical device. The design and manufacturing process for the implant is based on established engineering principles and prior knowledge.
9. How the ground truth for the training set was established
This question is not applicable. There is no training set as this is not an AI/ML device.
§ 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.