(107 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, traumatic arthritis, rheumatoid arthritis or polyarthritis. - Avascular necrosis of femoral condyle. - Post traumatic loss of joint configuration. - Primary implantation failure. Tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. If a semi-constrained insert is used, it is mandatory to implant an extension stem both on the tibial and the femoral components.
The GMK Full PE Tibial Components are symmetric and come in ultracongruent and posterior-stabilized designs in sizes 1-6 with thicknesses of 10, 12, 14, and 17mm and have an axial rotation of +/- 10°. The GMK Full PE Tibial Components are made from UHMWPE (ISO 5834 -2) Type 1. There are two radiopaque wires made of AISI 316 LVM (ISO 5832-1) to check the final implant position during radiography. The GMK Full PE Tibial Components can be used in place of the metal backed solution (K090988), where a component entirely made of UHMWPE replaces the metal backed solution (metallic tibial tray + UHMWPE tibial insert, K090988).
The Medacta International GMK Full PE Tibial Components is a medical device and the provided text is a 510(k) summary for its clearance. This type of submission relies on demonstrating substantial equivalence to existing predicate devices rather than conducting extensive clinical studies with human participants that would typically involve acceptance criteria, ground truth establishment, or multi-reader multi-case studies as might be found for AI/ML devices.
Therefore, the information you've requested regarding acceptance criteria, study design, expert involvement, and statistical analyses of human vs. AI performance is not directly applicable or present in this 510(k) summary for a physical medical device.
However, I can extract the closest equivalent information for the "Performance Testing" section provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Breakage | Equivalent to cleared devices; capable of withstanding expected in vivo loading without failure. |
| Implant detachment | Equivalent to cleared devices; capable of withstanding expected in vivo loading without failure. |
| Excessive wear of the articulating surface | Equivalent to cleared devices; capable of withstanding expected in vivo loading without failure. |
| Femoral luxation or subluxation due to insufficient constraints | Equivalent to cleared devices; capable of withstanding expected in vivo loading without failure. |
| Insufficient mobility and/or Range of Motion (ROM) according to ASTM 2083 | Equivalent to cleared devices; capable of withstanding expected in vivo loading without failure. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. The testing involves mechanical data and likely uses a defined number of device components for each test.
- Data Provenance: The data is generated from "mechanical data" testing, which implies laboratory-based tests rather than patient data. Country of origin for data is not specified, but the applicant (Medacta International SA) is in Switzerland, and the contact person (Medacta USA) is in the US. The nature of the tests (e.g., ASTM standards) suggests standardized laboratory conditions. It is retrospective in the sense that it's performed on manufactured devices for regulatory submission, not a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" for mechanical performance tests is typically established by engineering standards and validated testing protocols, not by expert consensus on clinical findings.
- Qualifications of Experts: Not applicable in the context of clinical expert review. The "experts" would be engineers and material scientists interpreting the test results against established safety and performance benchmarks for orthopedic implants.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This concept is relevant for clinical expert review of patient data, not mechanical performance testing. Test results are typically compared directly against pre-defined acceptance limits derived from engineering standards or predicate device performance.
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
- MRMC Study: No, an MRMC study was not done. This type of study is specific to evaluating diagnostic algorithms, often AI-powered, where human readers interpret medical images. The device in question is a physical knee prosthesis.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For mechanical testing, the "ground truth" is defined by engineering standards and specifications (e.g., ASTM standards like ASTM 2083 mentioned for ROM), and the performance of previously cleared predicate devices. The tests aim to demonstrate that the device performs equivalently or better than established benchmarks in terms of mechanical integrity and wear.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not an AI/ML device requiring a training set. The design of the device would be based on engineering principles and knowledge of biomechanics, rather than a data training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this physical device. The design and validation are based on engineering principles, material science, and testing against established performance metrics and predicate device data.
§ 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.