(57 days)
The GMK® knee prosthesis is designed for cemented application in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
The GMK 3D Metal® Tibial Baseplate is indicated for cemented application 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, rheumatoid arthritis or polyarthritis
- · Collagen disorders, and avascular necrosis of the femoral condyle
- · 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 or GMK Sphere Revision tibial tray is used, an extension stem must be implanted.
It is not possible to implant tibial wedges and extens with the GMK 3D Metal® Tibial Baseplate.
Limitations for use for GMK SPHERE/GMK SPHERIKA used with kinematic alignment
GMK® Sphere and GMK® SpheriKA can be implanted in kinematic alignment. In this case, this knee replacement system is indicated for:
- · Severely painful and/or disabled joint as a result of arthritis, rheumatic arthritis or polyarthritis
- · Collagen disorders, and/or avascular necrosis of the femoral condyle
- · Moderate valgus, varus, or flexion deformities
The GMK 3D Metal Tibial Tray is a line extension to Medacta GMK Total Knee System.
The subject devices are sterile, individually packaged implants designed for cemented use in Total Knee Arthroplasty procedures.
The GMK 3D Metal Tibial Tray is available in eleven sizes plus two bridge versions with right and left configuration.
The subject devices are manufactured using a Direct Metal Laser Sintering (DMLS) process with titanium alloy powder (Ti-6Al-4V) according to ASTM F2924-14.
This is a 510(k) premarket notification for a medical device, specifically a knee replacement component. The provided text outlines the device, its indications for use, and a comparison to predicate devices, along with performance data. However, it does not contain a study that proves the device meets specific acceptance criteria in the way an AI/ML device submission would.
The document states: "No clinical studies were conducted." and focuses on non-clinical performance data for the mechanical properties and biocompatibility of the implant. Therefore, I cannot provide the requested information regarding acceptance criteria and studies in the context of AI/ML device performance.
Here's why the prompt's request for acceptance criteria and a study to prove device performance (as would be applicable to an AI/ML device) cannot be fully answered from this document:
- No AI/ML Component: The GMK 3D Metal Tibial Tray is a physical implant (a knee prosthesis component). It is not an AI/ML-powered diagnostic, prognostic, or treatment guidance device.
- Performance Metrics Differ: The performance data provided is related to the material properties and mechanical integrity of the implant (e.g., stereological evaluation, tension tests, shear tests, fatigue tests, cementation studies, biocompatibility, shelf-life, pyrogenicity). These are not metrics like sensitivity, specificity, AUC, or reader performance improvement, which would be relevant for AI/ML devices.
- No Ground Truth or Human Expert Review: Since it's a physical implant, there's no "ground truth" derived from expert consensus or pathology in the AI/ML sense, nor a need for human experts to interpret AI output. The "ground truth" for an implant is its mechanical integrity, biocompatibility, and intended function within the body.
Therefore, for this specific submission, the categories requested (e.g., sample size for test set, number of experts, adjudication, MRMC study, standalone performance, ground truth type for test/training sets) are not relevant or applicable, as they pertain to the evaluation of AI/ML algorithms.
If this were an AI/ML device submission, the acceptance criteria would typically involve performance metrics related to its intended use (e.g., accuracy for image interpretation, specificity, sensitivity). The "study" would be a clinical or retrospective validation study comparing the device's output to a ground truth established by experts or pathology.
Summary of what can be extracted related to "performance" for this physical device:
The "acceptance criteria" and "study" are implicit in the Non-Clinical Studies section, demonstrating that the device meets engineering and safety standards for an orthopedic implant.
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Table of Acceptance Criteria and Reported Device Performance: This document does not provide a formal table of "acceptance criteria" against "reported device performance" in the format typically seen for AI/ML devices with specific metrics like sensitivity or specificity. Instead, the submission relies on demonstrating compliance with ASTM standards and biocompatibility evaluations. The "performance" is the fact that the device passed these tests.
Acceptance Criteria (Implied) Reported Device Performance Compliance with ASTM F1854-15 (Stereological evaluation) Studied/Evaluated Compliance with ASTM F1147-05(2017)e1 (Tension test) Studied/Evaluated Compliance with ASTM F1044-05(2017)e1 (Static shear test) Studied/Evaluated Compliance with ASTM F1160-14(2017)e1 (Dynamic shear test) Studied/Evaluated Compliance with ASTM F1978-18 (Taber abrasion resistance test) Studied/Evaluated Cementation study (implied mechanical stability with cement) Studied/Evaluated Compliance with ASTM F1800-19e1 (Dynamic endurance fatigue test) Studied/Evaluated Compliance with European Pharmacopoeia §2.6.14/USP (LAL) Studied/Evaluated Compliance with USP (Pyrogen test) Studied/Evaluated Biocompatibility Evaluated Shelf-life Evaluated Note: "Studied/Evaluated" implies the device met the requirements of these tests, as the submission states this data supports substantial equivalence.
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Sample size used for the test set and data provenance: Not applicable in the AI/ML sense. Test "samples" would be physical devices or materials undergoing mechanical and biological testing. There is no "data set" of patient images or records. The provenance is from Medacta International S.A. internal testing.
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Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth for an implant is established by engineering standards and biological safety assessments, not expert consensus on interpretations.
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Adjudication method for the test set: Not applicable.
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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, as this is not an AI/ML device. "No clinical studies were conducted."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
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The type of ground truth used: Material properties, mechanical integrity, biocompatibility, and absence of pyrogens per established ASTM and Pharmacopoeia standards.
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The sample size for the training set: Not applicable. This refers to the training of an AI model.
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How the ground truth for the training set was established: Not applicable.
§ 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.