(94 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.
The GMK® Total Knee System is a tricompartmental fixed bearing total knee prosthesis comprised of femoral, patellar, and tibial components with ultrahigh molecular weight polyethylene articular inserts. The femoral components are offered in left and right sizes in a standard and a posterior stabilized design of six sizes. The tibial baseplates are offered in six left and right sizes with an optional extension stem of 65 mm length. The tibial inserts are offered in three styles: standard, posterior-stabilized and ultra-congruent. Each of the three styles is offered in six sizes, corresponding to the tibial base plate sizes, in five thicknesses from 10 - 20 mm each. Tibial inserts work with either the left or right tibial baseplate of that size. The patellar components are offered in two options: an inset patella and a resurfacing patella. The inset patella is offered in the three diameters of 24, 28, and 32 mm and the resurfacing patella is offered in three sizes.
The provided text describes the "GMK® Total Knee System," a total knee prosthesis, and its submission for 510(k) clearance. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically expected for an AI/ML device.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (a knee implant) by comparing its design, materials, indications for use, and performance testing to established international standards and FDA guidance documents.
Therefore, I cannot fulfill parts 1, 2, 3, 4, 5, 6, 7, 8, and 9 of your request as the provided text doesn't describe the evaluation of an AI/ML device. The "Performance Testing" section states:
- "No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act." (This refers to specific performance standards for this type of implant, not a general lack of performance evaluation).
- "Performance testing of the GMK® Total Knee System was conducted in accordance with various international standards and FDA guidance documents."
- "The GMK® Total Knee System was tested as part of design verification to written protocols with pre-defined acceptance criteria."
- "The testing was conducted on the worst case component size and option/design. The testing met all acceptance criteria and verifies that performance of the GMK® Total Knee System is substantially equivalent to the predicate devices."
This indicates that internal performance testing was done with acceptance criteria, but the specific acceptance criteria, the detailed results, the study design (e.g., sample size, ground truth, expert involvement, etc.), and the reported performance are not included in this publicly available 510(k) summary. The summary only states that the testing "met all acceptance criteria."
§ 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.