(60 days)
The KINETIS™ Total Knee System components are indicated for use in skeletally mature patients, with severe knee pain and disability, undergoing primary surgery for total knee replacement due to:
- Rheumatoid arthritis, osteoarthritic, traumatic arthritis, polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis
- Moderate valgus, varus, or flexion deformities.
MAKO Kinetis" Total Knee System components are indicated for use only with cement and are single use devices.
The Kinetis™ Total Knee System is a patellofemorotibial polymer/metal/polymer semiconstrained cemented knee joint prosthesis. The system includes femoral component, tibial tray, biomimetic tibial inserts, patella component, and associated instruments. The biomimetic tibial inserts are manufactured from highly cross-linked vitamin E polyethylene. The system is for use in cases where the anterior and posterior cruciate ligaments are retained.
The provided text is a 510(k) summary for "The KINETIS™ Total Knee System." It describes the device, its intended use, predicate devices, and a list of performance tests conducted. However, it does not provide specific acceptance criteria or detailed results of these tests in a manner that allows for the creation of a table comparing acceptance criteria to reported device performance.
Specifically, the document states:
- "The Kinetis™ Total Knee System has been evaluated through non-clinical performance testing for;..." followed by a list of tests.
- "The results of performance testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues."
- "The device was found to be substantially equivalent to the predicate devices."
This information confirms that performance testing was done, but it does not list quantitative acceptance criteria for each test or the specific numerical results obtained from these tests. Without this specific data, a table comparing acceptance criteria to reported performance, as requested, cannot be generated from the given text.
Furthermore, the document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device through non-clinical and sometimes clinical data. It is not a detailed study report.
Therefore, for the points requested:
- A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document only lists the types of performance tests conducted.
For the remaining points, based on the provided text, here's what can be answered:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not specified. The document mentions "non-clinical performance testing," which typically involves bench testing, not human subjects.
- Data provenance: "Non-clinical performance testing" implies bench testing or mechanical testing, likely conducted in a lab environment. Country of origin is not specified, but the applicant is MAKO Surgical Corporation in Fort Lauderdale, Florida, USA. The testing is not clinical (retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The testing described is "non-clinical performance testing," which does not typically involve expert review for "ground truth" in the way a clinical study would. The performance is assessed against engineering specifications and industry standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical performance testing.
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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. This device is a mechanical knee replacement system, not an AI-assisted diagnostic or therapeutic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical performance testing, the "ground truth" or reference is typically derived from engineering specifications, established biomechanical principles, and comparison to predicate device performance data (if available and relevant for specific tests). The document states "The results of performance testing indicated the device performed within the intended use."
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The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable. There is no training set.
In summary, the provided document discusses the regulatory submission for a knee replacement system and lists the types of non-clinical performance tests conducted. It explicitly states that "The results of performance testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues." However, it does not detail the specific acceptance criteria or the quantitative results of these tests, nor does it describe a clinical study in the manner requested.
§ 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.