(30 days)
Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques.
Unicondylar knee system is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.
The ADVANCE® Unicondylar Knee System components are for single use only.
The ADVANCE® Unicondylar Knee System components are for cemented use only.
The ADVANCE® Unicondylar Knee System Less Conforming Tibial Component will be offered based on surgeon preference and patients requiring less conforming tibial components. The tibial components will consist of all poly ultra high molecular weight polyethylene (UHMWPE).
The design features of ADVANCE® Less Conforming Tibial Component are substantially equivalent to the design features of previously cleared predicate devices cited in this Premarket Notification.
This document, a 510(k) Summary, describes a medical device called the ADVANCE® Less Conforming Tibial Component. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through testing.
Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices. The core argument for safety and effectiveness is made by asserting that the new device's intended use, materials, and design features are "substantially equivalent" to already approved devices.
Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, ground truth, and expert adjudication are not present in this type of regulatory submission.
Here's an explanation based on the provided text, and where information is missing:
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A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided. This document does not present specific acceptance criteria or performance metrics for the ADVANCE® Less Conforming Tibial Component. Its approval is based on substantial equivalence to predicate devices, implying that the predicate devices have already met relevant performance standards.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Provided. No clinical or performance test sets are described in this summary to evaluate the device against specific criteria. The argument is based on design and material similarity.
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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)
- Not Applicable / Not Provided. As no specific performance data or test sets are presented, there is no mention of experts establishing ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. There is no test set described.
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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 is not an AI/software device. It's a physical knee implant component.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an AI/software device.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. No new, independent ground truth appears to have been established for this device's approval, beyond the established safety and effectiveness of its predicate devices.
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The sample size for the training set
- Not Applicable / Not Provided. There is no mention of a training set as this is not a machine learning device.
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How the ground truth for the training set was established
- Not Applicable / Not Provided. There is no mention of a training set.
Summary of Approach Used Instead of Performance Study:
The primary "proof" document for the acceptance of this device, within the context of this 510(k) summary, is the demonstration of Substantial Equivalence.
- Acceptance Criteria (Implicit): That the device is "substantially equivalent" to legally marketed predicate devices in terms of intended use, materials, and design features. This implicitly means that if the predicate devices were safe and effective, then this new, substantially equivalent device will also be.
- Study Proving Acceptance Criteria: The study is the 510(k) submission itself, which asserts and provides evidence (though not detailed in this summary) that:
- The intended use is the same as predicate devices.
- The materials (all poly ultra high molecular weight polyethylene (UHMWPE)) are standard and likely the same as or comparable to predicate devices.
- The design features are "substantially equivalent" to previously cleared predicate devices.
The document explicitly states: "The safety and effectiveness of the ADVANCE® Less Conforming Tibial Component is adequately supported by the substantial equivalence information, materials, and testing results provided within this Premarket Notification." While "testing results" are mentioned, the summary provided does not elaborate on what those tests were, their criteria, or their outcomes. They likely refer to bench testing (e.g., mechanical strength, wear) rather than clinical performance studies, done to show equivalence rather than to meet new performance thresholds.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.