(90 days)
Candidates for total knee replacement include patients with a severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
The ATTUNE Cemented Tibial Base, Fixed Bearing (FB) are available in sizes 1-10. The fixation surface incorporates a stem and keel to provide additional stability as well as recessed undercut cement pockets and a grit blasted surface for enhanced cement fixation. The tibial base utilizes a central universal locking mechanism to capture the tibial insert. The ATTUNE Cemented Tibial Base, FB is manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. Additionally, the ATTUNE Cemented Tibial Base, FB utilizes a previously cleared Base Protector assembled with the device to minimize potential marring of the proximal bearing surface of the tibial base during impaction. After impaction is completed, the Base Protector is then removed and discarded prior to inserting the ATTUNE Fixed Bearing Insert.
The ATTUNE CR Total Knee is designed to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion.
The ATTUNE PS Total Knee is designed to accommodate knee flexion to 145 degrees in those patients able to attain a high degree of knee flexion.
This document describes the premarket notification (510(k)) for the ATTUNE Cemented Tibial Base, Fixed Bearing, a component of a total knee replacement system. The application seeks to demonstrate substantial equivalence to previously cleared predicate devices.
Acceptance Criteria and Device Performance (based on provided text):
The acceptance criteria are implicitly derived from the successful completion of the non-clinical tests and the product's ability to maintain performance comparable to its predicate devices. The study concludes that the device meets these criteria by demonstrating substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Devices: Device performance is substantially equivalent to predicate devices for anticipated in-vivo loading. | Successful Functional Testing: The device successfully passed the following tests, verifying substantial equivalence for in-vivo loading: |
- Fatigue Testing per ASTM F 1800 (Cyclic Testing of Metal Tibial Tray Components)
- Intraoperative Range of Motion (ROM) simulation and pull-off testing with lipid and marrow
- Surgeon validation |
| Biocompatibility: Device materials are biocompatible. | Inherently Met: The device uses the same materials as the previously cleared ATTUNE Cemented Tibial Base (K101433) and is stated to have the same biocompatibility. |
| Bacterial Endotoxin Levels: Device meets bacterial endotoxin requirements. | Successful Bacterial Endotoxin Testing: The proposed devices meet the requirement of Bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011. |
| Manufacturing, Packaging, Sterilization: Methods are consistent with predicate devices. | Inherently Met: The device has the same manufacturing methods, packaging configurations, and sterilization methods as the previously cleared ATTUNE Cemented Tibial Base (K101433). |
| Indications & Intended Use: Consistent with predicate devices. | Inherently Met: The device has the same indications and intended use as the previously cleared ATTUNE Cemented Tibial Base (K101433). |
Detailed Study Information:
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Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (e.g., number of units tested) for the non-clinical tests (Fatigue Testing, ROM/pull-off testing, bacterial endotoxin testing).
- Data provenance: The testing was "non-clinical" and appears to be experimental, rather than based on patient data. This is typically laboratory or bench testing. No country of origin for the data is explicitly mentioned, but the submitter is based in Indiana, USA. The study is not retrospective or prospective in the sense of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions "Surgeon validation" as part of the non-clinical testing. However, it does not specify the number of surgeons, their qualifications, or how their "validation" contributed to establishing a "ground truth" in the context of the device's functional integrity. In this type of device submission, "surgeon validation" typically refers to confirmation of usability or fit, not necessarily establishing a clinical ground truth like in diagnostic AI.
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Adjudication method for the test set:
- Not applicable. This is a non-clinical, bench-top and materials testing study, not a study involving human readers or cases needing adjudication.
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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:
- No MRMC comparative effectiveness study was done. This document describes a submission for a knee implant component, not an AI or diagnostic device that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical/material device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering and biomechanical standards (e.g., ASTM F1800, ANSI AAMI ST-72:2011) and by comparison to the established performance of legally marketed predicate devices. The "truths" are determined by adherence to these standards and demonstrated equivalence in functional testing.
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The sample size for the training set:
- Not applicable. This is a medical device (implant component) submission, not an AI or machine learning device that requires a training set. The device itself is the product being evaluated.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 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.