(203 days)
The DePuy Attune™ Knee System is intended for cemented use as a total knee replacement system. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
The Attune™ femoral components are available in a cruciate retaining (CR) version. The CR femoral components have an asymmetric trochlear groove and are available in sizes 1-10 in right and left options. Sizes 3-6 are available in standard and narrow options. The fixation surface is textured. It incorporates two lugs (pegs) to provide additional stability and recessed cement pockets for enhanced cement fixation. The Attune Femoral Components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The Attune fixed bearing CR tibial insert is designed with a topography that, in the sagittal view, consists of multiple radii. The sagittal anterior radii are tight to aid in anterior constraint while the posterior radius is larger to allow rollback. The Attune design allows for the retained posterior cruciate ligament and/or balanced posterior capsule to assist in appropriate rollback of the femur. The design offers minimal but appropriate constraint in the posterior direction for maximal rollback and full range of motion. The Attune fixed bearing CR tibial inserts are available in sizes 1-10 and in thicknesses of 5, 6, 7, 8, 10, 12, 14, 16, and 18mm. The inserts are manufactured from AOX ultra high molecular weight polvethvlene conforming to ASTM F648. The Attune tibial bases are available in sizes 1-10. The Attune tibial base fixation surface is textured. It incorporates a stem and keel to provide additional stability and recessed cement pockets for enhanced cement fixation. The Attune tibial base utilizes a central universal locking mechanism to capture the tibial insert. The Attune tibial bases are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The Attune patellae are available in sizes 29, 32, 35, 38, and 41mm. The fixation surface incorporates 3 pegs to provide stability and recessed cement pockets for enhanced cement fixation. The patella components are manufactured from AOX ultra high molecular weight polyethylene conforming to ASTM F648. The Attune Knee System is designed to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion. Total knee replacement is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. The Attune Knee System is intended to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion.
The provided document is a 510(k) premarket notification for the DePuy Attune™ Knee System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. No acceptance criteria with specific performance metrics are explicitly stated in a table format, nor is there a study directly proving the device meets predefined acceptance criteria for clinical performance. Instead, the submission relies heavily on comparisons to predicate devices and various non-clinical tests to show substantial equivalence.
Here's an analysis of the information provided, addressing your requested points where applicable:
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria with corresponding performance is provided in the document. The document instead focuses on demonstrating similarity in materials, design, and functional performance to predicate devices and adherence to relevant ASTM and ISO standards.
However, the document does report on comparative wear testing with a control device. If we were to infer an "acceptance criterion" from this specific test, it would be performance comparable to or better than the predicate.
| Acceptance Criteria (Implied from Wear Test) | Reported Device Performance (Attune CR fixed bearing total knee system) |
|---|---|
| (Compared to Sigma Curved fixed bearing total knee system) | 50% less overall mean gravimetric wear (3.6 ± 0.3 mg/million cycles vs. 7.12 ± 1.2 mg/million cycles) |
| No significant difference in wear rate for thin inserts | No statistical difference in wear rate (5.4 ± 0.5 mg/million cycles vs. 5.7 ± 0.7 mg/million cycles) |
| No significant difference in wear debris characteristics | No significant difference between AOX and XLK debris samples found |
2. Sample sized used for the test set and the data provenance
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Wear Testing:
- Sample Size: Not explicitly stated as a number of devices or cases in a test set. The wear test used specific sizes of the Attune CR and Sigma CR products.
- Attune CR: Size 5 (all products), 6mm actual insert thickness (for 5 million cycle test), 5mm actual insert thickness (for 10 million cycle test).
- Sigma CR (control): Size 3 (all products), 8mm actual insert thickness (for 5 million cycle test), 6mm actual insert thickness (for 10 million cycle test).
- Data Provenance: In-vitro knee simulator wear testing. Not retrospective or prospective in a clinical sense, as it used physical devices in a lab setting. The testing was conducted by DePuy.
- Sample Size: Not explicitly stated as a number of devices or cases in a test set. The wear test used specific sizes of the Attune CR and Sigma CR products.
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Other Non-Clinical Testing (Physical & Mechanical, Biocompatibility, Functional):
- Sample sizes for these tests are not provided in the summary.
- Data provenance is "preclinical data" and in-vitro testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the submission describes non-clinical testing (material characterization, mechanical properties, wear simulation) and does not involve human subjects or expert assessment for "ground truth" in a clinical diagnostic context.
4. Adjudication method for the test set
This information is not applicable as the submission describes non-clinical, objective laboratory testing, not human-read clinical data requiring adjudication.
5. 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 submission is for a physical medical device (total knee replacement), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable to this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing:
- Physical and Mechanical Testing: Ground truth is established by the specified ASTM standard methods (e.g., ASTM F648 for UHMWPE characterization). The performance metrics (yield strength, ultimate tensile strength, etc.) are objectively measured against these standards.
- Biocompatibility Testing: Ground truth is established by compliance with ISO 10993 parts and specific USP tests.
- Functional Testing: Ground truth is established by compliance with FDA guidance for knee joint prostheses, specifically conducting various constraint and fatigue tests.
- Wear Testing: Ground truth is the gravimetric wear rate of the test and control devices, measured objectively in the simulator, and particle analysis (LALLS and SEM).
8. The sample size for the training set
This information is not applicable as this device is a physical implant and does not involve AI or machine learning models that require a training set.
9. How the ground truth for the training set was established
This information is not applicable as this device is a physical implant and does not involve AI or machine learning models that require a training set or ground truth in this context.
§ 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.