(99 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™ posterior stabilized (PS) 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 PS fixed bearing tibial insert is designed with a topography that, in the sagittal view, consists of multiple radii. The sagittal anterior radii are relatively conforming to the femoral component to aid in anterior constraint while the posterior radius is less conforming to allow rollback. The Attune PS fixed bearing tibial inserts are available in sizes 1-10 and in thicknesses of 5, 6, 7, 8, 10, 12, 14, 16, 18, 20, and 22mm. The inserts are manufactured from AOX ultra high molecular weight polyethylene conforming to ASTM F648. The Attune PS femoral components and PS fixed bearing inserts are compatible with the Attune FB tibial bases (K101433) and patellae (K103756). 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 is a 510(k) premarket notification for a medical device, specifically the DePuy Attune Total Knee System – PS Femoral Components and PS Fixed Bearing Inserts. It does not describe a study involving algorithms, AI, or human-in-the-loop performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical functional testing for mechanical properties.
Therefore, many of the requested categories related to AI/algorithm performance and clinical studies are not applicable to this document.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide specific numerical acceptance criteria or reported performance metrics in a readily comparable table format for each characteristic against a defined threshold. Instead, it states that "Functional testing was conducted... to verify that the implant performance would be substantially equivalent to predicate devices for anticipated in vivo loading via various constraint, contact, wear, and fatigue tests." This implies the acceptance criterion was "substantially equivalent" to predicate devices, and the reported performance met this criterion.
| Characteristic | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Functional Performance | Substantially equivalent to predicate devices for anticipated in vivo loading (via constraint, contact, wear, and fatigue tests). | Verified as substantially equivalent to predicate devices through non-clinical functional testing. |
| Material (Femoral) | Cast Co-Cr-Mo alloy conforming to ASTM F75 (same as predicate) | Cast Co-Cr-Mo alloy conforming to ASTM F75 |
| Material (Tibial) | AOX UHMWPE conforming to ASTM F648 (same as predicate) | AOX UHMWPE conforming to ASTM F648 |
| Sizes (Femoral) | Sizes 1-10 standard, Left/Right; Sizes 3-6 narrow, Left/Right; Proportional Sizing (same as predicate) | Sizes 1-10 standard, Left/Right; Sizes 3-6 narrow, Left/Right; Proportional Sizing |
| Sizes (Tibial) | Proportional sizing, sizes 1-10, various thicknesses (similar to predicate) | Proportional sizing, sizes 1-10, thicknesses of 5, 6, 7, 8, 10, 12, 14, 16, 18, 20, and 22mm. |
| Fixation Surface | Cemented (same as predicate) | Cemented |
2. 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 explicitly stated as this was non-clinical functional testing, not a clinical study with patient samples. The "test set" would refer to the physical components tested in a lab.
- Data Provenance: The testing was conducted by DePuy Orthopaedics, Inc. in Warsaw, IN, USA. It is non-clinical (laboratory) data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically understood in AI/algorithm studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for non-clinical functional testing is based on engineering specifications, material standards (e.g., ASTM F75, ASTM F648), and design parameters, which are evaluated by engineers and technical staff during the testing process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept applies to human expert disagreements in interpreting data, which is not relevant for non-clinical mechanical testing.
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
- Not applicable. This is a 510(k) for a knee replacement system, not an AI or imaging diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document is about a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" or reference for this device's performance is based on engineering standards (ASTM F75, ASTM F648), pre-defined design specifications, and the performance characteristics of predicate devices as demonstrated through established non-clinical functional tests (constraint, contact, wear, and fatigue tests).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. 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.