(88 days)
The EVOLUTION® BIOFOAM® Tibial, EVOLUTION® Revision Tibial, and EVOLUTION® Revision CCK Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
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Non-inflammatory degenerative joint disease: including osteoarthritis, or avascular necrosis;
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Inflammatory degenerative joint disease, including rheumatoid arthritis;
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Correction of functional deformity;
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Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® BIOFOAM® Tibial System implants are for cementless use only.
The EVOLUTION® Revision Tibial and EVOLUTION® Revision CCK Systems are for cemented use only.
A labeling change is taking place to include MR Conditional language and symbols to the implant components of the predicate device systems identified above. The changes only apply to the device labeling; therefore, the subject devices are identical to the predicate devices.
The non-clinical testing provided establishes the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment. The subject devices include the following components and basic design features:
- . Metal femoral components manufactured from cobalt chrome alloy
- . Femoral revision accessories, including augments, manufactured from titanium alloy
- . CCK tibial inserts manufactured from UHMWPE with locking screws and posts manufactured from titanium alloy
- . Tibial bases manufactured from titanium alloy available in porous and non-porous versions
- Tibial revision accessories, including keels, augments, stem extensions, and adapters, . manufactured from titanium alloy.
- . Patellae manufactured from UHMWPE and cobalt chrome alloy
The provided text is a 510(k) Summary for a medical device (EVOLUTION® Knee Systems – MR Labeling) and outlines nonclinical testing conducted to establish the device's conditional safety and compatibility in a magnetic resonance (MR) environment. It does not describe a study involving device performance against acceptance criteria in the usual sense of diagnostic accuracy or clinical outcomes, but rather safety and compatibility within an MR environment.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical or diagnostic performance are not applicable to this document. I will focus on what is provided regarding the MR safety testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a table format for MR safety. Instead, it refers to industry standards that define safe limits. The reported "performance" is that the device met these standards and showed no safety issues.
| Acceptance Criteria (Defined by Standards) | Reported Device Performance |
|---|---|
| Safety and Compatibility in MR Environment (e.g., within acceptable limits for RF heating, magnetic field interactions, and image artifacts as per ASTM, NEMA standards) | "The testing concluded that there are no safety issues related to magnetic field interactions under the specific conditions identified in the labeling." |
2. Sample size used for the test set and the data provenance
The document states, "The tests evaluated the worst case components and constructs for RF heating, field interactions, and image artifacts." It refers to "passive implants" but does not specify the exact number of components or constructs tested.
- Test set sample size: Not explicitly stated as a numerical count of individual devices, but "worst case components and constructs" were tested.
- Data provenance: Nonclinical testing performed according to U.S. FDA guidance and international standards (NEMA, ASTM). The location of the testing laboratory is not specified (e.g., country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The testing was nonclinical (MR safety testing), not involving human diagnostic interpretation or ground truth establishment by medical experts.
4. Adjudication method for the test set
This question is not applicable, as it was nonclinical testing, not involving human readers or interpretation 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
There was no MRMC comparative effectiveness study described, as this document concerns the MR safety labeling of knee implant systems, not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a knee implant system, not an algorithm.
7. The type of ground truth used
For an MR safety study, "ground truth" typically refers to the physical properties of the materials and their behavior in an MR field as measured by calibrated equipment following established standards. It's not expert consensus, pathology, or outcomes data in the clinical diagnostic sense. The ground truth is the quantitative measurements against the physical laws and established safety thresholds described by the ASTM and NEMA standards.
8. The sample size for the training set
This question is not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable as there was no training set.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.