(151 days)
The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.
For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.
For porous coated femoral component: This device is a single use implant and intended for cementless use only.
U2 Porous Coated Femoral Component-CR Type is manufactured from Co-Cr-Mo alloy confirming to ASTM F75. The inner surface is porous coated with Co-Cr-Mo beads (ASTM F75) to provide a porous surface for enhanced fixation. It is available in seven proportional sizes (#1~ #7, AP/ML ranging from 52mm to 76mm/ 80mm) and is provided in left and right configurations. The femoral component is the same as that of cleared U2 Total Knee System (K051640), except adding size #7.
The provided text describes a 510(k) submission for a medical device, the "U2 Femoral Component, CR, Porous Coated." This is a premarket notification to demonstrate that the device is substantially equivalent to a predicate device, and it primarily focuses on non-clinical performance data.
Therefore, the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment methods, and MRMC studies is not applicable or not provided in this type of submission. These details are typically associated with studies evaluating the performance of AI/CADe devices, which this document is not.
The device in question is a physical orthopedic implant, not a software or AI-based diagnostic tool. The performance data presented refers to mechanical and design-based tests.
Here's a breakdown of why each point of your request cannot be fully answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds against specific numerical values. The document states that "Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device, and the test results demonstrated that this device is safe and effective." This implies all tests met their inherent safety and effectiveness requirements, but specific performance metrics and their acceptance benchmarks are not detailed.
- Reported Device Performance: The document lists the types of non-clinical tests performed, but does not provide the results or specific performance metrics from these tests. It only states that the tests "demonstrated that this device is safe and effective."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical thresholds | Specific numerical results are not provided in this summary. The tests were reported as demonstrating safety and effectiveness. |
2. Sample sizes used for the test set and the data provenance
- Sample Size: Not applicable. The tests performed are non-clinical (e.g., mechanical tests on the implant itself), not involving human or clinical data.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts and qualifications: Not applicable. There is no "ground truth" to be established by experts as this is not a diagnostic device involving interpretation of data.
4. Adjudication method for the test set
- Adjudication method: Not applicable.
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
- MRMC study: No, this device is an orthopedic implant, not an AI or diagnostic tool. Thus, no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone performance: No, this is not an algorithm or AI device.
7. The type of ground truth used
- Type of ground truth: Not applicable. For devices like this, safety and effectiveness are confirmed through established engineering and materials testing standards (e.g., ASTM F75 for Co-Cr-Mo alloy).
8. The sample size for the training set
- Training set sample size: Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Ground truth establishment for training set: Not applicable.
Summary of Relevant Information from the Document:
- Device Type: U2 Femoral Component, CR, Porous Coated - a femoral component for total knee replacement, made from Co-Cr-Mo alloy and porous coated.
- Purpose of Submission: Demonstrate substantial equivalence to predicate devices (K051640 and K030612) by showing similar materials, design, manufacturing, and intended use, and adding a new size (#7).
- Performance Data: Non-clinical tests were conducted according to the "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA."
- Specific Tests Performed (Non-clinical):
- Range of Motion
- Contact Area and Contact Pressure on Femorotibial Joint
- Contact Area and Contact Pressure on Femoropatellar Joint
- Subluxation of Femorotibial Joint
- Fatigue Compression Test of Femoral Component
- Clinical Performance Data: "None provided as a basis for substantial equivalence." This further confirms that no studies involving human subjects or clinical outcomes were part of this specific 510(k) submission.
This 510(k) focuses on mechanical and physical properties of an implant, rather than the diagnostic accuracy or performance of a digital health or AI-driven device.
§ 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.