Search Results

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 can be satisfactorily balanced and stabilized at the time of surgery. This device system is intended for cemented use only in the U.S.A.

The Ultracongruent Insert is designed for the replacement of the bearing and/or articulating surfaces of the proximal tibia composed of an articulating bearing surface fixed in a metal tibial baseplate, and is used for patients with PCL incomplete, absent, nonfunctional or required release. It is used with the cruciate retained (CR) type Femoral Component. The anterior lip of Ultracruent Insert is more prominent when comparing with the U2 CR Insert (K051640, K103733), which increases the articulating surface area and expands the circumference to accommodate and stabilize the femur during knee flexion. The Ultracongruent Insert is available in seven proportional sizes (#1~ #7) and five thicknesses (thicknesses of insert + tibial baseplate: 9mm, 11mm, 15mm, and 18mm). The minimum thickness of Ultracongruent Insert is 6 mm on the bearing surface. It is manufactured from irradiated UHMWPE which conform to ASTM F2565, while the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834.

The provided text describes a 510(k) summary for the "Ultracongruent Insert," a medical device. This document is a premarket notification for a new device claiming substantial equivalence to existing predicate devices. It does not contain information about a study that establishes acceptance criteria for performance metrics in the way you've outlined for AI/diagnostic devices (e.g., sensitivity, specificity, accuracy, expert consensus, MRMC studies).

Instead, this document details mechanical and material tests conducted to demonstrate the safety and effectiveness of the orthopedic implant. The "acceptance criteria" for such a device are typically related to meeting specific engineering standards and showing performance comparable to existing, legally marketed devices.

Here's an attempt to structure the information based on your request, highlighting what is present and what is absent:

Acceptance Criteria and Study for the Ultracongruent Insert

This document describes a 510(k) premarket notification for a medical device called the "Ultracongruent Insert," a component of a total knee system. The "studies" conducted for this type of device are primarily engineering and material tests, not clinical or diagnostic performance studies involving human readers or AI.

1. Table of Acceptance Criteria and the Reported Device Performance

Note: For a 510(k) submission, "acceptance criteria" for these engineering tests are often that the device performs equivalently to the predicate device(s) or meets established industry standards for mechanical strength, wear, and biomechanical function. The document states that "the test results demonstrated that this device is safe and effective," implying these criteria were met.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample sizes for the mechanical tests. For engineered medical devices, sample sizes are typically determined by engineering standards (e.g., minimum number of samples for fatigue testing, static strength testing).

• Sample Size: Not specified in the provided text.
• Data Provenance: The tests were "conducted to evaluate the safety and effectiveness of the subjected device." The location of these tests (e.g., in-house, third-party lab) and country of origin of the data are not specified, but the applicant company is located in Taiwan. These are retrospective tests conducted on device prototypes/samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This device is an orthopedic implant, not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for these tests relates to engineering specifications and performance benchmarks from predicate devices or industry standards.

4. Adjudication Method for the Test Set

Not applicable, as this is not a study involving human interpretation or clinical adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. This document describes an orthopedic implant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This concept is applicable to AI algorithms. This document describes a physical medical implant.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on:

• Engineering Standards: Conformity to ASTM and ISO material standards.
• Predicate Device Performance: Demonstrating comparable mechanical and material performance to legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI algorithm or a diagnostic model for this type of device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set or associated ground truth establishment process is relevant for this device.

Ask a specific question about this device