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U2 Total Knee System - PF+ 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, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral joint surface erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. Femoral Component, PF+, Tibial Baseplate, PF+ and Tibial Extension Stem are indicated for both cemented and cementless use.

There are three components included in U2 Total Knee System- PF+ for this 510k, (1)Femoral Component, PF+, (2)Tibial Baseplate, PF+, and (3)Tibial Extension Stem. Both Femoral Component, PF+ and Tibial Baseplate, PF+ can collocate with U2 Total Knee System tibial insert and patellar component (K021657, K051640, K082469, K103733, K131864, K132752, K150829, K152430, K161705, and K210961). This system includes Cruciate Retained (CR) type and Posterior Stabilized (PS) type.

• Femoral Component, PF+
There are two types of Femoral Component, PF+ : Cruciate Retaining type and Posterior Stabilized type. Femoral Component, PF+ is manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The inner surface is coated with Co-Cr-Mo beads and Co-Cr-Mo powder (ASTM F75) to provide a porous surface to achieve biological fixation.

• Tibial Baseplate, PF+
Tibial Baseplate, PF+ is manufactured from titanium alloy (ASTM F620) which is forged by titanium alloy bars (ASTM F136). The backside of the subject device is coated with Titanium powder (ASTM F1580).

• Tibial Extension Stem
Tibial Extension Stem is collocated with tibial baseplate. The subject device is made of titanium alloy conforming to ASTM F136.

The provided document (K221705) is a 510(k) summary for a medical device called the "U2 Total Knee System-PF+". This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

It is crucial to understand that this document describes a mechanical orthopedic implant (knee replacement components), not an AI-powered or software-based medical device. Therefore, the concepts of acceptance criteria for AI performance, training and test sets for AI models, expert ground truth for imaging, MRMC studies, or standalone algorithm performance are not applicable to this submission.

The document discusses acceptance criteria and proof of meeting them, but these relate to the mechanical and material properties, biocompatibility, and sterilization of the knee implant components, not to the performance of an AI algorithm.

Therefore, I cannot provide the requested information for an AI-powered device based on this document.

However, I can extract information relevant to the device's performance, which is related to its mechanical and material integrity:

Information from the document relevant to the device's "performance" (mechanical/material):

1. A table of acceptance criteria and the reported device performance:

The document broadly states that "the test results indicated that this device is safe and effective" and that "Verification activities on Subject devices demonstrated equivalent safety and effectiveness as compared to the predicate devices."

Specific acceptance criteria (e.g., "fatigue strength must exceed X N at Y cycles") and the exact reported values are not explicitly provided in a table format within this 510(k) summary. The summary typically refers to the fact that these tests were conducted and met the necessary standards for substantial equivalence.

However, the types of performance tests conducted are listed:

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not explicitly stated for each mechanical test. For mechanical testing of components, samples typically refer to a number of physical units or prototypes tested, not patient data.
• Data Provenance: The tests are performed by the manufacturer, United Orthopedic Corporation (located in Hsinchu City, Taiwan). The testing is primarily laboratory-based mechanical and material characterization, not clinical data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" in the clinical sense are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This question is not applicable. This device is a mechanical implant, not an AI system interpreting medical images. "Ground truth" in this context would be defined by engineering specifications, material standards (e.g., ASTM F75, F136, F620, F1580), and validated test methodologies (e.g., fatigue testing standards). The "experts" involved would be materials scientists, mechanical engineers, and quality assurance professionals, whose qualifications are implicit in the adherence to recognized standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This question is not applicable. Mechanical tests have specific physical or chemical endpoints determined by validated methods and equipment, not human subjective 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:

This question is not applicable. MRMC studies are for assessing diagnostic accuracy of imaging or AI systems with human readers. This device is a mechanical implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not applicable. This device is a mechanical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is established by:

• Adherence to international and national standards for materials (e.g., ASTM F75, F136, F620, F1580).
• Validated mechanical testing methodologies (e.g., fatigue testing, surface finish measurements).
• Biocompatibility standards (e.g., USP for endotoxin).
• Comparison to the established performance characteristics of predicate devices.

8. The sample size for the training set:

This question is not applicable. There is no AI model or "training set" for this mechanical device.

9. How the ground truth for the training set was established:

This question is not applicable.

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The device is indicated for use in hip arthroplasty in patients with the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatoid arthritis or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery.

This device is a single use implant and intended for cemented stem which is designed for cemented use only.

UNITED U2 femoral head is a modification of the cleared UNITED femoral head (K994078, K022520, K111546, K122504 and K152439) which is intended to use in primary or revision total/hemi hip arthroplasty. U2 femoral heads include three series of products: U2 Femoral head, U2 Femoral head, 3/4 polished and U2 Femoral head, 4/5 polished.

U2 femoral heads provide five different diameters of 22 mm, 26 mm, 32 mm and 36 mm. 22 mm is available in +0, +3, +6 and +9 mm of neck length, 26 mm is available in -2, +0. +3, +6 and +9 mm of neck length and 28 mm to 36 mm are available in -3, +0, +2.5. +5, +7.5 and +10 mm of neck length. A variety of diameters and neck lengths are available for various patient anatomies, adjustment of the tension of the ligaments, and reconstruction of the center of the physiological head of the femur.

U2 femoral heads is design for compatibility with various types of UNITED Hip Stem (K062978, K003237, K003237, K151316, K111546, K111546, K152530, K123550, K132207). For total hip replacement, U2 femoral heads can be used in conjunction with U2 Acetabular Cup Liner (K050262), XPE Cup Liner (K111546), U2 HA/Ti Plasma Spray Cup (K050262, K121777), U2 Ti Plasma Spray Cup (K050262, K121777), U2 Ti Porous Coated Cup (K111546) and U-Motion II Acetabular System (K122185, K132455). For hemi hip arthroplasty, U2 femoral heads can be used with U2 Bipolar Implant (K152439).

The provided document describes the FDA 510(k) summary for the U2 Femoral Head prosthesis. This document does not describe the acceptance criteria and study proving device meets the acceptance criteria for an AI/ML device. Instead, it focuses on the substantial equivalence of a physical medical device (a femoral head implant) to previously cleared predicate devices.

Therefore, the requested information elements (acceptance criteria, device performance table, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC study, standalone performance, training set details) are not available in the provided text.

The document only states the following:

Performance Data:

• Non-clinical Performance:
  • Tests were conducted to evaluate safety and effectiveness.
  • Tests included:
    • Disassembly force between U2 femoral head and stem component.
    • Range of Motion.
    • Bacterial endotoxin testing, which met the endotoxin limit specified in USP .
  • The performance data demonstrated the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.
• Clinical Performance Data/Information: None provided as a basis for substantial equivalence.

This information pertains to the physical and biological properties of the implant, not to the performance of an AI/ML algorithm.

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