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510(k) Data Aggregation
(247 days)
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, 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 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+, Tibial Extension Stem, Patella, Onset, E-XPE, PF+, and Patella, Asymmetric Onset, E-XPE, PF+ are indicated for both cemented and cementless use.
USTAR II Total Knee System
- Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.
- Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
- Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
- Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.
- Joint instability resulting from excessive bone resection.
For Femoral component, Hinged/ Tibial baseplate, Hinged/ Cemented tibial stem/ Cemented Straight stem, RHS, non coated/ Cemented Curved stem, RHS, non coated/ Cemented Straight stem, RHS/ Cemented Curved stem, RHS/ Tibial Augment: These devices are single use implant and intended for cemented use only.
For Distal Femoral Component, RHS/ Proximal Tibial Component, RHS/ Tibial stem/ Segment Part, RHS/ Segment Part, RHS, Bridge: These devices are single use implant and intended for cementless use only.
The subject PF+ Patella is a line extension of the U2 Total Knee System, and is compatible to the USTAR II System. The subject device, U2 Total Knee System–PF+ Patella; USTAR II System - PF+ Patella, is a Metal-Backed Patella, indicated for both cemented or cementless application. There are two variations available: (1) Patella, Onset, E-XPE, PF+, and (2) Patella, Asymmetric Onset, E-XPE, PF+. Patella, Onset, E-XPE, PF+ is a symmetric, dome-type metal-backed patella, and Patella, Asymmetric Onset, E-XPE, PF+ is an asymmetric, anatomic-type patella. Each type is available in five sizes. The body of PF+ patella is manufactured from Vitamin E blended highly cross-linked UHMWPE (ASTM F2695, ASTM F648/ISO5834-1), while the part of the metal back and the three pegs are produced by additive manufacturing according to the FDA guidance "Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff", "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement", and "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Post market Surveillance Requirements." The metal back is made of Ti-6Al-4V alloy (ASTM 2924) and has a porous Ti structure on the bone side, peg side, and poly side. All types of PF+ Patella are compatibility with "United" U2 Total Knee System-Femoral components (K051640, K120507, K140073, K140075, K150829, and K150832), Femoral component, PSA (K082424), Femoral components, PF+ (K221705), and USTAR II System-Femoral components (K190100).
The provided text is a 510(k) Clearance Letter from the FDA for a total knee system. It details the device's name, regulation, a summary of its description, intended use, and a comparison to predicate devices, along with a list of non-clinical tests conducted.
However, the document specifically states "No clinical data is necessary." This means that the clearance was not based on a clinical study demonstrating the device's performance against detailed acceptance criteria in human patients with the format typically requested in your prompt (e.g., sensitivity, specificity, human-in-the-loop performance, ground truth establishment by experts, etc.).
Instead, the clearance is based on the substantial equivalence of the new device to existing legally marketed predicate devices, primarily through non-clinical testing and technological comparison.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from a clinical study, as no such study was presented or required for this 510(k) clearance.
The "acceptance criteria" for this device, as implied by the FDA clearance, revolve around demonstrating that its technological characteristics and non-clinical performance are substantially equivalent to already cleared devices.
Here's what I can extract from the document regarding the non-clinical tests that functionally served as part of the "proof" that the device meets some form of performance criteria:
Summary of Non-Clinical Tests (Implicit Acceptance Criteria & Performance):
| Test Conducted | Purpose (Implicit Acceptance Criteria) | Reported Performance |
|---|---|---|
| Pull-out test | To demonstrate adequate mechanical fixation strength, particularly for the patella's pegs and porous coating intended for cementless or cemented application. The implicit acceptance criterion would be that the pull-out strength meets or exceeds established industry standards or predicate device performance for similar implants, ensuring secure attachment in the bone. | (Details of results not provided in the 510(k) letter, but implied to be acceptable to FDA.) |
| Characterization of Ti porous coating | To ensure the porous Ti structure meets specifications for biocompatibility, porosity, and surface characteristics conducive to bone ingrowth and secure fixation. Acceptance criteria would involve adherence to specified material standards (e.g., ASTM 2924 for Ti-6Al-4V alloy) and potentially specific measurements of pore size, interconnectivity, and coating thickness, as referenced by the FDA guidance documents listed. | (Details of results not provided, but implied to be acceptable to FDA.) |
| Durability test | To assess the long-term mechanical integrity and resistance to wear and fatigue of the patella components (e.g., UHMWPE and metal back) under simulated physiological loading conditions. The acceptance criterion would be that the device maintains its structural integrity and functional performance over a clinically relevant lifespan, comparable to or exceeding predicate devices. | (Details of results not provided, but implied to be acceptable to FDA.) |
| Usability evaluation | To evaluate the ease of use, safety, and effectiveness of the device's design, particularly for the surgical implantation process. This might involve simulated use by surgeons or assessment of design features that minimize surgical errors. The acceptance criterion would be that the device can be safely and effectively implanted without undue difficulty or risk. | (Details of results not provided, but implied to be acceptable to FDA.) |
| Endotoxin testing | To ensure the device is free from harmful levels of bacterial endotoxins, which can cause adverse patient reactions if present. The acceptance criterion is typically a low or undetectable level of endotoxins, meeting pharmacopeial standards for medical devices. | (Details of results not provided, but implied to be acceptable to FDA.) |
Since no clinical study was conducted or referenced in this 510(k) clearance documentation, the following points of your request cannot be addressed from the provided text:
- Sample size used for the test set and data provenance: Not applicable, as no clinical test set was used. The non-clinical tests were performed on device prototypes or samples.
- Number of experts used to establish the ground truth... / qualifications of those experts: Not applicable. Ground truth for clinical performance was not established.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
- The type of ground truth used: For the non-clinical tests, the "ground truth" is defined by established engineering and material science standards and methodologies (e.g., ASTM standards for material properties, mechanical testing protocols).
- The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In essence, this 510(k) clearance is a regulatory determination of substantial equivalence based on non-clinical performance data and technological comparisons to predicate devices, not on a clinical trial demonstrating performance against specific diagnostic or treatment outcome acceptance criteria in humans.
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(230 days)
The device is indicated for use in total knee arthroplasty in skeletally mature patients with the following conditions:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
The device includes Cruciate Retained (CR) type, Posterior Stabilized (PS) type and Ultracongruent (UC) type. CR and UC types are designed to collocate with CR femoral component, while PS type is designed to collocate with PS femoral component.
This device is a single use implant and intended for cemented use only.
All Poly Tibial Components are made of Ultra High Molecular Weight Polyethylene (UHMWPE), including Cruciate Retained (CR) type, Posterior Stabilized (PS) type and Ultracruent (UC) type. All types are available in sizes #0~#7 (ranging from 39.5mm/60mm AP/ML to 58mm/84mm AP/ML) with ten thickness options (9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm and 18mm). The CR type of All Poly Tibial Component is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The PS type and UC type are intended to be used in situation where the posterior cruciate ligament is absent or cannot be preserved. All Poly Tibial Components can be used with femoral components of U2 Total Knee System and patella (K021657, K103733, K051640 and K082469) in primary or revision total knee arthroplasty. CR and UC types are designed to collocate with CR femoral component (K140073, K150829, K140075 and K150832) while PS type is designed to collocate with PS femoral component (K051640, K120507 and K150829). The X-ray marking wire which is made of Co-20Cr-15W-10Ni alloy is embedded in the All Poly Tibial Component for X-ray image identification purpose.
I am sorry, but based on the provided text, there is no information about acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment for a device that uses AI or machine learning.
The document describes a medical device called "All Poly Tibial Component," which is a knee implant. The "Performance Data" section explicitly states "Non-clinical Performance" and lists mechanical tests like Range of Motion, Contact Area and Contact Pressure, Constraint Test, Wear Simulation Test, and Fatigue Test. It also explicitly states "Clinical Performance Data/Information: None provided as a basis for substantial equivalence."
Therefore, I cannot provide the requested information.
Ask a specific question about this device
(179 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 can be satisfactorily balanced and stabilized at the time of surgery. This device is a single use implant and intended for cementless use only.
U2 Femoral Component, CR, Porous Coated, Additional Sizes is an extension of cleared "UNITED" U2 Femoral Component, CR, Porous Coated (K140075). The indications, major design features, materials, major manufacture processing and methods of this subject are identical to the cleared U2 Femoral Component, CR, Porous Coated (K140075). The cleared femoral components are available in size #1, #2, #3, #7, and the subjected femoral components are the intermediate sizes for #1.5, #2.5, #4.5, #5.5 and #6.5.
The provided text is related to a 510(k) premarket notification for a medical device: "U2 Femoral Component, CR, Porous Coated, Additional Sizes." This device is a knee joint prosthesis.
Based on the nature of this document (a 510(k) summary for a Class II knee prosthesis) and the content, this is not a document that describes an AI/ML medical device, nor does it detail a clinical study with diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for such a device.
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K140075) for additional sizes of a physical implant. The "performance data" mentioned refers to mechanical properties and engineering analysis, not diagnostic accuracy studies.
Therefore, most of the questions about acceptance criteria for AI/ML performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth types are not applicable to this document.
However, I can extract the relevant information from the provided text regarding the device and its compliance:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of precise acceptance criteria in terms of numerical thresholds for diagnostic performance (as would be typical for an AI/ML device). Instead, it states that the device was evaluated to conform to FDA guidance for mechanical properties.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Mechanical properties conformity to FDA guidance: "Class II Special Controls Guidance Document: Knee Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses." | "The analysis results demonstrate that the adding intermediate sizes would not affect the safety and effectiveness." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not an AI/ML diagnostic device, so there's no "test set" in that context. The "performance data" refers to mechanical testing/analysis of physical implants, not data samples.
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)
Not applicable. There is no ground truth, expert consensus, or clinical diagnostic evaluation described for this physical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here would essentially be established engineering principles and mechanical testing standards.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary based on the provided document:
- Device Type: Physical medical implant (U2 Femoral Component, CR, Porous Coated, Additional Sizes) - a knee joint prosthesis.
- Purpose of Submission: To add intermediate sizes to an already cleared femoral component (K140075), demonstrating substantial equivalence.
- Performance Evaluation: Focused on mechanical properties testing and analysis to ensure the additional sizes do not negatively affect safety and effectiveness. This evaluation was conducted to conform to the "Class II Special Controls Guidance Document: Knee Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses."
- Methodology: Engineering analysis and mechanical testing, not clinical trials or diagnostic performance studies involving patient data or expert reads.
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