(261 days)
This device is indicated in knee arthroplasty in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primatic 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 patellectorny, moderate valgus, varus, or flexion contraction. This device is intended for use in patients who require augmentations due to inadequate bone stock and/or require increased stabilization for tibiofemoral joint due to soft tissue imbalance. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws. Note: In the US, this device is for cemented use only.
U2 Total Knee System - PSA Tibial Insert is an extended design of U2 Total Knee System - PSA Type (K082424) including XPE Tibal Insert, PSA and XPE Tibial Insert, PSA, LC. This System is a patellofemorotibial polymer / metal / polymer, semi-constrained, cemented knee prosthesis, which is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock. U2 Total Knee System - PSA Tibial Inserts are available in a range of thicknesses and in two design configurations: PSA and PSA-LC type. For the PSA tibial insert, it is intended for use in patients who require constrained stabilization for tibiofemoral joint due to soft tissue imbalance. PSA-LC (low constrained) tibial insert provide less constrained stabilization than PSA tibial insert.
The provided FDA 510(k) summary (K161360) describes the U2 Total Knee System - PSA Tibial Insert. However, it does not provide information about acceptance criteria and a study proving device performance in the context of an AI/ML powered device. This document is for a traditional medical device (knee prosthesis) and its assessment is based on mechanical testing and comparison to predicate devices, not on AI/ML parameters.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/ML powered device study is not applicable or not available in the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not applicable/Not available in the context of AI/ML performance. The document focuses on mechanical and material properties of a physical medical device. It states that "Range of Motion and Spine Fatigue Test were conducted to evaluate the safety and effectiveness of the subjected device." However, specific acceptance criteria and detailed quantitative results for these tests are not provided in this summary. It mentions that the design has the same curvature as a previously cleared device, implying that its performance in terms of constraint, contact area, and pressure should be identical.
| Acceptance Criteria (Relevant for this device type) | Reported Device Performance (Summary) |
|---|---|
| Range of Motion | Evaluated, not detailed |
| Spine Fatigue | Evaluated, not detailed |
| XPE Wear Performance | Represented by predicate (K103733) |
| Constraint, Contact Area, Contact Pressure | Identical to predicate (K082424) |
| Bacterial Endotoxin Limit | Met USP <161> |
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 information pertains to studies for AI/ML performance, not mechanical testing of a physical implant. The "test set" in this context would refer to the physical specimens used for mechanical testing, but their number and provenance are not detailed in this summary.
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. This is relevant for AI/ML studies. Ground truth for a physical device's mechanical testing is established by engineering standards and measurements, not expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is relevant for AI/ML studies involving human reviewers.
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. This type of study is for evaluating AI-assisted diagnostic or interpretation tools. This document describes a knee implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is for AI/ML algorithms.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the AI/ML sense. For a physical device, "ground truth" for mechanical performance would be established through highly controlled, standardized laboratory measurements (e.g., ISO standards for knee implants). The summary states "Range of Motion and Spine Fatigue Test were conducted," implying such laboratory methods.
8. The sample size for the training set
- Not applicable. This is for AI/ML algorithms.
9. How the ground truth for the training set was established
- Not applicable. This is for AI/ML algorithms.
In summary: The provided document is a 510(k) clearance letter and summary for a physical medical device (knee implant). It assesses the device's substantial equivalence to predicate devices based on design, materials, and mechanical performance tests, not on the performance of an AI/ML algorithm. Therefore, requests for AI/ML specific study parameters cannot be fulfilled from this text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 1, 2017
United Orthopedic Corporation Karen Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu 300 Taiwan
Re: K161360 Trade/Device Name: U2 Total Knee System, PSA Tibial Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: December 13, 2016 Received: December 14, 2016
Dear Karen Ho:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161360
Device Name
U2 Total Knee System - PSA Tibial Insert
This device is indicated in knee arthroplasty in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primatic 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 patellectorny, moderate valgus, varus, or flexion contraction. This device is intended for use in patients who require augmentations due to inadequate bone stock and/or require increased stabilization for tibiofemoral joint due to soft tissue imbalance. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
Note: In the US, this device is for cemented use only.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary of Safety and Effectiveness
Submitter Information
| Name | United Orthopedic Corporation |
|---|---|
| Address | No 57, Park Ave 2, Science Park, Hsinchu 300, Taiwan |
| Phone Number | +886-3-5773351 ext. 2212 |
| Fax Number | +886-3-577156 |
| Name of Contact Person | Karen HoRegulation and Document Management |
| Date prepared | May 12, 2016 |
| Name of Device | |
| Trade Name | U2 Total Knee System – PSA Tibial Insert |
| Common Name | Tibial Insert |
| Regulation Name andNumber | The device classification for U2 Total Knee System - PSATibial Insert is “Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis” and is contained in the Code of FederalRegulation, under 21CFR 888.3560. This falls under theOrthopedic Panel. |
| Device Class | Class II |
| Classification Panel | Orthopaedics |
| Product Code | JWH |
| Predicate Device | 1. “UNITED” U2 Total Knee System – PSA Type (K082424)2. “UNITED” U2 XPE Total Knee System (K103733) |
Device Description:
U2 Total Knee System - PSA Tibial Insert is an extended design of U2 Total Knee System - PSA Type (K082424) including XPE Tibal Insert, PSA and XPE Tibial Insert,
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O U2 Total Knee System - PSA Tibial Insert
PSA, LC. This System is a patellofemorotibial polymer / metal / polymer, semi-constrained, cemented knee prosthesis, which is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock. U2 Total Knee System - PSA Tibial Inserts are available in a range of thicknesses and in two design configurations: PSA and PSA-LC type. For the PSA tibial insert, it is intended for use in patients who require constrained stabilization for tibiofemoral joint due to soft tissue imbalance. PSA-LC (low constrained) tibial insert provide less constrained stabilization than PSA tibial insert.
Indications for Use:
This device is indicated in knee arthroplasty 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 contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require increased stabilization for tibiofemoral joint due to soft tissue imbalance. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
Note: In the US, this device is for cemented use only.
Comparison to Predicate Device:
U2 Total Knee System - PSA Tibial Insert has the same basic design, intended use, materials, locking mechanism and sterilization as the predicate devices, U2 Total Knee System - PSA Type (K082424) and U2 XPE Total Knee System (K103733). The only difference between the subject and the predicate devices is the profile design of the spine. However, the performance evaluation of the subject device was conducted and would not post issues about safety and effectiveness. Thus, we believe that the subjected U2 Total Knee System - PSA Tibial Insert is substantially equivalent to the predicate device.
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Performance Data:
● Non-clinical Performance
Range of Motion and Spine Fatigue Test were conducted to evaluate the safety and effectiveness of the subjected device.
The subject U2 Total Knee System – PSA Tibial Insert has the same curvature design at the articular surface as U2 Total Knee system - PSA Type which was previously cleared by FDA (K082424). Thus, the constraint, contact area and contact pressure of the subject PSA Tibial Insert should be identical with U2 Total Knee system – PSA Type (K082424). In addition, the material, size distribution and the locking mechanism of the subject PSA-LC Tibial Insert is identical to the on-marketed PSA insert (K082424). The wear performance could be represented by the on-marketed U2 XPE Tibial Insert (K103733) due to the same contact area and size distribution.
Bacterial endotoxin testing was conducted and met the endotoxin limit as specified in USP <161>.
● Clinical Performance Data/Information
None provided as a basis for substantial equivalence.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.