(83 days)
The Scorpio® X3™ UHMWPE Cruciate Retaining and Posterior Stabilized tibial inserts and the Scorpio X3™ UHMWPE all polyethylene patcllar components are intended to be used with cemented or cementless Scorpio femoral components, cemented or ccmcntless Series 7000 tibial tray components and cemented Scorpio® tibial tray components in primary or revision total knee arthroplasty. The all polyethylene Scorpio 6 X3™ UHMWPE patellar components are intended for implantation with bone cement only.
The Scorpio® X3™ Total Stabilizer tibial inserts are intended to be used with the cemented Scorpio TS femoral components and the cemented Scorpio or Series 7000 tibial trays in primary or revision total knec arthroplasty.
The Scorpio® Knee System components are for use in total knee atthroplasty as a result of:
- Painful, disabling joint disease of the knee resulting from degencrative athritis, 후 rheumatoid arthritis or post-traumatic arthritis.
- Post-traumatic loss of knee joint configuration and function. .
- Moderate varus, valgus or flexion deformity in which the ligamentous structures . can be returned to adequate function and stability.
- Revision of previous unsuccessful knee replacement or other procedure. ●
Additional indications for Posterior Stabilized Components:
- Ligamentous instability requiring implant bearing surface geometries with ● increased constraint.
- Absent or non-functioning posterior cruciate ligament. .
Additional indications for Total Stabilized (TS) Components:
- Severe anteroposterior and medial/lateral instability of the knee. .
The device includes tibial and patellar components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the proximal tibia and patclla. The modification to the device subject of this premarket notification is the sequentially crosslinking and annealing of the UHMWPE material by a proprietary process. Tibial inserts will be made in Cruciate Retaining, Posterior Stabilized and Total Stabilizing designs. Patellar components will be made in Medialized Dome, Concentric Dome, Universal Dome, Recessed and Inset designs
The provided text does NOT describe acceptance criteria for a device, nor does it detail a study proving the device meets said criteria in the way typically associated with AI/ML device performance (e.g., sensitivity, specificity, AUC).
Instead, the document is a 510(k) summary for a medical device (Scorpio® X3™ UHMWPE Tibial Inserts and Patellar Components) seeking substantial equivalence to predicate devices. The "Summary of Data" section describes types of tests performed to establish equivalence, but not specific performance metrics or acceptance criteria as would be presented for an AI/ML diagnostic.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test/training sets) are not applicable or cannot be extracted from this document as they pertain to a different type of device assessment.
Here's an analysis based on the information available in the provided text, while making it clear where information relevant to AI/ML device assessment is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present acceptance criteria or reported device performance in the form of specific metrics (like sensitivity, specificity, or accuracy) against predefined thresholds, which is common for AI/ML diagnostic tools. Instead, it states that "Testing and analysis includes material properties characterization, wear testing, disassembly force evaluation, multi-axis fatigue testing, patella shear testing and finite element modeling of contact stresses" to demonstrate "equivalence of the subject products to the predicate devices."
The acceptance criteria are implicitly met by demonstrating "substantial equivalence" through these engineering tests, rather than clinical performance metrics. The document does not provide the specific numerical results or thresholds for these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Equivalence to predicate devices in material properties, wear resistance, disassembly force, fatigue strength, patella shear, and contact stresses. | Testing and analysis performed on material properties, wear, disassembly force, multi-axis fatigue, patella shear, and finite element modeling of contact stresses. (Specific results not detailed in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of an AI/ML algorithm evaluation. The testing described refers to engineering performance tests of the physical device components. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in the context of expert consensus for a test set is specific to diagnostic or interpretive AI/ML devices. This document refers to the physical properties and performance of an orthopedic implant.
4. Adjudication Method for the Test Set
Not applicable. As noted above, there is no "test set" in the AI/ML sense described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI/ML assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation would be the validated engineering standards, material specifications, and performance characteristics established for orthopedic implants, and in particular, for the predicate devices. This is assessed through physical and mechanical testing, not expert consensus, pathology, or outcomes data in the typical sense used for AI/ML.
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML model that requires a "training set" for this device's evaluation.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML model, there is no training set or ground truth in this context.
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510(k) Summary of Safety and Effectiveness
| Device: | Scorpio® X3™ UHMWPE Tibial Inserts and Scorpio®X3™ UHMWPE Patellar Components |
|---|---|
| Classification: | 21 CFR 888.3560 - Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis |
| 21 CFR 888.3565 - Knee joint patellofemorotibialmetal/polymer porous-coated uncemented prosthesis | |
| Product Code | 87 JWH, 87 MBH |
| Predicate Devices: | Scorpio® Polyethylene Tibial Inserts and Scorpio®Polyethylene Patellar Components |
| Contact Person: | Karen AriemmaSenior Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430(201) 831-5718(201) 831-6038 (FAX)karen.ariemma@stryker.com |
Date Summary Prepared: September 28, 2005
Device Description
The device includes tibial and patellar components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the proximal tibia and patclla. The modification to the device subject of this premarket notification is the sequentially crosslinking and annealing of the UHMWPE material by a proprietary process. Tibial inserts will be made in Cruciate Retaining, Posterior Stabilized and Total Stabilizing designs. Patellar components will be made in Medialized Dome, Concentric Dome, Universal Dome, Recessed and Inset designs
Indications For Use
The Scorpio® X3™ UHMWPE Cruciate Retaining and Posterior Stabilized tibial inserts and the Scorpio® X3TM UHMWPE all polyethylene patellar components are intended to be used with cemented or cementless Scorpio femoral components, cemented or ccmcntless Series 7000 tibial tray components and cemented Scorpio® tibial tray components in primary or revision total knee arthroplasty. The all polyethylene Scorpio 6 X3™ UHMWPE patellar components are intended for implantation with bone cement only.
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051977
The Scorpio® X3™ Total Stabilizer tibial inserts are intended to be used with the cemented Scorpio TS femoral components and the cemented Scorpio or Series 7000 tibial trays in primary or revision total knec arthroplasty.
The Scorpio® Knee System components are for use in total knee atthroplasty as a result of:
- Painful, disabling joint disease of the knee resulting from degencrative athritis, 후 rheumatoid arthritis or post-traumatic arthritis.
- Post-traumatic loss of knee joint configuration and function. .
- Moderate varus, valgus or flexion deformity in which the ligamentous structures . can be returned to adequate function and stability.
- Revision of previous unsuccessful knee replacement or other procedure. ●
Additional indications for Posterior Stabilized Components:
- Ligamentous instability requiring implant bearing surface geometries with ● increased constraint.
- Absent or non-functioning posterior cruciate ligament. .
Additional indications for Total Stabilized (TS) Components:
- Severe anteroposterior and medial/lateral instability of the knee. .
Summary of Data
Sunning you Data equivalence of the subject products to the predicate devices. Testing and analysis includes material properties characterization, wear testing, disassembly force evaluation, multi-axis fatigue testing, patella shear testing and finite element modeling of contact stresses.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
0CT 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Karen Ariemma Senior Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430
Re: K051977
Trade/Device Name: Scorpio Knee System-Tibial Inserts and Patellar Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH, MBH Dated: July 19, 2005 Received: July 21, 2005
Dear Ms. Ariemma:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Docker on (c) f
referenced above and have determined the device is substantially equivalent (for the indications for referented in the enclosure) to legally marketed predicate devices marketed in interstate commerce uss stated in the energies in the Medical Device Amendments, or to devices that provision in the provisions 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 thereone, manier the act include requirements for annual registration, listing of devices, good controls pro risions one labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your are rise to such 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Karen Ariemma
This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter watification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Mark N. Mello
Co Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K051977
510(k) Number (if known): _
Device Name: Scorpio Knec System - Tibial Inserts and Patellar Components
Indications for Use:
The Scorpio® X3™ UHMWPE Cruciate Retaining and Posterior Stabilized tibial inserts and the Scorpio X3™ UHMWPE all polyethylene patcllar components are intended to be used with Scorpio X3 ™ UHM WFL all polychylono parents, cemented or cementless Senies 7000 tibian total local cemented of cementiess Scopio" ithink tibiable and components in primary or revision total knews are interested arthroplasty. The all polyethylene Scorpio X3M UHMWPE patellar components are intended for implantation with bone cement only.
The Scorpio® X3™ Total Stabilizer tibial inserts are intended to be used with the cemented The Scorpio" X31" Total Stannisci dollar inserts are theirder woo cores.
Scorpio" TS femoral components and the cemented Scorpio" or Series 7000 tibial trays in primary or revision total knee arthroplasty.
The Scorpio " Knee System components are for use in total kncc arthroplasty as a result of:
- Painful, disabling joint disease of the knee resulting from degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis.
- Post-traumatic loss of knee joint configuration and function. .
- Fost-traumance 1033 or know John version ity in which the ligamentous structures can be . returned to adequate function and stability.
- Revision of previous unsuccessful knee replacement or other procedure. .
Additional indications for Posterior Stabilized Components:
- hial intuceatous for I overlex oring implant bearing surface geometries with increased . constraint
- Absent or non-functioning posterior cruciate ligament. .
Additional indications for Total Stabilized (TS) Components:
- Severe anteroposterior and medial/lateral instability of the knee joint. .
Prescription Use X (Per 21 CFR 801.109)
OR
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEBDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
2
Page 1 of l
(Division Sign-Off) Division of General, Restorative, and Neumlogical De
510(k) Number K051977
§ 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.