(112 days)
The Scorpio® Total Knee System components are for use in total knee arthroplasty to relieve pain and restore knee function for indications such as: 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; 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 the posterior stabilized components include: ligamentous instability requiring implant bearing surface geometries with increased constraint; absent or non-functioning posterior cruciate ligament. These products are intended to achieve fixation with and without the use of bone cement.
The device includes femoral, 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 distal femur, proximal tibia and patella to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.
The provided text describes the Scorpio® Total Knee System and its substantial equivalence to a predicate device, focusing on its proposed modification for use without bone cement. It details the testing performed to demonstrate this equivalence, rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested elements for an AI/device performance study are not applicable or cannot be extracted from this document.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a typical "device performance study" sense. Instead, it refers to demonstrating "equivalence to the predicate devices" and meeting "the requirements of this document" (referring to the Class II Special Controls Guidance Document).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to predicate devices. | Demonstrated through testing. |
| Meet requirements of Class II Special Controls Guidance Document (January 16, 2003). | The results demonstrate that the Scorpio® Total Knee System meets these requirements. |
| Porous coating characterization within acceptable limits. | Testing performed and results contributed to meeting requirements. |
| Baseplate fatigue performance within acceptable limits. | Testing performed and results contributed to meeting requirements. |
| Contact area / stress analyses within acceptable limits. | Testing performed and results contributed to meeting requirements. |
| Range of motion / constraint within acceptable limits. | Testing performed and results contributed to meeting requirements. |
| Locking mechanism performance within acceptable limits. | Testing performed and results contributed to meeting requirements. |
| UHMWPE material properties within acceptable limits. | Testing performed and results contributed to meeting requirements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to the provided document, as it describes a series of engineering and materials tests rather than a clinical study involving human subjects or data sets in the context of an AI/diagnostic device. The "tests" here refer to mechanical and material evaluations, not a test set of data for an algorithm.
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 information is not applicable. The "ground truth" for the device's mechanical and material performance was established through standardized engineering tests and material characterization, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable, as the evaluation involved engineering tests, not human reader adjudication of data.
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 information is not applicable. The document does not describe a clinical study of diagnostic performance, nor does it involve an AI component for human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The document describes the evaluation of a physical medical device (a knee implant), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the established scientific and engineering principles, material specifications, and performance requirements outlined in the FDA's Class II Special Controls Guidance Document for knee prostheses. This would include measurable physical properties, mechanical strength, durability under simulated physiological conditions, and material biocompatibility, confirmed through specific laboratory testing.
8. The sample size for the training set
This information is not applicable. The document does not describe the development or evaluation of an AI algorithm, and therefore there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set for an AI algorithm, there is no ground truth to be established in this context.
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Scorp10® Total Knee System
APR 1 2 2004
510(k) Premarket Notification K033972
Jaqe
Summary of Safety and Effectiveness
| Contact Person: | Denise DucheneSr. Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate Dr.Mahwah, NJ 07430(201) 831-5612 (Phone)(201) 831-6038 (FAX) |
|---|---|
| Date: | December 4, 2003 |
| Device: | Scorpio® Total Knee System |
| Classification: | Knee Joint; Patellofemorotibial; Metal/polymer; Porous-coated;Uncemented prosthesis - Class II - 21 CFR 888.3565 |
| Predicate Devices: | Scorpio® Total Knee System |
| Indications for Use: | The Scorpio® Total Knee System components are for use in totalknee arthroplasty to relieve pain and restore knee function forindications such as: painful, disabling joint disease of the kneeresulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; post-traumatic loss of knee joint configurationand function; moderate varus, valgus or flexion deformity in whichthe ligamentous structures can be returned to adequate functionand stability; revision of previous unsuccessful knee replacementor other procedure. Additional indications for the posteriorstabilized components include: ligamentous instability requiringimplant bearing surface geometries with increased constraint;absent or non-functioning posterior cruciate ligament.These products are intended to achieve fixation with and withoutthe use of bone cement |
| Proposed Modification: | Additional indication for use of product without bone cement. |
| Device Description: | The device includes femoral, tibial and patellar components of atotal knee system. These components are used for the replacementof the bearing and/or articulating surfaces of the distal femur,proximal tibia and patella to relieve pain, instability and therestriction of motion due to degenerative bone disease, includingosteoarthritis, rheumatoid arthritis, failure of other devices ortrauma. |
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Summary of Data:
A risk analysis and research and development testing have been performed to demonstrate equivalence of the proposed products to the predicate devices. The testing includes porous coating characterization, baseplate fatigue testing, contact area / stress analyses; range of motion range / range of constraint testing; locking mechanism testing; and UHMWPE material properties in accordance with the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA," dated January 16, 2003. The results demonstrate that the Scorpio® Total Knee System mects the requirements of this document.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2004
Ms. Denise Duchene Srenior Regulatory Affairs Specialist Stryker Howmedica Osteonics 325 Corporate Drive Mahwah, New Jersey 07430
Re: K033972 Trade/Device Name: Scorpio® Total Knee System Regulation Numbers: 21 CFR 888.3565 Regulation Names: Knee joint, patellofemorotibial metal/polymer, porous-coated uncemented prosthesis Regulatory Class: II Product Codes: MBH Dated: March 23, 2004 Received: March 24, 2004
Dear Ms. Duchene:
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 rcclassified 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, labcling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject 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 Fedcral 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); 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 -- Ms. Denise Duchene
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. 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 (301) 594-4659. 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely, yours,
Mark A. Mcpherson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
K033972 510(k) Number (if known):
Device Name: Scorpio® Total Knee System
Indications for Use:
The Scorpio Total Knec System components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as:
- 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 .
- 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 the posterior stabilized components include:
- Ligamentous instability requiring implant bearing surface gcometrics with increased . constraint
- Absent or non-functioning postcrior cruciate ligament t
These components are single use only and are intended for implantation with and without bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of D Division of General, Restorative. and New ological D Prescription Use OR (Per 21 CFR 801.109)
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.