(44 days)
The Scorpio® Knce System components are for use in total knee 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 .
- Moderate varus, valgus or flexion deformity in which the ligamentous structures can be . returned to adcquate function and stability;
- Revision of previous unsuccessful knee replacement or other procedure; .
- Ligamentous instability requiring implant bearing surface geometries with increased . constraint;
- Absent or non-functioning posterior cruciate ligament. .
These components are single use only and are intended for implantation with bone cenient.
This submission is intended to address a design modification to the Scorpio Total Knee System Posterior Stabilized tibial insert component. The tibial insert components were redesigned to provide for improved hyperextension.
The provided document is a 510(k) summary for a design modification to a knee implant (Scorpio® Total Knee System Posterior Stabilized Tibial Insert Components). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance against specific acceptance criteria for AI/ML devices or clinical studies. Therefore, much of the requested information (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) is not applicable or available in this document.
Here's an attempt to answer the questions based only on the provided text, recognizing its limitations for AI/ML-focused inquiries:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstration of Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Maintain same intended use | Shares same intended use as predicate device. |
| Maintain basic design concept | Shares basic design concept as predicate device. |
| Testing/Analysis: | Results: |
| Risk analysis performed | Performed; demonstrates equivalence. |
| Range of constraint testing | Performed; demonstrates equivalence. |
| Analysis of tibial insert post stress | Performed; demonstrates equivalence. |
| Contact stress/area analysis | Performed; demonstrates equivalence. |
2. Sample sized used for the test set and the data provenance
Not applicable. This document describes a mechanical device modification and its testing for substantial equivalence, not an AI/ML algorithm evaluated on a data test set. The tests conducted appear to be engineering/biomechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for AI/ML performance evaluation is not relevant here. The "ground truth" for this device's performance would be established through engineering analysis and physical testing.
4. Adjudication method 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. This is a knee implant, not an AI diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a knee implant.
7. The type of ground truth used
For the engineering tests mentioned (range of constraint, post stress, contact stress/area), the "ground truth" would be established through biomechanical testing and engineering analysis comparing the modified device's performance to the predicate device and established safety/performance standards for knee implants.
8. The sample size for the training set
Not applicable. This document does not describe an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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K040964 Page 1 of 2
Design Modification to the Scorpio® Posterior Stabilized Tibial Inserts Components
Special 510(k) Summary of Safety and Effectiveness: MAY 2 8 2004 Design Modification to the Scorpio® Total Knee System: Posterior Stabilized Tibial Insert Components
| Proprietary Name: | Scorpio® Total Knee System – Posterior Stabilized Tibial Inserte |
|---|---|
| Proposed Regulatory Class: | Class II |
| Classification: | Knee Joint; Patellofemorotibial; Polymer/metal/polymer; Semi- |
| constrained; Cemented prosthesis: 21 CFR 888.3560 · | |
| Device Product Code: | 87 JWH |
| For Information contact: | Karen Ariemma |
| Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Telephone: (201) 831-5718 | |
| Fax: (201) 831-6038 | |
| Email: karen.ariemma@stryker.com | |
| Date Summary Prepared: | April 13, 2004 |
Predicate Device Identification:
The Scorpio Total Knee System consists of various sizes of femoral, tibial and patellar components.
Description of Device Modification:
This submission is intended to address a design modification to the Scorpio Total Knee System Posterior Stabilized tibial insert component. The tibial insert components were redesigned to provide for improved hyperextension.
Indications for Use:
The Scorpio " Total Knee System tibial insert components are for use in total knee arthroplasty for painful, disabling joint disease of the kncc rcsulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; post-traumatic loss of knee joint configuration and function;
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K040964 Page 2 of 2
Special 510(k) Premarket Notification
moderate varus, valgus or flexion deformity in with the ligamentous structures can be returned to adequate function and stability; and/or revision of previous unsuccessful knee replacement or other procedure.
Statement of Technological Comparison:
The subject components share the same intended use and basic design concept as that of the predicate devices. A risk analysis, testing and analysis have been performed to demonstrate equivalence of the subject device to the predicate device. The testing includes range of constraint testing, analysis of tibial insert post stress and contact stress/area analysis. The results demonstrate equivalence.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
MAY 2 8 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Ariemma Regulatory Affairs Specialist Stryker Howmedica Osteonics 325 Corporate Drive Mahwah, New Jersey 07430
Re: K040964
Trade/Device Name: Scorpio® Knee System - Tibial Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Codes: JWH Dated: May 10, 2004
Dear Ms. Ariemma:
Reccived: May 11, 2004
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 adultcration.
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 Federal statutes and regulations administered by other Federal agencies. You must
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Page 2 - Ms. Karen Ariemma
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.
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-_. 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/cdrb/dsma/dsmamain.html
Sincerely yours,
Mark McMillan
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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Scorpio Knee System - Tibial Inserts_____________________________________________________________________________________________________________________________
Indications for Use:
The Scorpio® Knce System components are for use in total knee 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 .
- Moderate varus, valgus or flexion deformity in which the ligamentous structures can be . returned to adcquate function and stability;
- Revision of previous unsuccessful knee replacement or other procedure; .
- Ligamentous instability requiring implant bearing surface geometries with increased . constraint;
- Absent or non-functioning posterior cruciate ligament. .
These components are single use only and are intended for implantation with bone cenient.
Prescription Use Over-The-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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| (Division Sign-Off) |
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| Division of General, Restorative, |
| and Neurological Devices |
| Page | 1 of 1 |
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| 510(k) Number | K040969 |
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§ 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.