(90 days)
The Scorpio® Knec 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 adequate 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 cement.
The device includes the tibial insert components of a total knee system. These components are used for the replacement of the bearing surface of the proximal tibia 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 document is a 510(k) Premarket Notification for the Scorpio® Knee System - Tibial Inserts. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials for efficacy from scratch. Therefore, the information requested, particularly regarding "AI" and "human readers," is not directly applicable to this document, as it pertains to a mechanical orthopedic implant, not a diagnostic or AI-driven system.
Based on the provided information, here's an analysis of the acceptance criteria and the study that proves the device meets them, keeping in mind the context of a 510(k) submission for a mechanical orthopedic implant:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test Performed | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Range of constraint testing | "The results demonstrate equivalence." |
| Tibial insert post stress analysis | "The results demonstrate equivalence." | |
| Contact stress/area analysis | "The results demonstrate equivalence." | |
| Biocompatibility | Not explicitly detailed, but assumed to be equivalent to predicate | Not explicitly detailed |
| Material Properties | Not explicitly detailed, but implied by equivalence to predicate | Not explicitly detailed |
Note: For a 510(k) submission, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device. The performance data provided is typically to support this claim, rather than setting and meeting independent performance targets for a novel device type.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the mechanical tests (range of constraint, post stress, contact stress/area analysis). However, these types of tests for orthopedic implants typically involve a reasonable number of samples to establish statistical significance for engineering metrics. The data provenance is internal to the manufacturer (Howmedica Osteonics Corp.), indicating these were laboratory/bench tests focusing on the physical properties of the device, rather than human subject data. These would be considered prospective tests (i.e., designed and executed to evaluate the specific design modifications).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This concept is not directly applicable here. For mechanical engineering tests of an implant, the "ground truth" is typically established by engineering standards, validated testing methodologies, and objective physical measurements. The "experts" involved would be engineering professionals conducting and interpreting these mechanical tests, not medical professionals establishing a clinical "ground truth."
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies or image-reading scenarios where there's subjectivity and a need to resolve discrepancies between human readers. For the mechanical tests performed, the "results demonstrate equivalence" suggests objective measurements were taken and compared against established benchmarks or the predicate device's performance, without a subjective adjudication process.
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 a mechanical orthopedic implant, not an AI-driven diagnostic or assistive technology. Therefore, no MRMC study or AI-related improvement analysis would have been performed or is relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. As this is a mechanical implant, there is no "algorithm only" performance or "human-in-the-loop" concept relevant to its function.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed (range of constraint, tibial insert post stress, contact stress/area analysis) would be based on engineering specifications, validated mechanical testing methodologies, and the established performance characteristics of the predicate device. The goal was to prove the redesigned components perform equivalently to the existing, legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of mechanical testing for a 510(k) submission of a orthopedic implant. Training sets are relevant for machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set."
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| K033342 |
|---|
| 510(k) Premarket Notification |
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Summary of Safety and Effectiveness
| Contact Person: | Denise DucheneSr. Regulatory Affairs SpecialistHowmedica Osteonics Corp.59 Route 17 SouthAllendale, NJ 07401(201) 831-5612 (Phone)(201) 831-6038 (FAX) |
|---|---|
| Date: | September 17, 2003 |
| Device: | Scorpio ® Knee System - Tibial Inserts |
| Classification: | Knee Joint; Patellofemorotibial; Polymer/metal/polymer; Semi-constrained; Cemented prosthesis - Class II -21 CFR 888.3560 |
| Predicate Devices: | Scorpio ® Knee System - Tibial Inserts |
| Indications for Use: | The Scorpio ® Knee System tibial insert components are for use intotal knee arthroplasty for painful, disabling joint disease of theknee resulting from degenerative arthritis, rheumatoid arthritis orpost-traumatic arthritis; post-traumatic loss of knee jointconfiguration and function; moderate varus, valgus or flexiondeformity in with the ligamentous structures can be returned toadequate function and stability; and/or revision of previousunsuccessful knee replacement or other procedure. |
| Proposed Modification: | Redesign of the tibial insert component dimensions to provide forimproved hyperextension. In addition, to provide a claim for theCR insert that indicates it provides sufficient constraint for usewhen the posterior cruciate ligament (PCL) is absent or non-functioning. |
| Device Description: | The device includes the tibial insert components of a total kneesystem. These components are used for the replacement of thebearing surface of the proximal tibia to relieve pain, instability andthe restriction of motion due to degenerative bone disease,including osteoarthritis, rheumatoid arthritis, failure of otherdevices or trauma. |
| Summary of Data: | A risk analysis and Research and Development testing have beenperformed to demonstrate equivalence of the proposed products tothe predicate devices. The testing includes range of constrainttesting, analysis of tibial insert post stress and contact stress/areaanalysis. The results demonstrate equivalence. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2004
Ms. Lorraine T. Montemurro Regulatory Affairs Manager Stryker Howmedica Osteonics 59 Route 17 South Allendale, New Jersey 07401
Re: K033342 Trade/Device Name: Scorpio® Knee System - Tibial Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint, patellofemorotibial. polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Codes: JWH Dated: October 15, 2003 Received: October 17, 2003
Dear Ms. Montemurro:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labcling (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. Lorraine T. Montemurro
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,
Mark A. Millerson
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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Konzade 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Scorpio® Knee System – Tibial Inserts
Indications for Use:
The Scorpio® Knec 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 adequate 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 cement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | |
|---|---|---|
| OR | Over-the-Counter Use | |
| (Per 21 CFR 801.109) |
for Mark N Millan
§ 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.