(237 days)
The Scorpio® NRG™ Knee System components are for use in total knee arthroplasty for 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 with the ligamentous structures can be returned to adequate function and stability; and/or 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; and/or an absent or non-functioning posterior cruciate ligament.
The device includes femoral components and tibial insert 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 to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.
Acceptance Criteria and Study for Scorpio® NRG™ Knee
This document describes the acceptance criteria and the study performed for the Scorpio® NRG™ Knee.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Name/Method |
|---|---|---|---|
| Mechanical Performance | Equivalence to predicate devices in: | Demonstrated equivalence to predicate devices. | Risk analysis and Research and Development testing |
| Range of constrained testing | Demonstrated equivalence | Risk analysis and Research and Development testing | |
| Tibial insert post stress analysis | Demonstrated equivalence | Risk analysis and Research and Development testing | |
| Contact stress/area analysis | Demonstrated equivalence | Risk analysis and Research and Development testing |
2. Sample Size and Data Provenance for Test Set
The provided document does not specify a distinct "test set" in the context of an AI/ML device or a clinical trial with a defined patient cohort. The "study" described is a series of engineering and risk analyses.
- Sample Size: Not applicable in the context of typical clinical study sample sizes. The tests involved specific component designs and their mechanical properties.
- Data Provenance: The data originates from internal "Research and Development testing" and "risk analysis" conducted by Howmedica Osteonics Corp. This means the data is internal to the manufacturer and is likely from laboratory settings and simulations rather than patient data. The provenance is therefore considered retrospective/simulation-based rather than from a specific country of origin in a clinical sense.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
This is not applicable as the study described is a mechanical engineering evaluation and risk analysis, not a study requiring expert clinical adjudication of a test set in the traditional medical device sense. The "ground truth" for the mechanical tests would be the established engineering principles, material properties, and performance benchmarks for orthopedic implants.
4. Adjudication Method (Test Set)
Not applicable. There was no clinical test set requiring adjudication in the context of human interpretation or outcome assessment. The "adjudication" for the engineering tests would be adherence to pre-defined engineering standards and equivalence metrics.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a knee implant, and the assessment was based on engineering and mechanical equivalence to predicate devices, not on the interpretation of medical images or data by multiple human readers, with or without AI assistance. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not relevant or reported.
6. Standalone Performance Study (Algorithm Only)
No, a standalone (algorithm only) performance study was not done. This device is not an AI/ML algorithm; it is a physical knee implant.
7. Type of Ground Truth Used
The ground truth used for this study was engineering principles, material science properties, and performance data from predicate (already approved) devices. The goal was to establish "equivalence" to these existing, legally marketed devices. This involved:
- Benchmarking against known performance characteristics of the Scorpio® Total Knee and Scorpio® Scorpio-flex™ Tibial Inserts.
- Adherence to established mechanical testing protocols for orthopedic implants (e.g., range of constrained testing, stress analysis).
8. Sample Size for the Training Set
Not applicable. As this is a physical medical device (knee implant) and not an AI/ML algorithm, there is no "training set" in the sense of data used to train a model. The "training" in an engineering context would refer to material characterization, design iterations, and finite element analysis, which are not typically quantified by a "sample size" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI/ML algorithm. For the engineering design and iteration process relevant to physical devices, the "ground truth" for development would be established through:
- Biomechanical research: Understanding the physiological loads and movements of the knee joint.
- Material science: Characterizing the properties of the materials used.
- Clinical experience and outcomes: Data from existing knee implants (predicates) informing design decisions to improve upon or match their performance.
- Regulatory standards: Ensuring the design meets established safety and performance requirements for knee implants.
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NOV 2 0 2003
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: | February 14, 2003 |
| Device: | Scorpio® NRG™ Knee |
| Classification: | Knee Joint; Patellofemorotibial; Polymer/metal/polymer; Semi-constrained; Cemented prosthesis - Class II -21 CFR 888.3560 |
| Predicate Devices: | Scorpio® Total KneeScorpio® Scorpio-flex™ Tibial Inserts |
| Indications for Use: | The Scorpio® NRG™ Knee System components are for use in totalknee arthroplasty for 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 withthe ligamentous structures can be returned to adequate functionand stability; and/or revision of previous unsuccessful kneereplacement or other procedure. |
| Additional indications for the Posterior stabilized componentsinclude:Ligamentous instability requiring implant bearing surfacegeometries with increased constraint; and/or an absent or non-functioning posterior cruciate ligament. | |
| Proposed Modification: | Redesign the femoral and tibial insert component dimensions toprovide for increased range of motion. |
| Device Description: | The device includes femoral components and tibial insertcomponents of a total knee system. These components are used forthe replacement of the bearing and/or articulating surfaces of thedistal femur, proximal tibia 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 range of constrained testing, analysis of tibial insert post stress and contact stress/area analysis. The results demonstrate equivalence.
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NOV 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Denise Duchene Sr. Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 South Allendale, New Jersey 07401
Re: K030978
·
Trade/Device Name: Scorpio NRG Knee System Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint, patellofemorotibial, polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II
Product Codes: JWH Dated: August 21, 2003 Received: August 22, 2003
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 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.
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. Denise Duchene
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) 594-4659. 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 (vr (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celua 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
510(k) Number (if known):
K030978
Device Name: Scorpio® NRG™ Knee System Components
Indications for Use:
The Scorpio "NRG" Knee 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; .
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 components are single use only and are intended for implantation with bone cement.
Division Sign Off
(Division Sign-Off) Division of General, Restorative and Neurological Devices
(PLEASE DO NOT WRITE BELOW THIS LINE GE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-the-Counter Use OR (Per 21 CFR 801.109)
§ 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.