(163 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; revision of previous unsuccessful knee replacement or other procedure. Additional indications for 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.
The provided document describes the Scorpio® NRG™ Knee System, but it is a premarket notification (510(k)) for a medical device and does not contain the information requested in the prompt regarding acceptance criteria and a study proving those criteria were met for an AI/ML device.
The document states that the proposed modification is to "Redesign the femoral and tibial insert component dimensions to provide for increased range of motion." The "Summary of Data" section (labeled as {1} in the input) briefly details the testing conducted for this knee system.
Here's an analysis of what is available and why it doesn't fit the request for AI/ML device study information:
Analysis of Provided Information:
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Acceptance Criteria and Reported Device Performance:
- The document mentions "risk analysis and Research and Development testing have been performed to demonstrate equivalence of the proposed products to the predicate devices."
- Specific tests included "range of constraint testing, finite element analysis of contact stress/area and finite element analysis of femoral fatigue."
- The reported performance is simply: "The results demonstrate equivalence."
- This is not specific acceptance criteria in the format requested (e.g., sensitivity, specificity, AUC, or other quantitative metrics typically used for AI/ML performance), nor does it provide the detailed quantitative results of these tests.
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Sample Size and Data Provenance:
- Not applicable for AI/ML testing. The testing mentioned (range of constraint, finite element analysis) are mechanical engineering tests, not data-driven performance evaluations. No "test set" in the AI/ML sense is described.
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Number of Experts and Qualifications:
- Not applicable. No expert review for ground truth establishment is mentioned as this is not an AI/ML diagnostic or prognostic device.
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Adjudication Method:
- Not applicable. No adjudication process is relevant to the mechanical tests described.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, this was not done. This type of study is relevant for diagnostic imaging AI/ML devices where human readers' performance is compared with and without AI assistance. The Scorpio® NRG™ Knee System is a physical joint replacement, not a diagnostic AI/ML tool.
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Standalone (Algorithm Only) Performance:
- No, this was not done. The device itself is a physical implant. The "finite element analysis" mentioned is a computational simulation (an "algorithm" in a very broad sense) used to design and verify the mechanical properties, not to perform a diagnostic or prognostic task in a standalone manner like an AI/ML algorithm.
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Type of Ground Truth:
- Not applicable. The "ground truth" for mechanical equivalence would be the physical properties and performance of the predicate device under specific mechanical loads and conditions. It's not "expert consensus," "pathology," or "outcomes data" in the context of an AI/ML evaluation.
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Sample Size for Training Set:
- Not applicable. There is no AI model or "training set" for physical knee implants.
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How Ground Truth for Training Set was Established:
- Not applicable.
In conclusion, the provided document K042343 describes a traditional medical device (a knee implant) and its regulatory submission. It does not contain any information relevant to the acceptance criteria or studies typically performed for AI/ML-driven medical devices.
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Summary of Safety and Effectiveness – K042343
| Contact Person: | Denise DucheneSr. Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate Dr.Mahwah, NJ 07430(201) 831-5612 (Phone)(201) 831-6038 (FAX) |
|---|---|
| Date: | November 10, 2004 |
| Device: | Scorpio® NRG™ Knee System |
| Classification: | Knee Joint; Patellofemorotibial; Polymer/metal/polymer; Semi-constrained; Cemented prosthesis - Class II -21 CFR 888.3560Product Code: 87 JWH |
| Predicate Devices: | Scorpio® Total KneeScorpio® Scorpio-flex™ Tibial InsertsDuracon A/P Lipped Tibial Inserts |
| Indications for Use: | 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; revision of previous unsuccessful knee replacement or other procedure. Additional indications for posterior stabilized components include: ligamentous instability requiring implant bearing surface geometries with increased constraint; and/or an absent or non-functioning posterior cruciate ligament. |
| Proposed Modification: | Redesign the femoral and tibial insert component dimensions to provide for increased range of motion. |
| Device Description: | 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. |
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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 constraint testing, finite element analysis of contact stress/area and finite element analysis of femoral fatigue. The results demonstrate equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
FEB - 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Denise Duchene Sr. Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430
Re: K042343
K042343
Trade/Device Name: Scorpio® NRG™ Knee System (Cruciate Retaining Components) Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint, patellofemorotibial, polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Codes: JWH
Dated: January 18, 2005 Received: January 19, 2005
Dear Ms. Duchene:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave decembers of egally marketed predicate devices marketed in interstate for use statuu in the cholosure) to regally management date of the Medical Device Amendments, or to
r Commerce prior to May 28, 1976, the enactment date of the Medical Food D commence provided 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). and Cosmetic Act (Act) that do not require approvise the general controls provisions of the Act. The You may, ulciclore, market the device, basjes, basic include registration, listing of general controls provisions of the 110 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 If your device is classified (500 a0070) ins existing major regulations affecting your device can may be subject to such additional behind of the 21, Parts 800 to 898. In addition, FDA may be found in the Ooue of I cants concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuation or our device complies with other requirements of the Act that TDA has made a dolorimiation administered by other Federal agencies. You must or any Federal statutes and regulations commitives but not limited to: registration and issting (21 Comply with an the Ace STequirements, and manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) I mo reteet notification. The FDA finding of substantial equivalence of your device to a legally premainer noticate 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 11 you attire 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/cdrh/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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K042343
510(k) Number (if known): __
Device Name: _________________________________________________________________________________________________________________________________________________________________
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 .
- I out trainians rous 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 Devices:
- nial indivations 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.
Prescription Use X ___________________________________________________________________________________________________________________________________________________________
AND/OR
Over-the-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General. Restorative. and Neurological Devices
Number K047343
§ 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.