(30 days)
The Competitor Deuce femoral components are intended to be used for those patients whereby conditions exist that can not be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.
Indications include:
- Post-traumatic arthritis;
- Degenerative arthritis; and
- Failed osteotomies, hemiarthroplasties; and unicompartmental replacement
These indications will be used for the Competitor Deuce femoral components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.
The Competitor Deuce femoral components are single use only and are intended for implantation only with bone cement.
The components are used to replace the medial condyle and patellofemoral regions of a femoral knee joint. The Competitor Deuce femoral components will initially be available in both cobalt chrome and Oxinium. The overall design of the Competitor Deuce femoral components is based upon the existing Hybrid Knee femoral components and Competitor Duo femoral components subject of K042896 and K052265, respectively.
The provided document is a 510(k) summary for the Smith & Nephew Competitor Deuce Femoral Components. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth types) that would be typically associated with proving a device meets acceptance criteria in the context of an AI/software-as-a-medical-device (SaMD) study.
Instead, this document focuses on demonstrating substantial equivalence for a physical implantable device (a knee prosthesis component), primarily through mechanical and clinical data review, and comparison to predicate devices. It states: "A review of the mechanical and clinical data indicated that the Competitor Deuce femoral components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure."
Therefore, I cannot populate the requested table and answer the questions related to acceptance criteria and study details for an AI/SaMD device, as this information is not present in the provided text.
Here's a breakdown of what is available and why the requested information isn't:
Information Available:
- Device Name: Competitor Deuce Femoral Components
- Manufacturer: Smith & Nephew, Inc. Orthopaedic Division
- Device Description: Components used to replace the medial condyle and patellofemoral regions of a femoral knee joint. Available in cobalt chrome and Oxinium. Design based on existing Hybrid Knee femoral components and Competitor Duo femoral components.
- Intended Use/Indications: For patients with conditions that cannot be solely addressed by single-compartment devices, including post-traumatic arthritis, degenerative arthritis, and failed osteotomies, hemiarthroplasties, and unicompartmental replacements, affecting the medial condyle and patellofemoral regions. Single-use only, for implantation with bone cement.
- Classification: Class II, under 21 CFR 888.3560 (Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis).
- Substantial Equivalence: Claimed to be substantially equivalent to Smith & Nephew Hybrid Knee Femoral (K042896) and Competitor Duo Knee Femoral Component (K052265).
- Proof of Equivalence: A review of "mechanical and clinical data indicated that the Competitor Deuce femoral components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure."
Why the Requested Information (for AI/SaMD) is Not Applicable/Present:
The request asks for details typically found in validation studies for AI/Machine Learning algorithms or SaMDs. These studies involve quantifying performance metrics (e.g., sensitivity, specificity, AUC) against a ground truth established by experts, using specific datasets, and statistically proving performance against predefined acceptance criteria.
This document describes a physical medical device (a knee implant component). The "study" mentioned is a "review of mechanical and clinical data" to establish substantial equivalence based on existing predicate devices. This type of submission relies on:
- Design Similarity: How the new device is similar to predicate devices.
- Material Equivalence: Using materials known to be safe and effective.
- Biocompatibility Testing: (Though not explicitly detailed here, standard for implants).
- Mechanical Testing: Bench testing to demonstrate the device can withstand expected in vivo forces (e.g., fatigue testing, static strength testing). This is what the phrase "capable of withstanding expected in vivo loading without failure" refers to.
- Clinical Data Review: Often refers to reviewing literature, existing clinical experience with similar devices, or non-clinical data supporting the safety and effectiveness.
Since this is not an AI/SaMD, the concepts of "test set," "training set," "ground truth experts," "adjudication," "MRMC studies," or "standalone algorithm performance" are not relevant or discussed in this 510(k) summary.
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Summary of Safety and Effectiveness
Smith & Nephew Competitor Deuce Femoral Components
Contact Person and Address
Date of Summary: June 28, 2006
Jason Sells Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116 1901) 399-5520
JUL - 6 2006
Name of Device: Competitor Deuce Femoral Components Common Name: Knee Prosthesis
Device Description
The components are used to replace the medial condyle and patellofemoral regions of a femoral knee joint. The Competitor Deuce femoral components will initially be available in both cobalt chrome and Oxinium. The overall design of the Competitor Deuce femoral components is based upon the existing Hybrid Knee femoral components and Competitor Duo femoral components subject of K042896 and K052265, respectively.
Device Classification
21 CFR 888.3560 Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis - Class II
Mechanical and Clinical Data
A review of the mechanical and clinical data indicated that the Competitor Deuce femoral components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.
Intended Use
The Competitor Deuce femoral components are intended to be used for those patients whereby conditions exist that can not be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.
Indications include:
.
- 트 Post-traumatic arthritis;
- a Degenerative arthritis: and
- Failed osteotomies, hemiarthroplasties; and unicompartmental replacement 트
These indications will be used for the Competitor Deuce femoral components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.
The Competitor Deuce femoral components are single use only and are intended for implantation only with bone cement.
Substantial Equivalence Information
The Smith & Nephew Competitor Deuce femoral components are similar to the following commercially available devices regarding design features, overall indications, and materials;
- Smith & Nephew, Inc. Hybrid Knee Femoral (K042896) 트
- Smith & Nephew Competitor Duo Knee Femoral Component (K052265) ■
510(k) Summary.doc
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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 the department's emblem, which consists of a stylized caduceus-like symbol with three human profiles facing right. The emblem is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 6 2006
Mr. Jason Sells Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116
Re: K061569
Trade/Device Name: Competitor Deuce Femoral Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: NPJ Dated: June 28, 2006 Received: June 29, 2006
Dear Mr. Sells:
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. I isting 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 devise can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. IDA max 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 not he Act or any Federal statutes and regulations administered by other Federal agencies. You must
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Page 2 - Mr. Jason Sells
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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Taiba Buehner
Mark N. Mellekerson, M.S.
Mark N. Melker Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KOG 1569
Device Name: Competitor Deuce Femoral Components
Indications for Use:
The Competitor Deuce femoral components are intended to be used for those patients whereby conditions exist that can not be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.
Indications include:
- Post-traumatic arthritis; t
- 트 Degenerative arthritis; and
- Failed osteotomies, hemiarthroplasties; and unicompartmental replacement 트
These indications will be used for the Competitor Deuce femoral components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.
The Competitor Deuce femoral components are single use only and are intended for implantation only with bone cement.
Prescription Use x AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
IPLEASE 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 of General, Restorative, and Neurological Devices
510(k) Number K061569
Page 1 of
Indications.doc
§ 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.