(68 days)
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, rolar Nrece components in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, computible intire and designed stabilized knee systems are designed for use in patients in or tolarwiso replacement. primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact.
The Profix Flex Cruciate Retaining (CR) articular insert is a single-use component intended to be used in conjunction with existing components of the Profix Total Knee System cleared for cemented use (K933958) or uncemented use (K030623).
The Profix Flex Cruciate Retaining Articular Inserts are UHMWPE tibial components which accommodate The Profix Flex Cruciate Relaining Antoclarines in Subscribers of Series flexion range. The greater lies on to those patiente with his and patellar components of the Profix Total Knee System cleared via K933958 (cemented use) and K030623 (uncemented use).
The provided text describes a medical device, the Profix Flex Cruciate Retaining Articular Insert, and its clearance process. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the context of human or AI-assisted diagnostic performance.
Instead, the document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing and a comparison of design features, operational principles, and material composition.
Therefore, many of the requested sections about acceptance criteria and studies are not applicable to the provided document.
Here's an analysis based on the information provided:
Acceptance Criteria and Study for Profix Flex Cruciate Retaining Articular Insert
The provided 510(k) summary does not contain information about acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy) or a study evaluating such criteria. The document pertains to a medical implant and its mechanical and design equivalence, not a diagnostic or AI device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (N/A for this device type) | Reported Device Performance (N/A for this device type) |
|---|---|
| Diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) | No diagnostic performance metrics reported. |
| Clinical outcomes based on human or AI-assisted interpretation | No clinical outcomes based on human or AI-assisted interpretation reported. |
| Mechanical Test Data (General Statement) | "Mechanical test data indicated that the Profix Flex Cruciate Retaining Articular Insert is comparable to similar devices currently used clinically and is capable of withstanding expected in vivo loading without failure." |
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. The document does not describe a clinical test set in the context of diagnostic performance or AI evaluation. The "mechanical test data" mentioned is not given with sample sizes or data provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. No expert ground truth establishment for a diagnostic test set is mentioned.
4. Adjudication Method for the Test Set:
- Not applicable. No adjudication method for a diagnostic test set is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not describe an MRMC study comparing human readers with and without AI assistance. This type of study is irrelevant to the device described (an orthopedic implant).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No. The document does not describe any algorithm-only performance study. This is irrelevant to the described device.
7. Type of Ground Truth Used:
- Not applicable. No ground truth for diagnostic or AI performance is mentioned. The primary "truth" evaluated is substantial equivalence to predicate devices based on design, materials, and intended use, supported by mechanical testing results.
8. Sample Size for the Training Set:
- Not applicable. The document does not refer to a "training set" as it is not for an AI or diagnostic application.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for an AI or diagnostic application, no ground truth establishment method is mentioned.
Summary of what the document does provide:
- Device Description: The Profix Flex Cruciate Retaining Articular Inserts are UHMWPE tibial components for the Profix Total Knee System.
- Intended Use: For use in patients with rheumatoid arthritis, post-traumatic arthritis, failed osteotomies, unicompartmental replacement, or total knee replacement, especially where anterior and posterior cruciate ligaments are absent or incompetent, but collateral ligaments are intact.
- Substantial Equivalence: The device's equivalence is based on similarities in indications for use, design features, operational principles, and material composition to existing predicate devices (K933958, K030623, K041825).
- Mechanical Data: There's a general statement that "Mechanical test data indicated that the Profix Flex Cruciate Retaining Articular Insert is comparable to similar devices currently used clinically and is capable of withstanding expected in vivo loading without failure." No specific data, sample sizes, or acceptance criteria for this mechanical testing are detailed in the summary.
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JUL 20 2005
Smith & Nephew, Inc. Summary of Safety and Effectiveness Profix Flex Cruciate Retaining Articular Insert
K051229 f 1/2
Date of Summary: May 12, 2005
Contact Person and Address
Jason Sells Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 1901) 399-5520
Name of Device: Profix Flex Cruciate Retaining Articular Insert
Common Name: Articular insert
Common Name: Anticular Insert
Classification: 21 CFR 888.3560 (Knee joint patellofemorotibial polymer/metal/polymers/archmon ssification: 21 CFR 060.3500 (N) and 21 CFR 888.3565 (Knee joint patellofemorotibial metal/polyment porous-coated uncemented prosthesis - Class II)
Device Description
Device Deschiption
The Profix Flex Cruciate Retaining Articular Inserts are UHMWPE tibial components which accommodate The Profix Flex Cruciate Relaining Antoclarines in Subscribers of Series flexion range. The greater lies on to those patiente with his and patellar components of the Profix Total Knee System cleared via K933958 (cemented use) and K030623 (uncemented use).
Device Classification
| Identification of Device | ProductCode | Classification Name | Code | Predicate510(k) |
|---|---|---|---|---|
| Profix Flex CR insert foruse with Profix TotalKnee SystemComponents incemented applications | JWH-OrthopaedicsPanel/87 | Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented prosthesis -Class II | 21 CFR888.3560 | K933958 |
| Profix Flex CR insert foruse with Profix TotalKnee SystemComponents inuncementedapplications | MBH-OrthopaedicsPanel/87 | Knee joint patellofemorotibialmetal/polymer porous-coateduncemented prosthesis - Class II | 21 CFR888.3565 | K030623 |
Mechanical and Clinical Data
Mechanical and echanical test data indicated that the Profix Flex Cruciate Retaining Articular Insert is A review of the wices currently used clinically and is capable of withstanding expected in vivo loading without failure.
Indications for Use
indications for our our rolar Mod send with in older patients whose age, weight, and activity level are compatible with an degeneral vong -term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where r osterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact.
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K051229 1/2
The Profix Flex Cruciate Retaining (CR) articular insert is a single-use component intended to be used in conjunction with existing components of the Profix Total Knee System cleared for cemented use (K933958) or uncemented use (K030623).
Substantial Equivalence Information
The substantial equivalence of the Profix Flex CR Articular Insert is based on its similarities in indications for rine design features, operational principles, and material composition to the following predicate devices – aso, aborgh roaders, operation in provinces of the Genesis II Deep Flexion C/R Articular Insert (K041825).
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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 and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 0 2005
Mr. Jason Sells Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116
$\frac{1}{2}$
Re: K051229
RoJ1229
Trade/Device Name: Profix Flex Cruciate Retaining Articular Insert Regulation Number: 21 CFR 888.3560, 888.3565 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis, Knee joint patellofemorotibial metal/polymer porous- coated uncemented prosthesis Regulatory Class: II
Product Code: JWH, MBH Dated: July 14, 2005 Received: July 15, 2005
Dear Mr. Sells:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered prior to the) 2018 sified in accordance with the provisions of the Federal Food, DNA de vices that have occh reciasincat require approval of a premarket approval application (PMA). and Costine real (110.) that to hevice, subject to the general controls provisions of the Act. The r ou may, mererore, mains of the Act include requirements for annual registration, listing of general controls provisions 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 If your device is elassince (tional controls. Existing major regulations affecting your device can may or subject to back additions, 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 r louse of acrease a determination that your device complies with other requirements of the Act that I Dr has Intact a and regulations administered by other Federal agencies. You must or any I 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 OF It Fat 6077, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in and quinn ontrol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Jason Sells
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis iciter will anow you to organization of substantial equivalence of your device to a legally premaired predicated 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 If you dome 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 other general informational 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/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting 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):
Device Name: Profix Flex Cruciate Retaining Articular Insert
Indications for Use:
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, rolar Nrece components in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, computible intire and designed stabilized knee systems are designed for use in patients in or tolarwiso replacement.
primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact.
The Profix Flex Cruciate Retaining (CR) articular insert is a single-use component intended to be used in conjunction with existing components of the Profix Total Knee System cleared for cemented use (K933958) or uncemented use (K030623).
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Enalin
n of General, Restorative
Ko51229
Page 1 of /
§ 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.