(258 days)
The Prelude™ PF Resurfacing Knee System is intended to be used in cemented patella-femoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
The Prelude™ Patellofemoral (PF) Resurfacing Knee System is a patellofemoral resurfacing prosthesis incorporating a distal femoral trochlear surface articular component and a patella component. The cast femoral component is manufactured from CoCrMo (ASTM F-75) and the MIM femoral component is manufactured from CoCrMo (ASTM F-2886) both with a porous undersurface coating of titanium from polyethylene (UHMWPE) conforming to ASTM F-648 with a stainless steel x-ray wire. The implant system is intended to be implanted with bone cement.
The provided document is a 510(k) Summary for the Biomet Manufacturing Corp. "Prelude™ PF Resurfacing Knee System." This document describes a medical device submission seeking clearance for a new knee implant, and as such, it does not contain information about clinical studies involving AI, human readers, or performance metrics like accuracy, sensitivity, or specificity for diagnostic purposes.
Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) through non-clinical testing and shared technological characteristics.
Therefore, most of the requested information regarding acceptance criteria, device performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types cannot be extracted from this document, as it is not relevant to this type of device submission.
Here's what can be extracted based on the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document does not present quantitative acceptance criteria or device performance in terms of diagnostic accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices, meaning the device should perform "within the intended use" and "not raise any new safety and efficacy issues" as determined by non-clinical tests.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Technological Characteristics) | Design - Femoral: Variation in curvature of articulating surface, central keel (compared to K060127/K071413) Design - Patella: Single-peg and Three-peg (identical to K040770) Material: Co-Cr-Mo (shared with K060127/K071413, K080029/K082088) Material: UHMWPE (shared with K040770) Principle of operation: Replace articulating surfaces of knee (shared with K060127/K071413, K080029/K082088) Dimensions - Femoral: 9 options: 1-6 and 6W, 7W, and 8W (compared to K060127/K071413) Dimensions - Patella: 25mm x 8mm, 28mm x 8mm, 31mm x 8mm, 25mm x 6.2mm, 28 x 6.2mm, and 31mm x 6.2mm (compared to K040770) |
| Safety and Effectiveness (Demonstrated via Non-Clinical Tests) | Preclinical performance tests/rationales were provided to address the subject construct's: - Contact Area - Fatigue Strength - Surface Finish - Magnetic Resonance rationale Results indicate that the subject construct is substantially equivalent to legally marketed devices, performs within the intended use, and does not raise any new safety and efficacy issues. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device submission did not involve clinical studies with human subjects or data sets in the context of diagnostic performance. The "tests" mentioned are non-clinical (mechanical, material, etc.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There was no "ground truth" establishment by experts for a test set in the context of diagnostic performance as described in the prompt. The device is a knee implant, and its equivalence is based on engineering and material characteristics, not diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication methods were mentioned as there were no clinical or diagnostic test sets involving expert evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. An MRMC comparative effectiveness study was not done. This device is a knee implant, not an AI diagnostic tool. No AI assistance or human reader involvement is part of this submission's evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. A standalone algorithm performance study was not done. This device is a physical knee implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of diagnostic performance. The "truth" for this device's evaluation is primarily based on established engineering standards, material specifications, and comparative analyses with predicate device designs and performance under non-clinical conditions.
8. The sample size for the training set
Not applicable. There was no "training set" for an algorithm involved in this submission.
9. How the ground truth for the training set was established
Not applicable. There was no "training set" for an algorithm involved in this submission.
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Image /page/0/Picture/1 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a bold, sans-serif font, with the letters connected to each other. Below the logo, the words "MANUFACTURING CORP." are printed in a smaller, sans-serif font. The text is black and the background is white.
SEP 03 2013
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | |
|---|---|
| Name | Biomet Manufacturing Corp. |
| Address | 56 East Bell DriveWarsaw, IN 46581-0857 |
| Phone number | (574) 267-6639 |
| Fax number | (574) 371-1027 |
| EstablishmentRegistration Number | 1825034 |
| Name of contactperson | Elizabeth Wray |
| Date prepared | December 14, 2012 |
| Name of device | |
| Trade or proprietaryname | Prelude™ PF Resurfacing Knee System |
| Common or usualname | Unicondylar Knee Prosthesis |
| Classification name | Knee joint patello-femoral resurfacing prosthesis |
| Classification panel | Orthopedic |
| Regulation | 21CFR §888.3540 |
| Product Code(s) | KRR |
| Legally marketeddevice(s) to whichequivalence is claimed | Arthrosurface Hemicap Patello-femoral Resurfacing System(K060127/K071413)Mako Patellofemoral Knee Implant System(K080029/K082088)Vanguard Patella Components(K040770)Vanguard CR Femoral Component(K023546) |
| Reason for 510(k)submission | New Device |
| Device description | The Prelude™ Patellofemoral (PF) Resurfacing Knee Systemis a patellofemoral resurfacing prosthesis incorporating adistal femoral trochlear surface articular component and apatella component. The cast femoral component ismanufactured from CoCrMo (ASTM F-75) and the MIMfemoral component is manufactured from CoCrMo (ASTM F-2886) both with a porous undersurface coating of titanium |
| from polyethylene (UHMWPE) conforming to ASTM F-648 with a stainless steel x-ray wire. The implant system is intended to be implanted with bone cement. | |
| Intended use of the device | Resurfacing of the patella-femoral joint; cemented use. |
| Indications for use | The PreludeTM PF Resurfacing Knee System is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists. |
P-0.60 537
The Sin M-15481 10.000
Times R-1348 1500 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000000000000000000000000000
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Image /page/1/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The logo consists of the word "BIOMET" in a stylized font, with the letters connected and a small circle above the "T". Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font. The logo is black and white.
Summary of the technological characteristics of the device compared to the predicate
The Prelude PF Resurfacing Knee System femoral components are comprised of CoCrMo and will be available for cemented application for fixation to the prepared femoral. The femoral component is to replace the damaged portion of the focal defect in the trochlear groove of the femur in the patient and restore normal knee function similar to the movement of a natural knee. The predicate device femoral components are also comprised of CoCrMo for cemented application and are similar to the Prelude PF femoral components in design and dimension.
The Prelude PF Resurfacing Knee System patella components are comprised of polyethylene (UHMWPE) and intended for cemented application available in either single or three-peg options for fixation. These patella components are identical to the Vanquard Series A patella components (K040770) and similar to the patellofemoral predicate patella component designs.
A tabular summary of the technological characteristics is provided below.
| Characteristic | Subject Device | Predicate |
|---|---|---|
| Design - Femoral | Variation in curvature of articulatingsurface, central keel | K060127 /K071413 |
| Design - Patella | Single-peg and Three-peg | K040770 |
| Material | Co-Cr-Mo | K060127/K071413K080029/K082088 |
| Material | UHMWPE | K040770 |
| Principal of operation | Replace articulating surfaces of knee | K060127/K071413 |
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Image /page/2/Picture/0 description: The image shows the logo for Biomet Manufacturing Corp. The logo consists of the word "BIOMET" in a stylized font, with the letters connected and overlapping. Below the logo is the text "MANUFACTURING CORP." in a simple, sans-serif font. The logo is black and white.
| K080029/K082088 | ||
|---|---|---|
| Dimensions - Femoral | 9 options: 1-6 and 6W, 7W, and 8W | K060127/K071413 |
| Dimensions - Patella | 25mm x 8mm, 28mm x 8mm, 31mm x8mm, 25mm x 6.2mm, 28 x 6.2mm, and31mm x 6.2mm | K040770 |
STATE AND AND PERFORMANCE DATA PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Performance Test Summary-New Device
The Prelude™ PF Resurfacing Knee System has the same basic technological characteristics as the predicate devices except for slight modifications to the general design as described in this 510(k) notification. Preclinical performance tests/rationales were provided to address the subject construct's Contact Area, Fatique Strength, and Surface Finish. A Magnetic Resonance rationale was also provided. Results indicate that the subject construct is substantially equivalent to legally marketed devices.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical Performance Data/Information: None provided as a basis for substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The results of preclinical tests/engineering rationales and the similarities with legally marketed devices indicate the devices will perform within the intended use, and do not raise any new safety and efficacy issues.
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Image /page/3/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes that resemble human figures or flowing lines. The logo is printed in black ink on a white background.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
September 3, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Company Ms. Elizabeth Wray Regulatory Project Manager 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581
Re: K123907
Trade/Device Name: Prelude PF Resurfacing Knee System Regulation Number: 21 CFR 888.3540 Regulation Name: Knee joint patella-femoral polymer/metal semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KRR Dated: July 30, 2013 Received: August 1, 3013
Dear Ms. Wray:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Ms. Elizabeth Wray
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):__K123907
Device Name: Prelude PF Resurfacing Knee System
Indications For Use:
The Prelude™ PF Resurfacing Knee System is intended to be used in cemented patella-femoral arthroplasty in patients with degenerative arthritis in the distal femur and patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ NO (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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
Page 1 of 1
§ 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. 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 a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (§ 888.3027). The patellar component is designed to be implanted only with its femoral component.(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” and
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 7207-2:1998 “Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and
(viii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants,” and
(viii) F 1672-95 “Specification for Resurfacing Patellar Prosthesis.”