(47 days)
The CER-MET™ III Acetabular Cup System is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.
The CER-MET™ III Acetabular Cup System is a non-cemented acetabular cup system with a complete assortment of neutral and 10° hooded poly inserts as well as acetabular screws and screw hole covers (screw hole occluders).
Here's an analysis of the provided text regarding the CER-MET™ III Acetabular Cup System, focusing on the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biomechanical Equivalence to legally marketed predicate devices for in-vivo loading. | "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading." |
| Material Equivalence to legally marketed predicate devices. | "The CER-MET™ III Acetabular Cup System is equivalent to other legally marketed acetabular cup systems in design, materials and intended use." |
| Design Equivalence to legally marketed predicate devices. | "The CER-MET™ III Acetabular Cup System is equivalent to other legally marketed acetabular cup systems in design, materials and intended use." |
| Intended Use Equivalence to legally marketed predicate devices. | "The CER-MET™ III Acetabular Cup System is equivalent to other legally marketed acetabular cup systems in design, materials and intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided text does not specify the sample size used for the biomechanical tests. It only states that "Biomechanical tests have been performed."
The document also does not specify the country of origin of the data or whether the study was retrospective or prospective.
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)
The provided text does not mention the use of experts to establish ground truth for the biomechanical tests. The evaluation appears to be based on physical material and design testing rather than expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The provided text does not mention any adjudication method for the test set, as the study described is biomechanical testing, not a clinical study involving human interpretation.
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
A multi-reader, multi-case (MRMC) comparative effectiveness study was not performed. This document describes the premarket notification for a medical device (acetabular cup system), which primarily relies on biomechanical testing and equivalence to predicate devices, not AI assistance or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device described is a physical implant (acetabular cup system), not an algorithm or AI system. Therefore, standalone algorithm performance testing was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biomechanical tests, the ground truth would be established by engineering standards and established performance metrics for acetabular cups, comparing the device's performance against these predetermined benchmarks and against the performance of the identified predicate devices. It is based on physical measurements and mechanical properties, not clinical or pathological outcomes directly.
8. The sample size for the training set
This question is not applicable. The device is a physical implant and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as #8.
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KU71583
| Contact: | Mr. Mohan Emmanuel, PresidentImplants International, Ltd..71 Jay AvenueTeeside Industrial Est.Thornaby-On-TeesUnited Kingdom T517 9LZTelephone: 011-44-78433-80023Email: mohan.emmanuel@implantsinternational.com | JUL 25 2007 | ||
|---|---|---|---|---|
| Trade name: | CER-MET™ III Acetabular Cup System | |||
| Common name: | Acetabular Cup | |||
| Classificationname: | Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis | |||
| Hip joint metal/polymer/ceramic/polymer semi-constrained cementedor nonporous uncemented prosthesis | ||||
| Regulationnumber: | 21 CFR 888.3358 - Class II, Orthopedic Device Panel 87 | |||
| 21 CFR 888.3353 - Class II, Orthopedic Device Panel 87 | ||||
| Product Code: | MEH, LWJ, LZO, LPH | |||
| DeviceDescription andCharacteristics: | The CER-MET™ III Acetabular Cup System is a non-cementedacetabular cup system with a complete assortment of neutral and 10°hooded poly inserts as well as acetabular screws and screw holecovers (screw hole occluders). | |||
| Equivalence: | The CER-MET™ III Acetabular Cup System is equivalent to otherlegally marketed acetabular cup systems in design, materials andintended use. Equivalent devices include the: | |||
| Trident® "T' Acetabular Shells marketed by Stryker Orthopaedics(K040412 - S/E May 25, 2004) | ||||
| Indications: | The CER-MET™ III Acetabular Cup System is intended foruncemented use for all types of arthrosis, such as advanceddestruction of the hip joint due to degenerative, post-traumatic orrheumatoid arthritis, fracture or avascular necrosis of the femoralhead, sequelae of previous operations, such as internal fixation, jointreconstruction, arthrodesis, hemiarthroplasty or total hip replacement.The same considerations apply to acetabular revisions. | |||
| Performancedata: | Biomechanical tests have been performed. The test results wereequivalent to other similar implants and are sufficient for in vivoloading. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Implants International % Turnkey Intergration, Inc. Mr. Carl Knobloch 5349 Red Leaf Court Ovieda, FL 32765
JUL 25 2007
Re: K071583 Trade/Device Name: CER-MET® III Acetabular Cup System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: MEH, LWJ, LZO, LPH Dated: April 16, 2007 Received: June 8, 2007
Dear Mr. Knobloch:
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 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.
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Page 2 – Mr. Carl Knobloch
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Mark N. Melkerson 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:
Device Name(s):
CER-MET™ III Acetabular Cup System
Indications for Use:
The CER-MET™ III Acetabular Cup System is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.
Prescription Use X
AND/OR
Over-The-Counter-Use
(21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
Karlene Bowen
Division of G Restorative. and Neurological Devices
510(k) Number K07158
Page 1 of 1
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.