(88 days)
Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are for cementless or cemented use.
The Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are manufactured to be compatible for use with Zimmer's NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System and Zimmer's NexGen Complete Knee Solution - Legacy Knee Constrained Condylar Knee (LCCK) System. When used with the RHK System. the Trabecular Metal Cone Augments are for cemented use only. When used with the LCCK System, the Trabecular Metal Augments are for either cementless or cemented use.
This 510(k) premarket notification for the Zimmer Trabecular Metal Technology, Inc. Trabecular Metal Tibial and Femoral Cone Augments does not contain a study that proves the device meets specific acceptance criteria in the manner you've described (e.g., related to algorithm performance, human reading, or medical outcomes).
Instead, this submission seeks to demonstrate substantial equivalence to previously cleared predicate devices. Substantial equivalence for medical devices like this typically relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as a legally marketed predicate device. This is often achieved through non-clinical performance data (e.g., mechanical testing, biocompatibility) rather than clinical studies with defined acceptance criteria for diagnostic or AI performance.
Therefore, many of the specific questions you've asked about acceptance criteria for device performance with numerical metrics, expert adjudication, or AI performance are not applicable to this type of 510(k) submission.
Here's an assessment based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not applicable in this context. This 510(k) does not present a table of specific numerical acceptance criteria for a study proving device performance in the way a diagnostic or AI device approval might. The device is a knee implant augment, and its "performance" is primarily assessed through its material properties, design, and biocompatibility, which are implicitly covered by its substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. There is no mention of a "test set" for performance evaluation in the context of diagnostic or AI accuracy. The "performance data" mentioned in the submission refers to the characteristics that ensure substantial equivalence, which would typically be derived from engineering specifications and testing, not patient data in the sense of a test set for diagnostic accuracy.
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. Ground truth in the context of diagnostic accuracy or AI performance is not relevant to this submission. The device is a physical implant.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set or human adjudication process is described.
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
- Not applicable. This device is a component of a knee implant system, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, an MRMC study is irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no algorithm associated with this physical implant device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. Ground truth for diagnostic performance is not relevant. The "ground truth" for a device like this would be its physical properties, biocompatibility, and mechanical performance, which are assessed through engineering standards and testing, not clinical "ground truth" in the diagnostic sense.
8. The sample size for the training set
- Not applicable. No AI or machine learning model requiring a training set is mentioned.
9. How the ground truth for the training set was established
- Not applicable. As no training set is mentioned, this question is not relevant.
Summary of the Document's Approach to "Performance":
The core of this 510(k) submission, regarding "performance," is found in the statement:
"Performance Data: The predicate and subject devices are identical; performance characteristics therefore remain as documented in the predicate submission (K031962 and K051756)."
This indicates that the Zimmer Trabecular Metal Tibial and Femoral Cone Augments are considered to have the same "performance characteristics" as their predicate devices because they are described as "identical." In the context of medical devices like these, "performance characteristics" would typically refer to aspects such as:
- Material properties: Strength, ductility, fatigue resistance, porosity, etc.
- Biocompatibility: Demonstrated through standard biocompatibility tests.
- Mechanical integrity: Ability to withstand loads and stresses inherent in knee joint function.
- Design compatibility: Ensuring proper fit and function with the specified Zimmer knee systems.
Since the devices are stated to be "identical," no new "performance data" is presented in this submission itself; rather, it refers back to the data provided and accepted in the clearance of the predicate devices.
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K05334o
Zimmer Trabecular Metal Technology, Inc.
FEB 2 1 2006
Trabecular Metal Tibial and Femoral Cone Augments Cemented or Cementless Use 510(k) Premarket Notification
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Trabecular Metal Knee System Augments
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Submitter Name: Zimmer Trabecular Metal Technology, Inc. Submitter Address: 80 Commerce Drive Allendale, New Jersey 07401-1600 Contact Person(s): Marci Halevi Phone Number: (201) 818-1800 ext 507 Fax Number: (973) 829-0825 Date Prepared: November 28, 2005 Device Trade Name: Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments Device Common Name: Knee System Augments Classification Name: knee, patello/femorotibial, semi-constrained. Prosthesis, uncemented, porous, coated, polymer/metal/polymer
Substantial Equivalence: The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. determination of substantial র্ব equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts. -
Predicate Devices: Trabecular Metal Tibial Cone Augments (K031962) Trabecular Metal Femoral Cone Augments (K051756), Trabecular Metal Knee System Augments (K040487) NexGen Knee System Uncemented Components (K031462).
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053340
Zimmer Trabecular Metal Technology, Inc
510(K) Summary of Safety and Effectiveness - Continued...
Device Description: The Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Auaments are manufactured to be compatible for use with Zimmer's NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System and Zimmer's NexGen Complete Knee Solution - Legacy Knee Constrained Condylar Knee (LCCK) System. When used with the RHK System. the Trabecular Metal Cone Augments are for cemented use only. When used with the LCCK System, the Trabecular Metal Augments are for either cementless or cemented use.
Intended Use: Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are for cementless or cemented use.
- Performance Data: The predicate and subject devices are identical; performance characteristics therefore remain as documented in the predicate submission (K031962 and K051756).
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged around the seal's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2006
Zimmer Trabecular Metal Technology, Inc. c/o Ms. Marci Halevi Manager of Regulatory Affairs 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K053340
Trade/Device Name: Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments
Regulation Number: 21 CFR 888.3565 and 21 CFR 888.3560
Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis, Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis
Regulatory Class: II Product Code: MBH, JWH Dated: November 30, 2005 Received: December 1, 2005
Dear Ms. Halevi:
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
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Page 2 - Ms. Halevi
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 CMR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
fo
Mark N. Melkerson, M.S. 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 KOS 3340 510(k) Number (if known):
Device Name: Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments
Indications for Use:
Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Auqments and Trabecular Metal Femoral Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are for cementless or cemented use.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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Helbert Lumio
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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(Posted November 13, 200510(k) Number_
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.