(30 days)
The NexGen® TMT Tibia is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.
The NexGen TMT Tibia is manufactured from Trabecular Metal (Hedrocel Porous Tantalum) with direct compression molded ultra-high molecular weight polyethylene (UHMWPE). These tibial components are intended for use with Zimmer NexGen CR Femoral Components.
This document is a 510(k) Pre-Market Notification for a medical device called "The NexGen TMT Tibia." This type of submission to the FDA is for demonstrating that a new device is substantially equivalent to a legally marketed predicate device, rather than for proving efficacy through clinical trials. It does not contain the kind of detailed study information typically found in submissions for novel AI/medical imaging devices, which often involve specific acceptance criteria and performance metrics.
Therefore, many of the requested categories about acceptance criteria, study design, expert involvement, and reader studies are not applicable or cannot be extracted from the provided text.
Here's a breakdown of what can be inferred or explicitly stated based on the given document:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or provide performance metrics in the way one would see for an AI device. The "acceptance criteria" for a 510(k) submission generally revolve around demonstrating substantial equivalence to a predicate device, meaning it has the same intended use, technological characteristics, and safety and effectiveness profile.
The reported "performance" is that the device is deemed substantially equivalent to identified predicate devices, as stated in the Conclusion: "The NexGen TMT Tibia is substantially equivalent to the identified predicate devices." The FDA's letter confirms this with: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..."
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. This is a 510(k) submission focused on substantial equivalence to predicate devices, not on a clinical or performance study with a test set of patient data to measure diagnostic accuracy or similar metrics.
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. This submission does not describe a study involving human experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication method 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 is not an AI device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (a knee implant component), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate device. The new device is compared against this established standard. There is no specific patient-level "ground truth" in the context of a typical AI/diagnostic study.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI device.
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Implex Corp.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The NexGen TMT Tibia Submitter Name: Implex Corp. Submitter Address: 80 Commerce Drive Allendale, New Jersey 07401-1600 Robert A. Poggie, Ph.D. Contact Person: (201) 818-1800 Phone Number: Fax Number: (201) 995-9722 August 2, 2001 Date Prepared: The NexGen TMT Tibia Device Trade Name: Device Common Articular Surface and Tibial Components Name: Classification Number 21 CFR § 888.3560 and Name: Substantial The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of Equivalence: 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. A determination of substantial 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
- Device Description: The NexGen TMT Tibia is manufactured from Trabecular Metal (Hedrocel Porous Tantalum) with direct compression molded ultra-high molecular weight polyethylene (UHMWPE).
or their application by the courts.
These tibial components are intended for use with Zimmer NexGen CR Femoral Components.
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510(k) Summary (Continued)
The NexGen TMT Tibia is intended for use where severe Indications for Use: degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.
The NexGen TMT Tibia is substantially equivalent to the Conclusion: identified predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2001
Dr. Robert A. Poggie Director of Applied Research Implex Corp. 80 Commerce Drive. Allendale, New Jersey 07401
Re: K012866
Trade/Device Name: The NEXGEN® TMT Tibia Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Regulatory Class: II
Product Code: JWH Dated: August 24, 2001 Received: August 27, 2001
Dear Dr. Poggie:
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 - Dr. Robert A. Poggie
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Mark A. Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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NexGen® TMT Tibia Special 510(k) Premarket Notification
510(k) Number (if known) :
012866
Device Name:
The NexGen® TMT Tibia
Indications For Use:
NexGen® TMT Tibia is intended for use where severe The degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.
Mark n Melkerson
(Division eral, Restorative Division levices and Neu
510(k) N
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR . . .
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.