(62 days)
The Continuum Knee System® Cobalt Chromium Alloy Tibial Component is intended for use where severe degeneration, trauma, or pathology of the knee joint indicates cemented total knee arthroplasty.
The Continuum Knee System® Cobalt Chromium Alloy Tibial Component
The provided text is a 510(k) summary for the Implex Continuum Knee System® Cobalt Chromium Alloy Tibial Component. This document does not describe a study involving algorithms, AI, or performance criteria in the context of diagnostic accuracy or reader improvement. Instead, it focuses on demonstrating substantial equivalence of a medical device (a knee implant component) to predicate devices already on the market.
Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and AI-related metrics is not applicable to this document. The existing information pertains to the physical and material characteristics of a medical implant and its regulatory approval process, not an AI or algorithm-based diagnostic tool.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document is about a physical medical device (knee implant component), not an algorithm or diagnostic tool. The "acceptance criteria" here would be related to material properties, design specifications, and manufacturing processes, which are not detailed in this summary for reporting. The main "performance" reported is its substantial equivalence to existing devices.
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. No "test set" in the context of an algorithm's performance is mentioned. The "study" here is a regulatory comparison against predicate devices.
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. No experts were used to establish ground truth for a test set in the context of an algorithm. The "experts" involved would be FDA reviewers assessing the submission and mechanical/material engineers within the company designing and testing the device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method for a test set is mentioned.
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. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For a medical implant, "ground truth" would relate to its biocompatibility, mechanical integrity, and clinical safety/efficacy, which are established through general regulatory standards and predicate device comparisons, not in the way "ground truth" is used for AI validation.
8. The sample size for the training set
- Not Applicable. No training set is mentioned as this is not an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. No training set is mentioned.
The key information from the document related to "acceptance criteria" and "study" is encapsulated in the Conclusion section:
"The Implex Continuum Knee System® Cobalt Chromium Alloy Tibial Component is substantially equivalent to the identified predicate devices."
This statement, along with the detailed comparison of "Technological Characteristics and Comparison to Predicate Device" and "Materials Comparison," serves as the basis for its regulatory acceptance. The study proving this involves a comparison of the new device's design, materials (Cobalt-Chromium Alloy), and indications for use against already legally marketed predicate devices (titanium alloy and cobalt-chromium alloy fixed keel tibial components). The acceptance criteria are that these characteristics must be sufficiently similar to the predicate devices such that the new device is as safe and effective.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Implex Continuum Knee System® Cobalt Chromium Alloy Tibial Component
| Submitter Name: | Implex Corp. |
|---|---|
| Submitter Address: | 80 Commerce DriveAllendale, New Jersey 07401-1600 |
| Contact Person: | John Schalago or Robert Poggie |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (201) 818-0567 |
| Date Prepared: | November 24, 1998 |
| Device Trade Name: | Implex Continuum Knee System® Cobalt ChromiumAlloy Tibial Component |
| Device CommonName: | Tibial Component, Cemented |
| Classification Numberand Name: | Prosthesis, Knee, Femorotibial, Semi-Constrained,Cemented, Metal/Polymer 21 CFR § 888.3530 |
| Substantial Equivalence: | The term "substantial equivalence" as used in this510(k) notification is limited to the definition ofsubstantial equivalence found in the Federal Food,Drug and Cosmetic Act, as amended and asapplied under 21 CFR 807, Subpart E under whicha device can be marketed without premarketapproval or reclassification. A determination ofsubstantial equivalency under this notification isnot intended to have any bearing whatsoever onthe resolution of patent infringement suits or anyother patent matters. No statements related to, orin support of substantial equivalence herein shallbe construed as an admission against interestunder the US Patent Laws or their application bythe courts. |
| Device Description: | The Continuum Knee System® Cobalt Chromium Alloy |
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510(k) Premarket Notification-Continued
| Indications for Use: | The Continuum Knee System® Cobalt ChromiumAlloy Tibial Component is intended for use wheresevere degeneration, trauma, or pathology of theknee joint indicates cemented total knee arthroplasty. |
|---|---|
| Device TechnologicalCharacteristics andComparison toPredicate Device: | The Continuum Knee System® Cobalt ChromiumAlloy Tibial Component incorporates design andtechnological characteristics of several commerciallyavailable titanium alloy and cobalt-chromium alloyfixed keel tibial component. |
| Materials Comparison: | The change from titanium alloy to cobalt-chromiumalloy does not effect safety or effectiveness of theContinuum Knee System Tibial components. |
| Conclusion: | The Implex Continuum Knee System® CobaltChromium Alloy Tibial Component is substantiallyequivalent to the identified predicate devices. |
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Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of three abstract, curved shapes that resemble a bird in flight or a symbolic representation of human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1999
John A. Schalago, RAC Manager, Regulatory Affairs Implex Corporation 80 Commerce Drive 07401-1600 Allendale, New Jersey
Re: K984291 Implex Continuum Knee System® Cobalt Chromium Alloy Tibial Component Regulatory Class: II Product Code: JWH Dated: November 25, 1998 Received: December 1, 1998
Dear Mr. Schalago:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:
- This device may not be labeled or promoted for non-1. cemented use.
- All labeling for this device, including package label 2. and labeling included within the package, must prominently state that the device is intended for cemented use only.
-
- Any non-cemented fixation of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for non-
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Page 2 - John A. Schalago, RAC
cemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be
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Page 3 - John A. Schalago, RAC
obtained from the Division of Small Manufacturers Assistance obtained from the Division of Smart Handrasonist
at its toll-free number (800) 638-2041 or (301) 443-659 httpl at Its Coll Iree namber (600)- Soo Carb/dsmamain.html".
its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neil R.P. Oyler for
M.D Celia M. Witten, Ph Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name:
Indications For Use:
The Continuum Knee System® Cobalt-Chromium Alloy Tibial Component is intended for use where severe degeneration, trauma, or pathology of the knee joint indicates cemented total knee arthroplasty. :
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH; Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| NAPO | |||
| (Division Sign-Off) | |||
| Division of General Restorative Devices | |||
| 510(k) Number | K984291 | ||
| Prescription Use(Per 21 CFR 801.109) | X | 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.