(24 days)
The Trabecular Metal Technology Acetabular Augment System is intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.
The TMT Acetabular Augment possesses a truncated hemispherical geometry with an inner diameter 3mm larger than the major diameter of the corresponding acetabular cup. The TMT Augment is available in OD sizes 40 to 70 mm in 2 mm increments, and each size is offered in various thicknesses, 5mm to 30mm in 5 mm increments. The TMT Acetabular Augment includes portals that allow the use of Continuum Bone Screws, 5mm and 6.5mm, and Zimmer Trilogy and HGP II 6.5 mm bone screws for adjunct fixation. In addition, the portals also provide a containment system for bone graft in cementless applications.
This document is a 510(k) summary for the "Trabecular Metal Technology Acetabular Augment System." A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive de novo clinical study data to prove novel performance criteria. Therefore, the information you've requested regarding acceptance criteria and performance studies in the context of typical AI/software device submissions is largely not applicable or not present in this type of submission.
Here's a breakdown based on the provided text, indicating what is present and what is not:
1. A table of acceptance criteria and the reported device performance
Not Applicable/Not Provided: This document is concerned with demonstrating substantial equivalence to a predicate device, not with setting quantitative performance acceptance criteria for a novel device and then reporting against them. The "performance" here is implied by its similarity to existing, approved devices.
The acceptance criteria for this 510(k) submission are implicitly demonstrating that the augment system is substantially equivalent to the identified predicate devices in terms of indications for use, technological characteristics, and safety/effectiveness.
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/Not Provided: This type of information would be expected for a clinical study assessing the performance of a diagnostic or therapeutic device based on patient data (e.g., imaging, clinical outcomes). Since this submission focuses on substantial equivalence of a physical implant (acetabular augment), such a "test set" and data provenance are not part of the 510(k) summary provided. Substantial equivalence is typically established through material characterization, mechanical testing, and comparison of design features to 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/Not Provided: Ground truth establishment by expert consensus is relevant for diagnostic devices (e.g., AI in radiology). This submission is for a medical implant, and therefore, an "expert ground truth" in this context is not applicable. The implicit "ground truth" here is the established safety and effectiveness of the predicate devices to which this new device is compared.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not Applicable/Not Provided: Adjudication methods are used in studies involving human interpretation (e.g., radiologists reviewing images) to resolve discrepancies and establish a robust ground truth. As noted above, such a "test set" and expert review process are not part of this 510(k) submission for an implant.
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/Not Provided: MRMC studies are specific to evaluating diagnostic devices, particularly those involving human interpretation, and often when AI assistance is being assessed. This submission is for a physical medical implant, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable/Not Provided: This question is relevant for AI algorithms. The Trabecular Metal Technology Acetabular Augment System is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable/Not Provided in the typical sense: As an implant, the "ground truth" for its safety and effectiveness would be established through:
- Biocompatibility testing (e.g., ISO 10993 standards).
- Mechanical testing (e.g., fatigue strength, static strength, wear characteristics if applicable to the acetabular cup interface, but this is an augment, not the cup itself).
- Comparison to predicate device materials and design.
- Relevant clinical literature/experience with similar devices.
These are not "ground truth" in the diagnostic sense, but rather the evidence base for safety and performance. This 510(k) summary does not detail these specific tests, but rather concludes based on such evidence that the device is substantially equivalent.
8. The sample size for the training set
Not Applicable/Not Provided: This device is a physical implant, not a software algorithm that requires a training set.
9. How the ground truth for the training set was established
Not Applicable/Not Provided: As this is not a device based on machine learning, there is no "training set" or establishment of ground truth for such a set.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per 510(k) context):
The "study" in a 510(k) context for a device like this is a comparison and analysis demonstrating substantial equivalence to legally marketed predicate devices. The document explicitly states:
- Conclusion: "The Trabecular Metal Technology Acetabular Augment System is substantially equivalent to the identified predicate devices."
- Basis for Equivalence: Implied by the device description which details its geometry, sizes, and compatibility with existing bone screws, suggesting it functions similarly to existing acetabular augmentation devices (e.g., structural allografts, as mentioned in the Indications for Use). The FDA's letter confirms this finding of substantial equivalence.
While the provided text excerpt doesn't detail the specific tests conducted (e.g., mechanical tests, material characterization, biocompatibility studies), a full 510(k) submission would include these data to support the claim of substantial equivalence to a predicate. The "acceptance criteria" here is simply the FDA's regulatory threshold for substantial equivalence.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The Trabecular Metal Technology Acetabular Augment System
| Submitter Name: | Implex Corp. |
|---|---|
| Submitter Address: | 80 Commerce DriveAllendale, New Jersey 07401-1600 |
| Contact Person: | Robert A. Poggie, Ph.D. |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (201) 995-9722 |
| Date Prepared: | August 2, 2001 |
| Device Trade Name: | The Trabecular Metal Technology Acetabular AugmentSystem |
| Device CommonName: | Acetabular augmentation devices for total hip replacementacetabular components |
| Classification Number: | 21 CFR § 888.3358 |
The term "substantial equivalence" as used in this Substantial 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 A determination of substantial reclassification. 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 aqainst interest under the US Patent Laws or their application by the courts.
The TMT Acetabular Augment possesses a truncated Device Description: hemispherical geometry with an inner diameter 3mm larger than the major diameter of the corresponding acetabular cup. The TMT Augment is available in OD sizes 40 to 70 mm in 2 mm increments, and each size is offered in various thicknesses, 5mm to 30mm in 5 mm The TMT Acetabular Augment includes increments. portals that allow the use of Continuum Bone Screws, 5mm and 6.5mm, and Zimmer Trilogy and HGP II 6.5 mm bone screws for adjunct fixation. In addition, the portals also provide a containment system for bone graft in cementless applications.
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<012507
2 OF 2
510(k) Summary (Continued)
Indications for Use: The Trabecular Metal Technology Acetabular Augment System is intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.
Conclusion:
The Trabecular Metal Technology Acetabular Augment System is substantially equivalent to the identified předicate 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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2001
Robert A. Poggie, Ph.D. Director of Applied Research Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K012507
Trade Name: The Trabecular Metal Technology Acetabular Augmentation System Regulation Number: 888.3358 Regulatory Class: II Product Codes: LPH Dated: August 3, 2001 Received: August 6, 2001
Dear Dr. Poggie:
We have reviewed your Section 510(k) notification of intent to market the device referenced wo have and we 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 suiced in also are, 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). You may, therefore, market the device, subject to the general controls Cosisions of the Act. The general controls provisions of the Act include requirements for annual provisions of its in the concess, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Trenditor Inproval), in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 mspotions, and 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 regulations.
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Page 2 - Robert A. Poggie, Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 N Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
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510(k) Number (if known) :
Device Name:
The Trabecular Metal Technology Acetabular Augment System
Indications For Use:
The Trabecular Metal Technology Acetabular Augment System is intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH; Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K012507 |
| Prescription Use (Per 21 CFR 801.109) | Over-The-Counter Use |
| (Optional Format 1-2-96) |
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.