(87 days)
The Trabecular Metal Osteonecrosis Intervention Implant is indicated for use in patients with Stage I or Stage II osteonecrosis of the femoral head (Steinberg/UPenn System) and who would qualify for core decompression based upon physical and radiographic examination and medical history. The Trabecular Metal Osteonecrosis Intervention Implant may be used with or without bone graft.
The Trabecular Metal Osteonecrosis Intervention Implant is fabricated from Trabecular MetalTM porous tantalum. The implant is cylindrical in shape with a 10 mm diameter and length options from 70 to 130 mm in 5 mm increments.
The Trabecular Metal Osteonecrosis Intervention Implant possesses distal threads for engagement of bone. The threaded portion is 25 mm in length and the outer diameter is 14 mm, the inner diameter is 10 mm. Slots within the lateral most aspect of the implant interface with the driving instrument.
Here's an analysis of the provided text regarding the Trabecular Metal Osteonecrosis Intervention Implant, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list distinct "acceptance criteria" in a quantitative format, which is common for mechanical devices rather than software algorithms. Instead, the device's performance is described in terms of its ability to safely support weakened bone and its clinical performance.
| Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|
| Mechanical Performance: Safely supports weakened bone associated with early stage osteonecrosis of the femoral head. | Mechanical Testing: Characterized per modified ASTM testing standards for THR devices, mechanical test methods that simulated bone deficiencies caused by early stage femoral head osteonecrosis, and finite element modeling of the device. Results showed the subject device safely supports weakened bone. |
| Clinical Performance: Safe and efficacious use per the indicated patient population and conditions. | Clinical Data: Data collected under IDE G990234 showed the device to perform safely and efficaciously per the indications for use in patients with Stage I or Stage II osteonecrosis of the femoral head qualifying for core decompression. |
| Substantial Equivalence: Comparable to predicate devices in technological characteristics and properties. | Comparison to Predicate Devices: Demonstrates substantial equivalence to cited predicate devices based on a comparison of device technological characteristics and properties. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "clinical data collected under IDE G990234." However, it does not specify the sample size (number of patients or cases) of this clinical study that served as the "test set" for demonstrating clinical safety and efficacy.
- Data Provenance: The document does not explicitly state the country of origin. It refers to an "IDE G990234," which is an Investigational Device Exemption from the FDA, implying the clinical study primarily occurred in the United States. The study was prospective, as it was conducted under an IDE for collecting clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide any information regarding the number of experts used to establish ground truth for the test set or their qualifications. The clinical data was collected to demonstrate safety and efficacy, likely evaluated by clinical investigators and an independent review board, but specific details on "ground truth" experts in the context of diagnostic performance (as would be relevant for an AI device) are absent. This is a medical implant, not a diagnostic AI device.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. This level of detail is typically not included in a 510(k) summary for a medical device like an implant unless there's a specific need to reconcile divergent interpretations of clinical outcomes, which is not highlighted here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is designed to assess the performance of diagnostic tools (often imaging reads) and the impact of AI assistance on human readers. This device is a medical implant, not a diagnostic tool or an AI algorithm, so an MRMC study is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical implant, not an algorithm. Therefore, "standalone" algorithm performance is not relevant, and such a study was not conducted.
7. The Type of Ground Truth Used
For this medical implant, the "ground truth" used for performance assessment was based on:
- Clinical Outcomes/Performance Data: The term "safely and efficaciously" indicates that patient outcomes, perhaps in terms of pain reduction, improved mobility, or prevention of osteonecrosis progression, served as the clinical "ground truth."
- Mechanical Properties Data: "Modified ASTM testing standards for THR devices" and "mechanical test methods that simulated bone deficiencies" represent the mechanical "ground truth" against which the implant's structural integrity and support capabilities were evaluated.
- Finite Element Modeling (FEM) Data: FEM provides a computational "ground truth" for predicting how the device interacts with bone under various stress conditions.
8. The Sample Size for the Training Set
The concept of a "training set" is relevant for AI/machine learning algorithms. This device is a physical implant, not an AI algorithm. Therefore, there is no training set in the AI sense. The mechanical testing and finite element modeling would have involved various configurations and stress scenarios, but these are not "training data" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of an AI algorithm, this question is not applicable to the Trabecular Metal Osteonecrosis Intervention Implant. For the mechanical and clinical studies, the "ground truth" (i.e., the accepted standard for safety and efficacy) was established through scientifically recognized methods:
- Mechanical Studies: Established via "modified ASTM testing standards" and "finite element modeling." ASTM standards are widely accepted industry benchmarks for material and device testing.
- Clinical Studies: Established via a prospective clinical trial conducted under an IDE (G990234), which implies adherence to ethical guidelines and scientific rigor for evaluating patient safety and efficacy outcomes.
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Zimmer Trabecular Metal Technology, Inc.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
APR 1 5 2005 The Trabecular Metal Osteonecrosis Intervention Implant
| Submitter Name | Zimmer Trabecular Metal Technology, Inc. |
|---|---|
| And Address: | 80 Commerce DriveAllendale, New Jersey 07401-1600 |
| Contact Person: | Robert A Poggie, PhD |
| Phone Number: | (201) 818 - 1800, X 519 |
| Fax Number: | (973) 829 - 0825 |
| Date Prepared: | April 12, 2005 |
| Device Trade Name: | Trabecular Metal Osteonecrosis Intervention Implant |
| Device Common Name: | Porous metal rod |
| Classification Numberand Name: | 21 CFR § 888.3030; product code HRS - Single/multiplecomponent metallic bone fixation appliances and accessories |
| SubstantialEquivalence: | The term "substantial equivalence" as used in this 510(k)notification is limited to the definition of substantial equivalencefound in the Federal Food, Drug and Cosmetic Act, as amendedand as applied under 21 CFR 807, Subpart E under which a devicecan be marketed without premarket approval or reclassification.A determination of substantial equivalency under this notificationis not intended to have any bearing whatsoever on the resolutionof patent infringement suits or any other patent matters. Nostatements related to, or in support of substantial equivalenceherein shall be construed as an admission against interest underthe US Patent Laws or their application by the courts. |
| DeviceDescription: | The Trabecular Metal Osteonecrosis Intervention Implant isfabricated from Trabecular MetalTM porous tantalum. The implant iscylindrical in shape with a 10 mm diameter and length options from 70to 130 mm in 5 mm increments.The Trabecular Metal Osteonecrosis Intervention Implantpossesses distal threads for engagement of bone. The threadedportion is 25 mm in length and the outer diameter is 14 mm, the innerdiameter is 10 mm. Slots within the lateral most aspect of the implantinterface with the driving instrument. |
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Zimmer Trabecular Metal Technology, Inc.
Trabecular Metal Osteonecrosis Intervention Implant 510(k) Premarket Notification ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Summary Continued ...
Indications for The Trabecular Metal Osteonecrosis Intervention Implant is indicated Use: for use in patients with Stage I or Stage II osteonecrosis of the femoral head (Steinberg/UPenn System) and who would qualify for core decompression based upon physical and radiographic examination and medical history. The Trabecular Metal Osteonecrosis Intervention Implant may be used with or without bone graft.
Device Technological Characteristics & Comparison to Predicate Device: A comparison of device technological characteristics and properties demonstrates that the device is substantial equivalent to the cited predicate devices.
- Performance The Trabecular Metal Osteonecrosis Intervention Implant was Data: characterized per modified ASTM testing standards for THR devices, mechanical test methods that simulated bone deficiencies caused by early stage femoral head osteonecrosis, and finite element modeling of the device. The results of these tests showed that the subject device safely supports weakened bone associated with early stage osteonecrosis of the femoral head. The clinical data collected under IDE G990234 show the device to perform safely and efficaciously per the indications for use.
- Conclusion: The Trabecular Metal Osteonecrosis Intervention Implant is substantially equivalent to the cited predicate devices identified in this premarket notification.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
APR 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Robert A. Poggie, Ph.D. Zimmer Trabecular Metal Technology, Inc. 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K050101
Trade/Device Name: The Trabecular Metal Osteonecrosis Intervention Implant Regulation Number: 21 CFR 888.3030 Regulation Name: Single/ multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: January 17, 2005 Received: January 18, 2005
Dear Dr. Poggie:
We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave a nowe 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 docs 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 - Robert A. Poggie, Ph.D.
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/cdrl/industry/support/index.html.
Sincerely yours,
Stypk Rlurde
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ко50101 510(k) Number (if known) :
The Trabecular Metal Osteonecrosis Intervention Implant
Device Name:
Indications For Use:
The Trabecular Metal Osteonecrosis Intervention Implant is indicated for use in patients with Stage I or Stage II osteonecrosis of the femoral head (Steinberg/UPerin System) and who would qualify for core decompression based upon physical and radiographic examination and medical history. The Trabecular Metal Osteonecrosis Intervention Implant may be used with or without bone graft.
X Prescription Use
AND/OR. . .
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
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1 Rect 11 1146 Division of Ge and Neurologica Sec. 22.6
E10(k) Niimhe
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.