(49 days)
The Trabecular Metal Revision Shell Liner is indicated for cemented use in the Trabecular Metal Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage.
This modified device is intended for cemented use in conjunction with a Trabecular Metal Revision Shell. The liner is offered in a broad range of sizes with 0- and 10-degree face angle versions to accommodate a variety of patient anatomies.
The provided text describes a 510(k) premarket notification for a medical device called "Trabecular Metal™ Revision Shell Liners." This submission is a "Special 510(k): Device Modification" and relies on substantial equivalence to a predicate device.
Here's an analysis of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of specific performance thresholds for sensitivity, specificity, or similar metrics. Instead, it focuses on substantial equivalence to a predicate device.
The reported device performance comes from non-clinical testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device | Non-clinical testing demonstrated that the Trabecular Metal Revision Shell Liners are substantially equivalent to the predicate device. |
Note on Acceptance Criteria: For a 510(k) submission, especially a Special 510(k) for device modification, the primary "acceptance criterion" is often demonstrating that the modified device is as safe and effective as a legally marketed predicate device, and that any changes do not raise new questions of safety or effectiveness. This is typically achieved through comparative testing against the predicate or relevant standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "Non-clinical testing demonstrated that the Trabecular Metal Revision Shell Liners are substantially equivalent to the predicate device." It does not provide details on the number of units tested, the specific tests conducted, or the sample size used in those tests.
- Data Provenance: The tests are described as "Non-clinical Performance," suggesting laboratory or bench testing. The country of origin of the data is not specified, but the submitter (Zimmer, Inc.) is based in Warsaw, IN, USA. The data is implicitly retrospective in the sense that the testing was performed and then reported, but it is not clinical data derived from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is not an AI/ML device, and the evaluation relies on non-clinical performance testing rather than expert-derived ground truth from interpreting images or patient data.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is about non-clinical performance (bench testing), not expert consensus on interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data and conclusions were not needed for this device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done
Not applicable. This is not an AI/ML device with an algorithm for standalone performance.
7. The Type of Ground Truth Used
The "ground truth" for this submission is implicitly established by established engineering and material science principles and performance standards. The non-clinical testing would have been designed to measure physical and mechanical properties relevant to the device's function and safety, comparing them to the predicate device and potentially relevant ASTM or ISO standards.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device that requires a training set.
In summary, this document describes a traditional medical device submission (a Special 510(k) for a modification) that relies on non-clinical bench testing to demonstrate substantial equivalence to a predicate device. It does not involve AI/ML components, clinical studies, or expert-derived ground truth, which are typically found in submissions for AI-enabled devices.
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Image /page/0/Picture/0 description: The image contains the word "zimmer" in bold, black font. To the left of the word is a circle with a bold, black "Z" inside. There is a horizontal line underneath the word "zimmer". The logo appears to be for the Zimmer company.
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Summary of Safety and Effectiveness
JUL 2 7 2005
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Karen CainManager, Corporate Regulatory AffairsTelephone: (574) 372-4219Fax: (574) 372-4605 |
| Date: | June 7, 2005 |
| Trade Name: | Trabecular Metal™ Revision Shell Liners |
| Common Name: | Acetabular Cup |
| Classification Nameand Reference: | Prosthesis, Hip, Semi-Constrained, Metal/Polymer,Cemented21 CFR § 888.3350 |
| Predicate Device: | Implex Hedrocel® Replacement Cup Insert,manufactured by Zimmer TMT (formerly known asImplex), K983128, cleared December 3, 1998. |
| Device Description: | This modified device is intended for cemented usein conjunction with a Trabecular Metal RevisionShell. The liner is offered in a broad range of sizeswith 0- and 10-degree face angle versions toaccommodate a variety of patient anatomies. |
| Intended Use: | The Trabecular Metal Revision Shell Liners areindicated for cemented use in the Trabecular MetalRevision Shell for initial placement or as an in situreplacement polyethylene bearing surface for jointinstability, wear and/or damage. |
| Comparison to Predicate Device: | Except for a change in material and minordimensional changes, the Trabecular MetalRevision Shell Liners are identical to the predicatedevice. The modified device uses the sameoperating principle, intended uses and fixationmethod as the predicate device. |
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Image /page/1/Picture/0 description: The image contains the logo for Zimmer. The logo consists of a stylized letter Z inside of a circle, followed by the word "zimmer" in lowercase letters. The logo is black and white.
K051516/S1
Special 510(k): Device Modification
1 20
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
Non-clinical testing demonstrated that the Trabecular Metal Revision Shell Liners are substantially equivalent to the predicate device.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2005
Ms. Karen Cain Manager, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K051516
Trade/Device Name: Trabecular Metal™ Revision Shell Liners Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: July 14, 2005 Received: July 15, 2005
Dear Ms. Cain:
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 - Ms. Karen Cain
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter wifi anow you to organizal equivalence of your device of your device to a legally premarket notification: "The Pro Printings of 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 If you doon't 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 other general mionnal 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,
St. Kipti Church
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K 051576/51
Indications for Use
510(k) Number (if known):
Device Name:
Trabecular Metal™ Revision Shell Liners
Indications for Use:
The Trabecular Metal Revision Shell Liner is indicated for cemented use in the Trabecular Metal THE Travet and Mellar Revision Bhich Ement polyethylene bearing surface for joint instability, wear and/or damage.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hyt Slurdu
(Division 'Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
KOS 1516 510(k) Number.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.