(37 days)
The VerSys Beaded FullCoat Calcar Hip Prosthesis is designed to achieve biologic fixation to bone and is indicated for:
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, disability due to previous fusion, previously failed endoprostheses and/or total hip components in the affected extremity, and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip, elderly, debilitated patients when a total hip replacement is contraindicated, irreducible fractures in which adequate fixation cannot be obtained, certain high subcapital fractures and comminuted fractures, secondary avascular necrosis of the femoral head, pathological fractures of the femoral neck, and osteoarthritis in which the femoral head is primarily affected.
Like its predicate, the VerSys Beaded FullCoat Calcar Hip Prosthesis is a modular femoral stem manufactured from Co-Cr-Mo alloy and has a sintered Co-Cr-Mo alloy bead porous surface coating. The modified device features a calcar region designed with 10 and 20mm build-up heights in both straight and bowed hip stems.
The document provided describes a premarket notification (510(k)) for the VerSys® Beaded FullCoat Calcar Hip Prosthesis, not a study assessing the performance of Artificial Intelligence (AI) or a software product against acceptance criteria.
The information primarily focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for medical devices in the United States. Therefore, most of the questions pertaining to acceptance criteria and a study proving a device's performance with specific metrics like sensitivity, specificity, or human improvement with AI assistance are not applicable to this document.
However, I can extract the relevant information regarding the device description, intended use, and the performance data that was provided for its clearance.
Acceptance Criteria and Study for VerSys® Beaded FullCoat Calcar Hip Prosthesis
Given that this is a 510(k) submission document for a physical medical device (hip prosthesis) and not an AI/software product, the concept of "acceptance criteria" and "device performance" as typically applied to AI studies (e.g., sensitivity, specificity, human-in-the-loop improvement) is not directly presented in the same format.
Instead, the "acceptance criteria" for a 510(k) submission are primarily related to demonstrating substantial equivalence to a legally marketed predicate device. This involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The "study" in this context is the comparison and analysis performed to support this substantial equivalence.
Summary of Relevant Information from the Document:
1. Table of Acceptance Criteria and Reported Device Performance:
- No explicit table of quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) or direct "reported device performance" metrics (like clinical trial outcomes comparing the new device to a standard) is provided in this 510(k) summary.
- The primary "acceptance criterion" for this submission is substantial equivalence to the predicate device.
- The "reported device performance" is a finite element analysis (FEA) demonstrating equivalence.
| Aspect | Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The modified device must be substantially equivalent in intended use, technological characteristics, and not raise new questions of safety/effectiveness compared to the predicate device. | The modifications do not change the intended use or fundamental scientific technology. |
| Mechanical Performance/Safety | The mechanical properties and design should be equivalent to the predicate device to ensure safety and effectiveness. | Finite element analysis demonstrated that the device is equivalent to the predicate. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission does not involve a "test set" or "data provenance" in the context of an AI/software study. The "testing" involved a finite element analysis, which is a computational simulation. The "data" would be the engineering specifications and material properties of the devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this is a mechanical device and a 510(k) submission, there is no "ground truth" established by experts in the context of diagnostic accuracy for a test set. Engineering and materials science expertise would be involved in the design and analysis.
4. Adjudication method for the test set:
- Not applicable. No test set or adjudication method is described in the context of an AI/software study.
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 a physical hip prosthesis, not an AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical hip prosthesis, not an algorithm.
7. The type of ground truth used:
- Not applicable in the AI context. For a physical device like this, the "ground truth" for design validation and safety would be established through industry standards, biocompatibility testing, mechanical testing (fatigue strength, wear, etc.), and clinical history of similar devices. The document specifically mentions Finite Element Analysis (FEA) as the performance data. FEA uses mathematical models and simulations to predict how a product reacts to forces, heat, fluid flow, and other physical effects. Its "ground truth" or validation would come from physical tests of prototypes or established engineering principles.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" as this is not an AI/machine learning model.
In summary: The provided document is a regulatory submission (510(k)) for a revision hip prosthesis. The "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to a predicate device through engineering analysis (Finite Element Analysis) rather than clinical performance data or AI algorithm validation against specific metrics.
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Image /page/0/Picture/1 description: The image contains the word "zimmer" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized "Z" inside. The logo is black and white, with the "Z" being black and the circle being white. There is a horizontal line below the word "zimmer".
| 1 *21 | l1 |
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| NOV - 5 2003 | Summary of Safety and Effectiveness |
|---|---|
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
| Contact Person: | Karen CainManager, Regulatory AffairsTelephone: (574) 372-4219Fax: (574) 372-4605 |
| Date: | September 22, 2003 |
| Trade Name: | VerSys® Beaded FullCoat Calcar Hip Prosthesis |
| Common Name: | Hip prosthesis |
| Classification Nameand Reference: | Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis |
| 21 CFR § 888.3358 | |
| Predicate Device: | VerSys Beaded FullCoat Bowed Revision HipProsthesis, manufactured by Zimmer, K030079,cleared February 5, 2003 |
| Device Description: | Like its predicate, the VerSys Beaded FullCoatCalcar Hip Prosthesis is a modular femoral stemmanufactured from Co-Cr-Mo alloy and has asintered Co-Cr-Mo alloy bead porous surfacecoating. The modified device features a calcarregion designed with 10 and 20mm build-up heightsin both straight and bowed hip stems. |
| Intended Use: | The VerSys Beaded FullCoat Calcar Hip Prosthesisis designed to achieve biologic fixation to bone andis indicated for: |
| Total hip replacement for the following: severe hippain and disability due to rheumatoid arthritis,osteoarthritis, traumatic arthritis, polyarthritis,collagen disorders, avascular necrosis of thefemoral head, nonunion of previous fractures of the |
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| Ammer |
|---|
| ------- |
femur, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, disability due to previous fusion, previously failed endoprostheses and/or total hip components in the affected extremity, and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip, elderly, debilitated patients when a total hip replacement is contraindicated, irreducible fractures in which adequate fixation cannot be obtained, certain high subcapital fractures and comminuted fractures, secondary avascular necrosis of the femoral head, pathological fractures of the femoral neck, and osteoarthritis in which the femoral head is primarily affected.
The modifications to the VerSys Beaded FullCoat Comparison to Predicate Device: Bowed Revision Hip Prosthesis do not change either the intended use or the fundamental scientific technology of the device. It is packaged and sterilized utilizing the same materials and processes. The modified device is designed to offer another revision style line extension to the existing system of implants.
Performance Data:
Finite element analysis demonstrated that the device is equivalent to the predicate.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like shapes extending to the right.
Public Health Service
NOV = 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Cain Manager, Regulatory Affairs Zimmer. Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K033034
Trade/Device Name: Versys ® Beaded FullCoat Calcar Hip Prosthesis Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. Regulatory Class: II Product Code: LPH Dated: September 26, 2003
Received: October 6, 2003
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. Iisting 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) 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 (301) 594-4659. 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milkerson
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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Indications for Use
Page 1 of 1
0
510(k) Number (if known):
Device Name:
VerSys® Beaded FullCoat Calcar Hip Prosthesis
Indications for Use:
The VerSys Beaded FullCoat Calcar Hip Prosthesis is designed to achieve biologic fixation to bone and is indicated for:
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, disability due to previous fusion, previously failed endoprostheses and/or total hip components in the affected extremity, and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip, elderly, debilitated patients when a total hip replacement is contraindicated, irreducible fractures in which adequate fixation cannot be obtained, certain high subcapital fractures and comminuted fractures, secondary avascular necrosis of the femoral head, pathological fractures of the femoral neck, and osteoarthritis in which the femoral head is primarily affected.
(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 | K0 33034 |
|---|---|
| --------------- | ---------- |
| Prescription Use(Per 21 CFR 801.109) | OR | 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.