(72 days)
The indications for use of the Zirconia Ceramic Modular Heads include: 1) noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction of functional deformity, and 4) revision of failed hip arthroplasty.
The Biomet ceramic modular head is designed to be the articular surface of an artificial hip joint. The highly polished spherical surface articulates with a polyethylene lined cup. The ball attaches to a metallic femoral stem. These heads are compatible with all of Biomet's hip stems with Type I (4 0' ± 0 2') tapers. The metallic stems are manufactured from either titanium alloy (Ti-6Al-4V) conforming to ASTM F-136 or cobalt alloy (Co-Cr-Mo) conforming to either ASTM F-799. This submission covers 22.22 mm diameter heads with -3 and standard neck offsets.
Biomet Zirconia Ceramic Modular Heads are manufactured from Yttria Stabilized Zirconia. Manufacturing of these ceramic devices will be done entirely outside Biomet by Norton Advanced Ceramics. Mechanical testing was conducted with the final taper design in accordance with the FDA's guideline document. Devices were found to conform to all requirements including compression, pull-off and fatigue strength.
This document is a 510(k) premarket notification for a medical device, the Zirconia 22.22mm Ceramic Modular Head. It does not describe a study involving acceptance criteria and device performance in the context of an AI/algorithm-driven device. Instead, it details the regulatory submission process for a physical hip implant component.
Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI device. The document primarily focuses on:
- Device Description: A ceramic modular head for hip replacement.
- Intended Use: Noninflammatory degenerative joint disease, rheumatoid arthritis, functional deformity correction, and revision hip arthroplasty.
- Materials: Yttria Stabilized Zirconia, compatible with titanium alloy or cobalt alloy femoral stems.
- Manufacturing: Conducted by Norton Advanced Ceramics.
- Mechanical Testing: Mentioned as being conducted in accordance with FDA guidelines, covering compression, pull-off, and fatigue strength, and devices found to conform to all requirements. This is the closest mention of "acceptance criteria" and "study" but it refers to mechanical engineering tests for the physical product, not a clinical or AI performance study.
- Potential Risks: Standard risks associated with hip replacement surgery (e.g., nerve damage, infection, component loosening).
- Substantial Equivalence: Comparison to existing ceramic heads on the market, specifically mentioning a Zirconia 28mm Ceramic Modular Head by Norton (K964431) as a predicate.
- FDA Clearance: The letter from the FDA granting clearance based on substantial equivalence.
In summary, the provided text does not contain information on:
- A table of acceptance criteria and reported device performance (for an AI/algorithmic device).
- Sample size or data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone performance of an algorithm.
- Type of ground truth used (in the context of an AI device).
- Sample size for a training set.
- How ground truth for a training set was established.
The document describes the regulatory approval of a physical medical implant, not an AI software/device.
{0}------------------------------------------------
CUL 30 1994
SUMMARY OF SAFETY AND EFFECTIVENESS
Biomet, Inc. Sponsor: P.O. Box 587 Airport Industrial Park Warsaw, IN 46581-0587
Contact Person: Dalene Hufziger Binkley
Trade Name: Zirconia 22.22mm Ceramic Modular Head
Classification Name: Hip joint metal/ceramic/polymer semiconstrained cemented or non-cemented prosthesis.
Intended Use: The Zirconia 22.22 mm Ceramic Modular Head can be used for noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, and revision of failed hip arthroplasty.
Device Description: The Biomet ceramic modular head is designed to be the articular surface of an artificial hip joint. The highly polished spherical surface articulates with a polyethylene lined cup. The ball attaches to a metallic femoral stem. These heads are compatible with all of Biomet's hip stems with Type I (4 0' ± 0 2') tapers. The metallic stems are manufactured from either titanium alloy (Ti-6Al-4V) conforming to ASTM F-136 or cobalt alloy (Co-Cr-Mo) conforming to either ASTM F-799. This submission covers 22.22 mm diameter heads with -3 and standard neck offsets.
Biomet Zirconia Ceramic Modular Heads are manufactured from Yttria Stabilized Zirconia. Manufacturing of these ceramic devices will be done entirely outside Biomet by Norton Advanced Ceramics. Mechanical testing was conducted with the final taper design in accordance with the FDA's guideline document. Devices were found to conform to all requirements including compression, pull-off and fatigue strength.
Potential Risks: The potential risks associated with this device are the same as with any hip replacement device. These include, but are not limited to:
| Nerve Damage |
|---|
| Blood Vessel Damage |
| Cardiovascular Disorders |
| Delayed Would Healing |
| Fatigue Fracture of Component |
| Component Migration/Loosening |
Material Sensitivity Deformity of the Joint Muscle Laxity Soft Tissue Subluxation Dislocation
Bone Fracture Excessive Wear Infection Imbalance Hematoma
{1}------------------------------------------------
Substantial Equivalence: The Zirconia 22.22 mm Ceramic Modular Heads from Norton Advanced Ceramics are substantially equivalent to other ceramic heads on the market. A predicate to the 22.22 mm head is the Zirconia 28 mm Ceramic Modular Head also by Norton (K964431).
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, with three lines representing the head, body, and legs.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Ms. Dalene Hufziger Binkley Regulatory Specialist Biomet Inc. P.O. Box 587 Warsaw, Indiana 46581
Re: K991708
Trade Name: Zirconia 22.22mm Ceramic Modular Head Regulatory Class: II Product Code: LZO Dated: May 10, 1999 Received: May 19, 1999
Dear Ms. Binkley:
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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 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 regulations.
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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
{3}------------------------------------------------
Page 2 - Ms. Dalene Hufziger Binkley
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 obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Page / of /
510 (k) NUMBER (if KNOWN): _ | 991708
DEVICE NAME: Zirconia 22.22mm Ceramic Modular Heads
INDICATIONS FOR USE:
The indications for use of the Zirconia Ceramic Modular Heads include: 1) noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction of functional deformity, and 4) revision of failed hip arthroplasty.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Resterathe Devices
510(k) Number K991708
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.