(219 days)
The Metal on Metal Acetabular System is indic. ted for used in patients requiring total hip replacement due to the following:
- a.) Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, leg perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures, and traumatic arthritis
- b.) Rheumatoid arthritis
- c.) Correction of functional deformity
- d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- e.) Revision of previously failed total hip arthroplasty.
The Metal on Metal Acetabular System consists of a titanium outer shell with a cobalt chromium metallic liner, which articulates with a cobalt chromium modular head. Based on mechanical testing, it has been shown that the Metal on Metal Acetabular System exhibits decreased wear compared to the wear observed in the traditional polyethylene and metal acetabular systems.
This document is a 510(k) summary for a medical device (Metal on Metal Acetabular System) seeking substantial equivalence to existing devices. It does not describe a study to prove acceptance criteria or device performance in the way a clinical trial or performance study would for an AI/ML powered device. Instead, it focuses on describing the device, its intended use, and comparing it to predicate devices to demonstrate substantial equivalence for regulatory approval.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not available within this document because it describes a mechanical device, not an AI/ML powered medical device.
The document highlights the device's design, materials, and mechanical properties. The "acceptance criteria" in this context would likely refer to regulatory standards for mechanical device performance (e.g., wear, strength, biocompatibility), which are typically demonstrated through engineering tests and material specifications, rather than clinical studies with human readers or AI algorithms.
Summary of available information (and lack thereof for AI/ML specific questions):
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied): The document implies acceptance criteria related to mechanical properties and wear performance, as it states: "Based on mechanical testing, it has been shown that the Metal on Metal Acetabular System exhibits decreased wear compared to the wear observed in the traditional polyethylene and metal acetabular systems." Specific numerical acceptance criteria are not provided.
- Reported Device Performance:
- Wear: "decreased wear compared to the wear observed in the traditional polyethylene and metal acetabular systems." (No specific quantitative wear rates are mentioned for the new device itself, only a comparative statement).
- Liner Sphericity: Average Peak to Valley deviation of 59.8024 micro-inches. This is stated to be "less than half the allowable deviation set forth in the ISO standard for modular head sphericity." (This is a performance metric against an implied ISO standard acceptance criterion).
- Liner Surface Roughness: Articulating surface averages 0.17 micro-inches Rₐ.
- Modular Head Surface Roughness: Articulating surface is 0.43 micro-inches. Bore surface roughness is 34 micro-inches.
2. Sample size used for the test set and the data provenance: Not applicable. This is for a mechanical device; there's no "test set" in the context of an AI/ML study. Performance is evaluated through mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document pertains to a mechanical device, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. "Ground truth" for this device would be established by engineering specifications, material properties, and mechanical test results (e.g., measuring wear rates in a lab, verifying dimensions against blueprints).
8. The sample size for the training set: Not applicable. There is no training set for a mechanical device.
9. How the ground truth for the training set was established: Not applicable.
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MAY 1 8 2000
SUMMARY OF SAFETY AND EFFECTIVENESS
| SPONSOR: | Biomet, Inc.P.O. Box 587Airport Industrial ParkWarsaw, Indiana 46581-0587 |
|---|---|
| CONTANT PERSON: | Michelle L. McKinley |
| DEVICE NAME: | Metal on Metal Acetabular System |
| CLASSIFICATION NAME: | Prosthesis, Hip, Semi-constrained (MetalUncemented Acetabular Component) |
INTENDED USE:
The Metal on Metal Acetabular System is indic. ted for used in patients requiring total hip replacement due to the following:
- a.) Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, leg perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures, and traumatic arthritis
- b.) Rheumatoid arthritis
- c.) Correction of functional deformity
- d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- e.) Revision of previously failed total hip arthroplasty.
DEVICE DESCRIPTION:
The Metal on Metal Acetabular System consists of a titanium outer shell with a cobalt chromium metallic liner, which articulates with a cobalt chromium modular head. Based on mechanical testing, it has been shown that the Metal on Metal Acetabular System exhibits decreased wear compared to the wear observed in the traditional polyethylene and metal acetabular systems.
Acetabular Shell
The acetabular shells that will initially be available in two designs, the Mallory Head Radial and the Universal Acetabular Component. Both designs are modular two-piece systems consisting of a modular cobalt chromium (Co-Cr-Mo) liner and a porous coated titanium shell. Hemispherical shape of both outer shells closes matches the natural acetabulum, which leads to minimal bone removal in preparation for implantation. The two acetabular shell designs are available with holes or as a solid dome. If necessary, the
Image /page/0/Picture/16 description: The image shows a sequence of numbers, specifically '000358'. The numbers are printed in a bold, stencil-like font, giving them a slightly rugged appearance. The digits are uniformly sized and spaced, creating a clear and easily readable sequence.
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shell with holes allows the use of 6.5 mm dome and the 5.0 mm rim screws for optional supplemental fixation. The solid shell configuration without dome holes increases the surface area of the porous plasma spray coating. The Mallory Head acetabular shell features four fins, which aid in preventing rotation.
The outer surface of the shell is covered with a porous coating of titanium alloy (Ti-6Al-4V) powder conforming to ASTM-F136, which ensures immediate component fixation and maximum bone-to-implant contact. The plasma sprayed surface consists of particles which are bonded together to form a random pattern with interconnecting pores.
Acetabular Liner
The metallic cobalt chromium bearing liner fits into the outer shell by means of a taper similar to the taper used for the attachment of the modular head. The locking mechanism consists of a three degree taper with a maximum engagement of 0.075 inches. The surface roughness of the articulating surface averages 0.17 micro-inches Rg. The sphericity of the liner components has an average Peak to Valley deviation of 59.8024 micro-inches. This is less than half the allowable deviation set forth in the ISO standard for modular head sphericity.
Modular Femoral Head
The Metal on Metal Acetabular System utilizes a 28mm cobalt chromium (Co-Cr-Mo) modular femoral head with seven neck lengths (-6mm to +12mm). Each modular head has a four degree angle included in the bore with a surface roughness of 34 micro-inches. The articulating surface is highly polished with a surface roughness of 0.43 micro-inches.
The modular heads may be used in conjunction with any of Biomet's commercially available femoral components. At the time of surgery, the modular head is assembled with a femoral stem.
POTENTIAL RISKS:
The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
Fracture of the component Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the joint Tissue growth failure Delayed wound healing Metal sensitivity
Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Dislocation Breakdown of the porous surface
000359
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SUBSTANTIAL EQUIVALENCE:
The Metal on Metal Acetabular System is similar to previously marketed devices. Direct comparison was made with the following predicate devices:
Mallory Head Finned Acetabular Cup Universal Acetabular Cup Biomet Co-Cr Femoral Components Sulzer's Inter-Op Metasul
000360
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 2000
Ms. Michelle L. McKinley Regulatory Specialist Biomet. Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K993438/S1
Trade Name: Metal on Metal Acetabular Component Regulatory Class: III Product Code: KWA Dated: February 18, 2000 Received: February 22, 2000
Dear Ms. McKinley:
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.
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Page 2 - Ms. Michelle L. McKinley
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,
Russell Sage
Su Celia M. Whitten, 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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| Page | ____________ |
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| of | ____________ |
K993438 510(k) Number if Known: ______________________________________________________________________________________________________________________________________________________ Device Name: Metal on Metal Acetabular System
The Metal on Metal Acetabular System is indicated for used in patients requiring total hip replacement due to the following:
- a.) Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, leg perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures, and traumatic arthritis
- b.) Rheumatoid arthritis
- c.) Correction of functional deformity
- d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmar igeable using other techniques.
- e.) Revision of previously failed total 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 CFR 801.109)
or
Over the Counter Use (Optional Format 1-2-96)
Venetia Taylor. for term
(Division Sign-Off) (Division of General Restorative Devices 510(k) Number
000004
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.