(134 days)
The OMEGA® II Modular Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
Not Found
I'm sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document is an FDA 510(k) clearance letter for the OMEGA® II Modular Total Hip System.
This type of letter grants clearance for a device based on its substantial equivalence to a predicate device, but it does not contain information about specific acceptance criteria or the details of a study proving the device meets those criteria. The letter refers to the "indications for use" and mentions general controls and regulations but doesn't elaborate on performance testing or clinical studies for this particular submission.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and reported device performance: This information is not present.
- Sample size used for the test set and data provenance: Not mentioned.
- Number of experts used to establish ground truth and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- MRMC comparative effectiveness study details: Not mentioned.
- Standalone algorithm performance: Not mentioned.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How ground truth for the training set was established: Not mentioned.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 8 1000
Mr. Sam Son Vice President of Technical Affairs Osteoimplant Technology Inc. 11201 Pepper Road Hunt Valley, Maryland 21031
Re : K984227 OMEGA® II Modular Total Hip System (Size #3-#7) Regulatory Class: II Product Codes: JDI and LPH March 18, 1999 Dated: Received: March 19, 1999
Dear Mr. Son:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 Requlations, 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 In addition, FDA may publish further announcements action. 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.
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Page 2 - Mr. Sam Son
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.
If you desire specific advice for your device on our labeling requlation (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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.
Ph.D., M.D. Celia M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K984227 510(k) Number (if known): 510(k) Device Name: OMEGA® II MODULAR TOTAL HIP SYSTEM
Indications For Use:
The OMEGA® II Modular Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devic 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.