(71 days)
The cannulated screws may be used for fixation of long bone fractures and for bone reconstruction (i.e. fresh fractures, osteotomy, revision procedure where other treatments or devices have failed, arthrodesis, and in conjunction with other fixation hardware). These cannulated screws are not to be used for spinal application or Carpal Tunnel Sydrome.
Various styles of stainless steel and titanium alloy cannulated screws. Screw diameters range from 3.5mm to 8.0mm and 6.5mm to 8.0mm, respectively.
The provided text describes a 510(k) premarket notification for cannulated screws and is a regulatory document, not a study evaluating the performance of an AI-powered medical device. It does not contain information about acceptance criteria or a study proving that a device meets such criteria in the context of AI.
Therefore, I cannot answer the questions about:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done.
- Whether standalone performance was evaluated.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
This document is about the regulatory clearance of a physical medical device (cannulated screws) based on substantial equivalence to existing devices, not about the performance evaluation of an AI algorithm.
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3 10000 FEB
SUMMARY OF SAFETY AND EFFECTIVENESS
Sponsor: Biomet Inc. Airport Industrial Park Warsaw, Indiana 46580
Proprietary Names: Stainless Steel Taper Foreman Nail Cannulated Screw Stainless Steel Cannulated Screw, Short Thread Stainless Steel Pediatric Cannulated Cancellous Screw Stainless Steel Cannulated Hip Screw Stainless Steel Cannulated Screw
Titanium Cannulated Cancellous Screw Titanium Cannulated Cancellous Screw, Long Screw Titanium Cannulated Cancellous Screw, Fully Threaded Titanium Alloy Cannulated Screw
Common or Usual Name: Cannulated Screw
Classification Name: smooth or threaded metallic bone fixation fastener (21 C.F.R. 8888.3040)
Device Classification: Class II
Device Product Code: 87 HWC-screw, fixation, bone
Intended Use: The cannulated screws may be used for fixation of long bone fractures and for bone reconstruction (i.e. fresh fractures, osteotomy, revision procedure where other treatments or devices have failed, arthrodesis, and in conjunction with other fixation hardware). These cannulated screws are not to be used for spinal application or Carpal Tunnel Sydrome.
Device Description: Various styles of stainless steel and titanium alloy cannulated screws. Screw diameters range from 3.5mm to 8.0mm and 6.5mm to 8.0mm, respectively.
Potential Risks: The risks associated with these devices are the same as with any metallic internal fixation device. These include but are not limited to the following:
-Delayed or nonunion which may lead to breakage of the implant
-Bending or fracture of the implant
-Loosening or migration of the implant
- -Metal sensitivity, or allergic reaction to a foreign body
-Limb shortening or decrease in bone density due to compression of the fracture or bone resorption
-Pain, discomfort, or abnormal sensations due to the presence of the device
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 3 1999
Ms. Dalene Hufziger Binkley Regulatory Specialist Biomet Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
Re: K984209 Cannulated Screws Trade Name: Regulatory Class: II Product Code: HWC Dated: November 20, 1998 Received: November 24, 1998
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 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 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 requlations.
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Page 2 - Ms. Dalene Hufziger Binkley
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA debelibed in four tial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predicater 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 victo diagnobero at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. ene office of centitled, "Misbranding by reference to Other general premarket notification" (21 CFR 807.97). information on your responsibilities under the Act may be information of Small Manufacturers Assistancers 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,
sincerely yours,
Neil R.P. Eglen for
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
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510 (k) NUMBER (IF KNOWN): 984209
DEVICE NAME: Cannulated Screws
INDICATIONS FOR USE:
The cannulated screws maybe used for fixation of long bone fractures and for bone reconstruction (i.e. fresh fractures, osteotomy, revision procedures where other treatments or devices have failed, arthrodesis, and in conjunction with other fixation hardware.) These cannulated screws are not to be used for spinal application or Carpal Tunnel Syndrome.
ho
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K984276
(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)
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.