(188 days)
The DRG Sherlock™ MF Self-Tapping and Self-Tapping/Self-Drilling Bone Screws are intended for craniofacial and mandibular trauma and reconstruction.
DRG Sherlock™ MF Bone Screw, Cocrmo Self-Tapping, Ti Alloy
I apologize, but the provided text from the FDA 510(k) summary for the "DRG Sherlock™ MF Bone Screw" does not contain the detailed information necessary to answer your request regarding acceptance criteria, study details, and performance metrics as if it were an AI/ML device.
The document is a clearance letter for a medical device (bone screw), and it focuses on:
- Substantial Equivalence: It states that the device is substantially equivalent to legally marketed predicate devices. This is a regulatory pathway for traditional medical devices, not for AI/ML performance evaluation.
- Regulatory Class: It identifies the device's regulatory class (Class II) and product code (DZL).
- Intended Use: It specifies the indications for use for the bone screws (craniofacial and mandibular trauma and reconstruction).
- General Controls: It mentions compliance with general controls provisions like annual registration, good manufacturing practice (GMP), etc.
There is no mention of an algorithm or AI/ML performance, nor any data from a study that would include acceptance criteria, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluation.
Therefore, I cannot populate the table or answer the specific questions about AI/ML device performance and study details based on the information provided in the input text.
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DEC - 2 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard J. Deslauriers, M.D. President Doctor's Research Group, Incorporated 143 Wolcott Road Wolcott, Connecticut 06716
Re : K981881 DRG Sherlock™ MF Bone Screw, Cocrmo Self-Trade Name: Tapping, Ti Alloy Regulatory Class: II Product Code: DZL September 15, 1998 Dated: Received: September 15, 1998
Dear Dr. Deslauriers:
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 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). 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, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਚੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Dr. Deslauriers
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.
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) 594-4692. 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" (21CFR 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/dsma/dsmamajn.html" .
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Doctor's Research Group, Inc. 143 Wolcott Road Wolcott, CT 06716 (203) 879-9422
Statement of indications for use:
510(k) Number (if Known): 五月号 | 828
Device Name: Sherlock™ MF Bone Screws
Indications for use:
The DRG Sherlock™ MF Self-Tapping and Self-Tapping/Self-Drilling Bone Screws are intended for craniofacial and mandibular trauma and reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEE Concurrence of CDRG, Office of Device Evaluation (ODE)
Sandra L. Shire, DMD for USR
(Division Sign-Off)
n of Dental, Infection Control, d General Hospital De 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.