(371 days)
The DeRoyal Non-Locking Bone Fixation System components are provided non-sterile. The system is intended to treat fractures of various bones, including the clavicle, scapula, iong bones, (humerus, ulna, radius, femur, tibia and fibula), small bones (metacarpals, metatarsals, and phalanges).A Screw-Plate Usage Chart is included to assist the user in selection of the appropriate screws for recommended use with each plate.
Cannulated screws included in this bone fixation system are not designed to be used with specific plates. They can be used as a stand alone fracture fixation; or in the case of compromised bone stock, they can be used in conjunction with washers.
The washer components are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces / load over a larger area when used for fracture fixation of large (long) bone and bone fragments. Additionally, the washers are intended to prevent the projection of the screw head when the screw must be inserted at an acute angle such as in ankle arthrodesis.
The wires in this system are for use in the fixation of bone fractures, for bone reconstruction or as a guide for insertion of other medical devices.
The DeRoyal Non-Locking Bone Fixation System components are provided non-sterile. The system includes various screws (Cortical, Cancellous, Cannulated, Shaft, Malleolar), plates (One Third Tubular, Compression, Reconstruction, T Plate, Semi-Tubular, Narrow Compression, Broad Compression), washers, and wires. A Screw-Plate Usage Chart is provided to assist in selecting appropriate screws for each plate. Cannulated screws can be used for standalone fracture fixation or with washers in compromised bone. Washers distribute force to prevent screw head breakthrough and prevent screw head projection at acute angles. Wires are for fracture fixation, bone reconstruction, or as guides for other devices.
I'm sorry, but the provided text from the FDA 510(k) clearance letter and associated documents for the DeRoyal Non-Locking Bone Fixation System does not contain the type of acceptance criteria and study information you are requesting regarding AI device performance.
The document is a traditional 510(k) clearance for a physical medical device (bone fixation system), which relies on substantial equivalence to a predicate device rather than performance metrics derived from a study involving AI.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not describe performance metrics or acceptance criteria for an AI-powered device.
- Sample sized used for the test set and the data provenance: Not applicable to this type of device clearance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
This document describes a conventional bone fixation system and its intended uses, including various screws, plates, and washers. Its clearance is based on its similarity to other legally marketed predicate devices, not on the performance of an AI algorithm.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR 1 2 2010
DeRoval Industries, Inc. % Ms. Gracie Greenway Sr. Regulatory Affairs Specialist 200 DeBusk Lane Powell, Tennessee 37849
Re: K090975
Trade/Device Name: DeRoyal Non-Locking Bone Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: March 18, 2010 Received: March 19, 2010
Dear Ms. Greenway:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
{1}------------------------------------------------
Page 2 - Ms. Gracie Greenway
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Karbare Buehup
Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
K 090975
p. 1/2
Indications for Use
510(k) Number: K090975
Device Name: DeRoyal Non-Locking Bone Fixation System
Indications for Use: The DeRoyal Non-Locking Bone Fixation System components are provided non-sterile. The system is intended to treat fractures of various bones, including the clavicle, scapula, iong bones, (humerus, ulna, radius, femur, tibia and fibula), small bones (metacarpals, metatarsals, and phalanges).A Screw-Plate Usage Chart is included to assist the user in selection of the appropriate screws for recommended use with each plate.
Cannulated screws included in this bone fixation system are not designed to be used with specific plates. They can be used as a stand alone fracture fixation; or in the case of compromised bone stock, they can be used in conjunction with washers.
The washer components are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces / load over a larger area when used for fracture fixation of large (long) bone and bone fragments. Additionally, the washers are intended to prevent the projection of the screw head when the screw must be inserted at an acute angle such as in ankle arthrodesis.
The wires in this system are for use in the fixation of bone fractures, for bone reconstruction or as a guide for insertion of other medical devices.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Smittn for mxn
(Division Sign-Off)
Page 1 of 2
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090975
{3}------------------------------------------------
Cannulated screws are not designed to be used with specific plates. hastead as a stand alone fracture fixat
Or, in the case of compromised bone stock, they can be used in co
| DrawingNumber | Description | 2.7mm Cortical Screw | 4.0mm Cancellous Screw | 6.5mm Cancellous Screw | 3.5mm Cortical Screw | 4.5mm Cortical Screw | 4.5mm Malleolar Screw | 4.0mm Cannulated Screw | 4.5mm Cannulated Screw | 3.5mm Shaft Screw | 4.5mm Shaft Screw | 4.6ID | 3.3ID | 3.6ID | 6.6ID | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 22710 | 2.7mm Cortical Screw | X | X | X | X | X | X | X | ||||||||
| 14010.1 | 4.0mm Cancellous Screw | X | X | X | X | X | X | X | ||||||||
| 16530.5 | 6.5mm Cancellous Screw | X | X | X | X | X | ||||||||||
| 23510 | 3.5mm Cortical Screw | X | X | X | X | X | X | X | ||||||||
| 24514 | 4.5mm Cortical Screw | X | X | X | X | X | ||||||||||
| 34525 | 4.5mm Malleolar Screw | X | X | X | X | |||||||||||
| 54010.3 | 4.0mm Cannulated Screw | X | ||||||||||||||
| 54520.2 | 4.5mm Cannulated Screw | X | ||||||||||||||
| 63516 | 3.5mm Shaft Screw | X | X | X | X | X | ||||||||||
| 64528 | 4.5mm Shaft Screw | X | X | X | X | X | ||||||||||
| DrawingNumber | Description | One Third Tubular Plate | 3.5mm Compression Plate | 3.5mm Reconstruction Plate | 3.5mm T Plate 4 Head Hole | Semi-Tubular Plate | 4.5mm T Plate | 4.5mm Narrow Compression Plate | 4.5mm Broad Compression Plate | Washer | 33101 | 33652 | 337042 | 3313 | ||
| 73561 | One Third Tubular Plate | |||||||||||||||
| 73564.5 | 3.5mm Compression Plate | X | ||||||||||||||
| 73558 | 3.5mm Reconstruction Plate | X | ||||||||||||||
| 835564 | 3.5mm T Plate 4 Head Hole | X | ||||||||||||||
| 74571 | Semi-Tubular Plate | X | ||||||||||||||
| 74584 | 4.5mm T Plate | X | ||||||||||||||
| 745701.5 | 4.5mm Narrow Compression Plate | X | ||||||||||||||
| 7451062.5 | 4.5mm Broad Compression Plate | X | ||||||||||||||
| 33101 | Washer | X | ||||||||||||||
| 33101 | X | |||||||||||||||
| 33652 | X | |||||||||||||||
| 337042 | X | |||||||||||||||
| 3313 | X |
Screw - Plate Usage Chart
:
2 2
09075
N/A