(171 days)
Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an xray system. Implant surgery associated with the use of radiographic markers may include total joint replacement procedures, soft tissue repair and bone fracture fixation procedures.
The Tantalum Bead Set consists of 1mm spherical x-ray markers made of commercially pure, unalloyed tantalum. They are used as radio-opague markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an x-ray. The beads are applied with a manual surgical instrument. The beads are provided non-sterile in a cartridge which includes 16 beads. The cartridge, manufactured from PEEK is designed to be used with the Halifax RSA Bead Inserter (Class 1 device) to allow surgeons to deploy the beads into the bone and tissue surrounding an orthopaedic implant. The inserter and cartridge containing the beads must be sterilized by the hospital prior to use.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Halifax Biomedical Inc. Tantalum Bead Set. This document is a premarket notification to the FDA for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with acceptance criteria and performance data in the way you've requested for an AI/device performance study.
Therefore, the information you're asking for regarding acceptance criteria, reported device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data is NOT present in this document.
This document describes a physical medical device (tantalum beads) that serves as a radiographic marker. Its approval is based on demonstrating that its materials, intended use, and design are substantially equivalent to a previously approved device (Biomet's Tantalum Beads - K010348), not on a clinical performance study with specific metrics like sensitivity, specificity, or reader improvement.
To directly answer your request based only on the provided text, I must state that this document does not contain the information requested.
If you are looking for an example of a device and its study that would contain such information, you would typically need a document pertaining to an AI/ML-based medical device where diagnostic accuracy or a similar performance metric is the primary subject of the 510(k) or a clinical study report.
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Halifax Biomedical Inc. Traditional 510(k)
510(k) Summary of Safety and Effectiveness
| Manufacture Name: | Halifax Biomedical Inc. |
|---|---|
| Contact Name: | Chad Munro, P.Eng, MASc (Biomed.) |
| Postal Address: | 11493 Route 19Mabou, Nova Scotia,Canada B0E 1X0 |
| Phone Number: | 902-945-2771 |
| Fax: | 902-945-2324 |
| Contact: | Chad Munro, P.Eng, MASc (Biomed.) |
| Title: | President |
| Date: | February 6, 2009 |
| Device Proprietary Name: | Tantalum Bead Set |
|---|---|
| Device Common or Usual Name: | Radiographic Marker |
| Classification Name: | Marker, Radiographic, Implantable |
| Classification Code | NEU - Class II |
| Classification Panel | General & Plastic Surgery |
| Regulation Number | 878.4300 |
Predicate Device:
Substantial equivalence is claimed to the following device as related to intended use and design characteristics:
- . Tantalum Beads, Biomet, Inc. K010348
Description of the Device
The Tantalum Bead Set consists of 1mm spherical x-ray markers made of commercially pure, unalloyed tantalum. They are used as radio-opague markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an x-ray. The beads are applied with a manual surgical instrument. The beads are provided non-sterile in a cartridge which includes 16 beads. The cartridge, manufactured from PEEK is designed to be used with the Halifax RSA Bead Inserter (Class 1 device) to allow surgeons to deploy the beads into the bone and tissue surrounding an orthopaedic implant. The inserter and cartridge containing the beads must be sterilized by the hospital prior to use.
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Halifax Biomedical Inc. Traditional 510(k)
Tantalum Bead Set K090581
3/2
Intended Use of the Device
The Tantalum Bead Set is to be used with the Halifax RSA Bead Inserter. Tantalum beads are to be used as radio-opaque markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an x-ray system. Implant surgery associated with the use of radiographic markers may include total joint replacement procedures, soft tissue repair and bone fracture fixation procedures.
Clinical use references for tantalum markers are provided in Appendix A.
Substantial Equivalence
The Tantalum Bead Set is equivalent to the Biomet Tantalum Bead product based on the intended use, design, technology, material composition and performance.
Conclusion
Based on the information provided in this 510(k) premarket notification, the Tantalum Bead Set is substantially equivalent in terms of safety and effectiveness to the predicate device identified above.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract bird or a series of flowing lines, representing the department's mission related to health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Halifax Biomedical, Inc. % Canreg, Inc. Roshana Ahmed Regualtory Affairs Manager, Devices 4 Innovation Drive Dundas, Ontario Canada L9H 7P3
AUG 21 2009
Re: K090581
Trade/Device Name: Tantalum Bead Set Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: August 11, 2009 Received: August 19, 2009
Dear Roshana Ahmed:
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.
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 - Roshana Ahmed
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/cdrl/mdr/ 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 tollefire number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sincerely yours,
Mark N. Malkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Tantalym Bead Set K090581
Halifax Biomedical Inc.. Traditional 510(k)
Indications for Use
K090581 510(k) Number:
Device Name: Tantalum Bead Set
Indication for Use: Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an xray system. Implant surgery associated with the use of radiographic markers may include total joint replacement procedures, soft tissue repair and bone fracture fixation procedures.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Nil RP Qula for mkon
Division Sign-C Office of Device Evaluation Evaluation and Safety
510(k) K090581
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.