(87 days)
Fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and peri-articular fracture
TransFx External Fixation System
It appears the provided document is an FDA 510(k) clearance letter for the "TransFx External Fixation System." This document primarily grants clearance for a medical device based on substantial equivalence to a predicate device, rather than detailing a specific study proving the device meets acceptance criteria derived from a performance study.
FDA 510(k) clearances typically do not contain the type of detailed performance study information requested (e.g., specific acceptance criteria for AI algorithms, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment) because the basis of clearance is substantial equivalence. The device's performance is assumed to be similar to legally marketed predicate devices, and often bench testing or limited clinical data is used to demonstrate this equivalence, not a rigorously designed performance study as would be required for a novel AI-powered diagnostic device.
Therefore, the provided document does not contain the information necessary to answer the questions about acceptance criteria and the study that proves the device meets those criteria.
The document states: "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..." This is the core of a 510(k) clearance.
To answer your questions for an AI/ML medical device, one would typically need a much more detailed clinical study report or a 510(k) summary that specifically addresses the performance of such an algorithm.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 1999
Mr. Roy Bogert Director of R&D and Regulatory Affairs Immedica, Inc. 100 Passaic Avenue 07928 Chatham, New Jersey
K984357 Re: TransFx External Fixation System Trade Name: Requlatory Class: II Product Codes: LXT, KTT, and JDW Dated: December 4, 1998 December 7, 1998 Received:
Dear Mr. Bogert:
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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰ 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 requlations.
{1}------------------------------------------------
Page 2 - Mr. Roy Bogert
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 regulation (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,
Theodore J. Sager
← Célia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
$\theta_a$
$\theta_a$ = F
{2}------------------------------------------------
510(k) Number (if known):
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: TransFx External Fixation System
Indications For Use:
Fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and peri-articular fracture
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Venelli Lazaro fir cm
ivision Sign-Off ision of Genera 510k) Number
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.