(87 days)
The Fixano PF2 wrist fixation device is intended for use in upper extremity applications for the reduction, alignment and stabilization of intraarticular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.
The device is a balljoint-hinged external fixator capable of rotation and anqulation.
The provided text is a 510(k) summary for the Fixano PF2 device. This document is a premarket notification for a medical device submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
Based on the provided text, a "study that proves the device meets the acceptance criteria" in the context of AI/ML or diagnostic performance is not applicable. The PF2 device is an external bone fixator, a physical medical device. The 510(k) process for such devices typically focuses on mechanical reliability, biocompatibility, and substantial equivalence to existing devices, rather than a diagnostic performance study as would be conducted for an AI/ML algorithm.
Therefore, many of the requested criteria, such as "acceptance criteria and the reported device performance" (in the context of diagnostic accuracy), "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set sample size and ground truth establishment," are not relevant or available in this type of document for this type of device.
Here's a breakdown of what can be inferred from the provided text, addressing the spirit of the request where possible, even if directly answering the prompt for an AI/ML study is not possible:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Implicit): Substantial equivalence to predicate devices (K993649 - EBI XFIX DFS Wristfix System and others). This means demonstrating that the PF2 device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate devices.
- Reported Device Performance: The document does not provide specific performance metrics in a table for an AI/ML context. For a mechanical device, performance would typically be assessed through engineering tests (e.g., strength, durability, fatigue resistance) or clinical studies on mechanical stability, which are not detailed in this summary. The summary highlights that "The PF2 device is similar in its intended use to predicate devices and existent methodologies."
2. Sample Size Used for the Test Set and Data Provenance:
* Not applicable for an AI/ML diagnostic performance study. For a physical device, this would typically refer to the number of devices tested mechanically or patients in a clinical trial. This information is not present in the 510(k) summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
* Not applicable. This relates to diagnostic interpretation. For a physical device, experts might be involved in design review or clinical evaluation, but "ground truth" as defined for AI/ML does not apply.
4. Adjudication Method:
* Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
* No. This type of study is for evaluating human performance with and without AI assistance for diagnostic tasks. The PF2 is a surgical implant/fixator, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. The PF2 is a physical medical device, not an algorithm.
7. The type of ground truth used:
* Not applicable in the AI/ML sense. "Ground truth" for a physical device usually relates to objective measurements (e.g., material strength tests, biomechanical stability) or clinical outcomes. The 510(k) process relies on demonstrating equivalence to devices with established safety and effectiveness.
8. The Sample Size for the Training Set:
* Not applicable. (No AI/ML algorithm is described.)
9. How the Ground Truth for the Training Set was Established:
* Not applicable. (No AI/ML algorithm is described.)
In summary, the provided document is a regulatory submission for a physical medical device (an external bone fixator) and does not describe an AI/ML or diagnostic performance study. Therefore, the detailed criteria for describing such a study cannot be met by this text. The "study" in this context is the 510(k) submission process itself, where pre-clinical testing (mechanical, biocompatibility) and comparison to predicate devices are the primary methods for demonstrating safety and effectiveness.
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SEP 2 7 2001
KO12062
510(K) SUMMARY
Manufacturer:
Fixano S.A. Z.A. Les Bruyeres 01960 Peronnas France
Submitted By:
Ferquson Medical Consultant to Fixano S.A.
Single/multiple component metallic bone Classification Name: fixation appliances and accessories.
External others.
PF2
Common/Usual Name:
Proprietary Name:
21 CFR 888.3030/Procode 87 KTT Classification Number:
Substantial Equivalence:
Device Description:
Intended Use:
Technological Characteristics:
others.
EBI XFIX DFS Wristfix System (K993649) and
fixation device, wrist fixator, and
The device is a balljoint-hinged external fixator capable of rotation and anqulation.
The intended use is similar to that for other external fixators.
The PF2 device is similar in its intended use to predicate devices and existent methodologies.
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Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three profiles of human faces.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 7 2001
Mr. Frank Ferguson C/o Fixano S.A. Ferguson Medical P.O. Box 12038 La Jolla, California 92039-2038
Re: K012062 Trade/Device Name: PF2 Regulation Number: 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: II Product Code: KTT Dated: May 25, 2001 Received: July 2, 2001
Dear Mr. Ferguson:
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 ror answer 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 11 Jour artise to such 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); 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.
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Page 2 – Mr. Frank Ferguson
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Marke n Millken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (If known): KV / 2062
Device Name: PF2
Indications For Use:
The Fixano PF2 wrist fixation device is intended for use in upper extremity applications for the reduction, alignment and stabilization of intraarticular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Mulkeen
(Division Sign-Off) (Division Sign of General, Restorative Division ological Devices KOI 2062
510(k) Number --
Prescription Use _ XX (Per 21 CFR 801.109)
OR OR ..
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________
§ 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.