(231 days)
No
The description mentions "patent-pending algorithms" for image-superimposition and automatic detection of bony structures, but does not explicitly state or imply the use of AI or ML techniques. The focus is on precision, reproducibility, and low operator variability through these algorithms, which could be traditional image processing methods.
No
The device is a quantitative imaging software application designed for the analysis of motion in medical images to facilitate assessment and generate reports; it does not directly treat or diagnose a disease or condition.
Yes
The software provides quantitative assessment of relative motion and generates reports with graphics, charts, text, and statistical data based on medical images, which are used by physicians to analyze motion in musculoskeletal images. This functionality is consistent with a diagnostic device that aids in understanding a patient's condition.
Yes
The device description explicitly states "The FXA™ software is a software tool" and details its installation on workstations with a Windows® operating system. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, it is highly likely that this device is an IVD (In Vitro Diagnostic). Here's why:
- Intended Use: The software is designed for "quantitative assessment of relative motion" in medical images, specifically musculoskeletal images. This analysis is performed on images acquired from radiographic sources, which are external to the patient.
- Device Description: The software "measure[s] static dimensions and to analyze relative motion of implants or bony structures." This analysis is performed on "medical images such as functional radiographs."
- Input Imaging Modality: The input is from "Radiographic sources," which are external imaging devices.
- Analysis of Samples: While the "samples" are images, the software is performing analysis on data derived from biological structures (bones, implants) within those images. The analysis is quantitative and provides information about the state or function of these structures (motion).
- Comparison to Predicate: The predicate device, K022585 QMA™ software, is also a quantitative imaging software for analyzing motion in medical images. Predicate devices in 510(k) submissions are typically devices that have already been classified as medical devices, and often as IVDs if they perform analysis on samples or data derived from the body.
Why it fits the definition of an IVD (generally):
While the definition of an IVD can be nuanced, devices that perform analysis on samples (including images derived from the body) to provide information about a patient's health, condition, or function are often classified as IVDs. In this case, the software is analyzing images derived from the patient's musculoskeletal system to provide quantitative information about motion, which is relevant to assessing the patient's condition.
Why it's not a definitive "Yes" without further context:
The provided text doesn't explicitly state that the software is used for diagnosis, treatment planning, or monitoring in a way that directly fits the most stringent definitions of an IVD. However, the quantitative assessment of motion in musculoskeletal images is a common component of diagnostic evaluation and treatment monitoring in orthopedics and related fields.
Conclusion:
Given the analysis of medical images derived from the body to provide quantitative information about biological structures and their function (motion), and the nature of the predicate device, it is highly probable that the FXA™ software is considered an In Vitro Diagnostic device by regulatory bodies. The analysis is performed on data (images) obtained in vitro (outside the body) from the patient.
N/A
Intended Use / Indications for Use
The FXATM software is a quantitative imaging software application. It is designed for physicians and clinical professions who are interested in the analysis of motion in medical images, particularly in musculoskeletal images. The FXA™ software permits users to review static and dynamic digital images acquired from a variety of radiographic sources for the purpose of facilitating a quantitative assessment of relative motion. Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a report containing graphics, charts, text and statistical data.
Product codes
90 LLZ
Device Description
The FXA™ software is a software tool which was developed to measure static dimensions and to analyze relative motion of implants or bony structures. Basis for the analysis are medical images such as functional radiographs. The FXA™ software was developed with the aim to detect and analyze even small changes with high precision, high reproducibility and low operator variability. For this, patent-pending algorithms were developed and implemented for image-superimposition and the automatic detection of bony structures within selected areas of the image. The software may be installed on workstations with Windows® operating system according to the software requirement specification (SRS, (Attachment B01)).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
variety of radiographic sources
Anatomical Site
musculoskeletal images, bone structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians and clinical professions
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
- Tests under "best case" conditions, with the aim to exclude artifacts related to image acquisition or image quality (Attachment F01)
- Tests under real conditions
a. Through images obtained from in-vitro cadaver experiments (Attachment I)
b. Through side-by-side comparison with real clinical images (Attachment H) - Tests addressing the inter- and intra-observer variability (Attachment F04)
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The predicate device and the FXA™ software have been tested and characterized in various tests:
- Tests under "best case" conditions, with the aim to exclude artifacts related to image acquisition or image quality (Attachment F01)
- Tests under real conditions
a. Through images obtained from in-vitro cadaver experiments (Attachment I)
b. Through side-by-side comparison with real clinical images (Attachment H) - Tests addressing the inter- and intra-observer variability (Attachment F04)
The test results can be summarized in the table below:
Measurement Error for Range of Motion measurements mean ± standard deviation (reported absolute amount of error for predicate)
- Ideal Conditions: FXATM -0.01° ± 0.03°, QMATM 0.00° ± 0.10° (0.08° ± 0.06°)
2a) Cadaver Experiment: FXATM 0.04° ± 0.13°, QMATM 0.00° ± 0.53° (0.47° ± 0.24°) - Inter-observer Variability: FXATM 0.00° ± 0.06°, QMATM 0.00° ± 1.29° (0.88° ± 0.85°)
The data presented demonstrates that the FXA™ software is adequate to facilitate highly accurate motion analysis within radiographic images. In all tests, the accuracy of the FXA™ software was higher than that of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measurement Error for Range of Motion measurements mean ± standard deviation (reported absolute amount of error for predicate)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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K110765 P. 1 of 2
NOV - 4 2011
11. 510(k) Summary according to 807.92(c) & Executive Summary
Submitted by:
ACES GmbH Ludwigstr. 26 70794 Filderstadt, Germany
Contact:
Frank T. Trautwein, Principal & Managing Director Tel .: +49 (711) 787 4162 Email: ft@acesgmbh.de
| Trade Name: | FXATM |
|---|---|
| Regulation Name: | Picture archiving and communication system |
| Regulation Number: | 21 CFR §892.2050, |
| Regulatory Class: | II |
| Product Code: | 90 LLZ |
Intended Use:
The FXATM software is a quantitative imaging software application. It is designed for physicians and clinical professions who are interested in the analysis of motion in medical images, particularly in musculoskeletal images. The FXA™ software permits users to review static and dynamic digital images acquired from a variety of radiographic sources for the purpose of facilitating a quantitative assessment of relative motion. Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a report containing graphics, charts, text and statistical data.
Device Description:
The FXA™ software is a software tool which was developed to measure static dimensions and to analyze relative motion of implants or bony structures. Basis for the analysis are medical images such as functional radiographs. The FXA™ software was developed with the aim to detect and analyze even small changes with high precision, high reproducibility and low operator variability. For this, patent-pending algorithms were developed and implemented for image-superimposition and the automatic detection of bony structures within selected areas of the image. The software may be installed on workstations with Windows® operating system according to the software requirement specification (SRS, (Attachment B01)).
1
Predicate Device(s):
The selected predicate device is the QMA™ software by Medical Metrics Inc. (K022585).
Summary of Characteristic Performance Data:
The predicate device and the FXA™ software have been tested and characterized in various tests:
-
- Tests under "best case" conditions, with the aim to exclude artifacts related to image acquisition or image quality (Attachment F01)
-
- Tests under real conditions
- a. Through images obtained from in-vitro cadaver experiments (Attachment I)
- b. Through side-by-side comparison with real clinical images (Attachment H)
-
- Tests addressing the inter- and intra-observer variability (Attachment F04)
The test results can be summarized in the table below:
| Measurement Error for
Range of Motion measurements
mean ± standard deviation
| (reported absolute amount of error for predicate) | FXATM | QMATM |
|---|---|---|
| 1) Ideal Conditions | -0.01° ± 0.03° | 0.00° ± 0.10° |
| (0.08° ± 0.06°) | ||
| 2a) Cadaver Experiment | 0.04° ± 0.13° | 0.00° ± 0.53° |
| (0.47° ± 0.24°) | ||
| 3) Inter-observer Variability | 0.00° ± 0.06° | 0.00° ± 1.29° |
| (0.88° ± 0.85°) |
The data presented demonstrates that the FXA™ software is adequate to facilitate highly accurate motion analysis within radiographic images. In all tests, the accuracy of the FXA™ software was higher than that of the predicate device.
Both, FXA™ and QMA™ products are designed to be executed under the Windows operating system and PC hardware and are to be operated by qualified personnel only. The FXA™ and QMA™ products share the same conceptual technology of motion quantification through software assisted superimpositioning of medical images, and thus have the same potential error sources and analysis capabilities.
In conclusion, the FXA™ software is as safe, as effective, and performs as well as or better than the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
NOV - 4 2011
Mr. Frank T. Trautwein Principal & Managing Director ACES Ing .- GmbH Ludwigstr. 26 Filderstadt, BW, 70794 GERMANY
Re: K110765
Trade/Device Name: FXATM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 9, 2011 Received: September 12, 2011
Dear Mr. Trautwein:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
510(k) Number: K110765
Device Name: FXATM
Indications for Use:
The FXATM software is a quantitative imaging software application. It is designed for physicians and clinical professionals who are interested in the analysis of motion in medical images, particularly in musculoskeletal images. The FXA™ software permits users to review static and dynamic digital images acquired from a variety of radiographic sources for the purpose of facilitating a quantitative assessment of relative motion and static measurement parameters. Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a report containing graphics, charts, text and statistical data.
Caution: Federal law restricts this device to sale by or on the order of a physician.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Pastel
Division Sign-Off O In Vitro Diagnostic Devic Evaluation 510(k)
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