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)).

AI/ML Overview

Here's a detailed breakdown of the acceptance criteria and the study that proves the FXATM device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Implied/Compared against predicate)	Reported Device Performance (FXATM)
Measurement Error for Range of Motion (Ideal Conditions)	-0.01° ± 0.03°
Measurement Error for Range of Motion (Cadaver Experiment)	0.04° ± 0.13°
Inter-observer Variability	0.00° ± 0.06°
Overall accuracy and performance (compared to predicate)	Higher accuracy than predicate in all tests. The device is "as safe, as effective, and performs as well as or better than the predicate device."

Note: The document frames the acceptance criteria implicitly by comparing the FXATM's performance against its predicate device (QMA™ software by Medical Metrics Inc., K022585). The key "acceptance" is that FXATM performs as well as or better than the predicate.

Study Details

Sample Size used for the test set and the data provenance:
- Test Sets: The document refers to three types of tests:
  - "Tests under 'best case' conditions" (Attachment F01) - Sample size not specified.
  - "Tests under real conditions"
    - "Through images obtained from in-vitro cadaver experiments" (Attachment I) - Sample size not specified.
    - "Through side-by-side comparison with real clinical images" (Attachment H) - Sample size not specified.
  - "Tests addressing the inter- and intra-observer variability" (Attachment F04) - Sample size not specified.
- Data Provenance:
  - "In-vitro cadaver experiments"
  - "Real clinical images"
  - "Images obtained from" best case conditions (likely simulated or highly controlled).
  - Country of Origin: Not explicitly stated for any of the data sets. Given the submitter's location (Germany), it's plausible some data originated there, but this is not confirmed.
  - Retrospective or Prospective: Not explicitly stated for any of the data sets. "Real clinical images" could imply retrospective, but without further detail, it's unclear. Cadaver experiments are inherently experimental.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document mentions "inter-observer variability" tests, implying multiple observers were involved, but it does not detail how ground truth was established by experts or their qualifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. The document focuses on measurement error and variability rather than a diagnostic performance where adjudication methods are typically applied.
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:
- No. This was not an MRMC comparative effectiveness study involving human readers' performance with and without AI. The device (FXATM) is a quantitative imaging software, not an AI-assisted diagnostic tool for human readers in the traditional sense discussed in MRMC studies. The comparison is between the FXATM software itself and a predicate software (QMA™).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The performance data presented are for the "FXATM" software directly, measuring its output (e.g., measurement error, inter-observer variability when using the software). While the software is "designed for physicians and clinical professions," the reported performance metrics are intrinsic to the software's ability to measure motion accurately, rather than its impact on a human's diagnostic decision-making. The "inter-observer variability" tests assess how much different operators using the software vary in their results, which is still a measure of the software's robustness and precision in application, not necessarily a human "reading" performance improvement.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated in detail. For the "best case" and "cadaver experiment" conditions, the ground truth likely involved precise physical measurements or highly controlled setups from which true motion could be derived. For "real clinical images" and inter-observer variability, the ground truth for "accuracy" would have been relative to some gold standard measurement method or perhaps a detailed manual assessment that the software aims to replicate or assist. The document implies accuracy is measured against a "true" motion, but the specific method of establishing that "true" motion isn't detailed.
The sample size for the training set:
- Not specified. The document does not provide details about a training set for the algorithms. It discusses implementation of "patent-pending algorithms for image-superimposition and the automatic detection of bony structures." This implies algorithmic development, but without details on machine learning or adaptive algorithms, a distinct "training set" might not be applicable or specified in the same way it would be for modern AI/ML systems.
How the ground truth for the training set was established:
- Not applicable / Not specified. As no specific "training set" is mentioned or detailed, there's no information on how its ground truth might have been established.

Summary

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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:

Device Description:

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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:

1. Tests under "best case" conditions, with the aim to exclude artifacts related to image acquisition or image quality (Attachment F01)
1. 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)
1. Tests addressing the inter- and intra-observer variability (Attachment F04)

The test results can be summarized in the table below:

Measurement Error forRange of Motion measurementsmean ± 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.

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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

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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

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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)

Page 1 of 1

Regulation Number and Section

§ 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).