QualiFormeD LINACWATCH / LINACVIEW is stand-alone software that analyzes radiation therapy machine (linear accelerator) performance for each fraction automatically using log files provided by the radiation therapy machine. It is to be used by trained radiation oncology personnel as a guide to alert this professional to potential machine delivery issues that can affect treatment quality and workflow.

QualiFormeD LINACWATCH / LINACVIEW is not primary treatment planning or 3D dose calculation software, and cannot be used to generate radiotherapy treatment plans.

Device Description

QualiFormeD LINACWATCH / LINACVIEW is a standalone software product analyzes logfiles generated by Varian and Elekta linear accelerators during radiation treatments. Logfile analysis can be with respect to the "prescription" DICOM radiotherapy (RT) Plan or with respect to the first logfile in a series of logfiles for each treatment and each beam. Initial logfiles that may be created for pre-treatment intensity-modulated radiation therapy (IMRT) quality assurance (QA) can be excluded from treatment session analysis.

The preferred method of running QualiFormeD LINACWATCH / LINACVIEW is in "batch" mode. In this mode, QualiFormeD LINACWATCH / LINACVIEW automatically processes logfiles and analyzes them, sending emails to designated staff for non-compliant results over an internet connection.

QualiFormeD LINACWATCH / LINACVIEW allows the user to verify for every treatment, in real time, with email notifications on alert or failure, the following parameters:

The position of each moving multi-leaf collimator (MLC) leaf; ●
The position of MLC carriages and jaws;
The percentage of monitor units (MUs) delivered; ●
The gantry rotation angle; ●
The collimator rotation angle;
The beam on/off statistics; and
. The reconstructed integrated fluence.

Additionally, after any number of treatments has been analyzed, QualiFormeD LINACWATCH / LINACVIEW allows the user to create RT Plans that can simulate the composite behavior of the analyzed logfiles. These RT Plans can be imported into the treatment planning system (TPS) to compare intended doses with those actually delivered, although this estimated dose does not include dosimetric changes due to patient setup or geometric changes. Adobe Acrobat® PDF reports documenting machine performance can be created at any point during treatment.

At the end of a course of treatment when the treatment series is closed, a composite RT Plan is automatically created that summarizes the composite behavior of all analyzed logfiles as well as two (2) final reports, a short and a comprehensive report, that documents all aspects of the treatment course.

Step and Shoot, Sliding Window, and Volumetric Modulated Arc Therapy (VMAT) IMRT techniques are supported.

AI/ML Overview

The provided text is an FDA 510(k) summary for a medical device called QualiFormeD LINACWATCH/LINACVIEW. This document focuses on demonstrating substantial equivalence to a predicate device and covers software development processes, rather than detailed performance study results with specific acceptance criteria and metrics.

Therefore, many of the requested details regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement for ground truth, and MRMC studies are not present in this document. The document primarily states that the software was "rigorously verified and validated" and that "Test results indicated that QualiFormeD LINACWATCH / LINACVIEW complies with predetermined specifications." It does not provide the details of those specifications or the empirical performance data against them.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as quantifiable metrics in the document. The document only mentions that the device "complies with predetermined specifications." It does not list what those specifications are (e.g., specific accuracy, sensitivity, or specificity thresholds).
Reported Device Performance: No specific numerical performance metrics (e.g., accuracy percentages, error rates, or deviations) are reported. The document states that the testing showed compliance with specifications but does not provide the results themselves.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The document states "QualiFormeD LINACWATCH / LINACVIEW was tested in accordance – Bench with internal specifications," but the number of test cases or log files used is not mentioned.
Data Provenance: Not specified. There is no information on where the log files used for testing originated (e.g., specific countries, clinical sites).
Retrospective or Prospective: Not specified. The nature of the data collection for testing is not described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not specified.
Qualifications of Experts: Not specified. Given the device's function (analyzing linear accelerator log files), the "ground truth" would likely be established through physical measurements, simulation, or adherence to clinical standards by medical physicists or radiation oncology personnel, rather than radiologists. However, this is not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified.

5. 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

MRMC Study: No. This device is described as "stand-alone software that analyzes radiation therapy machine (linear accelerator) performance." It is not an AI-assisted diagnostic tool for human readers but rather an automated analysis system for machine log files. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable to this type of device and was not conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Yes, implicitly. The description focuses on the software's automated analysis of log files and its ability to alert personnel to potential issues. The testing performed ("Bench with internal specifications") would assess the algorithm's performance in this standalone capacity. However, the results of this standalone performance (e.g., specific metrics like accuracy in detecting non-compliant events) are not provided. The function is entirely "algorithm only" in its analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not explicitly stated, but for a device analyzing linear accelerator log files, the "ground truth" would almost certainly involve comparing the device's output (e.g., detected deviations in MLC position, gantry angle, MUs delivered) against:
- Machine specifications: What the machine should be doing according to its design and calibration.
- Physical measurements: Measurements taken directly from the linear accelerator during operation.
- Reference log files: Known good or known problematic log files.
- Clinical standards/tolerances: Pre-defined acceptable deviations for various parameters in radiation therapy.
  The document only broadly states "Test results indicated that QualiFormeD LINACWATCH / LINACVIEW complies with predetermined specifications."

8. The sample size for the training set

Not applicable/Not specified. This document describes a software application that analyzes log files. While software undergoes development and testing, it's not explicitly stated whether this particular application uses machine learning algorithms that require a distinct "training set" in the typical sense for AI/ML models. The focus is on validation against specifications rather than deep learning model training. If it were a machine learning model, the training set size would be crucial, but the text doesn't indicate this.

9. How the ground truth for the training set was established

Not applicable/Not specified, for the same reasons as point 8.

Summary of Device Performance Study (as described in the document):

The 510(k) Summary for QualiFormeD LINACWATCH/LINACVIEW describes an extensive software verification and validation process in accordance with FDA guidance documents and international standards (IEC 62304).

Study Type: Bench testing against internal specifications.
Purpose: To establish that the software "complies with predetermined specifications" and is "as safe, as effective, and performs as well as or better than the predicate device."
Key Findings (High-Level): "Test results indicated that QualiFormeD LINACWATCH / LINACVIEW complies with predetermined specifications." and "The results of these activities demonstrate that QualiFormeD LINACWATCH / LINACVIEW is as safe, as effective, and performs as well as or better than the predicate device."

Conclusion:

The provided FDA 510(k) summary focuses on regulatory compliance and demonstrating substantial equivalence through a robust software development and testing process (verification and validation). It affirms that the device meets its predetermined specifications but does not disclose those specific acceptance criteria, nor the quantitative results of the performance testing, the size of the test data set, or details about the ground truth establishment method. This level of detail is typically found in the full submission documents, not necessarily the publicly available summary letter.

Summary

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October 27, 2017

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.

QualiFormeD Sarl % Mr. Thomas Kroenke Principal Consultant Speek To Market. Inc. PO Box 3018 NEDERLAND CO 80466

Re: K172534

Trade/Device Name: QualiFormeD Sarl LINACwatch/LinacView Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: August 21, 2017 Received: August 22, 2017

Dear Mr. Kroenke:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 of medical 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Robert Ochs

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K172534

Device Name

QualiFormeD Sarl LINACwatch/LinacView

Indications for Use (Describe)

QualiFormeD LINACWATCH / LINACVIEW is not primary treatment planning or 3D dose calculation software, and cannot be used to generate radiotherapy treatment plans.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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5 510(k) Summary

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510(k) Summary provided in accordance with 21 CFR §807.92(C)

Submission Date:	21 August 2017
Submitter:	QualiFormeD Sarl14 rue de la Vieille Horloge85000 La Roche Sur Yon, France
Submitter Contact:	Mr. Stéphane BeaumontTechnical DirectorPhone: +011 33 9 77 00 91 29Fax: +011 33 2 51 24 85 79Email: stephane.beaumont@qualiformed.com
ApplicationCorrespondent:	Thomas KroenkeSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232
Manufacturing Site:	QualiFormeD Sarl14 rue de la Vieille Horloge85000 La Roche Sur Yon, France
Trade Name:	QualiFormeD LINACWATCH / LINACVIEW
Classification Name:	Accelerator, Linear, Medical
ClassificationRegulation:	21 CFR §892.5050
Product Code:	IYE
SubstantiallyEquivalent Devices:	NewQualiFormeDModel	Predicate510(k) Number	PredicateManufacturer / Model
	QualiFormeDLINACWATCH /LINACVIEW	K140660 K141800	Mobius Medical Systems Mobius3DSun Nuclear Corporation Model 1215PerFRACTION

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510(k) Summary provided in accordance with 21 CFR §807.92(C)

Device Description: QualiFormeD LINACWATCH / LINACVIEW is a standalone software product analyzes logfiles generated by Varian and Elekta linear accelerators during radiation treatments. Logfile analysis can be with respect to the "prescription" DICOM radiotherapy (RT) Plan or with respect to the first logfile in a series of logfiles for each treatment and each beam. Initial logfiles that may be created for pre-treatment intensity-modulated radiation therapy (IMRT) quality assurance (QA) can be excluded from treatment session analysis.

The preferred method of running QualiFormeD LINACWATCH / LINACVIEW is in "batch" mode. In this mode, QualiFormeD LINACWATCH / LINACVIEW automatically processes logfiles and analyzes them, sending emails to designated staff for non-compliant results over an internet connection.

QualiFormeD LINACWATCH / LINACVIEW allows the user to verify for every treatment, in real time, with email notifications on alert or failure, the following parameters:

The position of each moving multi-leaf collimator (MLC) leaf; ●
The position of MLC carriages and jaws;
The percentage of monitor units (MUs) delivered; ●
The gantry rotation angle; ●
The collimator rotation angle;
The beam on/off statistics; and
. The reconstructed integrated fluence.

Step and Shoot, Sliding Window, and Volumetric Modulated Arc Therapy (VMAT) IMRT techniques are supported.

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510(k) Summary provided in accordance with 21 CFR §807.92(C)

Intended Use: QualiFormeD LINACWATCH / LINACVIEW is stand-alone software that analyzes radiation therapy machine (linear accelerator) performance for each fraction automatically using log files provided by the radiation therapy machine. It is to be used by trained radiation oncology personnel as a guide to alert this professional to potential machine delivery issues that can affect treatment quality and workflow.

QualiFormeD LINACWATCH / LINACVIEW is not primary treatment planning or 3D dose calculation software, and cannot be used to generate radiotherapy treatment plans.

Technology QualiFormeD LINACWATCH / LINACVIEW employs the same Comparison: technological characteristics as the predicate device.

Characteristic	Mobius MedicalSystems Mobius3Dplus FX(K140660)	Sun NuclearPerFraction(K141800)	QualiFormeDLINACWATCH /LINACVIEW
Desktop software	Mobius3D:YesMobiusFX:No	No	Yes
IMRT/VMATAnalysis	Mobius3D:YesMobiusFX:Yes	Yes	Yes
Logfile-basedanalysis	Mobius3D:YesMobiusFX:Yes	No	Yes
All fractionsanalyzed	Mobius3D:NoMobiusFX:No	Yes	Yes
Analysis in real-time	Mobius3D:NoMobiusFX:No	No	Yes
Automatic process	Mobius3D:YesMobiusFX:No	Yes	Yes
Dashboard resultsfor therapists	Mobius3D:NoMobiusFX:No	No	Yes
Dashboard resultsfor physicists	Mobius3D:YesMobiusFX:Yes	Yes	Yes

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510(k) Summary provided in accordance with 21 CFR §807.92(C)

Summary of Performance Testing:

Software QualiFormeD LINACWATCH / LINACVIEW contains MODERATE level of concern software. Software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with • FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05; • FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99: • FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02; • FDA guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 02 Oct 14; and · IEC 62304: 2006, Medical device software - Software life cycle processes. Test results indicated that QualiFormeD LINACWATCH / LINACVIEW complies with predetermined specifications and the applicable standard. Performance Testing QualiFormeD LINACWATCH / LINACVIEW was tested in accordance – Bench with internal specifications: Test results indicated that QualiFormeD LINACWATCH / LINACVIEW complies with predetermined specifications. Conclusion Verification and validation activities were conducted to establish the performance and safety characteristics of QualiFormeD LINACWATCH / LINACVIEW. The results of these activities demonstrate that QualiFormeD LINACWATCH / LINACVIEW is as safe, as effective, and performs as well as or better than the predicate device. Therefore, QualiFormeD LINACWATCH / LINACVIEW is considered substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.