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The intended use of the myQA iON product is to perform patient quality assurance activities for radiation therapy treatment delivery systems. myQA iON is a software toolbox allowing the Medical Physicist to perform quality assurance activities before and after the patient treatment fractions for all patients undergoing radiation therapy.

The myQA iON product is a server-based software application for performing patient quality assurance for radiation therapy. In its full scope, the product delivers means for the verification of:

• The patient treatment plan prior to the first treatment fraction by
  • Using an independent dose algorithm to compute a dose map based on the patient treatment plan;
  • Performing measurements using external measurement devices and analyzing the results;
  • Performing machine log analysis during a treatment dry run session and reconstructing the delivered dose.
• The patient treatment delivery by
  • Performing machine log analysis and reconstructing the delivered dose for each treatment fraction.
    In its full scope, the product interfaces with the Treatment Planning System, the Oncology Information System, the treatment delivery System and the external measurement device.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance metrics for the myQA iON. Instead, it describes general testing categories to assess the device's performance. The study aims to demonstrate substantial equivalence, implying that its performance should be comparable to the predicate device but doesn't quantify this in a numerical acceptance table within this document.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for any of the described tests (Risk Analysis, Software, Physics, Integration, System, or Beta Testing). It also does not mention the country of origin of the data or whether the tests were retrospective or prospective. These tests appear to be internal verification and validation activities conducted by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth within the described non-clinical tests. The tests focus on software functionality, physics algorithms, and workflow, which typically rely on internal validation against established standards or expected behaviors rather than expert consensus on a "ground truth" dataset in the typical clinical AI sense.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the nature of the described non-clinical tests, such adjudication methods are typically not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document explicitly states: "The subject of this premarket submission, the IBA Dosimetry myQA iON product, did not require clinical testing to support substantial equivalence to the predicate device." Therefore, no MRMC comparative effectiveness study was done, and there is no reported effect size regarding human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document describes "Physics Testing verifying the correct behavior of the physics algorithms" and "Software Testing verifying the correct software implementation." While these evaluate the algorithm's performance in isolation from a human user in some sense, they are part of non-clinical verification and validation activities, not a formal standalone performance study as would typically be conducted for a diagnostic AI. The device's intended use is as a "software toolbox allowing the Medical Physicist to perform quality assurance activities," implying a human-in-the-loop interaction for its full functionality. However, the core independent dose calculation and analysis features could be considered standalone algorithmic functions. The document does not present a dedicated "standalone performance study" with metrics like sensitivity, specificity, or AUC.

7. Type of Ground Truth Used

The ground truth for the non-clinical tests appears to be based on:

• Identified hazard mitigations: For Risk Analysis Testing.
• Expected software implementation and behavior: For Software, Integration, and System Testing.
• Known physical principles and expected outputs: For Physics Testing verifying the correct behavior of physics algorithms.
• Usability goals: For Beta Testing.

This is not "expert consensus, pathology, or outcomes data" in the typical clinical context but rather internal validation against design specifications and established scientific/engineering principles.

8. Sample Size for the Training Set

The document does not mention a training set sample size. The myQA iON is described as a "software toolbox" and implies deterministic physics algorithms and analysis tools rather than a machine learning model that would require a distinct training set.

9. How the Ground Truth for the Training Set Was Established

Since the document does not indicate the use of a training set for a machine learning model, this information is not applicable and is not provided.

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The intended use of Blue Phantom PT is to move detectors in one dimension within a water tank. It transfers indicated ionization beams (proton beams) at a certain position into electrical signals.

The Blue Phantom PT system consists of a water tank with a one-dimensional servo including a common control unit (CCU PT) with integrated two-channel electrometer. An ionisation chamber (e.g. Stingray) is placed inside the Blue Phantom PT with a holder and is used as detector for measurements.

The Blue Phantom PT is intended to be used in the magnetic environment of a proton therapy treatment unit and its technology has been designed to meet those requirements.

On the horizontal Y-rail, detector holders for various detectors can be mounted on a sliding shoe. The detector can be positioned in the Y-direction for measuring horizontal beams.

The provided text is a 510(k) summary for the Blue Phantom PT device and discusses its substantial equivalence to a predicate device (WP 1D). It outlines performance testing but does not contain detailed acceptance criteria and performance data in the structured format requested. However, it does provide some device characteristics that can be interpreted as performance metrics.

Here's an attempt to extract and organize the information based on the provided text, recognizing that some requested details are not explicitly present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" but rather lists "Device Characteristics" for both the predicate and the new device. We can infer that the Blue Phantom PT aiming to at least match or improve upon the predicate's characteristics constitutes a form of meeting "acceptance criteria."

2. Sample Size Used for the Test Set and Data Provenance

The document states: "BP PT was successfully tested to demonstrate safety and effectiveness and substantial equivalence to the predicate device. It was subject to the following tests: System test, Clinical environment test, Usability test, Unit test (Mechanics), Firmware test, Non-clinical test against the following standards."

• Test Set Sample Size: Not specified.
• Data Provenance: The document implies internal testing ("Internal testing") and testing by "external test house" for some standards. There is no information on country of origin or whether the data was retrospective or prospective in the context of device performance data, as this is a physical measurement device, not an AI/software device processing patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable (N/A) as the device is a physical measurement tool, not an AI or diagnostic device that relies on expert ground truth for interpretation of medical data. The ground truth would be physical standards or direct measurements.

4. Adjudication Method for the Test Set

N/A. This concept is typically relevant for studies involving human interpretation or subjective assessments, not for objective physical measurements of device characteristics. The "ground truth" for the performance metrics would be derived from calibrated measurement instruments, not human adjudication.

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

N/A. The Blue Phantom PT is a physical device for radiation dosimetry, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. This refers to AI algorithm performance. The device is a hardware system with embedded firmware. Its performance is inherent to its design and operation.

7. The Type of Ground Truth Used

The ground truth for the performance metrics (e.g., position accuracy, reproducibility) would be established through physical standards, highly accurate calibration systems, and traceable measurement techniques. The document mentions testing against "standards" (e.g., IEC, ISO), which implies adherence to methods and limits defined by these standards.

8. The Sample Size for the Training Set

N/A. This is a physical device, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

N/A. (See point 8).

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The OmniPro Incline is a QA beam measuring system intended to be used for the verification of dose distribution in radio therapy. The system is intended to measure proton, photon and electron beams.

The Omni-Pro-Incline software is a workspace tool managing both the measurements and the analysis of depth dose distributions of particles with a range up to 33 cm Water Equivalent Thickness (WET): The software is delivered with a dedicated system of multi layer of ionization chambers and with a decicated electrometer based on the Tera chip technology. Single Bragg peaks as well as modulated distributions can be measured and analyzed with high spatial and temporal resolution (in the order of 2mm WET) with typical sampling time down to 10ms. The data format will be directly compatible with the one of the IBA Dosimetry conventional formats and at least easily exchangeable. The system is suitable for both active and passive delivery

I am sorry, but the provided text content does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving adherence to them for the OmniPro Incline device. The document primarily consists of a 510(k) summary and an FDA clearance letter, which focus on regulatory approval and substantial equivalence to a predicate device, rather than a detailed study report with specific performance metrics and study design elements.

However, I can extract the following information:

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

The provided text does not explicitly state acceptance criteria or reported device performance in a quantified manner. It describes the device's capabilities:

• "managing both the measurements and the analysis of depth dose distributions of particles with a range up to 33 cm Water Equivalent Thickness (WET)"
• "high spatial and temporal resolution (in the order of 2mm WET)"
• "typical sampling time down to 10ms"

Without specific numerical targets for accuracy, precision, or other performance metrics, a table of acceptance criteria and reported performance cannot be generated from the given text.

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

This information is not available in the provided text. The document acts as a summary for regulatory submission, not a detailed scientific study report.

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)

This information is not available in the provided text. The device is a QA beam measuring system, implying its measurements would be compared against expected physical properties or reference standards, not necessarily human expert consensus on diagnostic images.

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

This information is not available in the provided text.

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

Given the device's function as a "Radiation therapy dose calculation QA tool" and its purpose "for the verification of dose distribution in radio therapy," it is highly unlikely that an MRMC comparative effectiveness study involving human readers and AI assistance was conducted or would be relevant for this type of device. The OmniPro Incline is a measurement and analysis tool for physical dose distributions, not an AI diagnostic or decision-support system for human interpretation. Therefore, there is no information about such a study or effect size in the provided text.

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

The device is described as a "software" that "manag[es] both the measurements and the analysis." It is bundled with "a dedicated system of multi layer of ionization chambers and with a dedicated electrometer." This suggests the software operates in conjunction with hardware to make measurements. The document does not specify a "standalone" algorithm-only performance study in the context of typical AI device evaluations. Its function is to perform measurements and analysis, implying its "standalone" operation is its primary mode without human intervention in the data acquisition and initial analysis phases, but the specific wording of a "standalone study" akin to AI evaluation is not present.

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

The ground truth for a device like OmniPro Incline, which measures and analyzes radiation dose distributions, would typically involve established physics principles, reference dosimetry standards (e.g., traceable to national labs), or highly accurate alternative measurement techniques. The text does not explicitly state the type of ground truth used but implies comparison to expected physical properties of radiation beams.

8. The sample size for the training set

This information is not available in the provided text. The device is described as software for measurement and analysis, not as a machine learning or AI model that typically undergoes "training."

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

As the device is not described as a machine learning or AI model requiring a "training set" in the conventional sense, this information is not applicable and therefore not available in the provided text.

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