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Dosimetry Check quality control software uses the radiation fields that are measured with media such as x-ray film, electronic portal imaging devices (EPID), diode or ion chamber arrays, or in the case of TomoTherapy, a fan line detector array, and provides a theoretical calculation. Dosimetry Check computes the dose distribution using the patient specific CT or other image set or alternately a phantom that is likewise scanned, to calculate the reconstructed dose that is then compared to the plan dose. The results reported can include the computed percent difference at specific points as compared to the patient specific radiation treatment plan.

Dosimetry Check does not provide any conclusions regarding the comparisons and does not provide any criteria to be used for interpreting the results. The experienced radiological physicist can reevaluate his patient specific radiation treatment plan in accordance with his clinical judgment.

This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field applied to the patient and provided in an exported file, and a theoretical calculation. The product can only be used with photons (high energy x-rays) and cannot be used with electron or proton therapy. This product does not provide any quality assurance that the fields are in fact correctly aligned with the patient anatomy as planned. In addition, the product may be used to display the above dose on other fused image sets which could provide additional supportive quality information to the user regarding the correctness of treatment.

Dosimetry Check is a standalone software product intended to be used by an experienced radiological physicist for quality control purposes only. Dosimetry Check is intended to check the correctness of x-ray treatment plans delivered from high energy charged-particle radiation therapy treatment machines by using a measurement of the applied radiation fields that are planned to be or have been applied to a patient, and computing the calculated dose to the patient from the measured radiation fields that is intended to be used as a quality control tool tothen be compared to the intended planned dose. This product is to be used as a quality control check for the treatment planning system and delivery system. Dosimetry Check is not a treatment planning system. It does not design or transmit instructions to a delivery device, nor does it control any other medical device. Being a software only quality control tool, Dosimetry Check never comes into contact with patients or persons. Dosimetry Check is an analysis tool meant solely for quality assurance purposes when used by trained medical professionals.

The provided text describes information about the Dosimetry Check Version 5 Release 1 device, but it lacks the specific details required to fully address your request regarding acceptance criteria and a detailed study. The document is a 510(k) summary for FDA clearance, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with detailed performance metrics against predefined acceptance criteria.

However, based on the available information, I can extract and infer some details:

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

The document does not explicitly state quantifiable "acceptance criteria" for the device's performance in a table format, nor does it provide a direct comparison against such criteria. The "Testing" section mentions "successful testing was accomplished," implying that whatever internal criteria existed were met. The core "performance" of the device is described in relation to its function: computing dose distribution and comparing it to the plan dose, and using a new Convolution/Superposition "Collapsed Cone" Algorithm (CC).

The closest to a performance statement is from the "Conclusion": "The successful testing demonstrates the safety and effectiveness of the Dosimetry Check Version 5 Release 1 when used for the defined indications for use demonstrates that the device for which this 510(k) is submitted perform as well as or better than the legally marketed predicate devices." This is a general statement of equivalency rather than specific performance metrics.

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

The document does not specify the sample size of the test set used for the internal testing. It also does not provide any information about the data provenance (e.g., country of origin, retrospective or prospective nature).

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 provided in the document. The device is intended to be used by an "experienced radiological physicist," but there's no mention of experts involved in establishing ground truth for the testing.

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

This information is not provided in the document.

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

A MRMC comparative effectiveness study was not explicitly mentioned or described. The device is "standalone software" for quality control and does not appear to involve human readers in an AI-assisted diagnostic capacity. Its function is to check dose distribution, not to interpret images or assist human readers in diagnosis.

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

Yes, a standalone performance assessment was done. The "Testing" section clearly states: "Testing consisted of internal testing with and without the Graphic Processing Unit for the comparison of the results obtained using the Pencil Beam (PB) algorithm in the 510(k) cleared version of Dosimetry Check to the results obtained using the Convolution/Superposition 'Collapsed Cone' Algorithm (CC) added in Dosimetry Check Version 5 Release 1 as well as regression testing." This indicates the algorithm's performance was evaluated independently.

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

The document does not explicitly state the "ground truth" used for testing. However, given the device's function of calculating and comparing dose distributions, the ground truth would likely be established through:

• Physics-based calculations: Comparison against established physics models or highly accurate, independently verified dose calculation systems.
• Known measured radiation fields: Using precisely measured radiation fields to simulate and verify the accuracy of the computed dose.
• Comparison against predicate device results: The testing involved comparing results with the previously cleared version of Dosimetry Check (using the Pencil Beam algorithm) and the new Collapsed Cone algorithm. The predicate device's output would serve as a reference in this context.

8. The sample size for the training set

The document does not specify a training set sample size. This type of device (a dose calculation algorithm for quality control) might not involve a "training set" in the machine learning sense, but rather a set of test cases designed to validate the accuracy of its physics-based calculations.

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

Not applicable, as a training set or its associated ground truth establishment is not discussed in the provided text.

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Dosimetry Check is a standalone software product intended to be used by an experienced radiological physicist for quality control purposes only. Dosimetry Check is intended to check the correctness of x-ray treatment plans delivered from high energy charged-particle radiation therapy treatment machines by using a measurement of the applied radiation fields that are planned to be or have been applied to a patient, and computing the dose to the patient from the measured radiation fields. This product is to be used as a quality control check for the treatment planning system and delivery system.

Dosimetry Check quality control software uses the radiation fields that are measured with media such as x-ray film, electronic portal imaging devices (EPID), diode or ion chamber arrays, or in the case of TomoTherapy, a fan line detector array, and provides a theoretical calculation. Dosimetry Check computes the dose and dose distribution using the patient specific CT or other image set or alternately a phantom that is likewise scanned. to calculate the reconstructed dose that is then compared to the plan dose. The results reported can include the computed percent difference at specific points as compared to the patient specific radiation treatment plan.

Dosimetry Check does not provide any conclusions regarding the comparisons and does not provide any criteria to be used for interpreting the results. The experienced radiological physicist can reevaluate his patient specific radiation treatment plan in accordance with his clinical judgment.

This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field applied to the patient and provided in an exported file, and a theoretical calculation. This product does not provide any quality assurance that the fields are in fact correctly applied to and correctly aligned with the patient anatomy as planned. In addition. the product may be used to display the above dose on other fused image sets which could provide additional supportive quality information to the user regarding the correctness of treatment.

System 2100 for which 510(k) K993530 was cleared by the FDA on December 15, 1999 that is a medical image display system serves as a foundation that provides basic image display functionality for Dosimetry Check.

Dosimetry Check is a software program that will compute the dose and dose distribution to the patient from a measurement of the radiation fields that are applied to the patient. The dose so computed serves as a means to verify the correctness of the radiation treatment and to serve as a final sanity check. The radiation fields are measured with media such as x-ray film or electronic devices that will measure over the area of the field, such as electronic portal imaging devices (EPID), or diode or ion chamber arrays.

To extend Dosmetry Check to support the TomoTherapy machine, the device uses the data measured by the fan beam radiation detector that is part of the TomoTherapy machine. The detectors capture the radiation intensity periodically at predetermined gantry angles and couch positions. known as control points, from the treatment plan. The detector only measures the intensity across the center of the radiation beam in the transverse plane. A prior measured profile in the perpendicular longitudinal direction is then applied to complete the radiation field map. The radiation field map is then applied as a stationary beam at the center gantry angle and couch position for the integration period (between two control points), from which the dose to the patient is computed. The patient dose is then summed up from all such radiation field maps.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the Dosimetry Check version 4 release 1. Instead, it relies on demonstrating equivalence to the predicate device and successful external validation. The performance is reported qualitatively.

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

• Sample Size for Test Set: Not explicitly quantifiable from the provided text in terms of individual patient cases or measurements. The external validation was performed at 2 sites in Europe and 3 sites in the US. The text mentions "All aspects of using Dosimetry Check for quality control for TomoTherapy were tested during the beta testing." This suggests a comprehensive evaluation rather than a fixed number of cases.
• Data Provenance (Retrospective/Prospective, Country of Origin): The external validation involved prospective "beta testing" at 2 sites in Europe and 3 sites in the US. It doesn't specify if the data used for internal testing (modular, regression, verification) was retrospective or prospective, or its origin.

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

The text does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It mentions that the device is "intended to be used by an experienced radiological physicist for quality control purposes only." It is implied that these "experienced radiological physicists" at the beta test sites would be the ones evaluating the device's output against their clinical judgment or established facility standards, effectively forming the "ground truth" for the device's utility in their context.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1). The "beta testing" implies evaluation by the "intended users" (experienced radiological physicists), but the process of reaching consensus or resolving discrepancies is not described.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a quality control software for dose calculation and comparison, not an AI-assisted diagnostic tool for human readers. It's intended to verify treatment plans, not to assist humans in interpreting images or making diagnoses in the typical MRMC study context. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

Yes, in essence. Dosimetry Check is described as "standalone software" and its primary function is to "compute the dose and dose distribution" and "compare to the plan dose." While it is used by an "experienced radiological physicist," the software itself performs the calculation and comparison autonomously. The physicist then interprets the results. This aligns with the concept of standalone algorithmic performance in its core function. The "Nonclinical Testing" (modular, regression, verification, installation, performance testing) likely evaluated the algorithm's standalone accuracy in these computations.

7. The Type of Ground Truth Used

The ground truth used for assessing the device appears to be the patient-specific radiation treatment plan (planned dose) against which the device calculates and compares a "reconstructed dose" from measured radiation fields. The text states: "...to calculate the reconstructed dose that is then compared to the plan dose." The overall evaluation of performance during external validation would be based on whether the device's output (the comparison) was deemed acceptable and useful by the "experienced radiological physicist" in their quality control workflow.

8. The Sample Size for the Training Set

The document does not explicitly state a sample size for a training set. Given the nature of this software (dose calculation and comparison based on physical principles), it's more likely developed using well-established physics models and possibly calibrated with phantom measurements, rather than being "trained" on a large dataset in the machine learning sense. The kernel for deconvolution in the predicate device (Dosimetry Check version 3) was derived from "phantom measurements," which might be analogous to a calibration or parameter tuning set, but not a typical "training set" for AI.

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

As there's no explicit "training set" mentioned in the context of machine learning, the question isn't directly applicable. However, if we consider calibration or model parameter derivation:

• For the predicate device, the "kernel" used in the deconvolution process was "derived prior from phantom measurements with the same imaging device or media." This suggests the ground truth for these derivations would be known physical properties of phantoms and direct measurements using established dosimetry techniques.
• For the modified device, the extension to TomoTherapy uses a "fan beam radiation detector" and "a prior measured profile in the perpendicular longitudinal direction is then applied to complete the radiation field map." The establishment of these "prior measured profiles" would similarly rely on physical measurements and known ground truth for radiation fields.

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The product is to be used by radiation oncologist, dosimetrist, and radiation therapy physicist to check the correctness of the x-ray treatment fields from high energy treatment machines that are planned to be or have been applied to a patient. This product is to be used in addition to the treatment planning system to provide a means for additional and redundant verification that the plan is in fact successfully accomplished. This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field and a theoretical calculation. This product does not provide any quality assurance that the fields are in fact correctly applied to and correctly aligned with the patient anatomy as planned. In addition, the product may be used to display the above dose on other fused image sets which could provide additional clinical information to the radiation oncologist regarding the treatment.

Dosimetry Check with Exit Dose is a software program intended to provide a means for testing the dosimetry of radiation therapy treatments applied to a patient using high energy x-rays. This test is performed from measurements made during treatment of the patient by measuring the radiation fields after they have passed through the patient with a suitable imaging device such as an electronic portal imaging device or other measuring devices or media. The following software functions are then performed:

1. The patient's CT scan treatment plan image set is traced to provide the water equivalent path to points on the measured exit dose plane.
2. A deconvolution process is performed with a kernel that is a function of radius and the thickness transversed to convert the exit images back to x-ray intensity in air fluence prior to patient entry. The kernel is derived prior from phantom measurements with the same imaging device or media.
3. The derived in air fluence is now the same starting point as when the radiation fields are measured directly prior to patient entry.
4. The existing Dosimetry Check (FDA 510(k) K010225) software functions are then used to compute the dose to the patient using the in air fluence for each treatment beam and to evaluate the correctness of the dose to the patient.

I am sorry, but the provided text does not contain the information required to populate the requested table and answer the questions regarding acceptance criteria, study details, and performance metrics. The document is a 510(k) summary and FDA clearance letter for a device called "Dosimetry Check with Exit Dose". It describes the device's function and indications for use but does not include:

• Specific acceptance criteria for device performance.
• Details of a study conducted to prove the device meets acceptance criteria (e.g., sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets).

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This product is to be used by radiation therapy oncologist or staff under their direction to locate the position relative to the patient of the isocenter of a treatment beam on a gantry mounted radiation therapy treatment machine. Some internal marker must be visible on both a radiograph of the patient taken at the time of treatment and the images used for the treatment plan in order to use this software to align the marker image on the radiograph with the plan to find the proper patient support system coordinates. Only a translation along the couch lateral, longitudinal, and height directions are considered and solved for. Possible rotations or repositioning of the patient are not considered.

VisiTrak is a radiation therapy localization software system that assist in aiming the radiation beam. This software uses functions from System 2100, a Radiological Image Display System, 510(k) K993530, and Dosimetry Check, a treatment plan delivery testing system, 510(k) K010225.

The following functions are included in VisiTrak:

• (1) Means to download a treatment plan from a treatment planning system, to include a stackable image set (such as the CT scans used to generate the plan), beam geometry, and optional regions of interest outlines. [This function from Dosimetry Checkl
• (2) Means to define and trace a marker that is visible in the stackable image set. [This function from System 2100]
• (3) Means to draw the markers on two dimensional plane images and three dimensional perspective room views.
• (4) Means to read in radiographic images made of the patient in the treatment position on the gantry mounted treatment machine.
• (5) Means to define the geometry for each radiographic image, i.e., in the treatment machine coordinates.
• (6) Means to project the defined markers onto the radiographic images.
• (7) Means to manually select couch coordinates to match up the images of the markers on the radiographs with the projected marker images.
• (8) Means to trace the images of the markers on the radiographs.
• (9) Means to solve for the best estimate of the couch coordinates that will align the projected and traced marker images.
• Means to display the couch coordinates for each treatment beam using the (10) couch position found in (7) or (9) above.

The provided text is a 510(k) summary for VisiTrak, a radiation therapy localization software system. While it describes the device's functions and intended use, it does not contain information about specific acceptance criteria, a study proving performance against those criteria, or the detailed methodological information requested.

Therefore, many of the requested points cannot be answered from the provided document.

Here's a breakdown of what can and cannot be extracted:

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

• Cannot be answered from the text. The document does not define specific acceptance criteria (e.g., accuracy thresholds, precision measurements) or present a table of results from a performance study.

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

• Cannot be answered from the text. The document mentions the device "mathematically solves for the x, y,z coordinates" and projects markers, but it does not describe any specific testing or validation study with a test set.

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)

• Cannot be answered from the text. There is no mention of a test set, ground truth establishment, or experts involved in such a process.

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

• Cannot be answered from the text. No adjudication method is described as no test set or expert review process is detailed.

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

• Cannot be answered from the text. The document describes a software system that assists in aiming radiation beams, performing calculations and projections. It does not mention any MRMC comparative effectiveness study, nor does it quantify human reader improvement with or without AI assistance. The device's function is more about precision and alignment calculation than interpretive human assistance.

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

• Cannot be answered from the text. The document describes the software's functionality, which includes both automated projection/solving and manual selection/tracing by users ("Means to manually select couch coordinates," "Means to trace the images of the markers"). It doesn't explicitly state whether a standalone algorithm-only performance test was conducted. The nature of the device suggests it's an human-in-the-loop tool.

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

• Cannot be answered from the text. No ground truth type is specified, as no performance study or test set is described.

8. The sample size for the training set

• Cannot be answered from the text. The document does not describe any machine learning or AI models that would require a training set, nor does it mention a training set size. The device is described as mathematically solving coordinates and projecting images based on geometric definitions.

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

• Cannot be answered from the text. Since no training set or machine learning components are mentioned, the establishment of ground truth for a training set is not discussed.

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This product is to be used by radiation therapy oncologist, dosimetrist, and radiation therapy physicist, to plan the treatment with x-rays for patients undergoing radiation therapy for stationary and gantry arc beams. Support is included for field shaping with multi-leaf collimators and auxiliary blocking, and the use of wedges. Electron therapy and intensity modulated radiation therapy is not included in this product.

RtDosePlan is a radiation therapy external beam treatment planning program that supports treatment planning for x-rays only. The following functions are included:

1. Provide means to read in CT scans and form a patient model.
2. Provide means to define a skin boundary.
3. Provide means to convert CT numbers to physical density.
4. Provide means to define a plan that consists of one or more treatment beams.
5. Provide means to define a treatment beam.
6. Provide means to locate isocenter of the treatment beam within the patient model.
7. Provide means to set the gantry, collimator, and couch angles, and to specify a gantry arc rotation.
8. Provide means to specify a wedge.
9. Provide means to shape a field with a multi-leaf collimator.
10. Provide means to shape a field with auxiliary blocking (cerrobend).
11. Provide means to fit a poly-energetic pencil beam algorithm for the purpose of computing the dose.
12. Provide means to compute the dose to the patient model from the specified treatment beams.
13. Provide means to display the dose on 2d planes in the patient model and 3d room views.
14. Provide means to specify a dose prescription and calculate monitor units for each treatment beam.
15. Provide means to outline regions of interest.
16. Provide means to fuse other image sets and transfer outlines and points from the other image set.
17. Provide means to compute and display dose volume histograms.

The provided text is a 510(k) summary for a medical device called "RtDosePlan," a radiation therapy external beam treatment planning program. This type of document focuses on establishing substantial equivalence to a predicate device and outlining the device's functions and indications for use. It does not contain information about acceptance criteria, detailed study designs, sample sizes, expert qualifications, or ground truth establishment typically found in performance studies.

Therefore, I cannot extract the requested information to populate the table and answer the specific questions about device performance against acceptance criteria and the details of a proving study. The 510(k) summary confirms the device's functions but doesn't include the empirical evidence of its performance in the way you've requested.

Here's a breakdown of why the information isn't available in the provided text:

• Acceptance Criteria and Reported Device Performance: These are typically quantitative metrics (e.g., accuracy, precision) compared against predefined thresholds. The 510(k) summary lists the functions of the device but not its performance statistics.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth type, Training Set Size/Ground Truth): These details are integral to clinical or technical validation studies. A 510(k) submission generally refers to design controls and predicate comparisons, but often doesn't include the full performance study details if they are not specifically required for substantial equivalence. For a treatment planning system, performance would likely be validated through dose calculation accuracy and comparison against established physics principles and possibly phantom studies rather than human-in-the-loop performance with patients in the initial submission.

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MillComp is used to manufacture compensators that are designed for radiation therapy treatment beams. MillComp may be used with any system that can design compensators such that the thickness over the area of the beam is specified at some known source to compensator distance in a plane perpendicular to the central axis. The thickness on an evenly spaced grid may be specified on divergent rays or on rays perpendicular to the plane of the compensator which is perpendicular to the central ray. If on divergent rays, the milled surface may be specified as towards the x-ray source or as towards the patient.

MillComp is a program that will write the tool path program to mill radiation therapy compensators on an end mill. Compensators are attenuators that are to be inserted into the x-ray beams for the purpose of modifying the field distribution over the area of the treatment beam. MillComp takes as input a compensator specification. The compensator specification will come from multiple sources, such as current therapy treatment planning systems, and is converted into a standard specification file format that MillComp can read. The conversion programs to read a compensator specification and write out the standard file format will be written on an as need basis according to the customer's needs. MillComp will read the specification file, generate the surface defined in the specification, and compute the tool paths necessary to cut the surface in solid lead, cerrobend, or other material, on a three axis end milling machine.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The provided text is a 510(k) summary and an FDA clearance letter for a device called "MillComp Version 1.0." This device is a program that generates tool paths for milling radiation therapy compensators.

The 510(k) summary focuses on describing the device's function and its intended use, which is to manufacture compensators for radiation therapy treatment beams. The FDA clearance letter confirms that the device has been found substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done and its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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Ask a specific question about this device