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IMSure Brachy QA Software is a stand alone software application product intended for use as a quality assurance tool to verify brachytherapy treatment plans developed on a radiation therapy treatment planning system with the appropriate transfer format. It may also be used as a segregated standalone application in the IMSure QA Software suite of software products.

This product is intended for use by trained medical physicians, or dosimetrists. The calculation results must be evaluated by qualified personnel before a patient treatment. It is the responsibility of the medical physician or dosimetrist to determine whether the dosimetric accuracy is adequate for a particular patient.

Dose modeling of a source is based on the AAPM TG-43 formalism, and may be adjusted by a qualified user to match measured or published results. IMSure Brachy QA Software does not control any radiation delivery devices and does not allow the export of calculated information.

IMSure Brachy QA Software is a stand alone software application product intended for use as a quality assurance tool to verify brachytherapy treatment plans developed on a radiation therapy treatment planning system with the appropriate transfer format. It may also be used as a segregated standalone application in the IMSure QA Software suite of software products.

This product is intended for use by trained medical physicians, or dosimetrists. The calculation results must be evaluated by qualified personnel before a patient treatment. It is the responsibility of the medical physician or dosimetrist to determine whether the dosimetric accuracy is adequate for a particular patient.

IMSure Brachy QA Software independently computes a modeled dose that would be delivered by a high dosc rate (HDR) or low dose (LDR) brachytherapy system to a patient and compares it to the dose predicted by a primary treatment planning system. IMSure Brachy QA Software imports a file produced by a primary HDR or LDR treatment planning system (TPS), in the format of an industry standard Dicom-RT™ or vendor specific file, which contains information about a treatment. The files contain information about applicators or catheters and the associated source information in each catheter, such as source type, source strength, source location and source duration. The files may also contain information about specific calculation points and the dose predicted by the primary planning system, as well as patient specific information. The dose computation algorithm used is a superposition of point or line sources, incorporating 3-D geometrical features of the source construction, as well as radiological features of the source composition. Dosc modeling of a source is based on the AAPM TG-43 formalism, and may be adjusted by a qualified user to match measured or published results.

After importing a TPS plan, a user may edit the information, adding or modifying source positions, durations (or dwell times), type, or activity strength. Calculation point information may be edited as well. A 3-D view of the applicators, source positions, and calculation point positions is provided. A paper or electronic record can be stored including the final dose computation for each calculation point compared to the dose computed by the TPS, as well as relevant patient information for long term documentation. IMSure Brachy QA Software does not control any radiation delivery devices and does not allow the export of calculated information.

IMSure Brachy QA Software is provided to the customer on a CD. It requires the Microsoft Windows Operating System 2000 with service pack 2 or better, or XP. Computer system requirements include Pentium III or equivalent, a minimum of 256 MB RAM and 100 MB available hard drive space. Display requirements include 1024 x 768 minimum resolution and an OpenGL compatible video card meeting OpenGL 1.1 specifications.

The provided document does not contain explicit acceptance criteria in the form of a table or specific quantitative metrics with corresponding device performance values, nor does it detail a study designed to prove the device meets such criteria.

The document is a 510(k) summary for the Standard Imaging IMSure Brachy QA Software, primarily focusing on its purpose, intended use, and substantial equivalence to predicate devices. It describes functional areas addressed during verification and validation and lists beta sites for evaluation but does not provide details of a formal study with quantified performance data.

Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can be gleaned and what is missing:

1. Table of acceptance criteria and reported device performance:

• Not available. The document states that "The Standard Imaging IMSure Brachy QA Software has met its predetermined design specifications, risk analysis and validation objectives." However, it does not specify what those design specifications, risk analysis objectives, or validation objectives are in a measurable way, nor does it present device performance data against them.

2. Sample size used for the test set and the data provenance:

• Not available. The document mentions that the software was "successfully evaluated by the following beta sites:" and lists five hospitals. This suggests some form of testing, but it does not specify what constituted the "test set" (e.g., number of patient cases, treatment plans), its size, or the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not available. While the software is intended for use by "trained medical physicians, or dosimetrists," and beta sites are listed, there is no information about experts establishing ground truth for a test set. The software's function is to independently calculate and compare doses, with the primary treatment planning system's output serving as a reference. The "ground truth" for the software itself relies on the AAPM TG-43 formalism and user adjustments to match measured or published results.

4. Adjudication method for the test set:

• Not available. No details about a formal test set, expert adjudication, or adjudication method (e.g., 2+1, 3+1, none) are provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable / Not available. The IMSure Brachy QA Software is a "Dose Validation Software" intended as a quality assurance tool to verify brachytherapy treatment plans. It is not an AI-assisted diagnostic or decision-making tool for human readers in the context of image interpretation or treatment delivery. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not relevant to this type of device and is not mentioned.

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

• Yes, implicitly. The device itself is described as a "stand alone software application product" that "independently computes a modeled dose." The validation and verification efforts described ("Installation", "Import Tool Module", "QA Module", "Source Library Module", "User Management Module", and various source types/settings) imply testing of the algorithm's performance in isolation, comparing its calculations to expected or reference values (e.g., based on AAPM TG-43 formalism, measured, or published results). However, no specific performance metrics like accuracy, precision, or deviation values are provided from these standalone tests.

7. The type of ground truth used:

• AAPM TG-43 formalism, measured or published results. The document states: "Dose modeling of a source is based on the AAPM TG-43 formalism, and may be adjusted by a qualified user to match measured or published results." This indicates that the "ground truth" or reference standard for the software's dose calculations is derived from established physics formalisms and potentially empirical data.

8. The sample size for the training set:

• Not applicable / Not available. The IMSure Brachy QA Software is described as a software application that performs dose calculations based on specific formalisms (AAPM TG-43) and not as a machine learning or AI model that requires a "training set" in the conventional sense of data-driven learning. Its development likely involved engineering, physics modeling, and traditional software testing, rather than a supervised learning paradigm.

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

• Not applicable / Not available. As the software does not appear to be an AI learning model that uses a "training set," this question is not applicable.

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IMSure is indicated for use as a quality assurance tool to verify IMRT treatment plans developed on any radiation therapy treatment planning system with the appropriate transfer format. IMSure will also perform primary monitor unit calculations from measured physics data for plans of known geometry.

IMSure is a software program designed to provide a second, independent verification of IMRT plans created on primary radiation therapy treatment planning systems. After independently calculating the imported plan and fluence maps, IMSure compares results with the imported plan and maps, and calculates the differences. This second check provides an effective QA tool for verification of the original IMRT treatment plan. IMSure also may be used to compute primary monitor unit calculations for single and multiple beams with open, blocked, and wedged fields.

The provided 510(k) notification for the IMSure device (K031975) does not contain explicit acceptance criteria or detailed study results demonstrating performance against such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (RadCalc V4.0, K010464) by comparing technological characteristics and intended use. While it states that "The New Device has the same intended use and safety characteristics as the predicate device," it does not present a performance study with acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document. However, I can still provide what little is available:

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

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: Not reported in terms of specific metrics against acceptance criteria. The document claims "IMSure compares results with the imported plan and maps, and calculates the differences. This second check provides an effective QA tool for verification of the original IMRT treatment plan," but no quantitative performance data is given.

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 provided in the document. No formal test set or study data is presented.

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 as no formal test set and ground truth establishment process are described.

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

• This information is not provided as no formal test set and adjudication process are 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

• This information is not provided. The device is a software program for IMRT plan verification and monitor unit calculation, not an AI-assisted diagnostic tool that would typically involve human readers.

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

• The document implies a standalone performance comparison by stating "IMSure compares results with the imported plan and maps, and calculates the differences." However, no specific standalone performance metrics or studies are detailed. The comparison is against the primary radiation therapy treatment planning system, but the agreement or difference thresholds are not quantified.

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

• This information is not explicitly stated as no formal ground truth for a performance study is described. For a QA tool verifying IMRT plans, the "ground truth" would implicitly be the correct physical dose distribution and monitor units as determined by established physics principles and measurements, which the device aims to verify.

8. The sample size for the training set

• This information is not provided. The document describes the algorithms used (Single Source model, Three Source model, Clarkson scatter algorithm, Khan (classical)), which are based on established physics models rather than machine learning algorithms that typically require a "training set" in the conventional sense.

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

• Not applicable in the context of this device, as it employs physics-based algorithms rather than machine learning requiring a training set with established ground truth. The algorithms are based on "measured physical data" and "measured and modeled" scatter tables, implying established physical properties and calibrations as their basis.

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