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The ModuLeaf is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The ModuLeaf is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate the radiation delivery to a target based on a treatment plan generated by planning software. The device is used to help the clinician deliver well-defined target volumes of radiation while sparing the surrounding tissues and organs.

The ModuLeaf is a conformal radiation therapy and radiosurgery device that is mounted to a standard radiation therapy linear accelerator (Linac). The ModuLeaf receives input from planning system software that determines the collimator aperture shapes at different gantry positions along the arc around the target area. Radiation is delivered at a constant rate. The ModuLeaf consists of three parts: (1) the user console, (2) the control cabinet and (3) the collimator mechanism. The control cabinet with the user console serves as the control station for the operator and is located near the Linac operator console. The control cabinet contains the PC, an interface board and the power supply. The PC consists of a specified configuration of a CPU, motherboard. RAM, VGA board and HDD. It is used as the communication interface between the operator and the planning system software or the record and verify (R&V) system that contains the treatment positioning data. The PC also serves as the master for the control and verification system. The data received from the planning system software or the record and verify (R&V) system is processed and transferred to the micro-controllers on the control and verification boards. The operator initiates position adjustment at the console or at the record and verify (R&V) system depending on the configuration. When an R&V system is involved the leaf positions are downloaded to the PC. The PC then starts all the micro-controllers simultaneously and retrieves the position of the leaves, comparing the values of the control system with those of the verification system. The collimator mechanism is fitted to the accessory holder of the Linac gantry. It consists of 80 driving units that position the tunqsten leaves via a rack and pinion mechanism. Two independent potentiometers are directly connected with each tungsten leaf to retrieve information on the leaf position, i.e. there are 80 potentiometers for leaf positioning and an additional 80 potentiometers for independent leaf position verification. They serve as feedback for the verification system that checks the correct positioning of the leaves.

The provided text is a 510(k) summary for the ModuLeaf device, a Multileaf Collimator used in radiation therapy. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it would be relevant for an AI/ML powered medical device.

Therefore, I cannot fulfill the request for information on acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details. The document is for a traditional medical device (hardware) and not an AI/ML driven one, which would typically involve such performance metrics against a defined standard or ground truth.

The only relevant information from the provided text that could be extracted is:

• Device Name: ModuLeaf
• Intended Use: "The ModuLeaf is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The ModuLeaf is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate the radiation delivery to a target based on a treatment plan generated by planning software. The device is used to help the clinician deliver well-defined target volumes of radiation while sparing the surrounding tissues and organs."
• Predicate Device: Mini Multileaf Collimator (K011816) from MRC Systems GmbH.
• Regulatory Class: Class II (21 CFR 892.5710)

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KonRad is intended to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). Once the optimization is complete the dose distribution and dose volume histogram curves are displayed for the user to evaluate. After approval the results are exported to the delivery equipment, Linear Accelerator or Record and Verify system, for final verification before treatment delivery.

KonRad as described in this submission is a radiation therapy treatment planning package designed to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). KonRad is a PC based system. KonRad software uses defined anatomical structures for the optimization and treatment planning process. The images or contours are based on tomographic images imported via Dicom and Dicom RT protocols from various sources, e.g. CT. Virtual Simulation software etc. The users treatment machine beam data is utilized for plan calculation. The user defines the desired dose to be delivered to the target and the surrounding structures. Values are entered to weight the optimizations according to the importance of reaching the dose objectives for the target and other structures. After the user starts the optimization, the software calculates the required MLC or partial attenuation block shapes needed to achieve the dose objectives. This is done for each beam simultaneously and the resulting dose distribution and DVH are displayed. Once the optimization is complete, the dose distribution and DVH are displayed for the user to evaluate. If the user is not satisfied with the results of the optimization, the input parameters can be modified and the optimization repeated until the desired results are met. When the user is statisfied, the final treatment plan can be stored and is ready for export. The resulting treatment plan can be exported, to the appropriate delivery equipment. Linear Accelerator or Record and Verify system (R&V) via defined protocols, e.g. Dicom RT. The export of the treatment plan does not activate the delivery equipment, all information must be verified by the user prior to treatment.

The provided information does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or quantitative performance metrics for KonRad. This document is a 510(k) premarket notification for a radiation therapy planning system, KonRad, dated July 1, 2002. It focuses on establishing substantial equivalence to a predicate device (Nucletron PLATO ITP, K992434) rather than presenting a performance study with acceptance criteria.

The information primarily describes the device's intended use and technological considerations, stating it "enhances the functionality of the defined predicate device by providing the ability to finalize the dose calculation." However, it does not include a comparative effectiveness study, standalone performance metrics, or details on how the device's accuracy or efficacy was evaluated against specific criteria.

Therefore, I cannot provide the requested table and study details as the input document does not contain this information. The document focuses on regulatory approval through substantial equivalence, not on detailed performance validation against explicit acceptance criteria.

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The Mini Multileaf Collimator is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The Mini Multileaf Collimator is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate radiation delivery to a target based on a treatment plan generated by planning software. The device is used to help the clinician deliver well-defined target volumes of radiation while sparing the surrounding tissues and organs. The Mini Multileaf Collimator should only be used for fixed field X-ray treatments.

The Mini Multileaf Collimator is a conformal radiosurgery device that is a line to The Mini Multical Oonlinator to erapy linear accelerator (Linac). The Mini Multileaf Collimator mounted to a standard racines that determines the collimator aperture shapes at different gantry positions along the arc around the target area. Radiation is delivered at a constant rate.

The Mini Multileaf Collimator consists of three parts: (1) the user console, (2) the control cabinet and (3) the collimator mechanism.

The control cabinet with the user console serve as the control station for the operator and are I he control cabinet will the user console. The control cabinet contains the PC, an interface board located the power supply. The PC consists of a specified configuration of a CPU, motherboard, and the power supply. The F & consisted interface between the operator and the planning system software that contains the treatment positioning data. The PC also serves as the master for the control and verification system. The data received from the planning system software is processed and transferred to the micro-controllers (MC) on the control and verification boards.

The operator at the console initiates position adjustment. The PC then starts all the MC's I'm operator at the consore innussion of the leaves, comparing the values of the control system with those of the verification system.

The collimator mechanism is fitted to the accessory holder of the Linac gantry. It consists of 80 I it conmitte that position the fitted to theaves via a rack and pinion mechanism. A potentioneter is directly connected with each tungsten leaf to retrieve information on the leaf position. Independent potentiometers for verification are also included in the driving units.

The provided document is a 510(k) summary for a medical device called the "Mini Multileaf Collimator," submitted in 2001. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data for new safety and effectiveness claims. Therefore, the document does not contain the kind of specific performance data, acceptance criteria, ground truth details, or comparative study results you've requested that would typically be found in a study proving device meets acceptance criteria.

The document states that the new device has "minor differences" from its predicate and that "All tests were executed with all acceptance criteria met." However, it does not provide any specific details about what those acceptance criteria were, what tests were conducted, or the reported performance data from those tests.

Based on the provided text, I cannot complete most of the requested fields. Here's what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not specified. The document mentions "Verification, Validation and other testing activities" but does not detail the nature of these tests, their sample sizes, or data provenance.

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

• Not applicable/Not specified. The document does not describe a test set with human-established ground truth in the context of device performance. This is typically relevant for AI/diagnostic devices, not for a collimator's mechanical and electronic performance.

4. Adjudication method for the test set:

• Not applicable/Not specified. As above, no such test set is 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. This is not an AI device. It's a mechanical device (multi-leaf collimator) for radiation therapy. An MRMC study would not be relevant in this context.

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

• Not applicable. This device is hardware with control software, not a standalone algorithm in the AI sense. Its function is to be integrated with a linear accelerator and planning software, with a human operator.

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

• Not specified. Given the nature of the device (a mechanical collimator controlled by software), "ground truth" would likely refer to physical measurements of leaf positions, field shapes, and consistency with treatment plans, validated against engineering specifications. However, these details are not provided.

8. The sample size for the training set:

• Not applicable/Not specified. This is not an AI device that undergoes "training" in the machine learning sense. The software is deterministic and based on treatment planning data.

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

• Not applicable/Not specified. See point 8.

In summary: The provided 510(k) pertains to a hardware device (a multileaf collimator) and primarily focuses on demonstrating substantial equivalence to a predicate device based on engineering changes and subsequent testing. It explicitly states that "All tests were executed with all acceptance criteria met," implying successful verification and validation, but it does not provide the specific details of these tests, acceptance criteria, or performance data that you have requested. It is not an AI/diagnostic device, so many of your questions regarding ground truth, expert readers, and AI performance are not applicable to this document.

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