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Flexiplan is a Brachytherapy Treatment Planning System used by medical professionals. Flexiplan is used for the creation of HDR or PDR treatment plans for remote afterloader based brachytherapy. It especially supports the Flexitron Remote Afterloader from Isodose Control. Flexiplan calculates a proposed treatment course based on imported clinical images and other user entered data. Flexiplan supports the evaluation of clinical images in calculating the local and global dose to organs at risk and target volume.

Flexiplan is a software package which runs on a Windows - based PC and is used by medical professionals to create a radiation therapy plan based on the input entered by the operator. The isotopes used in the calculations match those which are normally used in High Dose Rate (HDR) and Pulsed Dose Rate (PDR) Remote Afterloaders. The software offers tools to enhance imported images and offers contouring of the planned target volume and organs at risk. The main use of Flexiplan is to calculate the required dwell times at the pre - determined dwell positions in a uniform way so that the Planning Target Volume (PTV) is treated with the prescribed dose while sparing the Organs At Risk (OAR).

Flexiplan can reconstruct one or more applicators. Based on the contoured target volume and the prescription dose, Flexiplan will calculate the optimal dose distribution for the tumor volume. Evaluation tools are available to qualify of the proposed treatment. The therapy planning is then transferred from the Flexiplan to the Afterloader.

The Flexiplan software is intended to be used with the Flexitron Brachytherapy Remote Controlled Afterloading Device.

The Flexiplan System comprises subjoined listed subsystems:

• . Personal Computer It executes the Flexiplan software.
• . Monitor To visualise the treatment planning process.
• . Keyboard To enter treatment data.
• . Mouse To select objects on the screen

The PC is used to execute the Flexiplan software and runs under Windows XP Professional / Vista. The hard disk stores patient data and the built in DVD-RW is used for making backup of the Patient Data. The PC can be connected to the hospital network to import Patient Image Data.

Accessory: Film Scanner
The Film Scanner allows the user to scan in an X-Ray image to present it on the screen to visualise the implant.

Accessory: Printer
The Printer allows for hard copy of the patients treatment plan and other stored data.

Accessory: Pen Tablet
The Pen Tablet acts as an alternative replacement for the mouse enabling the user to outline more accurately and faster a contour on the monitor.

Accessory: Touch Panel
The Touch Panel acts as an alternative replacement for the mouse enabling the user to outline more accurately and faster a contour on the monitor.

The provided text discusses the Flexiplan Brachytherapy Treatment Planning System. It describes the device, its intended use, and its substantial equivalence to predicate devices, leading to its 510(k) clearance. However, the document does not contain information regarding acceptance criteria, reported device performance metrics, or details about a study to prove these criteria were met.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance.
• Information on the sample size used for any test set or its provenance.
• The number or qualifications of experts used for ground truth establishment.
• The adjudication method for any test set.
• Details of a multi-reader, multi-case (MRMC) comparative effectiveness study, including effect sizes.
• Information on standalone algorithm performance.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• The sample size for any training set.
• How ground truth for any training set was established.

The document primarily focuses on explaining the device's function, its components, its intended use for calculating radiation therapy plans (specifically for HDR and PDR remote afterloader based brachytherapy), and arguing for its substantial equivalence to previously cleared devices (PLATO BPS and BrachyVision). The 510(k) clearance letter confirms this determination based on the provided information.

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