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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 pescribed 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 the proposed treatment. The therapy planning is then transferred from 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 or 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.

The provided text pertains to a 510(k) submission for a medical device called "Flexiplan V2.5," a Brachytherapy Treatment Planning System. However, the document does not contain any information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or specific performance metrics for the device.

The document primarily focuses on:

• Administrative details of the 510(k) submission (submitter, contact, date).
• Device identification (name, common name, classification, product code).
• Substantial equivalence to a previously cleared device (Flexitron, K081112), emphasizing that Flexiplan V2.5 has the same intended use, operating principle, and technological characteristics as its predecessor.
• Description of the device and its accessories, outlining its function as software for creating radiation therapy plans for brachytherapy.
• Intended use statement for the Flexiplan V2.5.
• FDA's response letter granting 510(k) clearance based on substantial equivalence.

The core of the submission revolves around demonstrating that changes in version 2.5 of Flexiplan do not adversely affect safety or effectiveness compared to the previous cleared version (K081112). This type of submission often relies on a comparison to a predicate device rather than presenting new clinical study data with acceptance criteria.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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