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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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Brachytherapy applicators are commonly used to facilitate the positioning of a radioactive source inside or near the patient in order to administer radiation therapy to cancerous tissue.

Cervix Ring Applicator: The Cervix Ring Applicator is for gynecological Brachytherapy of cervix, endometrium and vagina, to be used only by trained physicians. The Maximum implementation per treatment application is 28 days.

Trocar Needle Sets: The intended use is interstitial HDR/PDR brachytherapy treatment, to be used only by trained physicians. The maximum implantation period of the needles is 28 days.

Martinez Prostate Template Set: The Martinez Prostate Template Set is for assisting interstitial HDR/PDR brachytherapy of the prostate gland, to be used only by trained physicians. The Maximum application duration per treatment application is 28 days.

Bonvoisin Gerard Esophageal Applicator Set: The Bonvoisin Gerard Esopheagel Applicator is intended for brachytherapy treatment of the esophagus, to be used only by trained physicians. The maximum implementation duration per treatment application is 24 hours.

The following described medical instruments are brachytherapy applicators for use with the Flexitron Brachytherapy Afterloader. Brachytherapy applicators are commonly used to facilitate the placement and positioning of a radioactive source inside or near the patient in order to administer radiation therapy to cancerous tissue. Prior to treatment radiation X-ray markers are positioned into the applicator channel(s) in order to determine source dwell positions with the help of radiographic images as part of the brachytherapy treatment planning process.

Cervix Ring Applicator: The Cervix Ring Applicator is a tandem and ring brachytherapy instrument. The applicator consists of 2 separately placed ridged brachytherapy channels, i.e. 1 tandem (intrauterine tube) and a ring tube. The Cervix Ring Applicator is used as a gynaecological intracavitary instrument to assist the positioning of a radioactive source under remote control (involving HDR or PDR Flexitron Remote Afterloader system), in order to administer radiation therapy to cervix and uterus carcinoma.

Trocar Needle Sets: The trocar Needles are straight ridged needles made out of stainless steel and have closed end sharp tip for skin and tissue perforation. The Trocar Needles are used as interstitial brachytherapy instruments to assist the positioning of a radioactive source under remote control (involving HDR or PDR Flexitron Remote Afterloader system), in order to administer radiation therapy to tissue and organ carcinoma.

Martinez Prostate Template Set: The Martinez Prostate template is to be used for HDR/PDR brachytherapy of the prostate gland. In order to administer brachytherapy to the prostate, needles are inserted interstitially into the prostate with the guidance of a prostate template. The prostate template can be mounted on an Ultra Sound probe stepper device in such a manner that the US grid coordinates projected over the images of the prostate are corresponding to the grid indication of the prostate template and its holder.

Bonvoisin Gerard Esophageal Applicator Set: The Bonvoisin Gerard Esophageal Applicator consists of a flexible tube with a tapered distal tip. This applicator tube is advanced through the mouth into the esophagus, the tapered distal tip gently dilitates the esophagus, in order to facilitate the placement of the applicator tube. When the applicator tube is in position the tube is to be immobilised in relation to the patient's mouth with the accompanied fixation mask. For connection and treatment with the brachytherapy remote afterloader a separate flexible treatment catheter is provided in the set. The distal end of the treatment catheter is to be inserted into the applicator tube and the proximal end is to be connected to the afterloader device. In order to fit different esophagus anatomy sizes and/or treatment requirements the applicator tube is provided in different diameter sizes, ranging in diameter from 5 mm to 20 mm. Both the fixation mask and the treatment catheter can be applicator tube sizes.

This product is a medical device, and the provided text is a 510(k) summary for its clearance. Therefore, the "acceptance criteria" for a medical device in this context refer to the criteria for demonstrating Substantial Equivalence to legally marketed predicate devices, rather than a performance study with specific quantitative metrics. The study proving this typically involves comparing the new device's technological characteristics and intended use to those of the predicate devices.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not describe a "test set" in the context of a performance study with a defined sample size. This 510(k) submission relies on a comparison to predicate devices, not a clinical trial or performance evaluation of the device in isolation against specific metrics. Therefore, there is no sample size for a test set or data provenance from a performance study to report. The "data" here refers to the design specifications and intended use of the new devices in comparison to existing ones.

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

Since there was no "test set" for a performance study evaluating the device's accuracy or efficacy in the way a diagnostic algorithm might be assessed, there is no mention of experts used to establish ground truth. The "ground truth" for a 510(k) submission of this type is essentially derived from the established safety and effectiveness of the legally marketed predicate devices.

4. Adjudication Method for the Test Set

As there was no "test set" or performance study described in the document, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this 510(k) summary. This type of study is typically used for diagnostic devices to compare human reader performance with and without AI assistance. The submitted devices are brachytherapy applicators, which are instruments used in radiation therapy, not diagnostic devices or AI-powered tools.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study (algorithm only) was not done. The devices are physical medical instruments, not algorithms.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate devices. The new devices are deemed "substantially equivalent" if they share the same intended use and similar technological characteristics, and do not raise new questions of safety or effectiveness compared to these predicates.

8. The Sample Size for the Training Set

There is no mention of a training set or its sample size. The devices are physical instruments, not AI algorithms that require training data.

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

As there is no training set, there is no information on how ground truth for a training set was established.

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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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The Flexitron Remotely Controlled Brachytherapy Afterloading System is intended to enable an operator to apply by remote control a radionuclide source (Flexisource) into the body or to the surface of the body for radiation therapy.

Flexitron is intended to be used in combination with applicators which makes it suitable for intracavitary, interstitial, intralumenary, bronchial, endovascular, intra-operative and surface brachytherapy treatment.

Flexitron is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and authorized medical professional.

Flexitron is a computer controlled medical device for brachytherapy treatment. The Flexitron Remotely Controlled Brachytherapy Afterloading System comprises subjoined listed subsystems: TDU - Treatment Delivery Unit, TCC - Treatment Communications Console, and TCP Treatment Control Panel. The TDU houses the radioactive source in its built-in shielding safe, the microcomputer controlled driving mechanism and channel selector mechanism. The TCC is for treatment program data entry, data storage and data displaying. The TCP comprises the basic operator elements for start and stop treatment and for displaying device status and used and remaining treatment time. The TDU is designed for positioning the source at 401 separate dwell positions in each of the 40 treatment channels and together with dwell time settings for each individual dwell position it enables the creation of isodose shapes targeted to the patients anatomy and geometry in order to irradiate the target patient body site and spare the healthy surrounding tissue. Dwell positions can be programmed at 1 mm intervals. The maximum source outdrive distance is 1400 mm from the channel selector front plate. Dwell times are programmable with increments of 0.1 second. Maximum dwell time is 999.9 seconds per position. Minimum dwell time is 0.1 second per position. A dwell position is skipped if its dwell time is 0 seconds. Before the radioactive source is moved into a treatment channel a check cable is first moved into it. A check cable is of a similar construction of a source cable but without radioactive isotope. It is a measure to check the treatment channel for free passage of the source immediately after the check. The TDU is connected to TCC via a serial data communications link to receive the patient treatment program and to return data of the performed patient treatment. TCC allows for manually entering a patient treatment program or for electronically transferring a patient treatment program from Brachytherapy Treatment Planning Software (Treatment planning software is not subject of this 510(k) PreMarket Notification). During patient treatment TCC displays treatment progress and logs patient treatment data and machine performance data in separate log files. TDU is connected via another serial communications port to TCP. TCP is a touchscreen device which is directly controlled from the TDU embedded microprocessor. TCP allows for starting the patient treatment when all conditions are fulfilled.

The provided document is a 510(k) summary for the Flexitron Remotely Controlled Brachytherapy Afterloading System. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria through a clinical study with detailed performance metrics.

Therefore, much of the requested information regarding acceptance criteria and performance studies (e.g., sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) is not present in this type of regulatory submission.

The document primarily discusses the device's technical characteristics and intended use in comparison to predicate devices. It states that "The differences between Flexitron and predicate devices do not concern the basic principle of operation nor does it adversely effect the safety or effectiveness of the device." This implies that the device is considered safe and effective because it is technologically similar to existing approved devices.

Here's what can be extracted and what cannot:

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

   • Acceptance Criteria: Not explicitly stated as quantifiable metrics in the provided document. The overarching "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device, meaning it is as safe and effective.
   • Reported Device Performance: No specific quantitative performance metrics (e.g., accuracy, precision) from a study are reported. The document focuses on describing the device's capabilities (e.g., dwell positions at 1 mm intervals, dwell times with 0.1-second increments).

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

   • Not applicable / Not provided. The document describes a comparison to predicate devices and the device's technical specifications, not a study with a test set of data 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 provided. No ground truth establishment is described for a test set.

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

   • Not applicable / Not provided. No test set or adjudication method 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 device is a remote-controlled brachytherapy afterloading system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant or included.

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

   • Not applicable / Not provided. This is a hardware system for delivering radiation, not an algorithm, so "standalone performance" in the AI sense is not relevant. Its "standalone" performance is inherent in its operational specifications.

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

   • Not applicable / Not provided. No "ground truth" (in the context of clinical AI performance) is mentioned. The ground truth for this device's function would be its ability to accurately deliver radiation as programmed, which is validated through engineering and dosimetry checks, not clinical data labels.

8. The sample size for the training set:

   • Not applicable / Not provided. This device is not an AI/ML model that requires a training set.

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

   • Not applicable / Not provided. Not an AI/ML model.

Summary of what is provided related to acceptance and evidence:

• Acceptance Criteria (Implied by 510(k) process): Substantial equivalence to legally marketed predicate devices in terms of safety and effectiveness.
• Study Proving Acceptance (Method): Comparison of technological characteristics and intended use to predicate devices.
• Predicate Devices Used:
  • microSelectron-HDR Version 2 (Nucletron bv, K953946)
  • GammaMed Plus 3/24 High Dose Rate (HDR) Remote Afterloader (Varian Medical Systems Inc, K031524)
• Key Similarities (evidence presented):
  • All devices have a subsystem comprising a shielding safe, drive mechanism, channel selection, and controlling electronics connected to a personal computer for treatment program data entry.
  • All use a radioactive source sealed in a stainless steel capsule connected to a stranded cable.
  • Intended use is the same: remote-controlled application of a radionuclide source for radiation therapy (intracavitary, interstitial, intralumenary, bronchial, endovascular, intra-operative, and surface brachytherapy).
• Conclusion: The Flexitron device is considered substantially equivalent to the predicate devices because its differences do not concern the basic principle of operation nor do they adversely affect the safety or effectiveness of the device.

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