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Brachyvision 6.0 is designed to allow the dose distribution of an implant or applicator to be individually shaped for each patient. Brachy Vision is a general purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy, using either temporary or permanent implants of various radioisotopes.

Brachy Vison 6.0 may be used for any brachytherapy planning activity, but has been specifically optimized for use with remote afterloaders (especially the VariSource unit from Varian), and for use with 3D images such as may be obtained from CT or MRI, or Ultrasound images.

Brachy Vision is a computer based product used for calculating and displaying prospective or verification treatment plans for particular patients undergoing a course of Brachytherapy. The system consists of a computer with graphics display, film scanner input, and plotter output. Patient data may be entered from network connection, via the film scanner, via the optional back lit digitizer, or via the keyboard. Source placement information may be added to the patient data and isodose distributions, which would result from those source placements, may be displayed, analyzed and plotted. For use with remote afterloader devices, source dwell times may be optimized to user selected criteria.

The provided text describes Brachyvision 6.0, a computer-based product for calculating and displaying brachytherapy treatment plans. However, it does not contain specific acceptance criteria or a study detailing device performance against such criteria.

Therefore, I cannot provide the requested information. The document focuses on:

• Product Description: What Brachyvision does (calculates and displays treatment plans, works with various inputs like film scanner, digitizer, keyboard, network).
• Intended Use: For individual dose distribution shaping in brachytherapy, prospective and confirmation dose calculations using temporary or permanent implants of various radioisotopes.
• Technological Characteristics: References a "Specifications/Features Comparison Chart" which is not provided in the input.
• Regulatory Information: 510(k) submission details, substantial equivalence to a predicate device (Nucletron Plato Brachytherapy), and general information about FDA regulations.

Without a specifications table, performance data, or details of a validation study within the provided text, I cannot answer questions regarding acceptance criteria, sample sizes, ground truth establishment, or expert involvement in a study.

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Somavision is an advanced treatment planning preparation workstation for the physician and include high quality 3-D image capabilities. As part of the Varis Vision System, Somavision integrates treatment palnning in the overall therapy process, while taking advantage of the Varian Vision database.

Somavision is an advanced treatment planning preparation workstation with 3D image capabilities.

This document is a 510(k) Premarket Notification for the Varian SomaVision 6.0 device. It describes the device's intended use and technological characteristics, and ultimately summarizes the FDA's decision regarding its substantial equivalence to a predicate device.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

Therefore, I cannot fulfill your request for this specific information based on the provided document. The 510(k) summary focuses on regulatory approval based on substantial equivalence, not on detailed performance study results that would typically include acceptance criteria and study methodologies.

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CadPlan 6.0 is used to plan radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 1-50 MV, as well as Cobalt-60, and electron energies from 1 to 50 MeV, and to plan brachytherapy treatments. CadPlan will plan the 3D radiotherapy treatment approaches to combined modality plans, asymmetric and non-coplanar field, total body irradiation, multileaf collimators, motorized and dynamic wedges, customized blocking, compensating filters, and bolus.

CadPlan 6.0 includes export capabilities to verify beam and patient date, dose-planning results, and provide on-line information to block-cutting devices.

CadPlan 6.0 is a comprehensive 3D Treatment Modeling Workstation for external beam and brachytherapy planning.

This 510(k) summary for CadPlan 6.0 primarily focuses on demonstrating substantial equivalence to a predicate device (CadPlan ver. 2.62 Radiation Therapy Treatment Planning) based on technological characteristics and intended use. It does not describe specific acceptance criteria and a study proving the device meets those criteria in the way you've outlined for clinical performance studies.

Here's an analysis based on the provided text, highlighting what's not present:

1. Table of acceptance criteria and reported device performance:

   • Not provided. The document states "See the attached 'Specification Comparison Chart', Tab F" for technological characteristics, but this chart itself is not included in the provided text. Therefore, we cannot extract specific performance metrics or acceptance criteria.

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

   • Not provided. There is no mention of a clinical test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective). This submission focuses on demonstrating equivalence through technical specifications rather than a clinical performance study with a test set.

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

   • Not provided. As there's no described test set, there's no mention of experts or their qualifications for establishing ground truth.

4. Adjudication method:

   • Not provided. No adjudication method is described, as there's no performance study involving independent expert review.

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:

   • Not provided. This document predates common AI/MRMC studies for medical devices. CadPlan 6.0 is described as a "3D Treatment Modeling Workstation" for planning radiation therapy, not an AI-assisted diagnostic or assistive device that would typically undergo MRMC studies comparing human readers with and without AI.

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

   • Not provided. The device is a "Treatment Modeling Workstation," implying intended use with a human operator. There's no discussion of standalone algorithmic performance.

7. The type of ground truth used:

   • Not provided. If a performance study were conducted, common ground truths for radiation therapy planning software might include dosimetric measurements, comparison to established phantoms, or expert physicist review of plans. However, none of this is described in the provided text.

8. The sample size for the training set:

   • Not applicable/Not provided. This device is a software planning tool, not an AI/ML device that requires a "training set" in the modern sense. Its functionality would be based on underlying physics models and algorithms, not trained on patient data in the same way.

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

   • Not applicable/Not provided. (See point 8).

Summary of what is present:

The document is a Premarket Notification [510(k)] Summary for CadPlan 6.0, indicating its submission date, contact person, device name, classification, and predicate device. It briefly describes the product as a "comprehensive 3D Treatment Modeling Workstation" for external beam and brachytherapy planning and lists its intended uses, including planning various radiotherapy treatment approaches and export capabilities. The FDA's response letter confirms the 510(k) clearance based on substantial equivalence.

Conclusion regarding acceptance criteria and performance study:

The provided text does not contain the information requested regarding specific acceptance criteria, a clinical performance study, sample sizes, expert involvement, adjudication methods, or ground truth establishment. This is typical for 510(k) submissions of this era for a software planning tool where substantial equivalence is demonstrated primarily through comparison of technical specifications and intended use against a legally marketed predicate device, rather than through a de novo clinical performance study with defined acceptance criteria. The requested information would typically be found in detailed verification and validation reports, which are part of the full 510(k) submission but not routinely included in the publicly available summary.

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The Varian Millennium 120 Multileaf Collimator (MLC) is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In a static mode, the MLC performs the same function as the customized shadow blocks. In a dynamic mode, a series of MLC leaf positions can be indexed to either Clinac® dose fraction or gantry angle to create a changing beam shape while the radiation beam is on to create a three dimensional dose distribution.

The Varian Millennium Multileaf Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac® radiation therapy linear accelerator beneath the standard field defining the collimator jaw.

This 510(k) premarket notification for the Varian Millennium MLC-120 Multileaf Collimator does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

This document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, as required by the FDA. It primarily addresses the device's technical characteristics, intended use, and comparison to an existing device.

Here's why the requested information is not present:

• Acceptance Criteria and Reported Device Performance: This document states: "See the attached 'Specification Comparison Chart' (Tab F)." This chart, which would likely contain acceptance criteria and performance data, is not provided in the given text.
• Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Size, Training Set Ground Truth: These details would typically be found in a clinical study report or a detailed performance validation document, which are not included in this 510(k) summary. A 510(k) summary generally focuses on comparing the new device to a predicate device rather than presenting a full clinical trial report with these granular details.

Therefore,Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study details.

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The Varian VariSource™ Remote High Dose Rate Afterloader [system, including applicators and accessories] is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy. The VariSource Wright Vaginal Cuff applicator which is the subject of this 510(k) is a component of the VariSource system.

Applicators for the Varian VariSource Remote High Dose Rate Afterloader are a part of a remote controlled radionuclide applicator system, including an electromechanical device to enable an operator to apply, by remote control, a radionuclide source of high activity at various internal or surface body locations for radiation brachytherapy. The shape and materials of the applicator determine where it will be utilized for treatment.

The provided text is a 510(k) summary for the "VariSource Wright Vaginal Cuff Applicator" and does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information. It appears the document is not a performance study report but rather regulatory submission for market clearance based on substantial equivalence.

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The Varian VariSource Remote High Dose Rate Afterloader system, including the applicators included in this notification, is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy with a high specific activity radioisotope source to reduce the exposure times required to achieve a prescribed dose.

The applicators for the Varian VariSource Remote High Dose Rate Afterloader are part of a remote controlled radionuclide applicator system, including an electromechanical device to enable an operator to apply, by remote control, a radionuclide source of high activity to be placed at various internal or surface body locations for radiation brachytherapy. The shape and materials of the applicator determine where it will be located for treatment.

This document describes an applicator system for radiation brachytherapy, not a diagnostic or AI-powered device. Therefore, many of the requested criteria, such as those related to AI performance, ground truth, sample sizes for training/testing, expert adjudication, and MRMC studies, are not applicable.

Here's an analysis based on the provided text, focusing on what is relevant for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not outline specific numerical acceptance criteria (e.g., accuracy, sensitivity, specificity) or performance metrics as would be expected for a diagnostic or AI-driven device. Instead, the "acceptance criteria" for this type of device are primarily based on demonstrating substantial equivalence to predicate devices in terms of materials, intended use, and technological considerations.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a submission for a physical medical device (applicators) and not a data-driven device. There is no "test set" in the context of diagnostic performance or AI model validation. The "testing" involves demonstrating physical and functional equivalence to predicate devices, and likely verifying manufacturing specifications.

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)

Not applicable. There is no concept of "ground truth" established by experts for a test set in the context of this device's submission. The "truth" is established by the physical properties of the materials and the design's adherence to safety and functional standards, compared to previously cleared devices.

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

Not applicable for the same reasons as #2 and #3.

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

Not applicable. This device is not an AI system nor a diagnostic imaging tool that would involve "human readers" or "AI assistance."

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

Not applicable. This is not an algorithm or AI system.

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

Not applicable in the AI/diagnostic sense. The "ground truth" for this device's clearance is conformity to engineering specifications, material composition, and functional principles demonstrated by previously cleared predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI device or a data-driven model.

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

Not applicable.

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To assist the therapist in verification of the treatment field and shielding blocks in relation to anatomical landmarks in radiotherapy treatment.

VARiS PortalVision™ is an on-line electronic portal imaging system which allows for verification of the treatment field and shielding blocks in relation to anatomical landmarks in radiotherapy treatment. The imaging mechanism of VARiS PortalVision™ is an ionization chamber.

VARiS PortalVision™ is fully integrated into Varian's VARiS environment. It is a subsystem of the VARiS Images application. The VARiS PortalVision™ software supports image acquisition, image processing, and image evaluation by means of quantitative comparison tools.

As a subsystem of VARiS Images, VARiS Portal Vision™ runs on the VARiS Images workstation. The VARiS Images workstation is based on an Intel Pentium processor based PC running Microsoft Windows NT or the Win 95 operating system.

The provided text is a K955774 submission for the VARiS PortalVision™ device. It describes the device, its intended use, and technological considerations, but it does not contain information about acceptance criteria, a study proving performance against those criteria, or details regarding ground truth, sample sizes, or expert involvement for assessing performance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone performance study results.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document primarily focuses on the device's description, predicate comparison, and intended use as part of a 510(k) submission, which typically outlines the device's functionality and its substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria and clinical results.

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CADPLAN BT is designed to allow the dose distribution of an applicator to be individually shaped for each patient.

CADPLAN BT is a Windows NT software application that is designed to work together with the VariSource High Dose Rate Remote Afterloader. It allows for applicator placement for up to 20 channels, and allows dose distribution of an applicator to be individually shaped for each patient. It also allows for calculation of the dwell time of the catheter.

This document is a Summary of Safety and Effectiveness Information (SSEE) for a medical device submitted to the FDA. It is not a clinical study report and therefore does not contain the acceptance criteria or a study proving the device meets those criteria in the way you've requested.

The SSEE's purpose is to summarize the device, its intended use, and its technological characteristics in comparison to a predicate device for 510(k) clearance. It is an administrative document for regulatory submission, not a scientific publication detailing performance evaluation.

Therefore, I cannot provide the requested information because it is not present in the provided text.

Here's why each point you requested cannot be addressed by this document:

1. A table of acceptance criteria and the reported device performance: This document describes the functionality of the device ("allows for applicator placement," "allows dose distribution...to be individually shaped," "calculates dwell time") and compares it to a predicate device's functionality. It does not provide quantitative performance metrics against pre-defined acceptance criteria.
2. Sample sized used for the test set and the data provenance: No tests with a "test set" are described, let alone 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: No ground truth establishment for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set adjudication is mentioned.
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 is a treatment planning system, not an "AI" diagnostic or assistive tool in the modern sense. No MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study is mentioned. The device is a "software application that is designed to work together with the VariSource High Dose Rate Remote Afterloader," implying human-in-the-loop operation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): No ground truth is discussed as no formal performance study is presented.
8. The sample size for the training set: No training set is mentioned. This is a deterministic treatment planning system, not a machine learning model that would typically have a "training set."
9. How the ground truth for the training set was established: Not applicable, as there's no mention of a training set or ground truth for one.

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Ask a specific question about this device