Search Results

Accusoft-XL v.4.04 / CrossPlan is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.

CrossPlan / AccuSoft-XL v. 4.04 is an upgraded version of the Company's proprietary AccuSoft-XL. CrossPlan / AccuSoft-XL v. 4.04 is a radiation treatment planning system (RTPS), consisting of a collection of software modules that execute algorithms to produce estimates of beam radiation dose distribution in body tissues. It includes the image, delineation and beam planning techniques. CrossPlan / AccuSoft-XL v. 4.04 is designed to operate with Cones, Blocks and Wedges, as well as with a Micro-Multi-Leaf Collimator (MMLC), such that the shape of the radiation beam conforms to the irregular shape of the lesion. The ability to shape the radiation beam enables maximization of the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures. CrossPlan / AccuSoft-XL v. 4.04 is used for computation, display, evaluation, and output of dose estimations, including those for several modes of treatment, such as Conformal, Blocks and Wedges, Cones and Intensity Modulated Radiation Therapy (IMRT). There are several IMRT treatment modes: (1) Intensity Modulated Arc Therapy (IMAT) - in which an irradiating Linac rotates while leaves form a sequence of apertures (arcs), (2) Dynamic Intensity Modulated Radiation Therapy (DIMRT) – in which irradiating Linac is stationary while leaves form a sequence of apertures, as well as (3) Intensity Modulated Radiation Therapy (also called Step-and-Shoot), during which apertures are formed prior to irradiation As an option, some of the data can be imported via DICOM server that will include information of RT objects (RT Plan, RT Structure Set, RT Images) and CT Images. CrossPlan / AccuSoft-XL v. 4.04 is able to combine two registered images to create a fusion image. This is often used to combine two images acquired differently but from a single source to enhance the display of various materials or tissues.

The provided text describes a 510(k) premarket notification for a radiation treatment planning system (RTPS) called AccuSoft-XL v. 4.04 (also marketed as CrossPlan). However, it does not contain the specific information required to complete the detailed breakdown of acceptance criteria and a study proving device performance as requested.

Here's why and what information is missing:

• Acceptance Criteria and Reported Performance Table (Item 1): The document lists voluntary standards that the device complies with (IEC 60601-1-4, FDA guidances), but these are general guidelines for software in medical devices, not specific performance acceptance criteria for dose computation or a comparative table of measured performance against those criteria.
• Study Details (Items 2-7): The text mentions "performance validation" and "performance testing" but provides no details on any specific study, including sample size, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.
• Training Set Details (Items 8-9): Information about the training set size or how its ground truth was established is completely absent.

Conclusion:

Based on the provided text, it is not possible to fill in the requested table and answer the questions about the study that proves the device meets acceptance criteria. The document focuses on regulatory compliance through substantial equivalence to predicate devices and adherence to general software standards, rather than detailing a specific performance validation study with quantitative acceptance criteria.

To answer your request, such a study would typically be detailed in a separate section of the 510(k) submission, often under "Performance Data" or "Clinical Performance," which is not present in the provided "510(k) Summary."

Ask a specific question about this device

AccuSoft-XL is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radia fon therapy.

AccuSoft-XL is a radiation treatment planning system (RTPS), consisting of a collection of software modules that execute algorithms to produce estimates of beam radiation dose distribution in body tissues. It includes the image, delineation and beam planning techniques. AccuSoft-XL is an upgraded version of the Company's proprietary AccuSoft v3.14. It is designed to operate with Cones, Blocks and Wedges, as well as with a Micro-Multi-Leaf Collimator (MMLC), such that the shape of the radiation beam conforms to the irregular, shape of the lesion. The ability to shape the radiation beam enables maximization of the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures. AccuSoft-XL is used for computation, display, evaluation, and output of dose estimations, including those for several modes of treatment, such as Conformal, Blocks and Wedges, Cones and Intensity Modulated Radiation Therapy (IMRT). There are several IMRT treatment modes: (1) Intensity Modulated Arc Therapy (IMAT) – in which an irradiating Linac rotates while leaves form a sequence of apertures (arcs), (2) Dynamic Intensity Modulated Radiation Therapy (DIMRT) – in which irradiating Linac is stationary while leaves form a sequence of apertures, as well as (3) Intensity Modulated Radiation Therapy (also called Step-and-Shoot), during which apertures are formed prior to irradiation The Linac and Cones / MMLC configuration parameters shall be written to a file to be sent to both the Linac and the Company's proprietary Cone Changer / MMLC devices. In the AccuFusion module, AccuSoft-XL combines two different types of axial images. This enables to enhance the display of various materials or tissues and to perform target delineation on fused images. Thus, CT images and Secondary Images (CT, MRI, PET, etc.) in DIOOM format from the same patient can be combined, resulting in an improved single image.

The provided document (K062032) is a 510(k) summary for the AccuSoft-XL radiation treatment planning system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain acceptance criteria or detailed study results proving the device meets acceptance criteria.

The document states:

• "No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act."
• "Based on validations and performance testing results, Direx Systems Corp. believes that AccuSoft-XL is substantially equivalent to the above predicate devices without raising new safety and/or effective use issues." (This implies that testing was done, but the results are not detailed here).

Therefore, I cannot provide the requested information from the given text. A 510(k) summary typically does not include the detailed testing protocols and results that would be found in the full 510(k) submission.

Ask a specific question about this device

AccuSoft is intended to be used for the computation, display, evaluation, and output documentation of radiation Treatment (IMRT) that thise for Thrensity arounded and clinical review and verification by a physicist or physician prior to use. The application provides output data in the form of displays or The application provides output a physician in selecting the bound by natucopy printouts to garao a personal provide a report to be used by patient treathent professional such as a radiation oncologist, a comportist, radiation therapist or dosimetrist.

AccuSoft is a radiation treatment planning system. It consists of a Software package that aloous and of extensive verification and produce radiation dose coundations to enable the proper system and patient setup and adequate radiation delivery. It includes the image, delineation and beam planning techniques. The it includes the miage, delineation beam enables the user to treat irregularly shaped lesions, maximizing the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures.

The provided text is a 510(k) summary for the AccuSoft radiation therapy treatment planning system. It discusses the device's intended use, description, and predicate devices, but it does not include a study describing acceptance criteria, device performance, or any of the detailed information requested in the prompt.

Therefore, I cannot provide the requested table and information as the provided text does not contain the necessary details. The document is primarily a regulatory submission for premarket notification, focusing on equivalence to existing devices rather than a detailed performance study report.

Ask a specific question about this device

AccuSoft is intended to be used for the computation, display, evaluation, and output documentation of radiation dose estimations that are to be submitted for independent clinical review and verification by a physicist or physician prior to use.

The application provides output data in the form of displays or hardcopy printouts to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.

AccuSoft is a radiation treatment planning system. It consists of a software package that executes accepted algorithmic approaches to produce radiation dose estimations and of extensive verification and quality assurance (QA) procedures to enable the proper system and patient setup and adequate radiation delivery. It includes the same image acquisition, localizing, delineation and beam planning techniques. AccuSoft is designed with stationary or "static" radiation beams. These beams can be shaped with a shaping device, a Micro-Multi-Leaf Collimator (MMLC), such that the shape of the radiation beam conforms to the irregular shape of the lesion. The ability to shape the radiation beam enables the user to treat irregularly shaped lesions, maximizing the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures.

The provided text is a 510(k) summary for a medical device called AccuSoft, a radiation treatment planning system. However, the document does not contain any information regarding specific acceptance criteria, study data, sample sizes, ground truth establishment, or multi-reader multi-case (MRMC) studies.

The summary focuses on:

• Administrative details: Applicant information, contact, trade name, classification, predicate device, and performance standards.
• Compliance with general standards: Guidance documents for software, electrical safety, risk analysis, and failure mode analysis.
• Intended Use: For computation, display, evaluation, and documentation of radiation dose estimations for clinical review and verification.
• Device Description: Software package for radiation dose estimations, verification, QA procedures, and beam planning techniques (static beams, MMLC).
• Substantial Equivalence claim: Based on validations and performance testing results (without providing details).
• FDA Clearance Letter: Confirming the substantial equivalence determination for marketing the device.

Therefore, based solely on the provided text, I cannot complete the requested tables and answer the questions. The information requested (acceptance criteria, device performance, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not present in this document.

Ask a specific question about this device