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It is intended for localization of patient position in the conduct of radiation therapy with a linear accelcrator and registration of patient position between the planning and conduct of treatment. Patient Tracking System is an optical system for tracking patient position to linear accelerators used for before and during facilomeraly. It is an accessory of 3 dimensional radiotherapy.

DynaTrac System Cod. 50-1A is a state-of-the-art optical tracking system that tracks patient position before and during a radiotherapy treatment session. It can track the patient in real time allowing the treatment system to respond to uncxpected movements. It shortens the time required to prepare a patient for a treatment session because of the speed with which spatial registration with a treatment plan can be confirmed.

The provided text is a 510(k) summary for the DynaTrac System, an optical patient tracking system for radiation therapy. It establishes substantial equivalence to a predicate device (ExacTrac) but does not contain any information about specific acceptance criteria, study designs, or performance metrics from a validation study.

Therefore, I cannot provide the requested information in a table or as descriptive text regarding the acceptance criteria and a study proving the device meets them. The document focuses on regulatory approval based on demonstrating substantial equivalence, not on presenting performance data from a specific study.

The document only states: "DynaTrac has the same intended use and Davoluntial Dquiraliso to ExacTrac. There are no technical differences that raise issues of safety and effectiveness." This implies that the device is considered equivalent based on its design and intended use being similar to a legally marketed device, not through a new performance study detailed in this submission.

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ERGO SRS is stcreotactic radiosurgery module for DMLCIV-ERGO (K001163). It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3 dimensional radiation therapy.

ERGO SRS is a stereotactic radiosurgery treatment planning software module for 3D Line USA's ERGO radiotherapy treatment planning system (K001163).

This 510(k) summary (K031281) for ERGO SRS, a stereotactic radiosurgery treatment planning module, does not contain the detailed acceptance criteria or study results typically found in performance studies for AI/ML-driven medical devices.

The document primarily focuses on establishing substantial equivalence to a predicate device (PLATO SRS V2) based on the fact that ERGO SRS is "identical to PLATO SRS V2. It is the same software integrated with 3D Line USA's ERGO system rather than Nucletron's PLATO system."

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.

Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The document states that the device is "identical" to the predicate, implying that its performance is presumed to be equivalent to the predicate, but no specific performance metrics or acceptance criteria are listed for the ERGO SRS device itself.

2. Sample size used for the test set and the data provenance: Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.

4. Adjudication method for the test set: Not provided.

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 type of study is more common for diagnostic AI tools, whereas ERGO SRS is a treatment planning module.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly stated, however, as a treatment planning software, it is inherently a "standalone" algorithm in its function of generating plans, which are then reviewed by human clinicians. No performance metrics for this standalone function are provided in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided. For a treatment planning system, ground truth would typically relate to the accuracy of dose calculations, geometric accuracy of planned beams, or clinical outcomes (though outcomes data would be for post-market surveillance rather than 510(k) clearance).

8. The sample size for the training set: Not applicable/provided. This device is described as being "identical" to a previously cleared predicate and is software for treatment planning, not a machine learning model that undergoes "training" in the modern sense.

9. How the ground truth for the training set was established: Not applicable/provided.

In summary: The provided 510(k) summary primarily relies on substantial equivalence to a predicate device by stating the software is "identical" and merely integrated into a different system. It does not contain the detailed performance study results that would typically include acceptance criteria, specific performance metrics, sample sizes, or ground truth establishment methods for an independent evaluation of the ERGO SRS device's performance.

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Stereotactic Body Frame Cod. 70-1A is patient localization system for use in stereotactic radiosurgery. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning and conduct of 3 dimensional radiation therapy.

Stereotactic Body Frame is a spatial reference system external to the body of a patient undergoing radiotherapy treatment that provides accurate positioning of the patient in spatial registration with diagnostic images and a radiotherapy treatment plan.

The provided text is a 510(k) summary for the Stereotactic Body Frame, focusing on its substantial equivalence to a predicate device. It specifies the intended use and compares characteristics, but it does not contain information about studies proving the device meets specific acceptance criteria related to its performance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
• If a standalone study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to a previously cleared device (Elekta Instrument AB's Stereotactic Body Frame, K960338) based on similarities in intended use, design, and materials, rather than presenting a performance study with acceptance criteria.

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EVTOOL software module provides the ability to compare and evaluate the radiation dose delivery to the tumor volume and surrounding organs from generated dose volume histograms and radiobiological values. It expands the DMLC IV-ERGO system, which is a combination of a radiation collimator with multiple tungsten leaves that move during delivery of radiation therapy and a computer based treatment planning and control system.

EVTOOL is a software module that has been designed to expand the features and functions of the DMLC IV- ERGO treatment planning software. The software runs on a silicon graphics workstation and Irix operating system. EVTOOL software is used for comparing and evaluating radiation therapy treatment plans from a quantitative and radiobiological point of view. The software displays one or more stored plans for comparison and analysis. It can display the dose volume histograms of the various plans and organ dose statistics (mean, modal, maximum and minimum dose). It allows the user to input radiobiological corrections in order to enhance the evaluation of the treatment plan. It also optimizes the dose prescription by displaying reference dose and number of treatment fractions. EVTOOL is fully integrated into the ERGO treatment planning environment in order to easily exchange information from the patients' database. The patient information is selected and automatically loaded into the EVTOOL software. From the patient database the user can select one or multiple treatment plans to display and calculate the dose statistics, including dose volume histograms and radiobiological models. The analytical information is displayed in 4 windows with a zoom capability. These windows can display the overall plan and individual organs of interest. EVTOOL provides options for incorporating radiobiological corrections to assist the physician in determining the optimal dose prescription and fractionation based on TCP (Tumor Control Probability), NTCP (Normal Tissue Complication Probability) and UTCP (Uncomplicated Tumor Control Probability) values. This software is a useful tool in evaluating the entire volumetric treatment plan, it is not used to directly treat the patient. It provides the physician with a tool to compare various plan versions side by side in order to determine the most appropriate treatment plan to be used with the DMLC IV equipment. The display of the treatment plans within EVTOOL provides a permanent record and effective control on the actual dose delivered to the patient.

The provided text is a 510(k) Premarket Notification for the EVTOOL software. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study with performance metrics. Therefore, many of the requested details about acceptance criteria and study design are not present in this document.

Here's an attempt to answer the questions based only on the provided text, noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific quantitative "acceptance criteria" or report "device performance" in terms of clinical outcomes or diagnostic accuracy. The core of this 510(k) is to demonstrate substantial equivalence to a predicate device for its intended use as a radiation therapy planning assessment tool.

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

• Sample Size: Not applicable. This document does not describe a clinical performance study with a test set of patient data to evaluate device performance against ground truth. It describes a software module.
• Data Provenance: Not applicable.

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

• This information is not provided. The document does not detail a study involving expert-established ground truth.

4. Adjudication method for the test set

• This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study is mentioned or implied in this document. The EVTOOL is described as a tool to assist physicians in evaluating treatment plans, not necessarily as an AI system designed to improve human reader performance in a diagnostic sense in this context.

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 module" that "provides the physician with a tool to compare various plan versions." It's explicitly stated, "it is not used to directly treat the patient."

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

• Not applicable. The document does not describe a study requiring ground truth for performance evaluation. The "ground truth" for this type of software would typically be the accuracy of its calculations and displays based on established physics and radiobiology models, which would be validated through software testing processes, not clinical studies with patient outcomes.

8. The sample size for the training set

• Not applicable. This document describes a software module for radiation therapy planning evaluation, not a machine learning or AI algorithm that requires a training set.

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

• Not applicable.

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