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Real Time HDR is a software application for Brachytherapy Treatment Planning, for the treatment of cancer, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources.

Real Time HDR (RT HDR) is a "real time" treatment planning system for brachytherapy especially meant for treatment of cancer in the prostate. Direct 3D Ultrasound imaging of the treatment gives the physician the possibility to update the planning of the dwell positions of the source in the prostate of the patient. The program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution, i.e. dose volume histograms, dose verification points and dose profiles. The software program provides the physician wih anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to radiation treatment. The program also provides the treatment time and dose distribution for the specified loading. From this the information the patient can be treated with the dwell positions of the source. Modifications to SPOT previously cleared K992303, have been made to add functionality for: - o Post Planning , ----- - . Auto activation dwell positions The Ultrasound acquisitation has been changed form longitidinal to transversal. The Post Planning functionality has been derived from Plato BPS K983343. The Dicom 3 Import/Export has been derived from Plato External Beam K964206. Real Time HDR (RT HDR) is an accessory to the microSelectron-HDR (V2). The program constists of two modules: - Treatment Planning Software: Real Time HDR ● - Database: Smoothbase ● The software runs on a Windows 2000 platform.

The provided document is a Special 510(k) submission for the Nucletron Real Time HDR system, an accessory to a radiotherapy device. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria, a specific study proving device performance against acceptance criteria, or most of the other detailed study-related information requested.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted, and why:

Information NOT available in the document:

• 1. A table of acceptance criteria and the reported device performance: The document describes the device modifications and its intended use, but it does not specify any quantitative performance metrics or acceptance criteria for those metrics.
• 2. Sample sized used for the test set and the data provenance: There is no mention of a "test set" in the context of device performance evaluation, nor any sample size or data origin.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set or ground truth establishment is described.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 a treatment planning system, not an AI-assisted diagnostic tool for human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes a software system that assists physicians; it does not present a standalone algorithm being evaluated.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: There is no mention of a "training set" as this is not an AI/ML device in the modern sense that would typically involve supervised learning with a training set.
• 9. How the ground truth for the training set was established: Not applicable.

Information that CAN be extracted or inferred:

Description of the Device and its Purpose (from the "study" context):

The "study" in this context is the Special 510(k) submission itself, which aims to demonstrate that a modified medical device ("Real Time HDR") is "substantially equivalent" to a previously cleared predicate device ("SPOT - Sonographic Planning of Oncology Treatments," K992303). The "proof" is the FDA's clearance letter (K022739), stating that the device is substantially equivalent for its stated indications for use.

The document highlights modifications made to the predicate device:

• Added "Post Planning" functionality (derived from Plato BPS K983343).
• Added "Auto activation dwell positions."
• Changed Ultrasound acquisition from longitudinal to transversal.
• Added Dicom 3 Import/Export (derived from Plato External Beam K964206).

The intended use is stated as: "Real Time HDR is intended for use with Brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, involving afterloading radioactive sources."

The device is a "real time" treatment planning system for brachytherapy, specifically for prostate cancer. It uses 3D Ultrasound imaging to update dwell positions, provides plan evaluation tools (dose volume histograms, dose verification points, dose profiles), and supplies anatomical and dosimetric information for source positioning and loading.

Conclusion:

The provided text is a regulatory submission for device clearance based on substantial equivalence, not a clinical or performance study evaluating specific acceptance criteria with detailed statistical results. Therefore, most of the requested information regarding "acceptance criteria" and "study results" is not present in this document.

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SPOT PRO is a software application for Brachytherapy Treatment Planning, for the treatment of cancer, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources.

SPOT PRO is a "real time" treatment planning system for brachytherapy especially meant for treatment of cancer in the prostate. Direct 3D Ultrasound imaging of the treatment gives the physician the possibility to update the planning of the radioactive seeds implant in the prostate of the patient. The software program provides the physician wih anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to insertion. The software program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution, i.e. dose volume histograms, dose verification points and dose profiles. The software program also provides the treatment time and dose distribution for the specified loading. From this the information the patient can be treated with radioactive sources. Modifications to SPOT previously cleared K992303, have been made to add functionality for: . Post Planning functionality . Auto activation dwell positions . Auto contouring . Usage of CT / MR images acquired by Dicom 3 Import/Export . The Post Planning functionality has been derived from Plato BPS K983343. The Dicom 3 Import/Export has been derived from Plato External Beam K964206. The software runs on a Windows NT platform.

The provided text describes a Special 510(k) for the Nucletron SPOT PRO device, a "real-time" treatment planning system for brachytherapy. However, the document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement in a study.

The document primarily focuses on:

• Identification of the device: Nucletron SPOT PRO, a radiation therapy planning system.
• Purpose: For brachytherapy treatment planning, especially for prostate cancer, assisting physicians in determining the positioning and loading of radioactive sources.
• Modifications: Post Planning functionality, Auto activation dwell positions, Auto contouring, and DICOM 3 Import/Export capabilities.
• Intended Use: Same as the predicate device (SPOT, K992303).
• Substantial Equivalence: To the predicate device and other Nucletron software (Plato BPS K983343 and Plato External Beam K964206).
• Regulatory information: Classification, product codes, and the FDA's clearance letter.

Therefore, I cannot provide the requested information in the table or answer the specific questions about acceptance criteria and study details because this information is not present in the provided text. The document is a regulatory submission for substantial equivalence rather than a detailed performance study report.

Ask a specific question about this device