(171 days)
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:
- 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.
- 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.
- 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.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set adjudication is mentioned.
- 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.
- 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.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): No ground truth is discussed as no formal performance study is presented.
- 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."
- 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.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.