Search Results

The VariSource iX Series is indicated for use in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of remote-controlled High Dose Rate (HDR) brachytherapy.

The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or turnor bed in a practice known as brachytherapy.

The provided text is a 510(k) Summary for a medical device called "VariSource iX and VariSource iX(t) Afterloaders." This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not include information about acceptance criteria or a study proving that the device meets those criteria, as typically understood for AI/ML device performance.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not specified in the provided document. The document states "All the tests that were performed met the applied pass criteria," but it does not detail what those criteria were.
• Reported Device Performance: The document only states that "Results of Verification and Validation Testing showed conformance to applicable requirements and specifications and assured hazard safeguards functioned properly." It does not provide specific performance metrics (e.g., accuracy, sensitivity, specificity, or error rates) for the device's functional aspects.

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

• Test Set Sample Size: Not applicable. The document explicitly states: "No Clinical Tests have been included in this pre-market submission." The non-clinical tests mentioned are verification and validation of the device's engineering and safety aspects, not performance derived from analyzing patient data.
• Data Provenance: Not applicable, as no clinical data was used for testing.

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. Since no clinical tests or human-in-the-loop performance studies were conducted, there was no need for experts to establish ground truth.

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

• Not applicable. No clinical test set or adjudication method described.

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

• No. The document explicitly states: "No Clinical Tests have been included in this pre-market submission." This device is a remote-controlled radionuclide applicator system, not an AI/ML-driven diagnostic or assistive tool, so an MRMC study is not relevant to its type.

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

• Not applicable. This device is a piece of medical hardware (an afterloader) used for brachytherapy. It is not an algorithm or software-only device in the context of typical AI/ML devices where standalone performance is measured. The "console software" mentioned is for controlling the hardware, not for making independent diagnostic or treatment decisions.

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

• Not applicable. For the engineering verification and validation, the "ground truth" would be the device meeting its design specifications and safety requirements, as opposed to clinical ground truth derived from patients.

8. The sample size for the training set

• Not applicable. This device is hardware with control software. It does not use machine learning, and therefore does not have a "training set" in the sense of AI/ML models.

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

• Not applicable. As there is no training set, this question is not relevant.

Summary from the provided text:

The 510(k) submission for the VariSource iX and VariSource iX(t) Afterloaders focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and non-clinical verification and validation testing. It explicitly states that no clinical tests were included in this pre-market submission. Therefore, the document does not contain the information requested regarding acceptance criteria for clinical performance, details of performance studies involving patient data, ground truth establishment, or sample sizes related to such studies, as these types of studies were not part of this particular submission. The device is a piece of medical equipment for brachytherapy and not an AI-powered diagnostic tool.

Ask a specific question about this device