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The GammaMedplus 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 High Dose Rate (HDR) and Pulsed Dose Rate (PDR) remote-controlled brachytherapy.

The GammaMedplus 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 tumor bed in a practice known as brachytherapy.

The provided text is a 510(k) Summary for the GammaMedplus™ iX and GammaMedplus™ 3/24 iX afterloaders. This document focuses on demonstrating substantial equivalence to predicate devices through technological characteristic comparison and non-clinical testing. It does not contain information about acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy, nor does it describe a study proving the device meets such criteria in a clinical sense.

Medical devices like brachytherapy afterloaders are evaluated for safety and effectiveness through different types of assessments than, for example, diagnostic AI algorithms. Their "performance" is typically related to precise mechanical operation, safety mechanisms, and adherence to dose delivery protocols.

Here's an analysis based on the information provided and what is intentionally absent from this type of regulatory submission:

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

The document does not explicitly state "acceptance criteria" in the format of sensitivity, specificity, or similar performance metrics typically seen for diagnostic AI. Instead, the "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate devices and meeting safety and functional specifications. The "reported device performance" is a comparative analysis of its technological characteristics against the predicate devices (Nucletron MicroSelectron V3 and GammaMedplus iX Series HDR Afterloaders (K071381)).

Below is a table summarizing key characteristics that would be considered "performance" in the context of this device, comparing the proposed device (GammaMedplus™ iX, Console Software version 1.2) against its predicate (Nucletron MicroSelectron V3). The "acceptance criteria" are implied to be that the proposed device performs at least as well as or is equivalent to the predicate.

Note on "Max. exposure rate": The proposed device has a higher maximum activity (15 Ci vs 10 Ci in the predicate), which inherently allows for a higher exposure rate. The specified value of 0.3 mrem/hr (3 µSv/hr) for the higher activity would need to be considered acceptable from a safety perspective, likely meeting some regulatory threshold for leakage radiation. The document implicitly claims "performa as well or better than the predicate."

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

The document explicitly states: "No Clinical tests have been included in this pre-market submission."

Therefore, there is no "test set" in the context of patient data, no sample size, and no data provenance from clinical sources for performance evaluation. The "tests" mentioned are non-clinical, focusing on software and hardware functionality.

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)

Since no clinical tests or human-in-the-loop evaluations were performed or submitted, there was no need for experts to establish ground truth for a test set. Ground truth, in this context, would be based on engineering specifications, physical measurements, and regulatory standards for safety and performance of medical devices.

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

Not applicable, as no clinical test set or expert ground truth was established for performance evaluation with patient data.

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 an afterloader for brachytherapy, not a diagnostic AI tool that assists human readers in interpreting medical images. There are no human readers or AI assistance in that context for this device.

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

This refers to the "Non Clinical Tests" section. The document states:
"For each device, in every mode of use, a full set of verification tests were performed on every pertinent aspect of the software and hardware to determine the safe functioning of the device."

This constitutes a standalone evaluation of the device's functional performance against engineering and safety specifications, without human intervention in the "performance" as one might see in an AI algorithm. The device's performance here relates to its mechanical accuracy, software control, shielding, dose delivery capabilities (though not clinical dose), and safety features.

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

For the non-clinical tests, the "ground truth" would be the engineering specifications, design requirements, and established industry standards for brachytherapy devices. For example:

• Mechanical Accuracy: Measured distances and positions verified against design specifications.
• Radiation Leakage: Measured radiation levels compared against regulatory limits.
• Software Functionality: Software outputs and control actions verified against expected behavior and safety interlocks.
• Source Activity: Measurements verified against manufacturer specifications.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set of patient data.

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

Not applicable, as there is no training set for this type of device.

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