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The GammaMedplus 3/24 is a remotely controlled afterloading brachytherapy device used to apply a radionuclide source into the body or to the surface of the body for radiation therapy. The system is designed to provide a predetermined dose of radiation to tissue and organs by means of manipulating a radioactive source from a shielded position within in the device into a catheter, applicator, or needle, which has been placed within or on a patient. The remote afterloading device must be contained in a shielded facility during extension of the radioactive source. The GammaMedplus 3/24 may optionally be configured as a transportable device.

The GammaMedplus 3/24 is a remote afterloading system used to deliver a radioactive source for use in high-dose rate brachytherapy. The Gammamed 3/24 is loaded with sources no greater than 10 curies. The GammaMedplus 3/24 differs from its predicate device in that it has only five treatment channels.

The GammaMedplus 3/24 consists of a remote afterloading device, an optional transportable trolley, and operator console. The GammaMedplus 3/24 remote afterloading device contains a radioactive source, a shielded safe in which to park the source when not in use, motors to drive the source, an indexer to determine the treatment channel for the source, position encoders for the source, electronic control circuit boards, a battery pack for backup power, and a power supply.

The radioactive material is sealed inside a stainless steel source capsule. The source capsule is attached to the source cable to form the source assembly. The source cable is also fabricated from stainless steel. The source assembly is housed inside a source tube. The source tube assembly is surrounded by tungsten metal which is used as shielding material. The radiation dose rate at a distance of one meter from the GammaMedplus 3/24 afterloading device when containing a source of the maximum activity is less than 3μGy/h.

An electro-mechanical key lock is provided to prevent actuation of the source when the afterloading device is not in use.

The source quide tubes attach to the afterloading device by means of a special quick connector. The source may be exposed through a particular channel only if the source guide tube is properly attached to this channel. The applicators to be employed in a particular treatment are connected to the GammaMedplus indexer by way of the source quide tubes.

The afterloading device also contains a simulation ("dummy") source assembly. This simulation source assembly is identical to the actual source assembly except that it does not contain radioactive material. The simulation source makes it possible to test the condition and location of the source guide tube and the applicators and their connections before carrying out the actual treatment. The device is equipped with 5 access channels, through which the single iridium192 source can be manipulated. The source exit port can be raised or lowered into a position that is optimal in relation to the particular patient. The position of the exit port of the afterloading device can be varied from 900 millimeters (34 inches) above the floor to 1800 millimeters (51 inches) above the floor. A wide range of flexible and rigid applicators is available for a wide variety of brachytherapy techniques.

The afterloading device is equipped with an emergency hand crank to permit the emergency retraction of the source. The hand crank is a "one way" hand crank, which allows only retraction of the source. It is not possible to expose the source using this hand crank.

The afterloading device can be installed onto a trolley for transportation. The GammaMed trolley consists of a rectangular chassis with four large casters for easy movement of the equipment. It has a manually operated brake that reliably maintains its position during treatment.

The provided text is a 510(k) summary for the GammaMed plus 3/24 High Dose Rate (HDR) Remote Afterloader. It describes the device, its intended use, and compares it to a substantially equivalent predicate device (K983436).

However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, primarily through a comparison of physical and functional characteristics.

Therefore, many of the requested sections regarding a performance study cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

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

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

• Not Applicable. The document describes a comparison to a predicate device and functional specifications, not a performance study with a test set of data.

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. No ground truth establishment is described as part of a performance study.

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

• Not Applicable. No test set or adjudication method is 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. This device is a remote afterloading system for brachytherapy, not an AI-assisted diagnostic or interpretation tool. An MRMC study is not relevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. No ground truth is described. The "truth" here is compliance with technical specifications and similarity to the predicate device.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Not Applicable. No training set or ground truth establishment is described.

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