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The Catheter Surface Flap Applicator Set is intended for use for skin cancer treatment using HDR or PDR brachytherapy.

The Catheter Surface Flap Applicator Set is an applicator for Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.

The key performance characteristics of this applicator set are as follows:

• Surface applicator intended for the treatment of skin cancers.
• A 10mm thick flap allowing for up to 38 channels spaced at 5 mm allows for a large uniform treatment.
• Hollow pattern design and semi translucent material provides good visibility of the treatment area.
• The material high flexibility allows the applicator to conform closely to complex patient anatomies such as when treating nose or ear lesions.
• Silicone material gives excellent biocompatibility and durability.
• Single patient multiple use.
• The Catheter Surface Flap is MR and CT compatible.
• Patient-contacting parts constructed of silicone and Polyvinylchloride; suitably for patient contact for a period up to 24 hours.

The fixation buttons are used for locking the mould probes in place after insertion in the catheter surface flap. Some of these are supplied in the fixation button kits but they are also available to be purchased separately as spares. As spares, they are packed in sterile pouches, with 10 pieces per pouch and sold as pack of 10 pouches respectively.

The provided text is a 510(k) summary for a medical device called the "Catheter Surface Flap Applicator Set (GM11011830)". This document is not a study proving a device meets acceptance criteria for an AI/ML algorithm. Instead, it's a submission to the FDA to demonstrate substantial equivalence to a predicate device, primarily focusing on materials, design, and intended use as an applicator for brachytherapy.

Therefore, I cannot extract the requested information because the document does not contain details about:

• Acceptance criteria for an AI/ML device's performance.
• A study involving a test set, training set, ground truth experts, or MRMC studies for an AI/ML algorithm.
• Any mention of AI or machine learning.

The document discusses non-clinical performance testing for a physical medical device, including biocompatibility, cleaning/disinfection/sterilization, human factors validation, and mechanical/acoustic testing. These are typical tests for a physical medical device, not an AI/ML software device.

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