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The Mould Probe MR Safe is intended for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease using HDR or PDR brachytherapy. IORT = Intraoperative Radiation Therapy.

The Mould Probe MR Safe is a Brachytherapy applicator. 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 Mould Probe MR Safe is intended for HDR or PDR brachytherapy and the key performance characteristics are as follows:

• Suitable for intraoperative, intraluminal, and interstitial brachytherapy.
• Can be used for surface treatments in combination with the suitable Varian flap.
• Equipped with stabilizing mandrins for easy insertion.
• MR Safe, if used without mandrins.
• CT compatible, if used without mandrins.
• Elastomer material construction provides increased flexibility for easy placement as well as luminal rigidity, which prevents kinks.
• Steam sterilizable.
• Suitable for patient contact for up to 24 hours. The stainless steel mandrins are not intended to have patient contact.

The provided text is a 510(k) premarket notification summary for the "Mould Probe MR Safe" device. It describes the device, its intended use, and its comparison to a predicate device. However, this document does not contain information about the acceptance criteria and performance study outcomes related to an AI/ML device.

The document states:

• "Software Verification and Validation Testing: This item is not applicable to the subject device. The devices do not contain or consist of software/firmware. No software verification and validation testing have been included in this submission in support of the substantial equivalence determination."

Therefore, I cannot extract the requested information about acceptance criteria and study that proves the device meets the acceptance criteria for an AI/ML device from the provided text. The device in question is a physical medical instrument (brachytherapy applicator), not one that relies on AI/ML for its function.

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