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The Heyman Packing Applicator Set is indicated for use for treating endometrial cancer using HDR or PDR brachytherapy.

The Heyman Packing Applicator Set consists of various sized Heyman-capsules which may be connected to compatible brachytherapy afterloaders via guide tubes. The set also includes a number of associated accessories for sterilization (Cleaning Cap, Leak Stop Button, and Leak Stop Channel Marker Sets). The Heyman Packing Applicator Set is an applicator for intracavitary 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 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 device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization. The Heyman Packing Applicator Set includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Heyman Packing Applicator Set is intended to be used in a healthcare or treatment facility by trained and qualified personnel.

The provided text describes a 510(k) premarket notification for a medical device called the "Heyman Packing Applicator Set (GM11004580)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through a separate study with specific performance metrics (like accuracy, sensitivity, specificity, etc.) that would typically apply to AI-driven or diagnostic devices.

Instead, the "acceptance criteria" here refer to the device's conformance to established engineering standards, biocompatibility, and safety, as well as its functional characteristics. The "study that proves the device meets the acceptance criteria" is primarily a series of non-clinical performance tests and adherence to consensus standards.

Here's a breakdown of the information requested, based on the provided text:

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

Since this is a physical medical device and not an AI or diagnostic software, the "acceptance criteria" are not reported as statistical performance metrics like sensitivity or specificity. Instead, they relate to functional and safety attributes. The "reported device performance" refers to the confirmed characteristics after testing.

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