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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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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 intended for cancer treatment of the endometrium using HDR or PDR brachytherapy. The Heyman Packing Applicator Set is an applicator for intracavitary Brachytherapy. The applicator acts to quide the radioactive source to the correct location or locations for treatment.

This document is a 510(k) premarket notification for the Heyman Packing Applicator Set, not a study report that includes specific acceptance criteria and performance data in the format requested. The document outlines the device description, its indications for use, and a comparison to a predicate device. It also lists the non-clinical tests performed to support substantial equivalence.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance or details about a study proving the device meets those criteria, as this information is not present in the provided text.

Specifically:

1. A table of acceptance criteria and the reported device performance: This information is not provided. The document lists types of non-clinical tests (biocompatibility, sterilization, mechanical, MRI/CT compatibility, afterloader validation) that were performed, but does not detail the specific acceptance criteria for these tests nor the quantitative results that demonstrate meeting those criteria.
2. Sample size used for the test set and the data provenance: Not applicable, as this document describes non-clinical engineering and bench testing, not clinical studies involving test sets, human subjects, or data provenance in that sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set or human expert ground truth was established for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set or adjudication was performed.
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 a medical applicator set, not an AI-assisted diagnostic or interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical applicator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth was established for this non-clinical submission. The "ground truth" for the non-clinical tests would be the established scientific and engineering standards for biocompatibility, sterilization, and material compatibility.
8. The sample size for the training set: Not applicable, as this device does not involve a "training set" in the context of an algorithm or machine learning.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided document is a regulatory submission for a physical medical device (applicator set) and details non-clinical testing for safety and effectiveness in demonstrating substantial equivalence to a predicate device. It does not contain the kind of clinical study or performance data that would involve acceptance criteria for diagnostic accuracy, expert evaluations, or AI performance metrics.

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