Search Results

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.

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

The document does not provide details on specific sample sizes for tests like biocompatibility, MR testing, or cleaning/sterilization. These types of tests typically involve a defined number of device units or material samples rather than "test sets" in the clinical data sense. The data provenance (country, retrospective/prospective) is not mentioned, but it's implied to be internal testing conducted by the manufacturer, Varian Medical Systems, Inc.

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)

This information is not applicable and therefore not provided. The "ground truth" concept is relevant for diagnostic or AI-driven devices where a reference standard is needed to compare against the device's output. For a physical applicator set, the "truth" is established by direct measurement, material science, and engineering validation against specifications and safety standards.

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

Not applicable. Adjudication methods are typically used in clinical studies or expert reviews of diagnostic interpretations, which are not relevant for this device's type of testing.

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 physical brachytherapy applicator set, not an AI or diagnostic tool that would involve "human readers" or AI assistance.

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

Not applicable. This device does not have an algorithm or "standalone" performance in the context of AI or diagnostic software. Its performance is evaluated through physical and material testing.

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

Not applicable. As explained in point 3, the concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not relevant for the type of device being described. The validation relies on established engineering principles, material science, and consensus standards for safety and performance (e.g., ISO 10993 for biocompatibility, ASTM F2503 for MR safety).

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device, so there is no concept of a "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device