(113 days)
The Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are indicated for use for cancer treatment of the vagina, vaginal stump and rectum using HDR or PDR brachytherapy.
The applicator sets in this submission are designed to be used with the GammaMed Plus afterloader series, Varisource 200 and IX afterloaders to deliver high dose rate (HDR) and pulsed-dose-rate (PDR) brachytherapy treatment for gynecological and rectal applications. The intracavitary applicators will be used for the treatment of cancerous tumors, and are designed to be inserted into a body cavity.
This document is a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study proving the device meets specific acceptance criteria in a clinical context.
Based on the provided text, the device is the "Universal Segmented Cylinder Applicator Set" and "Universal Stump Applicator Set," used for cancer treatment via brachytherapy. The submission does not contain a clinical study with acceptance criteria and reported device performance in the way typically associated with diagnostic AI systems or new therapeutic treatments.
Instead, the submission relies on non-clinical bench testing to demonstrate the device's functionality and safety. Therefore, many of the requested categories for a study are not applicable in this context.
Here's an attempt to answer your questions based on the available information:
1. Table of acceptance criteria and the reported device performance
Since this is a brachytherapy applicator set and the submission focuses on substantial equivalence to a predicate device through bench testing rather than a clinical performance study with statistical endpoints, the "acceptance criteria" are related to mechanical function, material properties, and compatibility, not diagnostic accuracy or treatment efficacy in patients as would be for an AI algorithm.
| Acceptance Criteria (Bench Testing Objectives) | Reported Device Performance (Conclusion) |
|---|---|
| Device functions correctly with specified afterloaders | "Results of Bench Testing showed conformance to applicable requirements and specifications" |
| Device withstands the number of cycles of use in its lifetime | "Results of Bench Testing showed conformance to applicable requirements and specifications" |
| Device enables radioactive source to be located with required accuracy | "Results of Bench Testing showed conformance to applicable requirements and specifications" |
| "[Positional accuracy] is adequate." | |
| Device materials are not significantly affected by radiation over lifetime | "Results of Bench Testing showed conformance to applicable requirements and specifications" |
| Device can be sterilized effectively | "Results of Bench Testing showed conformance to applicable requirements and specifications" |
| "[Device] may be sterilized effectively." | |
| Device can be used and sterilized for the specified number of times | "Results of Bench Testing showed conformance to applicable requirements and specifications" |
| "[Device] can be used and sterilized for the specified number of times." | |
| Positional accuracy of the source within the applicator is adequate | "Results of Bench Testing showed conformance to applicable requirements and specifications" |
| "[Positional accuracy] is adequate." | |
| Usability assessed to requirements of IEC 62366:2007 | "Results of Bench Testing showed conformance to applicable requirements and specifications" |
2. Sample size used for the test set and the data provenance
Not applicable. No clinical test set or patient data was used. The evaluation was based on non-clinical bench testing of the device units themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was bench testing against engineering specifications, not expert-adjudicated clinical ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. 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 is not an AI/software device. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device. No standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" or reference standard for this submission was based on engineering specifications, design requirements, and international standards (e.g., IEC 62366:2007) for the physical performance, safety, and compatibility of the brachytherapy applicators.
8. The sample size for the training set
Not applicable. No "training set" in the context of machine learning or clinical data was used. Bench testing involves evaluating the physical devices.
9. How the ground truth for the training set was established
Not applicable. As above, no training set was used. The ground truth for the bench testing was established by engineering design specifications and safety/performance standards.
Summary of the Document's Scope:
The provided document is a 510(k) Pre-Market Notification, which is a regulatory pathway to demonstrate that a new device is "substantially equivalent" to an already legally marketed device (predicate device). For a device like a brachytherapy applicator set, this typically involves:
- Comparison of Technological Characteristics: As shown in the tables on pages 4 and 5, the new device is compared feature-by-feature (e.g., compatible afterloader, intended use, design, materials, sterility) to its predicate device. This is the primary "study" presented here.
- Non-Clinical Testing (Bench Testing): This demonstrates that the device meets its own design specifications and is safe and performs as intended, often in a laboratory setting. This is explicitly stated in the "Non Clinical Tests" section on page 5.
- No Clinical Testing: The document explicitly states: "No clinical tests have been included in this pre-market submission." This means there was no in-human study to evaluate patient outcomes, diagnostic accuracy, or treatment efficacy when the device is used clinically. The focus is on the device's functional integrity and safety.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.