(71 days)
The Vaginal CT/MR Multi Channel Applicator Set is intended for gynecologic Brachytherapy treatment of the vagina, cervix and endometrium.
The Vaginal CT/MR Multi Channel Applicator Set is a modification of the Miami Vaginal Applicator Set. It is intended for gynecologic brachytherapy of the vagina, cervix and endometrium. The applicator consists of a central channel and surface channels, which are equally spaced around the surface of the cylinder. The vaginal cylinder is several sizes, each diameter with a specified number of surface channels. The surface channels follow the shape of the cylinder's dome. By selectively and individually loading these channels, the dose can be directed laterally and sculpted to the required shape, for instance for treatment of asymmetrically located turnors. The Vaginal CT/MR Multi Channel Applicator Set can be used in combination with X-ray, CT and MRI. Markers for the treatment channels are available to assist in visualization of the source path on the acquired images. The devices are used as accessories to Nucletron afterloaders.
This document is a 510(k) summary for a medical device (Vaginal CT/MR Multi Channel Applicator Set), demonstrating substantial equivalence, not a study report proving specific device performance criteria against reported metrics. Therefore, it does not contain the detailed information requested regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, or ground truth establishment typically found in a clinical or performance study.
Based on the provided text, here's what can be extracted and what is explicitly not available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document focuses on showing substantial equivalence to a predicate device.
- Reported Device Performance: The summary states: "Bench testing shows that the device meets its performance requirements, and that the device performance is equivalent to the Miami Vaginal Applicator Set." However, it does not provide specific numerical performance metrics that can be tabulated against acceptance criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified (focus on substantial equivalence) | "meets its performance requirements, and that the device performance is equivalent to the Miami Vaginal Applicator Set." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to "bench testing" but does not detail the number of units tested.
- Data Provenance: Not specified.
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, as the submission is not a clinical study requiring expert assessment for ground truth. The "ground truth" for this type of device (an applicator) would relate to its physical and functional performance, verified through engineering tests, not expert medical consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified, as this is not a study involving human interpretation or subjective assessment of data.
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
- MRMC Study: No.
- Effect Size of AI Improvement: Not applicable. This device is a physical applicator for brachytherapy, not an AI-powered diagnostic or treatment planning software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this type of device primarily relies on engineering specifications, material properties, and physical functionality testing (bench testing). The document mentions "Validation of sterilization processes and biocompatibility" and "Bench testing shows that the device meets its performance requirements."
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
§ 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.