(48 days)
The HDR CT Compatible Split Ring type applicator is indicated for use in any case where high dose rate Brachytherapy treatment of the cervix or uterus is an accepted clinical practice.
The HDR CT Compatible Split Ring Applicator presented in this 510(k) notification has been developed to function for the positioning of HDR Remote After-Loader sealed sources in the treatment of cancer of the cervix or uterus. The design of these systems is similar to that of the predicate devices listed below. The delivery of radiation therapy via high dose rate Brachytherapy treatment of the cervix or uterus requires not only a stable system for precise dosimetry but also a reproducible and predictable geometry for positioning of the radioactive source under remote control. The HDR CT Compatible Split Ring Applicator is designed to act as such a device.
The provided document K063382 is a 510(k) Pre-Market Notification for a medical device called the "HDR CT Compatible Split Ring Applicator." This type of submission focuses on demonstrating substantial equivalence to pre-existing devices, rather than a clinical study proving its performance against detailed acceptance criteria in the way an AI/software device would. Therefore, much of the requested information (like sample size, ground truth, expert opinions, MRMC studies) is not applicable to this document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not specify quantitative "acceptance criteria" or report "device performance" in terms of metrics like sensitivity, specificity, accuracy, or similar for a clinical study. The acceptance criteria for this type of submission are primarily demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and performance characteristics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Similar design and construction | "Similar in design and construction" |
| Identical materials | "utilizes the identical materials" |
| Same intended use | "has the same intended use" |
| Same performance characteristics | "and performance characteristics to the predicate devices." |
| No new issues of safety or effectiveness | "No new issues of safety or effectiveness are introduced by using this device." |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This submission does not involve a "test set" or a clinical study with data from patients. It's a regulatory submission for a physical medical device based on its design and comparison to existing, already-approved devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No ground truth for a test set was established as no clinical test set was used for performance evaluation in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method was used.
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 a physical medical device, not an AI or software device. Therefore, no MRMC study involving human readers and AI assistance was conducted.
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.):
- Not Applicable. No ground truth in the context of clinical data or diagnostics was established for this submission. The "ground truth" for the submission itself is the FDA's determination of substantial equivalence based on the provided engineering and manufacturing data.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is a physical medical device submission, not a machine learning model.
9. How the ground truth for the training set was established:
- Not Applicable. No training set was used.
§ 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.