(41 days)
The Henschke Titanium Applicator Set is designed for treatment of the cervix and endometrium.
The Henschke Titanium Applicator Set is a modification of the Henschke Applicator Set (K953946). It is intended for intracavitary brachytherapy and is used for cancer treatment of the cervix and endometrium.
The Henschke Titanium Applicator Set is a gynecological applicator for Brachytherapy procedures. The applicator uses an intrauterine tube and two colpostat tubes. A colpostat cap can be placed on each colpostat tube.
The tubes guide the radioactive source of the afterloader to the location where treatment is to be applied. Transfer tubes are required to connect the applicator to the afterloader.
With the adjustable cervical stopper, the intrauterine tube-length can exactly be fitted to the patient's anatomy. The intrauterine tube has adjustment centimeter-markings.
The device is compatible with Nucletron afterloaders.
The applicator is made of Titanium and PPSU, to minimize distortion on CT imaging. This enables conformal treatment planning with the use of CT images.
This document is a 510(k) premarket notification for a medical device called the "Henschke Titanium Applicator Set." It is not a study proving the device meets specific acceptance criteria based on its performance in analyzing medical data.
Instead, this document focuses on demonstrating substantial equivalence to a previously legally marketed device (K953946, a Henschke Applicator Set). The "testing" mentioned is primarily for functional verification of the physical device and its materials, not for the accuracy or diagnostic performance of an AI algorithm or a data-driven system.
Therefore, many of the requested categories in your prompt are not applicable to the content provided. Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria and reported device performance in the context of diagnostic accuracy, sensitivity, specificity, or similar metrics for a data-driven device. The "performance" described relates to the physical device's functionality and material suitability.
| Acceptance Criteria (Functional/Material) | Reported Device Performance (Summary) |
|---|---|
| Functional Verification | Performed as defined in requirements. |
| Meeting Clinical Expectations | Met clinical expectations. |
| Safety | Deemed safe for clinical use. |
| Effectiveness | Deemed effective for clinical use. |
| Compatibility with CT imaging | Minimized distortion on CT imaging (due to Titanium and PPSU materials). Enables conformal treatment planning with CT images. |
| Compatibility with afterloaders | Compatible with Nucletron afterloaders. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study involving a test set of medical data for an AI/diagnostic device. The "testing" involved bench testing and user review of the physical applicator.
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)
Not applicable. There was no "ground truth" to establish in the context of diagnostic accuracy. "Experienced users reviewed the device design and executed validation tests," but their qualifications and exact number are not specified beyond "clinical personnel."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set of medical data requiring adjudication.
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 applicator for brachytherapy, not an AI or diagnostic application that would involve human readers or comparative effectiveness studies of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical applicator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the testing performed relates to the device's functional specifications, material properties, and suitability for clinical use (e.g., whether it fits correctly, guides the source, minimizes CT distortion), verified through bench testing and expert review, rather than a diagnostic 'ground truth'.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
Summary of the Study/Testing (as described in the document):
The "study" or "testing" mentioned in this document is primarily focused on demonstrating the functional performance and material suitability of the Henschke Titanium Applicator Set to ensure it is safe and effective and substantially equivalent to its predicate device.
- Type of Study: Functional verification testing and bench testing. It was conducted under clinical conditions at a hospital site, involving clinical personnel, but "excluding the delivery of treatment of patients."
- Purpose: To show that the modified device (with Titanium and PPSU materials for improved CT imaging) performs as defined in requirements, meets clinical expectations, and is safe and effective for clinical use, similar to the predicate device.
- Key Findings: The new materials (Titanium and PPSU) successfully minimize distortion on CT imaging, enabling conformal treatment planning. The device maintained its core functionality, operating principle, and indications for use, making it substantially equivalent to the predicate device.
- Overall Conclusion: Nucletron concluded that the Henschke Titanium Applicator Set is substantially equivalent to its legally marketed predicate device based on the data and information presented, with no safety or effectiveness issues identified.
§ 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.