(202 days)
The Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set are intended for cancer treatment of the vagina, vaginal stump and rectum using HDR or PDR brachytherapy.
The Universal Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are intended for cancer treatment of the vaginal stump, cervix, uterus and endometrium using HDR or PDR brachytherapy.
The Universal Titanium Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are intended for cancer treatment of the vaginal stump, cervix, uterus and endometrium 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 gynaecological 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.
The provided document is a 510(k) Premarket Notification for the Universal Cylinder Applicator Family (K172611). This is a medical device, not a diagnostic AI/ML algorithm. Therefore, the information requested regarding acceptance criteria and studies that prove a device meets those criteria (especially sections related to AI/ML such as test set sample size, data provenance, ground truth, MRMC studies, standalone performance, and training set details) are not applicable to this document.
Instead, this document describes a traditional medical device (brachytherapy applicators) and its substantial equivalence to a predicate device based on technological characteristics and functional testing.
Here's an analysis based on the document's content, focusing on what is provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of formal acceptance criteria with numerical performance targets alongside reported device performance in the way one might expect for an AI/ML algorithm (e.g., sensitivity, specificity, AUC). Instead, it describes various bench tests conducted to demonstrate conformance to applicable requirements and specifications. The "reported device performance" is a general statement of compliance.
| Acceptance Criteria (Implied from Bench Tests) | Reported Device Performance |
|---|---|
| Correct functioning with specified afterloaders | Conformance to requirements |
| Withstanding specified number of use cycles | Conformance to requirements |
| Accurate radioactive source localization | Conformance to requirements |
| Material resistance to radiation exposure | Conformance to requirements |
| Effective sterilization | Conformance to requirements |
| Usability and sterilizability for cycle limits | Conformance to requirements |
| Adequate positional accuracy of the source | Conformance to requirements |
| Biocompatibility (per ISO 10933) | Conformance to requirements |
| Safe and effective use in CT environments | Conformance to requirements |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a hardware medical device; testing was primarily bench testing, not involving clinical data sets in the AI/ML sense.
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. Ground truth, in the context of expert consensus for AI/ML, is not relevant here. Device functionality was assessed against design specifications and relevant standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method was described as this is not an AI/ML diagnostic device requiring clinical image interpretation.
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 an applicator for brachytherapy, not an AI system. No MRMC study was conducted or is relevant.
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 for AI/ML ground truth. The "ground truth" for this device's performance is its ability to meet engineering specifications, functional requirements, material properties, and safety standards verified through bench testing.
8. The sample size for the training set
Not applicable. This is a hardware medical device; it does not utilize a training set in the AI/ML context.
9. How the ground truth for the training set was established
Not applicable. As above, there is no AI/ML training set.
Summary regarding the device and its studies:
The document states:
- Non-Clinical Tests: "Bench Testing has been performed to demonstrate that... [list of functional and safety attributes]."
- Clinical Tests: "No clinical tests have been included in this pre-market submission."
- Conclusions: "All the tests that were performed met the applied pass criteria. Varian considers the devices to be safe and effective and to perform as well or better than the predicate."
This 510(k) submission relies on a comparison to a predicate device (K160516 - Universal Cylinder Applicator Family) and extensive bench testing to demonstrate substantial equivalence, rather than clinical studies or AI/ML performance evaluation.
§ 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.