(65 days)
The device is intended for intracavitary for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial brachytherapy.
The Geneva is a gynecological applicator for intracavitary brachytherapy with the option for interstitial brachytherapy treatment. It can be used for the treatment of the cervix and endometrium. The applicator consists of tubes and ovoids, guiding the radioactive source of the afterloader to the target volume. Compatible components can be combined to reach a wide range of target areas.
This document is a 510(k) summary for the Geneva Brachytherapy Applicator. It does not contain the detailed study results needed to complete all sections of your request. Specifically, it lacks quantitative performance metrics, sample sizes for specific tests, and expert qualifications for ground truth establishment.
Based on the provided text, here’s what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use | Suitable for intracavitary brachytherapy for cancer treatment of the cervix and endometrium, with optional interstitial brachytherapy. |
| User Needs | Tests demonstrated suitability of the device to its intended use and user needs. |
| Clinical Acceptance | Tests demonstrated clinical acceptance of the device. |
| Usability | Usability testing demonstrated the device can be used by intended users under simulated clinical conditions without serious use errors or problems. |
| Reprocessing | Validation of reprocessing processes performed. |
| Biological Evaluation | Biological evaluation performed. |
| Imaging Compatibility | Can be used in MR, CT, X-ray, and US environments. |
| Performance Requirements (General) | Bench testing shows that the device meets its performance requirements. Performs as defined in the requirements, meets clinical expectations, and is safe and effective for clinical use. |
| Substantial Equivalence | Determined to be substantially equivalent in intended use, function, design, and technological characteristics to the legally marketed predicate device (Nucletron B.V. Utrecht Interstitial CT/MR Applicator Set, K091154). |
Missing Information for this Section: The document does not provide specific quantitative acceptance criteria (e.g., "accuracy must be > 95%") or specific quantitative performance metrics achieved by the device (e.g., "achieved 98% accuracy"). The descriptions are high-level and qualitative.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "bench testing" and "usability testing" but does not give a number of cases, applicators, or participants.
- Data Provenance: The bench testing was performed at a "hospital site" under "simulated clinical conditions." This indicates prospective testing in a controlled environment, likely within the Netherlands, given the submitter's address. It is not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified. The document states "involvement of clinical personnel" and "Experienced users reviewed the device design and executed validation tests."
- Qualifications of Experts: The clinical personnel and experienced users were involved, but their specific qualifications (e.g., type of physician, years of experience) are not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified. The exact method by which "experienced users reviewed the device design and executed validation tests" and how "clinical acceptance" was determined is not detailed. It likely involved expert review and consensus given the clinical context but no specific method like 2+1 is mentioned.
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. This device is a physical medical device (brachytherapy applicator), not an AI software. Therefore, an MRMC study related to AI assistance for human readers is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a hardware device, not an algorithm. Performance testing was focused on the device's physical and functional capabilities, not an algorithm's standalone performance.
7. The type of ground truth used
- Type of Ground Truth: The ground truth appears to be based on expert consensus/clinical judgment and engineering requirements. The "suitability of the device to its intended use and user needs," "clinical acceptance," and compliance with "performance requirements" were assessed by clinical personnel and experienced users during simulated clinical conditions. There's no mention of pathology, outcomes data, or other objective patient-specific ground truth as it was not a patient study.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not specified. This is a physical device, not a machine learning algorithm that requires a training set in the conventional sense. The "training" for such devices typically involves iterative design, prototyping, and internal testing, which isn't described with a formal "training set" size in this context.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set Was Established: Not applicable/Not specified. As this is not an AI/ML device, the concept of a training set ground truth does not apply. The development would have followed engineering design principles and standards, with requirements likely established based on existing clinical practices, predicate device characteristics, and regulatory standards.
§ 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.