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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

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.

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The intended use of the Advanced Gynecological Applicator is intracavitary for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.

The Advanced Gynecological Applicator is a gynecological applicator for intracavitary and interstitial brachytherapy treatment. It can be used it for treatment of the vagina, cervix and uterus. The applicator consists of tubes, caps and templates to place needles. Components can be combined to reach a wide range of target areas. The tubes and the needles, if used, guide the radioactive source of the afterloader to the target volume.

This document is a 510(k) premarket notification letter from the FDA to Nucletron B.V. regarding their Advanced Gynecological Applicator. It primarily addresses the device's substantial equivalence to existing legally marketed devices, rather than presenting a detailed clinical study with specific acceptance criteria, study methodologies, and performance metrics like those typically found for AI/ML-based devices or studies requiring statistically significant findings for efficacy.

Therefore, many of the requested details about acceptance criteria, performance tables, sample sizes, expert involvement, ground truth establishment, and MRMC studies are not present in this document. This letter is a regulatory approval notice, not a clinical study report.

Here's an analysis of the information that is present, addressing your points where possible:

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of quantitative acceptance criteria or specific performance metrics as one would expect for an AI/ML device or a device requiring significant clinical outcome validation. The "acceptance" here is the FDA's determination of substantial equivalence based on a comparison to predicate devices.

The "performance" is generally described qualitatively:

• "The test results demonstrated suitability of the device to its intended uses and clinical acceptance of the device."
• "Usability testing demonstrates that the device can be used by the intended users, under simulated clinical conditions, without serious use errors or problems."
• "Bench testing... shows that the device meets its performance requirements, and that the modified device performance is equivalent to the marketed devices."
• "The results of the testing provided in this submission adequately demonstrate that the Advanced Gynecological Applicator performs as defined in the requirements, in accordance with the recognized standards, meets clinical expectations and is safe and effective for clinical use."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document states, "Bench testing was performed at a hospital site, under clinical conditions and with the involvement of clinical personnel but excluding the delivery of treatment of patients."
• It does not specify the sample size (e.g., number of tests, number of devices tested, or number of simulated cases).
• The data provenance is implied to be from "a hospital site" where "experienced users" reviewed the device, likely in The Netherlands, given the company's address. It was conducted under "simulated clinical conditions," suggesting it was prospective testing focused on usability and functional performance, not a retrospective clinical data study.

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)

• The document mentions "Experienced users reviewed the device design and executed validation tests."
• It does not specify the number of experts or their specific qualifications (e.g., number of years of experience, specific medical specialty).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• The document does not describe any specific adjudication method for performance evaluation, as the testing described is primarily functional and usability-focused, not diagnostic accuracy requiring ground truth establishment through expert consensus or adjudication. The "validation tests" and "usability testing" appear to be direct observations and assessments of the device's function.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly AI-driven ones where human-AI interaction is assessed. This device is a physical medical instrument (brachytherapy applicator), not a diagnostic imaging or AI 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)

• For this type of device (a physical applicator), "ground truth" would relate to its physical performance, safety, and functional capabilities (e.g., source path accuracy, sterility, material compatibility, ease of use). The "summary of testing" indicates that the device's performance was evaluated against "performance requirements" and "recognized standards." The testing included:
  • Bench testing for performance
  • Usability testing
  • Validation of sterilization processes
  • Biological evaluation (biocompatibility)
  • Testing for use in MR and CT environments.
• The "ground truth" for these tests would be the established engineering specifications, safety standards (e.g., ISO standards for sterility, biocompatibility), and user requirements (for usability). This is not "ground truth" in the sense of clinical diagnostic accuracy.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. This is a physical medical device, not an AI/ML algorithm.

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The Martinez Prostate Template Set is for assisting interstitial HDR/PDR brachytherapy of the prostate gland, to be used only by trained physicians. The maximum application duration per treatment application is 28 days.

Not Found

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study that proves the device meets acceptance criteria for the "Martinez Prostate Template Set." The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a legally marketed predicate device. It specifies the indications for use but does not detail performance metrics, study design, or results.

Therefore, I cannot provide the requested information in the table or answer the specific questions about sample size, data provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance.

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