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510(k) Data Aggregation
(259 days)
The MR Endoscope by Tronnier (Magnetic Resonance) allows visual observation of the operating site with simultaneous utilization of the working, supply and drain channels.
The Obturator is used for atraumatic insertion of the endoscope.
For examination, diagnosis and therapy in neurosurgery in conjunction with endoscopic accessories during intracranial procedures, such as: the fenestration of cysts, the removal of cysts, biopsies of lesions, coagulation of intraventricular lesions, etc.
NOTE: The MR Endoscope is specially designed for use in open nuclear magnetic resonance tomographs.
The submitted endoscope set is equivalent to standard endoscopes with a working channel, but for the use in magnetic resonance applications.
The provided document does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of typical AI/ML medical device performance evaluations.
Instead, this document is a 510(k) summary for an endoscope set, which is a physical medical device, not an AI/ML software. The crucial sections for answering your request are 5.0 Performance Data and 6.0 Clinical Tests.
Here's a breakdown based on the provided text, highlighting the absence of information relevant to your AI/ML questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to international standards IEC 601-1 and IEC 601-2-18 for medical electrical equipment. | The devices are conforming to the international standards IEC 601-1 and IEC 601-2-18. |
| Thermal heat rise verification to be within acceptable levels. | Thermal heat rise has been verified to be within acceptable levels. |
| Safety and effectiveness when used according to the instructions manual. | These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual. |
2. Sample size used for the test set and the data provenance
- No information provided. The "performance data" refers to engineering tests against standards, not a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no clinical test set for which ground truth would be established by experts.
4. Adjudication method for the test set
- Not applicable. No clinical test set.
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 not an AI-assisted device. The document explicitly states "No clinical tests performed."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used
- Not applicable for the kind of ground truth usually associated with AI/ML. The "ground truth" here refers to whether the device physically met engineering standards.
8. The sample size for the training set
- Not applicable. There is no AI model or training set.
9. How the ground truth for the training set was established
- Not applicable. There is no AI model or training set.
Overall Conclusion:
The provided document describes a traditional medical device (an endoscope set) and its submission for 510(k) clearance based on substantial equivalence to existing devices and compliance with relevant engineering standards. It does not involve AI/ML technology, clinical performance studies with patient data, or the use of expert-derived ground truth as would be relevant for an AI/ML device.
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