(85 days)
Aesculap's MINOP System is intended for use in endoscope-assisted microneurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for direct visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.
The MINOP System consists of trocars (cannulas with blunt obturators). neuroendoscopes, instruments and electrodes. There are three different styles of operating cannulas which function as the base for the device system. The MINOP System operating cannulas have either 1, 3, or 4 working channels. The Neuroendoscopes for the MINOP System are rigid, rod-lens neuroendoscopes with either 0° or 30° direction of view. The lens evepiece is angled at 90° to allow an unobstructed view when used in conjunction with a surgical microscope. The MINOP System consists of reusable devices composed primarily of stainless steel. An optional holding device, Aesculap's Flexible Titanium Support Arm, can be used to position and hold the neuroendoscopes. With use of the flexible support arm, the surgeon can freely operate with both hands.
The Aesculap MINOP System is a medical device intended for endoscope-assisted microneurosurgery and pure neuroendoscopy (ventriculoscopy) for direct visualization, diagnostic, and/or therapeutic procedures (e.g., ventriculostomies, biopsies, removal of cysts, tumors, and other obstructions).
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Performance Standards | No applicable performance standards promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. | The MINOP System complies with the requirements of IEC 601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment). |
| Safety Testing | Evaluation for electrical safety | Underwent evaluation to ensure safety for intended use. |
| Evaluation for thermal safety | Underwent evaluation to ensure safety for intended use. | |
| Evaluation for irrigation safety | Underwent evaluation to ensure safety for intended use. | |
| Sterilization | Ability to be sterilized prior to use | Provided non-sterile and can be sterilized by steam sterilization. |
| Substantial Equivalence | Similar features and function to legally marketed predicate devices. | Shares similar features and function with corresponding devices distributed by: Aesculap (Ventriculoscope, Angled Neuroendoscopes), Codman (Neuroendoscopes), Neuro Navigational (Neuroview), Richard Wolf (Neuro-Endoscope). |
2. Sample size used for the test set and the data provenance:
The provided document does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for proving the device's performance against the stated criteria. The compliance with IEC 601-2-18 and safety evaluations would have been conducted through engineering tests and possibly bench testing, rather than a clinical 'test set' in the typical sense of a patient study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. Given that the acceptance criteria are related to compliance with an electrical safety standard (IEC 601-2-18) and general safety evaluations, it's unlikely that "experts" in the context of ground truth for a clinical test set were used. Rather, the evaluations would involve qualified engineers and technicians.
4. Adjudication method for the test set:
This information is not provided in the document. An adjudication method, typically associated with clinical trials or expert reviews, is not mentioned for the safety and performance evaluations described.
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:
This information is not applicable and not provided. The Aesculap MINOP System is a physical neuroendoscopic system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. As mentioned above, the device is a physical endoscopic system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance criteria appears to be compliance with an international standard (IEC 601-2-18) and successful completion of internal safety evaluations (electrical, thermal, irrigation). For substantial equivalence, the ground truth is the existence and characteristics of predicate devices already on the market. This is not "ground truth" derived from patient data like pathology or outcomes.
8. The sample size for the training set:
This information is not provided and is not applicable. The MINOP System is a hardware device; it does not involve a "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established:
This information is not provided and is not applicable for the reasons stated in point 8.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).