(475 days)
The Olympus Neuro Endoscopes are rigid endoscopes indicated for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.
The Olympus Neuro Endoscopes are rigid endoscopes indicated for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures. The telescopes and recommended ancillary equipment will be sold nonsterile and can be reused after proper cleaning and sterilization before usage as outlined in the instruction manual. The endoscopes are made of stainless steel and are comprised of a combined optical (rod-lens system) and illumination system.
The provided text describes a 510(k) submission for the Olympus Neuro Endoscope. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving performance against those criteria as would be expected for a novel device.
Therefore, many of the requested sections cannot be filled from the provided text because the submission explicitly states "Not applicable" for clinical tests and discusses non-clinical tests only in the context of voluntary safety standards.
Here's the breakdown based on the provided information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Expected/Regulatory Standard) | Reported Device Performance (Summary from submission) |
|---|---|
| Compliance with IEC-601-1 (safety standard) | Meets the requirements of IEC-601-1. |
| Substantial equivalence to predicate devices | Similar in intended use, design, and construction to predicate devices (Codman Gaso Hopkins Diagnostic Telescope, K#923555 and Neuro Navigational Neuroview 700R Rigid Scope: K#955037). No significant changes in intended use, method of operation, material, or design that could affect safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states "Discussion of Clinical Tests Performed: Not applicable." Therefore, no test set for clinical performance was used, and no data provenance information is available.
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 as no clinical test set was described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical test set was 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
- Not applicable. This is a rigid endoscope, not an AI-assisted diagnostic device. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a rigid endoscope, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable as no clinical test set requiring ground truth was described. The "ground truth" for this submission focuses on compliance with safety standards and substantial equivalence to predicate devices based on design and intended use.
8. The sample size for the training set
- Not applicable. There is no mention of an algorithm or machine learning model that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. There is no mention of an algorithm or machine learning model that would require ground truth for a training set.
§ 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).