(144 days)
MACHIDA Floxible Neuro-Endoscopes, Model NEU-4/NEU-4L are designed to be introduced into the cranium area through the surgically created orifice for the purpose of the observation, the treatment and the recording by photography.
Flexible Neuro-Endoscope, NEU-4/4L are mainly desighed for observation and treatment by small instrument which is inserted through the working channel, specifically in the intra-cranium area. The device is mainly constructed with the fiber optic system for imaging and illumination. The device is covered internally by thin stainless spiral plate and outside by a tube so that the flexibility is always maintained. The device is mainly composed of the control grip, insertion tube, deflecting section, internal working channel, light guide cable and the distal end where the objective lens system are incorporated in addition to the fiber optic imaging and illuminating system. All the material specifically those which are in direct contact with human tissue are proven safe for the medical use.
The provided document is a 510(k) Premarket Notification for the Machida Flexible Neuro-Endoscope, Model NEU-4/4L. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics for the novel device.
Therefore, the document does not contain the requested information regarding specific acceptance criteria for performance, detailed study designs, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance data, or training set details.
Here's what can be extracted and why other points are not available:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document describes general characteristics of the device (high resolution, maneuverability, watertightness, improved recording capability) and its intended use, but it does not specify quantitative acceptance criteria or report specific performance metrics against such criteria. The focus is on comparing features to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. No formal test set or clinical study with a specified sample size is described in this 510(k) summary. This type of submission relies on substantial equivalence and often does not require new clinical data if technological characteristics and intended use are similar to a predicate.
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 Available. As no specific test set or ground truth establishment process is described, this information is not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available. No test set or an adjudication method for it 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
- Not Applicable/Not Available. The device is a flexible neuro-endoscope, an optical instrument for direct observation and intervention, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Available. The device is a physical endoscope, not an algorithm. Standalone algorithm performance is not relevant to this product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available. Since no formal clinical study or test set requiring ground truth is described, this information is absent. The safety and effectiveness are established through substantial equivalence to a predicate device.
8. The sample size for the training set
- Not Available. As this is not an AI/machine learning device, the concept of a training set is not applicable.
9. How the ground truth for the training set was established
- Not Available. As above, a training set is not applicable to this device.
Conclusion:
The K992510 document is a 510(k) Premarket Notification summary. Its primary purpose is to demonstrate substantial equivalence to a predicate device already on the market. It describes the device's features, intended use, and technological characteristics (e.g., high resolution, maneuverability, watertightness) to argue for equivalence. It explicitly states, "No performance standards or special controls have been developed for this device," reinforcing that the submission relies on equivalence rather than meeting new, specific performance criteria through detailed studies. Therefore, the detailed study-related information requested is not present in this document.
§ 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).