(150 days)
The KARL STORZ Flexible Video-Neuro-Endoscope System is indication and access during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection, hydrocephalus treatment, endoscopic third ventriculostomy with choroid plexus cauterization (ETV/CPC), endoscopic third ventriculostomy, cyst fenestration, and aqueduct exploration.
The Flexible Video-Neuro-Endoscope System is a videoscope indicated for viewing and providing access during cranial diagnostic and therapeutic procedures. The system consists of the KARL STORZ Flexible Video-Neuro-Endoscope (Model Number: 11161V) and the IMAGE1 SPIES Camera Control Unit (CCU), which has been cleared in K160044.KARL STORZ Flexible Video- Neuro-Endoscope's working shaft is 350 mm long with 8.5 Fr elliptical shaped distal tip (minor diameter is 2.4 mm and major diameter is 3.2 mm). The shaft has a Pellathane (polyurethane) cover and contains a PTFE working channel with an I.D. of 1.2 mm. The working channel length is 519 mm. Both instrument and irrigation ports have stopcocks, and there are no check valves or other restrictions to prevent the back flow within any point of the fluid path. The Video Neuroscope's direction of view is 0° and the direction of view is 90°. The distal tip houses the CMOS (complementary metal oxide semiconductor) imaging sensor, and the illumination is provided by two glass fiber light bundles, whose LED light source is located in the handpiece. In the handpiece of the KARL STORZ Flexible Neuro-endoscope, the user will find a deflection lever, which allows the distal tip to deflect 270 degrees in the UP/DOWN direction. Next to the deflection lever is three control buttons (“Select", "Left (Up)", and "Right (Down)") that provide a remote means for the user to interact with the IMAGE1 SPIES CCU and can be programmed to initiate specific functions such as white balance, image capture, zoom, and access to CCU setup menu. Once set by user, the control button assignment is retained after the system being switched on and off. LED (Light Emitting Diode) is integrated in the handpiece, and it is used to provide illumination of the anatomy under examination. The light is transmitted from the LED to the distal tip via two glass fiber light bundles. The raw data captured at the distal tip CMOS imaging sensor is converted to a standard NTSC (National Television System Committee) video signal by the printed circuit board (PCB), also housed in the handpiece.
The provided document describes the KARL STORZ Flexible Video-Neuro-Endoscope System. It does not contain information about an AI-powered device or a study involving human readers or AI assistance. The document focuses on the substantial equivalence of the neuro-endoscope system to a predicate device through non-clinical bench testing and biocompatibility assessments. Therefore, I cannot extract information related to AI performance, human reader improvement with AI assistance, or related metrics.
However, I can provide the acceptance criteria and study findings for the non-AI device presented in the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test / Verification | Acceptance Criterion Description | Reported Device Performance |
|---|---|---|---|
| Optical Performance | Field of view | Verified optical requirements | Pass |
| Distortion | Verified optical requirements | Pass | |
| Resolution | Verified optical requirements | Pass | |
| Image Quality | White Balance | Verified white balance | Pass |
| Color Accuracy | Verified color accuracy | Pass | |
| Temporal Noise | Does not exceed specified limit | Pass | |
| Spatial Noise | Does not exceed specified limit | Pass | |
| Illumination/Sensitivity | Minimum Response | Sufficient brightness for surgical functions under worst-case conditions | Pass |
| AE Step Response | Smooth transition (no excessive 'ringing') and acceptable transition time from dark to light scene | Pass | |
| Exposure Brightness | Luminance output within acceptable limits for each of the five available Brightness settings | Pass | |
| Illumination | Functional performance and light output specification | Pass | |
| Mechanical Performance | Dimensions | Verified mechanical requirements | Pass |
| Deflection | Verified mechanical requirements | Pass | |
| Bend radii | Verified mechanical requirements | Pass | |
| Weight | Verified mechanical requirements | Pass | |
| User Interface | Camera Head Button | Correct response to button presses | Pass |
| Biocompatibility | Cytotoxicity | Performed according to ISO 10993-5 and FDA Guidance | Pass (Biological-toxicological safety not affected) |
| Sensitization | Performed according to ISO 10993-11 and FDA Guidance | Pass (Biological-toxicological safety not affected) | |
| Irritation | Performed according to ISO 10993-11 and FDA Guidance | Pass (Biological-toxicological safety not affected) | |
| Systemic Toxicity | Performed according to ISO 10993-10 and FDA Guidance | Pass (Biological-toxicological safety not affected) | |
| Sterilization | STERRAD NX/100NX | SAL=10^-6, Half cycle method | Pass |
| V-PRO maX and V-PRO 60 | SAL=10^-6, Half cycle method | Pass | |
| STERIS SYSTEM 1E | Complete liquid chemical sterilization | Pass | |
| 100% Ethylene Oxide | SAL=10^-6, Half cycle method, Residuals per ANSI/AAMI/ISO 109937:2008 | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in terms of patient data or images. The evaluation was done through non-clinical bench testing and biocompatibility testing on the device itself and its materials. There is no information regarding the country of origin of data or whether it was retrospective or prospective, as it did not involve clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The evaluation was primarily engineering and laboratory-based, focusing on performance specifications and material compatibility, not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring adjudication.
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. This device is a neuro-endoscope, which is a viewing and access tool, not an AI-assisted diagnostic or interpretive system. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests was established by predefined engineering specifications, performance limits, and standardized testing methods (e.g., ISO 10993 standards for biocompatibility, specific sterilization cycle parameters).
8. The sample size for the training set
Not applicable. There is no training set mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. No training set or associated ground truth was established for this device.
§ 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).