(90 days)
The KARL STORZ ShuntScope is indicated to provide visualization and access during cranial diagnostic and therapeutic procedures such as shunt placement, tumor biopsy and resection, hydrocephalus treatment, endoscopic third ventriculostomy with choroid plexus cauterization (ETV/CPC), endoscopic third ventriculostomy, cyst fenestration, and aqueduct exploration in pediatrics and adult population.
The components subject of this submission are: (1) the KARL STORZ ShuntScope (Model Number: 28164SSA), (2) the examination sheath (Model Number: 11577KA) and (3) operating sheath (Model Number: 11577KE)
The KARL STORZ ShuntScope is indicated to provide visualization and access during cranial diagnostic and therapeutic procedures. This response pertains to the non-clinical performance data for the device. Clinical studies were not required or performed to demonstrate substantial equivalence to predicate devices, as non-clinical bench testing was deemed sufficient.
1. Table of Acceptance Criteria and Reported Device Performance:
| Verification Test | Acceptance Criterion | Reported Performance |
|---|---|---|
| Surface and Edges | The surface of the ShuntScope shall be free of pores, cracks, and tooling agent remainders. | Pass |
| Maximum insertion portion width | The maximum insertion portion width shall not be larger than 1 mm, as stated in the instruction manual. | Pass |
| Field of View | The deviation of field of view shall not be greater than 15%. | Pass |
| Direction of View | The deviation of direction of view shall not be greater than 0° ± 10°. | Pass |
| Resolution | Characterization only. (No specific numerical acceptance criterion stated, but performance was assessed.) | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size (number of ShuntScope units) used for each bench test. The term "bench testing" refers to in-vitro testing, suggesting the tests were performed on manufactured devices. The provenance of the data is from KARL STORZ Endoscopy-America, Inc., and these tests are inherently prospective as they are performed to verify the design of the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This is a non-clinical bench testing study assessing physical and optical characteristics of a device, not a diagnostic or clinical performance study requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" here is adherence to manufacturing specifications and design requirements.
4. Adjudication Method for the Test Set:
Not applicable. As this is non-clinical bench testing, there is no adjudication method in the context of clinical interpretation or diagnosis. The "Pass" results indicate that the device met its pre-defined engineering and performance specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. An MRMC comparative effectiveness study was not done. This study focuses on the technical performance of the device itself (e.g., its physical dimensions, optical properties) rather than its effectiveness in a clinical setting with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a neurological endoscope, which is a physical instrument for visualization and access, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used:
The ground truth used for these bench tests consisted of pre-defined technical specifications and engineering requirements. For instance, the "Maximum insertion portion width" has a ground truth of "not larger than 1 mm," and the "Direction of view" has a ground truth of "0° ± 10°." These are objective, measurable criteria established during the device's design and manufacturing process.
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set" in the context of this performance evaluation.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of 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).