(293 days)
The Clarus Model 2121-XXX NeuroPEN Endoscopic Shunt Placement Kit is intended for endoscopic intraoperative intracranial neurosurgical shunt placement procedures where cerebrospinal fluid (CSF) may be contacted. The endoscope and the shunt are supplied sterile and are intended for single use.
The Model 2121-XXX NeuroPEN Endoscopic Shunt Placement Kit contains an endoscope designed and manufactured by Clarus Medical and a FDA cleared shunt.
The Model 2121-XXX NeuroPEN endoscope is manufactured using medical grade biocompatible materials. The design of and materials used are the same as those used in other Clarus Series 2100 and Series 2200 Endoscopes. Further, the sizes and configurations of the endoscope are equivalent as well. The Model 2121-XXX endoscope is a tubular device with molded plastic connectors. The optical element of the endoscope consists of a fiber optic image bundle with a distal lens and a fiber light guide. The endoscope also has a separate fluid irrigation channel. The light and image guides are terminated with standard connectors designed to interface with light cables and video cameras. The fluid irrigation channel is terminated with a standard Luer-Lok™ connector.
This document describes the Clarus Model 2121-XXX NeuroPEN Endoscopic Shunt Placement Kit, a Class II device intended for endoscopic intraoperative intracranial neurosurgical shunt placement procedures. The provided text, however, does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance or efficacy in a clinical setting.
Instead, the document focuses on:
- Substantial Equivalence: The primary argument for approval is based on substantial equivalence to predicate devices (Model 2120 NeuroPen Endoscope, Model 2125 MurphyScope, and Catalog No. 82-6570 NEUROGUIDE Endoscopic Shunt Placement Kit). This means the device is considered safe and effective because it is very similar to legally marketed devices.
- Bench Testing/Engineering Verification: The "Testing" section describes physical and biocompatibility tests performed on the device materials and components. These are primarily engineering verification tests, not clinical performance studies.
Therefore, I cannot populate the requested table or answer the specific questions about clinical study details, as that information is not present in the provided text. The document does not describe a study involving a "test set," "training set," "ground truth," "experts," or "MRMC comparative effectiveness."
Here's how I would answer your request based only on the provided text, highlighting what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (as implied by testing) | Reported Device Performance (from "Testing" section) |
|---|---|
| Biocompatibility | All materials passed biocompatibility testing and are suitable for this application. |
| Dimensional Accuracy | Dimensional inspection yielded acceptable results. |
| Visual Workmanship | Visual examination for workmanship yielded acceptable results. |
| Bond Strength | Bond strength testing yielded acceptable results. |
| Optical Clarity | Optical clarity yielded acceptable results. |
| Light Transmittance | Light transmittance yielded acceptable results. |
| Distal Tip Temperature Stability | Distal tip temperature study yielded acceptable results. |
| Fluid Flow | Fluid flow testing yielded acceptable results. |
Note: These acceptance criteria are for engineering and material performance, not clinical efficacy or diagnostic accuracy, as this is a surgical instrument. The document emphasizes substantial equivalence rather than a new clinical performance study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. The document describes bench testing and material compatibility, not a clinical "test set" for performance evaluation in a human population.
- Data Provenance: Not applicable. The data is from internal "Biocompatibility testing" and "Physical testing" of the device components/materials, not human subjects.
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. There was no "ground truth" derived from expert consensus for a clinical performance test set described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or adjudication method is 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
- No. This is not an AI/diagnostic imaging device, and an MRMC study was not performed or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical performance. The "ground truth" for the described testing relates to engineering specifications and material standards (e.g., whether a bond strength met a certain threshold, or if a material was biocompatible according to established standards).
8. The sample size for the training set
- Not applicable. There is no mention of a "training set" as this is not an algorithm being developed through machine learning.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned in the 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).