(84 days)
The Introducer Sheath is a device used to make a channel through the brain into the ventricular system.
The Introducer Sheath includes two parts, a peelaway sheath and a blunt ended obturator, which fits inside the sheath. The Introducer Sheath provides an atraumatic passage into the ventricular system.
The provided document is a 510(k) premarket notification for a medical device called the "Medtronic PS Medical Endoscope Introducer." This type of document focuses on demonstrating substantial equivalence to a previously legally marketed device, rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria.
Therefore, many of the requested details about performance, sample sizes, ground truth establishment, and comparative effectiveness studies are not available in this document. The document's purpose is to show that the new device is as safe and effective as existing ones, based on similar design and intended use.
Here's an analysis based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria or specific performance metrics that the Medtronic PS Medical Endoscope Introducer was tested against in a formal study.
Instead, the document asserts technological comparison and substantial equivalence to predicate devices (Navigational F Sheath and Codman Peel Away Sheath) based on:
- Device configuration/contents: Peel Away Sheath, Obturator
- Sterility Method: EtO (Ethylene Oxide)
- Sterile: Sterile single-use device
- Intended Use: To make a channel through the brain into the ventricular system.
The "reported device performance" is implicitly that it performs like the predicate devices, enabling the creation of a channel through the brain for ventricular access. No quantitative performance data is provided.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. As a 510(k) submission based on substantial equivalence, it relies on the established safety and effectiveness of the predicate devices. There is no mention of a specific test set or data derived from testing the Medtronic PS Medical Endoscope Introducer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. Ground truth establishment for a test set is typically part of a dedicated performance study, which is not detailed in this 510(k) submission.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done (or at least, not reported in this document). The 510(k) process for this device relies on demonstrating equivalence to predicate devices, not on a human-in-the-loop study with AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This device is a physical medical instrument, not an algorithm or AI. Therefore, the concept of "standalone (algorithm only)" performance is not applicable to this product.
7. The Type of Ground Truth Used
The "ground truth" here is not clinical outcome data or expert consensus on performance of the new device. Instead, the "ground truth" for this 510(k) submission is implicitly the established safety and effectiveness of the predicate devices (Navigational F Sheath (K931973) and Codman Peel Away Sheath (K883607)), which allow for the "creation of a channel through the brain into the ventricular system." The new device is deemed substantially equivalent in its design, materials, and intended use.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This is a physical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided.
§ 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).