(28 days)
The Integra NeuroSciences Burr Hole Valve and Shunt System is used in treatment of patients with hydrocephalus. The Burr Hole Valve is a component of a system designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site such as the atrium of the heart or to the peritoneal cavity.
The Integra NeuroSciences Burr Hole Valve incorporates a membrane valve with integral connectors and domed reservoir to fit into a formal burr hole. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Burr Hole design includes a flat silicone membrane, which provides resistance to CSF flow. The silicone membrane scats on a conical polypropylene base. This base is int4egral to a rigid outlet port. The design allows for accurate and precise regulation of CSF flow due to its structural integrity. The flat silicone membrane also prevents retrograde flow of CSF. The Burr Hole valve is available in two sizes designed to fit a 12mm or 16mm formal burr Both sizes are available in three (3) pressure/Now characteristics ranges: low, hole. medium, and high.
The provided text describes a 510(k) summary for the Integra NeuroSciences Burr Hole Valve and Shunt System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies is not applicable or available in this document.
Here's an analysis based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for the device's performance in the context of clinical efficacy or diagnostic accuracy. Instead, it details that the device was tested for various physical and functional properties. The "reported device performance" are the results of these tests, which were deemed satisfactory by the manufacturer and accepted by the FDA for substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Pressure/Flow | Suitable for shunting cerebrospinal fluid (CSF) in hydrocephalus patients. | Tested and found satisfactory for intended use. |
| Leakage | No leakage that would compromise the system's function or patient safety. | Tested and found satisfactory for intended use. |
| Catheter Elongation | Maintain structural integrity under normal physiological conditions. | Tested and found satisfactory for intended use. |
| Catheter Bending | Maintain structural integrity and patency under normal physiological conditions. | Tested and found satisfactory for intended use. |
| Markings Visual Inspection | Clear, legible, and accurate markings. | Tested and found satisfactory for intended use. |
| Pull Testing | Sufficient strength to withstand forces encountered during implantation and use. | Tested and found satisfactory for intended use. |
| Radiopacity | Visible under imaging for proper placement and monitoring. | Tested and found satisfactory for intended use. |
| Sterility | Sterile upon delivery. | Provided sterile. |
| Non-pyrogenicity | Free from pyrogens. | Provided non-pyrogenic. |
Explanation: For a 510(k) submission concerning a device like a shunt system, the "acceptance criteria" are implied by the performance characteristics of predicate devices and consensus standards for medical devices. The manufacturer's goal is to demonstrate that their new device performs at least as well as and is as safe and effective as the predicate device. The text states "The Burr Hole Valve and Shunts have been tested for pressure/flow, leakage, catheter elongation and bending, markings visual inspection, pull testing and radiopacity," and concludes that the modified device is "substantially equivalent" and "do not raise new issues of safety and effectiveness." This implicitly means the results of these tests met the necessary standards for safety and function.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details about the sample size for the test set or the data provenance (country of origin, retrospective/prospective) for the physical and functional tests described. The tests mentioned (pressure/flow, leakage, etc.) are bench-top or mechanical tests, not clinical studies involving patients or human expert analysis of data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The "test set" in this context refers to the manufactured devices undergoing engineering and functional verification, not clinical data requiring expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical data or imaging that required expert adjudication. The tests were objective measurements of physical properties.
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. This device is a hydrocephalus shunt system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study or AI component is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the physical and functional tests was based on engineering specifications and established performance standards for hydrocephalus shunt systems. For example, a leakage test would have a "ground truth" of "no leakage" or "leakage within acceptable predefined limits."
8. The Sample Size for the Training Set
Not applicable. There is no AI or machine learning component mentioned that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an algorithm, there is no corresponding ground truth establishment method for it.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).