(236 days)
The Miethke proGAV Programmable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
The Miethke proGAV 2.0 Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
The Miethke proSA Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
The proGAV is a "programmable" shunt that can be set for a range of pressures. The valve in the proGAV is a leaf spring and ball mechanism that is mechanically controlled by internal magnets. The outer case for the device is made of titanium. The shunt comes with a manual device to verify the pressure setting and another to set or re-set the pressure. These manual accessories are both for external use by the physician. Various Miethke shunt system accessories such as shunt assistants, catheters, connectors, deflectors and reservoirs are also offered with the proGAV.
proGAV 2.0 is an adjustable differential pressure valve that can be set for a range of pressures. The proGAV 2.0 valve is comprised of a titanium housing that contains a leaf spring and ball mechanism that is mechanically controlled by internal magnets. Manual devices are available to locate, verify the pressure setting and to set or re-set the pressure pre and postoperatively. These manual accessories are for external use by the physician. The device will be distributed by itself or in combination with the ShuntAssistant valve or proSA valve. The proGAV 2.0 adjustable differential pressure valve includes the same legally marketed accessories that are available with the Miethke Shunt Systems.
proSA is an adjustable gravitational valve that can be set for a range of pressures. The proSA valve is comprised of a titanium housing that contains a tantalum weight, leaf spring and ball mechanism that is mechanically controlled by internal magnets. Several manual devices are available to verify the pressure setting and to set or re-set the pressure pre and postoperatively. These manual accessories are for external use by the physician. The device will be distributed by itself or in combination with the miniNAV valve or proGAV valve. The proSA adjustable gravitational valve includes the same legally marketed accessories that are available with the Miethke Shunt Systems.
The provided text describes the acceptance criteria and performance data for three medical devices: the Miethke proGAV Programmable Shunt System, the Miethke proGAV 2.0 Adjustable Shunt System, and the Miethke proSA Adjustable Shunt System.
The primary purpose of the studies was to demonstrate that each of these devices, when used with specific non-invasive verification tools (proGAV Verification Tool, proGAV Verification Compass, or proGAV 2.0 Compass), could accurately verify the shunt setting, thereby removing the need for radiographic (X-ray) confirmation. The acceptance criterion for each device was to demonstrate "substantial equivalence" between the required radiographic verification method and the non-invasive method.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for all three devices:
- Demonstrate substantial equivalence between the radiographic verification method and the non-invasive verification method using the specified tools.
- The non-invasive method using the specified tools must be able to accurately measure the shunt setting, making X-ray confirmation no longer required.
| Device | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Miethke proGAV Programmable Shunt System | The test results met the acceptance criteria by demonstrating substantial equivalence between the required radiographic verification method and the non-invasive method using the proGAV Verification Tool and proGAV Verification Compass. This implies that the measurement agreement between these non-invasive tools and X-ray confirmation was within acceptable limits, allowing for the removal of the radiographic verification requirement in the labeling. | Verification testing assessing the measurement agreement between X-ray confirmation and the proGAV Verification Tool when used with the proGAV Programmable Shunt System. |
| Verification testing assessing the measurement between X-ray confirmation and the proGAV Verification Compass when used with the proGAV Programmable Shunt System. | ||
| Result: Test results met acceptance criteria, demonstrating substantial equivalence between radiographic and non-invasive methods. | ||
| Miethke proGAV 2.0 Adjustable Shunt System | The test results met the acceptance criteria by demonstrating substantial equivalence between the required radiographic verification method and the non-invasive method using the proGAV 2.0 Compass, proGAV Verification Compass, and proGAV Verification Tool. This implies that the measurement agreement between these non-invasive tools and X-ray confirmation was within acceptable limits, allowing for the removal of the radiographic verification requirement in the labeling. | Verification testing assessing the measurement agreement between X-ray confirmation and the proGAV 2.0 Compass when used with the proGAV 2.0 Adjustable Shunt System. |
| Verification testing assessing the measurement between X-ray confirmation and the proGAV Verification Compass when used with the proGAV 2.0 Adjustable Shunt System. | ||
| Verification testing assessing the measurement agreement between X-ray confirmation and the proGAV Verification Tool when used with the proGAV 2.0 Adjustable Shunt System. | ||
| Result: Test results met acceptance criteria, demonstrating substantial equivalence between radiographic and non-invasive methods. | ||
| Miethke proSA Adjustable Shunt System | The test results met the acceptance criteria by demonstrating substantial equivalence between the required radiographic verification method and the non-invasive method using the proSA Verification Tool and proSA Verification Compass. This implies that the measurement agreement between these non-invasive tools and X-ray confirmation was within acceptable limits, allowing for the removal of the radiographic verification requirement in the labeling. | Verification testing assessing the measurement between X-ray confirmation and the proSA Verification Tool when used with the proSA Adjustable Shunt System. |
| Verification testing assessing the measurement between X-ray confirmation and the proSA Verification Compass when used with the proSA Adjustable Shunt System. | ||
| Result: Test results met acceptance criteria, demonstrating substantial equivalence between radiographic and non-invasive methods. |
2. Sample size used for the test set and the data provenance
The document specifies "Bench testing" for the performance data. It does not provide specific sample sizes (e.g., number of shunts tested, number of measurements taken) for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth for comparison in these studies was "X-ray confirmation." The text does not mention the use of human experts to establish this ground truth or their qualifications. The X-ray is presented as the objective, established method of verification.
4. Adjudication method for the test set
Not applicable. The study involved comparing a device-tool measurement to an X-ray confirmation, not expert adjudication of subjective assessments.
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 is not an AI-based diagnostic or assistive device. The study focused on the performance of mechanical devices and their verification tools.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is not an algorithm or AI device. The "standalone" performance here would refer to the performance of the non-invasive tools in indicating the shunt setting, which was the core of the bench testing.
7. The type of ground truth used
The ground truth used was radiographic (X-ray) confirmation of the shunt setting.
8. The sample size for the training set
The document does not mention a training set, as these are mechanical devices undergoing bench testing for performance and equivalence, not machine learning algorithms requiring training data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for these types of device studies based on the provided document.
§ 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).