(294 days)
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. Adjustments of the proGAV 2.0 shunt can be verified by using the proGAV 2.0 Compass but must be confirmed by radiograph (X-ray).
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. Once verified using the Compass the setting must be confirmed with an X-ray. 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.
The provided text is related to the Aesculap Miethke proGAV 2.0 Adjustable Shunt System, a medical device. This document is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to a predicate device through preclinical testing, rather than a clinical study involving human patients or detailed AI performance metrics. Therefore, many of the requested sections about AI-related performance, human reader studies, and training set details are not applicable or cannot be extracted from this specific document.
Here's the information that can be extracted and a note on what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resistance to Leakage | No leakage detectable within 5 min under 100cm applied overpressure. | No leakage detectable within 5 min under 100cm applied overpressure. Samples passed the acceptance criteria. |
| Pressure-Flow | The measured pressure has to remain inside manufacturers declaration between the flow range of 5 to 50 ml/h. | The pressure flow performance of each tested valve remains inside manufacturers declaration. Samples passed the acceptance criteria. |
| Overpressure | Valve function/performance verified by an additional measurement of the pressure flow performance after applying overpressure. Integrity verified by passing the dynamic breaking force. Device shall withstand a positive pressure of 1 m water column applied to the open shunt. | Valve function/performance was verified due to an additional measurement of the pressure flow performance after applying the overpressure. Integrity was verified by passing the dynamic breaking force. Samples passed the acceptance criteria. |
| Dynamic Break Strength | No rupture or crack after applying 100,000 cycles with a frequency of 1 Hz ±0.2, tension applied in flow direction, leading to an elongation of 10% or a maximum force of 5 N. | No sample had a rupture or crack after applying 100,000 cycles. Samples passed the acceptance criteria. |
| Bursting Pressure | Device must withstand a positive pressure of 2 m of water column inside the device without any change within a tolerance of ± 10% (no later than 2 hours after application). | No later than 2 hours after applying the positive pressure of 2m water column the valve pressure flow performance was inside manufacturers declaration. Samples passed the acceptance criteria. |
| Reflux performance | A maximum flow of 0.04 ml/min is allowed to be drained back using a water bath for 500 mm of water column against the flow direction. | All tested items had a measured reflux lower than allowed. Samples passed the acceptance criteria. |
| Long Term Stability | All items remained inside the manufacturers declaration over the period of 28 days (immersed in distilled water at 36°C ±5, pumping at 20 ml/h, patient position simulated for 14 days/horizontal and 14 days/vertical). | All items remained inside the manufacturers declaration over the period of 28 days. Samples passed the acceptance criteria. |
| Valve adjustability/readability | The adjustability and verification of all items remained inside the manufacturers declaration when tested with different materials/thicknesses between the valve and tools. | The adjustability and verification of all items remained inside the manufacturers declaration. Samples passed the acceptance criteria. |
| MRI Compatibility | MR Conditional in 3-Tesla Magnetic Resonance Imaging (MRI) systems according to ASTM F 2503 (based on evaluation of MR Image Artifacts, RF Induced Heating, Magnetically Induced Torque, and Magnetically Induced Displacement Force). | The device is MR Conditional in 3-Tesla Magnetic Resonance Imaging (MRI) systems according to ASTM F 2503. |
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size (number of devices) used for each preclinical test. It consistently refers to "Samples" or "All tested items" without specifying the quantity.
- Data Provenance: The data is from preclinical bench testing performed by the manufacturer, Aesculap, Inc., to demonstrate the device's performance and substantial equivalence to a predicate device in accordance with ISO 7197:2009 standards and ASTM standards for MRI compatibility. It is not patient data (retrospective or prospective).
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. This document describes preclinical bench testing of a medical device, not a study involving diagnostic images or clinical data requiring expert human interpretation or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this is preclinical bench testing and does not involve adjudication of expert opinions.
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 document is not about an AI device. It's about a physical medical device (a shunt system).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This document is not about an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is established by the predefined physical and engineering specifications and performance criteria for the shunt system, as outlined in relevant international standards (ISO 7197:2009) and internal manufacturer declarations. The tests directly measure physical properties and functionality.
8. The sample size for the training set:
- Not Applicable. This document describes preclinical testing, not the development or training of an AI model.
9. How the ground truth for the training set was established:
- Not Applicable. As above, this document is not about an AI model.
§ 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).