(154 days)
The Miethke Shunt System GAV 2.0 and SA 2.0 are used for cerebrospinal fluid (CSF) shunting.
The Aesculap Miethke Shunt System is used in the treatment of hydrocephalus. Components of the Miethke Shunt System can include the GAV (Gravity Assisted Valve) 2.0 valve and SA (SHUNTASSISTANT) 2.0 valve.
The GAV 2.0 is a posture dependent, fixed gravitational valve that combines a differential pressure unit and gravitational unit. This combination allows an automatic adjustment of the opening pressure according to the patient's different body position and is used to control overdrainage. The housing of the GAV 2.0 valve is manufactured from titanium. The GAV 2.0 valve is available in three models, each model is offered in six pressure level settings in various accessory configurations. The GAV 2.0 valve is available as a single device as well as with various Miethke shunt system accessories such as catheters, connectors, deflectors and reservoirs.
The SA 2.0 valve is a posture dependent gravitational valve and is used to control overdrainage. The SA 2.0 is designed for use in combination with an adjustable or non-adjustable differential pressure valve to add increased resistance to the shunt system as a patient changes position. housing of the SA 2.0 valve is manufactured from titanium. The SA 2.0 valve is available in three models, each model is offered in six pressure level settings in various accessory configurations. The SA 2.0 valve is available as a single device as well as with the proGAV 2.0 valve and various Miethke shunt system accessories such as catheters, connectors, deflectors and reservoirs.
This document is a 510(k) summary for the Miethke Shunt System GAV 2.0 and SA 2.0 Valves, which is a cerebrospinal fluid (CSF) shunting device. This type of device regulates the flow of CSF to treat hydrocephalus.
Based on the provided information, the device is a shunt system, not an AI/ML powered device. As such, concepts like "acceptance criteria for an AI/ML powered device," "sample sized used for the test set," "number of experts used to establish the ground truth," "adjudication method," "multi reader multi case (MRMC) comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established" are not applicable in this context.
The acceptance criteria and study that proves the device meets the acceptance criteria are related to the physical performance and safety of the shunt system.
Here's the information extracted from the document regarding the acceptance criteria and performance of the device:
1. A table of acceptance criteria and the reported device performance:
The document summarizes that "All samples met predefined acceptance criteria and the proposed devices passed design verification test activities." It does not provide a specific table of quantitative acceptance criteria values for each test, but rather lists the types of tests performed and attests to a "Pass" result for all of them.
| Test | Test Method Summary | Acceptance Criteria (Implicit: Predefined) | Reported Device Performance |
|---|---|---|---|
| Radiopacity | ISO 7197:2006, Clause 4.2 | (Predefined Acceptance Criteria Met) | Pass |
| Biocompatibility | ISO 7197:2006, Clause 4.3 | (Predefined Acceptance Criteria Met) | Pass |
| Control of the implanted shunt | ISO 7197:2006, Clause 4.5 | (Predefined Acceptance Criteria Met) | Pass |
| Pressure flow characteristics | ISO 7197:2006, Clause 4.6 | (Predefined Acceptance Criteria Met) | Pass |
| Identification of shunts in vivo | ISO 7197:2006, Clause 4.7 | (Predefined Acceptance Criteria Met) | Pass |
| Ability to withstand overpressure | ISO 7197:2006, Clause 4.8 | (Predefined Acceptance Criteria Met) | Pass |
| Dynamic breaking strength | ISO 7197:2006, Clause 4.9 | (Predefined Acceptance Criteria Met) | Pass |
| Behavior under MR imaging | ISO 7197:2006, Clause 4.10 | (Predefined Acceptance Criteria Met) | Pass |
| Bursting pressure | ISO 7197:2006, Clause 4.11 | (Predefined Acceptance Criteria Met) | Pass |
| Reflux performance | ISO 7197:2006, Clause 5.1.1 | (Predefined Acceptance Criteria Met) | Pass |
| Long term stability | ISO 7197:2006, Clause 5.1.2 | (Predefined Acceptance Criteria Met) | Pass |
| Influence of the changed posture of the patient on the valve performance | ISO 7197:2006, Clause 5.1.3 | (Predefined Acceptance Criteria Met) | Pass |
| MRI Safety Testing | |||
| Evaluation of MR Image Artifacts | ASTM F2119 | MR Conditional in 3-Tesla MRI systems | Pass |
| Measurement of Radio Frequency Induced Heating During Magnetic Resonance Imaging | ASTM F2182 | MR Conditional in 3-Tesla MRI systems | Pass |
| Qualitative Measurement of Magnetically Induced Torque in the Magnetic Resonance Environment | ASTM F2213 | MR Conditional in 3-Tesla MRI systems | Pass |
| Measurement of Magnetically Induced Displacement Force on the in the Magnetic Resonance Environment | ASTM F2052 | MR Conditional in 3-Tesla MRI systems | Pass |
2. Sample sized used for the test set and the data provenance:
The document states, "All samples met predefined acceptance criteria and the proposed devices passed design verification test activities." However, it does not specify the sample size used for these performance tests. The data provenance (e.g., country of origin, retrospective or prospective) is not stated, but given it's a device manufactured by Aesculap, Inc. in Center Valley, Pennsylvania, the testing was likely conducted in a controlled lab environment, not on patient data directly.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable for a physical device performance test. The "ground truth" for a medical device like a shunt is its compliance with established engineering standards and its physical performance characteristics, measured in controlled laboratory settings, not established by human experts in the way an AI algorithm's output might be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a term used in validating expert assessments for AI/ML models. For a physical device, the "adjudication" is typically adherence to predefined test protocols and measurement verification.
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 relevant to AI/ML software. This document is for a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm. Its performance is inherently "standalone" in mechanical terms, meaning it functions without human intervention once implanted, but its pre-market testing is bench testing.
7. The type of ground truth used:
The ground truth for the device's performance is established by physical measurements and adherence to international and national standards for medical device safety and performance, specifically ISO 7197:2006 and various ASTM F standards for MRI compatibility.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device that requires a training set.
§ 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).