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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.

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.

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The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

The components of the Miethke Shunt System can include the Paedi-GAV-Valve, a "ballin-cone" valve in line with a gravitational valve. The modified device, is a slightly larger version of the Paedi-GAV-Valve and has slightly higher opening pressures. This modified device will be known as the Gravity Assisted Valve (GAV) and will also be offered as a part of the Miethke Shunt System.

The provided text does not contain information about acceptance criteria or a study proving that the device meets such criteria.

Specifically:

• The section titled "PERFORMANCE DATA" explicitly states: "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system."
• The document primarily focuses on establishing "SUBSTANTIAL EQUIVALENCE" to a previously marketed device, rather than presenting new performance data against specific acceptance criteria. This implies that the regulatory pathway chosen did not require a new study with predefined acceptance criteria for the new device's performance.

Therefore, I cannot populate the requested tables and information as the necessary details are not present in the provided text.

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The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

The components of the Miethke Shunt System can include the NPH-DualSwitch® -Valve, a proximal diaphraqm valve. The modified NPH-DualSwitch® - Valve consists of two chambers and is offers a new low pressure setting (5 cmH2O) for patients in the lying position.

This document describes a 510(k) premarket notification for a medical device, specifically a cerebrospinal fluid (CSF) shunt system. For such a device, the focus is on demonstrating substantial equivalence to a predicate device, rather than meeting specific performance criteria demonstrated through clinical studies in the same way an AI/ML device would.

Therefore, many of the requested elements (like a table of acceptance criteria, sample sizes for test sets, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth for training data) are not applicable in this context. The review is based on direct comparison to an existing device and engineering testing, not algorithms or AI.

Here's an analysis based on the provided text, highlighting what can be extracted and what is not relevant for this type of submission:

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Submission)

The document explicitly states: "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system."

Instead of acceptance criteria based on performance metrics, the "acceptance" is based on demonstrating substantial equivalence to a legally marketed predicate device. The key claims for equivalence are:

• The Miethke Shunt System with NPH-DualSwitch® – Valve is substantially equivalent to Aesculap®, Inc.'s currently marketed Miethke Shunt System with DualSwitch® - Valve.
• The new low pressure setting (5 cmH2O) for patients in the lying position is also equivalent to the setting on the Codman Hakim Micro Precision Valve.

The document implies that the "design input for the new features" (the NPH-DualSwitch® - Valve and the new low pressure setting) were "verified by engineering testing," but no specific results or methods of this testing are provided in this summary.

Study Details (Not Applicable for AI/ML device, but can infer for Substantial Equivalence)

• Sample size used for the test set and the data provenance: Not applicable. There isn't a "test set" in the sense of a dataset for an AI/ML model. The evaluation is likely based on bench testing of device components and comparison of device specifications to predicates.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not a concept here.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is a shunt system, not an imaging interpretation or diagnostic AI device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device.
• The type of ground truth used: Not applicable in the context of AI/ML. For a physical device, "ground truth" would relate to measured physical properties and performance characteristics (e.g., flow rates, pressure settings, durability), which are assumed to be validated through engineering testing.
• The sample size for the training set: Not applicable. No AI/ML model involved.
• How the ground truth for the training set was established: Not applicable. No AI/ML model involved.

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The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

The ventricular catheter is a part of the Miethke Shunt System. It is used to gain access to the cavities of the brain for removal of excess CSF.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Miethke Shunt System. It describes the device, its intended use, and claims substantial equivalence to previously cleared devices. However, the document explicitly states, "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new Miethke Shunt System conforms to applicable ASTM and ISO standards."

This crucial statement indicates that

1. No specific acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy) were required or defined for this device in the context of this 510(k) submission. The regulatory pathway here is substantial equivalence, meaning the device is compared to existing legally marketed devices, not assessed against novel performance benchmarks derived from clinical studies.
2. No study proving the device meets performance-based acceptance criteria is presented. The "performance data" section only mentions conformity to ASTM and ISO standards, which are related to manufacturing, materials, and mechanical aspects, not clinical efficacy or diagnostic accuracy.

Therefore, many of the requested items cannot be answered from the provided text because they pertain to a type of performance study (e.g., comparative effectiveness, standalone algorithm performance, clinical validation with ground truth) that was not conducted or required for this 510(k) clearance based on substantial equivalence.

Here's an attempt to fill in as much as possible based on the given information, with explanations for what cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not applicable / Not provided. No specific test set for evaluating device performance against clinical outcomes or diagnostic accuracy was used or reported in this 510(k) summary. The clearance was based on substantial equivalence to existing devices and conformity to design/manufacturing standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable / Not provided. No test set requiring ground truth establishment by experts was part of this submission for performance evaluation.

4. Adjudication method for the test set

• Not applicable / Not provided. No test set requiring adjudication was part of this submission. The regulatory pathway focused on technical and design equivalence.

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 cerebrospinal fluid shunt system, not an AI-assisted diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant and was not conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is a hardware medical device (shunt system), not an algorithm or AI system. Therefore, standalone algorithm performance is irrelevant and was not assessed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. No clinical ground truth was established for a performance study in this 510(k) submission. The basis for clearance was a comparison of device characteristics and intended use to predicate devices, and conformity to relevant engineering standards.

8. The sample size for the training set

• Not applicable / Not provided. There is no mention of a training set as this is not an AI/ML device.

9. How the ground truth for the training set was established

• Not applicable / Not provided. Not relevant for this type of device.

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