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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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