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Horizontal-Vertical Lumbar Valve Systems are implantable devices used in the treatment of patients with communicating hydrocephalus to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid region to the peritoneal cavity. They provide controlled intraventricular pressure and CSF drainage in patients with hydrocephalus. The antechamber can be electively mounted in line with the Valve Unit to allow for CSF sampling or injections in the subarachnoid space.

Percutaneous lumbar peritoneal shunting may be utilized in the treatment of communicating hydrocephalus. It is designed to shunt CSF from the lumbar subarachnoid space to the peritoneal cavity.

The shunt may be used for diagnosis, evaluation or treatment of normal pressure communicating hydrocephalus.

A percutaneous lumbar peritoneal shunt is also useful in the management of persistent cerebrospinal fluid fistulas, bulging cranial and suboccipital decompressions and in transient CSF absorption defects, e.g. post-meningitic or post-hemorrhagic hydrocephalus.

The In-Line Valve, available as a separate component of the system, is indicated for use where added resistance is desired to alleviate symptoms of low pressure in the small percentage of patients who, after normal drainage and in the normal course of treatment, develop such symptoms.

The Horizontal-Vertical Lumbar Valve and the Spetzler Lumbar-Peritoneal Shunt systems are implantable devices used in the treatment of patients with communicating hydrocephalus to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid region to the peritoneal cavity. Both are differential pressure valves designed to open when the difference between ventricular or lumbar pressure and outlet cavity pressure exceeds a certain threshold.

The Integra LifeSciences K101381 submission describes the Horizontal-Vertical Lumbar Valve Systems and Spetzler Lumbar Peritoneal Shunt Systems, which are implantable devices for shunting cerebrospinal fluid. The submission focuses on adding MRI safety information to the labeling, classifying the devices as "MR Conditional."

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Summary of Device Performance: The non-clinical testing, which included the tests listed above, demonstrated that the Horizontal-Vertical Lumbar Valve Systems and Spetzler Lumbar Peritoneal Shunt Systems are MR Conditional, as defined in the ASTM 2503-05 Standard. This classification signifies that the devices pose "no known hazards in specific MR environment with specified conditions."

2. Sample Size Used for the Test Set and the Data Provenance:

• Sample Size: The document does not specify the exact number of devices or components used for each of the non-clinical tests (Magnetically Induced Displacement Force, Torque, RF Heating, Image Artifact). It only refers to "All test samples" for visual inspection and "the device" for the other tests.
• Data Provenance: The testing was conducted by "Integra NeuroSciences" which indicates the tests were performed internally by the manufacturer. The data is from non-clinical bench testing, not from human subjects. The country of origin is not explicitly stated for the testing, but Integra LifeSciences is based in Plainsboro, NJ, USA. The data is prospective in the sense that the tests were performed specifically for this submission to support the MR Conditional claim.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This submission did not involve a test set requiring human expert ground truth. The "ground truth" for these tests are the objective physical measurements and adherence to ASTM standards regarding magnetic forces, heating, and image artifacts. These are quantifiable engineering and physics measurements.

4. Adjudication Method for the Test Set:

Not applicable, as this was non-clinical bench testing involving objective measurements against defined standards, not subjective assessments requiring expert consensus or adjudication. The results would be objectively measured and compared to the predefined acceptance criteria.

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 submission is for medical devices (shunt systems) and focuses on their physical properties and safety in an MR environment, not on an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reading improvement with AI is irrelevant here.

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

Not applicable. This is not an algorithm or AI-powered device.

7. The Type of Ground Truth Used:

The "ground truth" for this non-clinical testing comprises:

• Defined ASTM standards (ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119, ASTM 2503-05).
• Objective physical measurements of magnetic force, torque, temperature increase, and observation of image artifacts, performed according to these standards.
• The criterion for MR Conditional classification ("no known hazards in specific MR environment with specified conditions").

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set. The devices are physical medical implants.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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