Search Results

Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:

1. Reduce ICP, e.g., pre-, intra- or postoperative.
2. Monitor CSF chemistry, cytology, and physiology.
3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
   Monitoring of ICP is indicated in selected patients with:
4. Severe head injury.
5. Subarachnoid hemorrhage graded III, IV or V preoperatively.
6. Reyes syndrome or similar encephalopathies.
7. Hydrocephalus.
8. Intracranial hemorrhage.
9. Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
   Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.

The Exacta External Drainage and Monitoring System (EDMS) is provided as a complete closed system for the drainage and monitoring of cerebrospinal fluid (CSF) flow from the lateral ventricles or the lumbar subarachnoid space. The system is offered in various kit configurations for various clinical applications.
The Exacta EDMS product family is comprised of a single use drainage system, a reusable blue pole clamp and a laser level accessory. The single use drainage assembly is comprised of a patient line, main system stopcock, graduated cylinder and drainage bag. The single use drainage assembly is mounted on the reusable blue pole clamp. The reusable blue pole clamp secures the system to an I.V. pole and includes the system pressure scale and holds an optional laser level accessory. The optional laser level accessory assists the user in leveling the single use drainage system to the patient's Foramen of Monro or lumbar catheter exit site.

This document is a 510(k) summary for the Medtronic Exacta External Drainage and Monitoring System (EDMS). The submission focuses on changes to a laser level accessory and does not involve AI. Therefore, several requested sections, especially those related to AI model evaluation, are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are qualitative (e.g., "met the acceptance criteria") rather than quantitative thresholds.

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

The document does not specify the sample size for the test set used in the bench testing. It only states that the testing was performed, but not how many units were tested.

• Data Provenance: The tests were "design verification bench testing," implying they were conducted in a lab setting by the manufacturer, Medtronic, Inc., located in Irvine, California, USA. The data is retrospective in the sense that it was collected as part of the device development and submission process.

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

Not applicable. The testing described is bench testing of physical device characteristics (mechanical, laser performance, electrical safety) against established engineering and safety standards, not against clinical ground truth requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. This was bench testing against engineering specifications, not a clinical study requiring expert adjudication of results.

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 an External Drainage and Monitoring System and its laser level accessory. It is a physical medical device, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the bench testing was defined by engineering specifications and international standards for mechanical strength, beam uniformity, laser accuracy, laser safety (IEC/EN 60825-1:2014), electrical safety (IEC 60601-1:2005 + AMD1:2012), and EMC (IEC 60601-1-2:2014 / EN 60601-1-2:2015).

8. The Sample Size for the Training Set

Not applicable. This device does not use a training set as it is not an AI/machine learning product.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Ask a specific question about this device