Search Results

The Olympic Medical Lectromed Cerebral Function Monitor System is intended to be used by a variety of clinicians to acquire and utilize EEG signals, when used in conjunction with other clinical data, in intensive care areas, Operating Room, Emergency Room, and clinical research lab:

• to monitor the state of the brain .
• for determination of, and long-term monitoring of, the neurological status of patients that may have suffered an hypoxic-ischemic event.
• for monitoring of neurological status to assist in the clinical management and treatment of the patient by observing how the treatment affects the neurological status as shown by the CFM.
• to assist in the prediction of neurological outcome -
• to monitor and record frequency and intensity of seizures to assist in management of anti-convulsive therapy.
• to assist in the prediction of severity of Hypoxic-Ischemic Encephalopathy and long-term outcome in infants who have suffered an hypoxic-ischemic event.

The Olympic Medical Lectromed Cerebral Function Monitor System consists of three modules. A header amplifier module is used to connect the patient electrode leads to a plug-in module that produces three outputs that may be monitored or recorded on a 2-channel strip-chart recorder. The three outputs are cerebral function (activity), impedance, and raw EEG.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for the Olympic Medical Lectromed Cerebral Function Monitor System, focusing on:

• Device classification and name
• Company information
• Intended use
• Predicate devices
• Device description
• Safety and Standards (mentioning BS EN 60601-1-1 and BS EN 60601-1-2: 1993)
• FDA's substantial equivalence letter
• Indications for Use statement

There is no section detailing specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity, or technical benchmarks) or any study results demonstrating that the device meets such criteria. The document asserts compliance with general safety standards and substantial equivalence to predicate devices, but lacks the detailed performance study information you requested.

Ask a specific question about this device

The Olympic Medical Lectromed Cerebral Function Monitor System is intended to monitor the state of the brain by acquisition of EEG signals in the intensive care unit, operating room, and for clinical research.

The Olympic Medical Lectromed Cerebral Function Monitor System consists of three modules. A header amplifier module is used to connect the patient electrode leads to a plug-in module which produces three outputs which mav be monitored or recorded on a 2-channel strip-chart recorder. The three outputs are cerebral function (activity), impedance, and raw EEG.

The provided text is a 510(k) summary and an FDA clearance letter for the Olympic Medical Lectromed Cerebral Function Monitor System. It does not contain details about specific acceptance criteria or dedicated studies proving the device meets them, in the sense of a performance study with metrics like sensitivity or specificity.

Instead, the documentation focuses on:

• Classification and Intended Use: Defining what the device is and what it's for.
• Predicate Device Comparison: Establishing substantial equivalence to previously cleared devices (Aspect Medical Systems A-2000 EEG Monitor with BIS and SpaceLabs 90482 EEG BIS Module). The implication is that if the predicate devices meet safety and effectiveness, then a substantially equivalent new device also meets them.
• Device Description: What the device consists of.
• Safety and Standards: Listing general electrical safety and EMC standards (BS EN 60601-1-1 and BS EN 60601-1-2: 1993) that the device meets. These are general product safety standards, not performance criteria specific to EEG monitoring accuracy.

To answer your request, I will extract the information that is present and note when specific details (like clinical study results, expert qualifications, or sample sizes for performance evaluations) are not found in this document.

Acceptance Criteria and Device Performance Study Details

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide quantitative performance metrics such as sensitivity, specificity, accuracy, or any other objective measure against a clinical ground truth for the device's ability to 'monitor the state of the brain'. The "performance" is primarily established through its substantial equivalence to predicate devices and adherence to general safety standards.

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

The provided documentation does not describe a specific "test set" or a clinical study with a defined sample size for evaluating the device's performance against clinical outcomes or a ground truth.

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

Not applicable. The document does not mention a test set with expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. The document does not mention a test set or an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. The device is an EEG monitor, not an AI-assisted diagnostic tool for human readers. This document focuses on the device's ability to acquire EEG signals, not to interpret them with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable in the context of an algorithm's diagnostic performance. The device is a monitor that acquires and outputs EEG signals, not an algorithm that interprets them in a standalone capacity for diagnosis.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

No specific clinical ground truth (e.g., pathology, outcomes data, or expert consensus on EEG interpretation) is mentioned as being used to assess the performance of the Olympic Medical Lectromed Cerebral Function Monitor System within this document. The assessment relies on substantial equivalence to existing devices and compliance with safety standards.

8. The Sample Size for the Training Set

Not applicable. The document does not describe a training set for a machine learning model.

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

Not applicable. The document does not describe a training set or its ground truth establishment.

Summary of what the document implies about "proving" the device meets acceptance criteria:

The primary method of demonstrating that the Olympic Medical Lectromed Cerebral Function Monitor System meets its purpose and is safe is through its substantial equivalence to legally marketed predicate devices. This means that the FDA determined the device is as safe and effective as the predicate devices, which would have undergone their own review processes (though not detailed in this specific document). Compliance with general electrical safety and EMC standards (BS EN 60601-1-1 and BS EN 60601-1-2) is also cited as proof of basic safety. No specific clinical performance studies with quantitative metrics, ground truth, or expert review are described within this 510(k) summary.

Ask a specific question about this device