Search Results

The LiDCOunity Monitor is intended for use under the direct supervision of a licensed healthcare or by personnel trained in its proper use for:

1. The measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients.

2. When connected to the BIS Module: monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

3. When connected to the LiDCO CNAP Module it may be used for the continuous, non-invasive monitoring of arterial blood pressure in adults and pediatric (>4yrs) patients by medical professionals. The LiDCO CNAP Module is intended for use with the LiDCOunity Monitor

4. The measurement of cardiac output via Lithium Indicator Dilution in adult patients (>40Kg/88lbs) with pre-inserted arterial and venous catheters, and for monitoring continuous blood pressure and cardiac output in patients with preexisting peripheral arterial line access

5. In addition to arterial blood pressure parameters and cardiac output, the LiDCOunty Monitor of derived parameters: Body Surface Area, Pulse Pressure Variation, Stroke Volume Variation, Cardiac Index, Stroke Volume, Stroke Volume Index, Systemic Vascular Resistance, Systemic Vascular Resistance Index, Oxygen Delivery/ Index

Location of Use: Suitable patients will be receiving treatment in the following areas: Medical and Surgical Intensive Care Units Operative Suites Step Down / High Dependency Units Trauma/Accident & Emergency Departments Coronary Intensive Care Units Cardiac Catheter Laboratories

Not Found

I am sorry, but the provided text from the FDA 510(k) K163334 document for the LiDCOunity v2 Hemodynamic Monitor does not contain any information regarding acceptance criteria or the study that proves the device meets acceptance criteria in the context of an AI/ML-based medical device.

The document is a clearance letter and the "Indications for Use" statement for a non-AI/ML medical device. It focuses on:

• Substantial Equivalence Determination: The FDA has determined the LiDCOunity v2 Monitor is substantially equivalent to legally marketed predicate devices.
• Regulatory Information: Details about its classification (Class II), product codes, and applicable regulations.
• Indications for Use: What the device is intended to measure (blood pressure, cardiac output, EEG signals with BIS Module, continuous non-invasive arterial blood pressure with CNAP Module, etc.) and where it is intended to be used.
• General Controls: Mentions general controls like annual registration, listing, good manufacturing practice, and labeling.

It does not describe:

• Acceptance criteria in a quantitative sense (e.g., specific metrics like accuracy, sensitivity, specificity, AUC).
• A "study" with a test set, training set, ground truth, experts, or statistical analysis.
• Any mention of AI, machine learning, or algorithms that would require such a study as per your request parameters.
• Any comparative effectiveness studies with or without human-in-the-loop for an AI component.

Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a document that details the validation study of an AI/ML medical device.

Ask a specific question about this device

The LiDCOunity Monitor is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for:

1. The measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients.
2. When connected to the BIS Module: monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
3. When connected to the LiDCO CNAP Module it may be used for the continuous, non-invasive monitoring of arterial blood pressure in adults and pediatric (>4yrs) patients by medical professionals. The LiDCO CNAP Module is intended for use with the LiDCOunity Monitor
4. The measurement of cardiac output via Lithium Indicator Dilution in adult patients (>40Kg/88lbs) with pre-inserted arterial and venous catheters, and for monitoring continuous blood pressure and cardiac output in patients with pre-existing peripheral arterial line access
5. In addition to arterial blood pressure parameters and cardiac output, the LiDCOunity Monitor calculates a number of derived parameters: Body Surface Area, Pulse Pressure Variation, Stroke Volume Variation, Cardiac Index, Stroke Volume, Stroke Volume Index, Systemic Vascular Resistance, Systemic Vascular Resistance Index, Oxygen Delivery/Index

Not Found

The provided text is a 510(k) premarket notification approval letter for the "LiDCOunity Monitor." It details the device's intended uses and regulatory classification but does not contain information about acceptance criteria or a study proving the device meets these criteria in the context of an AI/ML medical device.

The document describes a traditional medical device (monitor for physiological parameters) and its substantial equivalence to previously marketed predicate devices. It focuses on regulatory approval based on the device's functional capabilities, not on performance metrics of an AI/ML algorithm against a ground truth.

Therefore, I cannot extract the requested information using the provided text. The questions assume the context of an AI/ML device study, which is not what this document describes.

Ask a specific question about this device

The LiDCO CNAP Module is Indicated for the continuous, non-invasive monitoring of arterial blood pressure in adults and pediatric patients from the age of 4 years by medical professionals. The LiDCO CNAP Module is intended to be used with, and display on, the LiDCOrapid V2 Monitor. The LiDCO CNAP Module supports the following parameters: Continuous and oscillometric arterial blood pressure Arterial systolic pressure Arterial diastolic pressure Arterial mean pressure Heart rate Locations of Use: Suitable patients will be receiving treatment in the following areas: Medical and Surgical Intensive Care Units Operative Sultes Step Down / High Dependency Units Trauma / Accident & Emergency Departments Coronary Intensive Care Units Cardiac Catheter Laboratories

Not Found

The provided text is a 510(k) clearance letter from the FDA for the LiDCO CNAP Module. It outlines the device's indications for use and regulatory classification but does not contain information about acceptance criteria or a study proving its performance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone performance (algorithm only) study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This document is a regulatory approval, not a technical performance report. To find the information you're looking for, you would typically need to consult the full 510(k) submission, scientific publications, or the manufacturer's technical documentation.

Ask a specific question about this device

The LiDCOrapid V2 Monitor is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for:

1. The measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients.
2. When connected to the BIS Module: monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation

Locations of Use:
Suitable patients will be receiving treatment in the following areas:
Medical and Surgical Intensive Care Units
Operative Suites
Step Down / High Dependency Units
Trauma / Accident & Emergency Departments
Coronary Intensive Care Units
Cardiac Catheter Laboratories

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the LiDCOrapid V2 Monitor, which outlines its indications for use and regulatory classification. It does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Ask a specific question about this device

The LiDCOp/us Hemodynamic Monitor is intended for use as a diagnostic aid for the measurement of blood pressure, cardiac output and associated hemodynamic parameters in patients greater than 88lb (40kg) in weight.

SUITABLE PATIENTS:
Patients requiring cardiovascular monitoring who have pre-inserted and venous catheters and preexisting peripheral arterial line access.

LOCATIONS OF USE:
Suitable patients will be receiving treatment in the following areas:
Medical and Surgical Intensive Care Units
Operative Suites
Step Down / High Dependency Units
Trauma / Accident & Emergency Departments
Coronary Intensive Care Units
Cardiac Catheter Laboratories

The LiDCOplus Hemodynamic Monitor calculates a number of derived parameters: Body Surface Area, Systolic Pressure Vanation, Cardiac Index, Stroke Volume, Stroke Volume Index, Systemic Vascular Resistance, Systemic Vascular Resistance Index, Oxygen Delivery/Index.

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) clearance letter from the FDA for the LiDCOplus Hemodynamic Monitor, outlining its regulatory classification and indications for use. It primarily focuses on the substantial equivalence of the device to legally marketed predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement.

Ask a specific question about this device

Ask a specific question about this device

INTENDED USE: LIDCO SYSTEM for CARDIAC OUTPUT MONITORING
Indications for Use - Diagnostic aid (cardiac output determination). The LiDCO System is intended for the monitoring of cardiac output (blood flow in litres per minute) in patients of greater than 88 lbs (40 kg) in weight.

The LIDCo System revisits and improves the indicator dilution technique of cardiac output determination. It avoids the complications of pulmonary artery catheterisation. The LIDCo System will have clinical utility in patients with pre-placed arterial and venous lines, where the determination of cardiac output is required minimally invasively without the insertion of a pulmonary artery catheter.
The lithium cation sensor is biocompatible, thermally compensated and unaffected by changes in arterial blood pressure.
Despite the potential complication of secondary marker recirculation, the LIDCo System software has been demonstrated in a number of bench and clinical studies to calculate the area under the primary indicator dilution curve.
Flow cell moulded from polycarbonate.
Lithium ion selective electrode made from PVC membrane cast onto polyurethane.
Blood contact material PVC - blood not returned to patient.
Monitor CM-31/32: Power supply is by + 5VDC AC to DC Power Supply Unit. Recorder and digital outputs by optical circuits and transformer.
Blood Withdrawal Pump CM-33: Connection with sensor interface is optically isolated. Power supply is by battery operation (6v DC). Low battery warning. Fail safe against arterial blood pressure. "One way" only insertion of pump tubing.
Dimensions & Weight: 320 mm x 260 mm x 40 mm,

Here's an analysis of the acceptance criteria and study proving device performance for the LiDCo System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantified manner. Instead, it presents "clinical investigations" to demonstrate close correlation with existing standard methods. The implicit acceptance criteria appear to be a strong correlation coefficient, low bias, and acceptable precision when compared to established methods.

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

• Test Set (PAC Comparison): 51 patients
• Test Set (CCO Comparison): 11 patients
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "Clinical investigations" and "clinical studies," suggesting these were conducted in a clinical setting. Given the company is based in London, UK, it's likely the studies were conducted there. The timing implies these were conducted prior to the submission date of the 510(k) in June 1996, likely making them prospective studies designed to support the regulatory submission.

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

The document implicitly uses existing, established clinical methods (Pulmonary Artery Catheter and Continuous Cardiac Output monitoring) as the "ground truth." It does not mention a panel of human experts explicitly establishing ground truth for the test set.

4. Adjudication Method for the Test Set:

Not applicable. The ground truth was established by direct comparison with measurements obtained from established medical devices (Pulmonary Artery Catheter and Continuous Cardiac Output), rather than by expert consensus requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The LiDCo System is a medical device for measuring cardiac output, not an AI-assisted diagnostic tool that would typically involve human readers. Therefore, the concept of improving human reader performance with AI assistance is not relevant here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, the performance presented for the LiDCo System in comparison to predicate devices is a standalone performance. The LiDCo System itself calculates the cardiac output based on its indicator dilution technique and software, without continuous human intervention or interpretation that would typically define a "human-in-the-loop" scenario in AI/diagnostic device contexts. The human operator injects the indicator and initiates the measurement, but the calculation is performed by the device's software.

7. Type of Ground Truth Used:

The ground truth used was comparison with established medical device measurements. Specifically:

• Pulmonary Artery Catheter (a widely accepted invasive method for cardiac output measurement).
• Continuous Cardiac Output (another established method, likely derived from PAC or similar continuous monitoring).

8. Sample Size for the Training Set:

The document does not explicitly mention a "training set" in the context of machine learning or AI development. The "software" is mentioned as having been "demonstrated in a number of bench and clinical studies to calculate the area under the primary indicator dilution curve." This implies iterative development and testing, but not a distinct 'training set' as understood in current AI contexts. The clinical investigation data (51 and 11 patients) would be considered the validation data for regulatory submission.

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

Since there's no explicit "training set" described as in modern AI development, this question is not fully applicable. However, the "bench and clinical studies" that informed the software's development would have used similar methodologies to establish what a correct cardiac output measurement should be (e.g., using known flow rates in bench models or measurements from reference devices in clinical settings) to refine the software's calculation algorithms.

Ask a specific question about this device