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The 7271-500 module monitors ECG and Respiration, and the results are displayed on a Kolormon host system.

The ECG and respiration are measured from a 3 lead system providing an ECG waveform and heart rate from one of three selectable ECG vectors as well as a respiration waveform and respiration rate. Respiration is also measured from the active ECG electrode pair. There are two AC coupled sources of power to the front end to power the ECG and respiration circuits. Current is injected into the patient through the ECG electrodes to detect when a lead falls off the patient and through the respiration electrodes to determine the thoracic impedance across the chest to which the respiration cycle correlates. Measurement of the ECG waveform is by potential difference between two of three possible electrodes. The electrode pair is user selected.

The module may be used on either adults or neonates by selecting the adult/neonate option link in the module.

The Kolormon system is a generic patient monitor used in the operating theatre, critical care unit or as a bedside monitor on the ward. Its purpose is to measure and display clinical parameters of a patient via the module and module housing.

The basic system comprises a host monitor and its module housing. Modules, capable of measuring one or more clinical parameters of a patient to which they are connected, may be inserted into the module housing from which the clinical parameters for that module will be monitored. The generic nature of the system comes from the ability to select clinical parameters for monitoring by insertion of the appropriate modules.

The host has a colour screen which displays up to 6 waveforms, numeric values of the clinical parameters monitored (termed derived parameters), trends of clinical parameters, messages (information/cautions and warnings) and labels for keys used to select functions of the modules. There are a set of keys which control the basic functions of the monitor and a strip of six trikeys used to select module functions. Sets of key labels are presented at the bottom of the screen defined by the module whose keys have been selected for display and the previous key selections for that module.

The 7271-500 module monitors ECG and Respiration, and the results are displayed on a Kolormon host system.

The ECG and respiration are measured from a 3 lead system providing an ECG waveform and heart rate from one of three selectable ECG vectors as well as a respiration waveform and respiration rate. Respiration is also measured from the active ECG electrode pair. There are two AC coupled sources of power to the front end to power the ECG and respiration circuits. Current is injected into the patient through the ECG electrodes to detect when a lead falls off the patient and through the respiration electrodes to determine the thoracic impedance across the chest to which the respiration cycle correlates. Measurement of the ECG waveform is by potential difference between two of three possible electrodes. The electrode pair is user selected.

The module may be used on either adults or neonates by selecting the adult/neonate option link in the module.

The Kolormon system is a generic patient monitor used in the operating theatre, critical care unit or as a bedside monitor on the ward. Its purpose is to measure and display clinical parameters of a patient via the module and module housing.

The basic system comprises a host monitor and its module housing. Modules, capable of measuring one or more clinical parameters of a patient to which they are connected, may be inserted into the module housing from which the clinical parameters for that module will be monitored. The generic nature of the system comes from the ability to select clinical parameters for monitoring by insertion of the appropriate modules.

The host has a colour screen which displays up to 6 waveforms, numeric values of the clinical parameters monitored (termed derived parameters), trends of clinical parameters, messages (information/cautions and warnings) and labels for keys used to select functions of the modules. There are a set of keys which control the basic functions of the monitor and a strip of six trikeys used to select module functions. Sets of key labels are presented at the bottom of the screen defined by the module whose keys have been selected for display and the previous key selections for that module.

The provided document is a 510(k) clearance letter from the FDA for the Kontron Kolormon Plus ECG with Respiration Module 7271-500. This document primarily focuses on the regulatory approval process and does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in the way one might find in a clinical trial report.

However, based on the context of a 510(k) submission, the "acceptance criteria" are interpreted as the requirements for "substantial equivalence" to a predicate device, and the "study" is the information provided in the 510(k) notification itself (which is summarized here by the FDA's decision).

Here's an attempt to answer your questions based on the provided document:

1. A table of acceptance criteria and the reported device performance

Based on this 510(k) clearance, the primary "acceptance criterion" is proving substantial equivalence to a legally marketed predicate device. The document does not provide a table of performance specifications or test results. Instead, it states that the device is "substantially equivalent" for its stated indications for use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a clinical study with a specified sample size for a test set. 510(k) submissions typically rely on existing engineering tests, performance data, and comparison to a predicate device, rather than new extensive clinical trials, unless new clinical data is explicitly required to demonstrate substantial equivalence. The document does not provide details on data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This document does not refer to a test set requiring expert-established ground truth. The FDA's determination of substantial equivalence is based on its review of the submitted 510(k) documentation, including performance data and comparisons to existing devices, reviewed by FDA staff (e.g., Thomas J. Callahan, Ph.D., Director, Division of Cardiovascular, Respiratory, and Neurological Devices).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no external test set requiring expert adjudication is described in this document. The FDA's review process is its own form of "adjudication."

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. The Kontron Kolormon Plus ECG with Respiration Module 7271-500 is a patient monitoring device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be relevant.

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

This device is not an algorithm-only device. It's a hardware module that monitors physiological parameters and displays them to a human operator via a host system. Performance assessment would involve the module's accuracy and reliability in measuring ECG and respiration. The document does not detail specific standalone performance studies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Given the nature of the device (ECG and respiration monitor), "ground truth" for performance testing (which is not detailed here) would typically come from:

• Calibration standards: For verifying the accuracy of measurements (e.g., known electrical signals for ECG, known respiration simulators).
• Comparison to reference devices: Using another already validated and highly accurate medical device as a reference standard.
  The document itself does not specify the ground truth methodology used for any performance testing that would have been part of the 510(k) submission.

8. The sample size for the training set

Not applicable. This document pertains to a 510(k) clearance for a medical device that monitors physiological parameters, not an AI/machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

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

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