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The primary use of ambulatory monitoring are listed below.

• 1 Evaluation of suspected of known cardiac rhythm disorders.
• 2 Evaluation of symptoms suggestive of an arrhythmia disorder.
• 3 Holter recordings are also used to screen patients who have clinical syndromes in which the presence of an arrhythmia may increase the risk of sudden death.
• 4 Patients who have suspected pacemaker malfunction may also require long term monitoring to document an intermittent episode of failure to capture or failures to sense.
• 5 Evaluation of chest pain.
• 6 Holter monitors are used in a serial fashion to judge the efficacy of antiarrhythmic drug treatment.
• 7 The Galix GBI-3SM Digital Holter Recorder is intended primarily as a 24 hour ECG Ambulatory Holter Recorder. However the unit has the ability to record Very High Resolution ECG, at a sampling rate of 1000 samples per second.

The ECG data stored is then analyzed with the Late Potential Software.

Warning: The clinical significance of Late Potential measures should be determined by a qualified physician.

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This document is a 510(k) summary for the Galix Biomedical Instruments Inc., 3 Channel Digital Ambulatory ECG Recorder, GBI-3SM. It does NOT contain the detailed information required to answer your specific questions regarding acceptance criteria and the study used to prove the device meets them. This document is primarily an Indication for Use statement and the FDA's letter of "substantial equivalence" determination, comparing it to legally marketed predicate devices.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
6. Information on standalone algorithm performance.
7. The type of ground truth used in studies (beyond stating "clinical significance of Late Potential measures should be determined by a qualified physician").
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore, based on the provided text, I cannot answer your questions.

To obtain this information, you would typically need to refer to the full 510(k) submission, specifically the sections detailing performance testing and clinical data, which are not included in this excerpt.

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The GALIX ECG Professional Station system is intended for 12 Channel ECG recording and monitoring (running the ECG-PS software module) and 12 channel cardiac stress testing (running the ERGO-PS software). It is indicated for use:

• with Male/Female Pediatric to Adult population
• in Hospital, Clinic and Physician´s office
• under prescription by a physician

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The provided document is an FDA 510(k) clearance letter for the "GALIX ECG Professional Station, Models ECG-PS and ERGO-PS". It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain specific acceptance criteria or an associated study report detailing device performance against such criteria.

The 510(k) clearance letter is a regulatory approval document, not a detailed technical study report. It states the indications for use and classification but typically doesn't include the raw data, methodology, or results of performance testing that would be submitted to the FDA during the review process.

Therefore, I cannot provide the requested information based solely on the text provided. The document itself does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
6. Results of a standalone algorithm performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

To obtain this information, one would typically need to review the full 510(k) submission summary or associated clinical/performance study reports, which are not part of this clearance letter.

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The GALIX WinTer ECG Holter Analysis system is intended for patients requiring 24hr ambulatory monitoring. It is indicated for use in:

• the replay, analysis, display, editing and report generation of ambulatory ECG data
• . the assessment of cardiac disturbance and myocardial ischemia

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The provided document is a 510(k) clearance letter from the FDA for the "GALIX WinTer ECG Holter Analyzer." It confirms substantial equivalence to a predicate device but does not contain information about acceptance criteria, device performance, or specific study details such as sample sizes, expert qualifications, or ground truth establishment.

The document states the intended use of the device: "the replay, analysis, display, editing and report generation of ambulatory ECG data" and "the assessment of cardiac disturbance and myocardial ischemia." However, it does not specify performance metrics or the studies conducted to demonstrate these.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide details on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the information given. This type of information is typically found in the 510(k) summary or the full 510(k) submission, which is not provided here.

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The GALIX PaceStar External Paccmaker may be used in any clinical situation in which the use of a temporary pacemaker on a patient provides therapentic or diagnostic value. Specifically, indications for teaporary paccusions include, but are not limited to, the following: - temporary treatment of arrhythmias and heart block . - pro-, intra- and postoperative temporary stimulation of patients undergoing cardiac surgery .

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I am sorry, but the provided text content does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the GALIX PaceStar External Pacemaker, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

It details the product name, regulation number, regulatory class, and indications for use. However, it does not include any performance data, acceptance criteria, study details (like sample size, data provenance, expert qualifications, adjudication methods, or ground truth establishment), or information about standalone or comparative effectiveness studies.

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The Galix GBI-3S-LP Digital Holter Recorder is intended primarily as a 24 hour ECG Ambulatory Holter Recorder. However the unit has the ability to record up to 10 minutes of Very High Resolution ECG, at a sampling rate of 1000 samples per second. The ECG data stored is then analyzed with the Late Potential Software, Warning: The clinical significance of Late Potential measures should be determined by a qualified physician.

GALIX GBI - 3S - LP Digital Holter Recorder

The provided document is a 510(k) clearance letter from the FDA to Galix Biomedical Instrumentation, Inc. for their GALIX GBI-3S-LP device. It primarily focuses on regulatory approval and does not contain detailed information about acceptance criteria, specific performance studies, sample sizes, or ground truth establishment for the device's analytical capabilities.

Therefore, I cannot provide the requested information as it is not present in the given text. The letter only states that the device is "substantially equivalent" to marketed predicate devices and outlines general regulatory compliance requirements. It does not include the detailed technical study information that would be necessary to answer the questions you've posed.

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Electrocardiographic recording to document a patient's arrhythmia has had widespread application as a non invasive tool in cardiology. A patient's arrhythmia may be with application as a lectrocardingram; however the use of techniques with longer monitoring periods, usually for 24 hours or more (Holter monitoring), increases the likelihood of documenting the arrhythmia. Since the original description by Dr Norman Holter in the 1950 s, Holter monitoring or continuous ambulatory electrocardiographic monitoring has been a useful technique for patients with cardiac arrhythmias.

Indications for Holter monitoring are listed in Table I. The primary use of ambulatory monitoring is for the evaluation of cases of suspected cardiac rhythm disturbances. Since these archythmias can be episodic, detection of complex ventricular arrhythmias will vary, depending of the duration of the recording.

A 24 - hour Holter recording permits the recording of cardiac rhythm during both sleep and awake states. Thus the variation of arrhythmias during waking hours and during physical and mental stress can be demonstrated.

TABLE I: Indications for Holter monitoring
1 - Evaluation of suspected or known cardiac rhythm disorders.
2 - Evaluation of symptoms suggestive of an arrhythmia disorder.
3 - Evaluation of clinical syndromes in which arrhythmias may increase the risk of sudden death.
4 - Evaluation of pacemaker function.
5 - Evaluation of chest pain.

Holter monitors are used in a serial fashion to judge the efficacy of antiarrhythmic drug treatment.

Holter monitors are frequently used as part of diagnostic studies to determine whether a new cardioactive drug has either antiarrhythmic or proarrhythmic effects. Because of spontaneous variability of a patient's arrhythmia these studies are often limited and should be viewed with caution.

Studies that have used longer monitoring periods may be more accurate.

Holter monitors may also be used for screening patients with symptoms suggestive of sinus node or AV node conduction problems.

Holter monitoring can be useful in correlating episodes of chest pain with diagnostic ST segment abnormalities.

Holter recordings are also used to screen patients who have clinical syndromes in which the presence of an arrhythmia may increase the risk of sudden death.

Such situations include the period after myocardial infarction." Congestive heart failure and dilated cardiomyopathy, hypertrophic obstructive cardiomyopathy, and the congenital prolonged QT syndrome.

Holter recordings may also be useful in screening for arrhythmias in patients with the mitral valve prolapse syndrome and in those recovering from coronary artery bypass surgery.

Holter monitoring can also be used to screen patients with symptomatic or asymptomatic Wolff - Parkinson - White syndrome.

Patients who have suspected pacemaker malfunction may also require longterm monitoring to document an intermittent episode of failure to capture or failure to sense. These abnormalities and oversensing problems may be easily documented during ambulatory monitoring.

3 CHANNEL DIGITAL AMBULATORY ECG RECORDER

This document is a 510(k) premarket notification decision letter from the FDA regarding the GBI-3S Ambulatory ECG Holter Recorder. It indicates that the device has been found substantially equivalent to predicate devices, allowing it to be marketed.

However, this document does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or any comparative effectiveness studies.

The document primarily covers:

• The FDA's decision to clear the device for marketing.
• The regulatory classification (Class II).
• General controls and applicable regulations.
• Indications for use of the device (Holter monitoring).

Therefore, based solely on the provided text, I cannot answer your specific questions regarding acceptance criteria and performance studies. The information you're asking for would typically be found in the 510(k) submission itself or a separate performance study report, neither of which are provided here.

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