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The Ivy Biomedical Model 7600EP/7800EP is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party diagnostic imaging systems that require ECG synchronization, such as nuclear medicine, computed axial (CAT), or positron emission (PET) tomography and other imaging systems requiring similar cardiac cycle specific timing. The Ivy Biomedical Model 7600EP/7800EP monitors can also be used to provide cardiac trigger pulse output used by a third-party ablation and lithotripsy systems.

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I understand you're asking for details about the acceptance criteria and study data for a medical device. However, the provided text is an FDA 510(k) clearance letter for the Ivy Biomedical Model 7600EP/7800EP Cardiac Synchronization Monitor.

This document explicitly states that the device is a "Cardiac Monitor (Including Cardiotachometer And Rate Alarm)" and is intended to "provide cardiac trigger pulse outputs used by third-party diagnostic imaging systems that require ECG synchronization."

This is not an AI/ML medical device, and the provided text does not contain any information about acceptance criteria, study data, ground truth establishment, or any of the other AI/ML-specific details you are asking for.

Therefore, I cannot extract the information requested for a study proving an AI/ML device meets acceptance criteria, as the document concerns a traditional medical device.

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The Ivy Biomedical Model 7600, 7800 is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party systems that require ECG synchronization is commonly used in diagnostic imaging modalities (i.e., nuclear medicine, computed axial (CAT), or positron emission (PET) tomography) or other applications requiring such synchronization.

The Model 7600/7800 is intended for use in neonatal, pediatric and adult patients undergoing diagnostic imaging and related procedures in inpatient and outpatient centers under the supervision of licensed healthcare professionals.

The product is not intended for use as a life support, home monitoring, or magnetic resonance imaging (MRI) modality.

The Ivy Biomedical Model 7600, 7800 is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party systems that require ECG synchronization.

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) clearance letter for the Ivy Biomedical Systems Cardiac Trigger Monitor, Models 7600 and 7800. It outlines the regulatory classification, indications for use, and general requirements for marketing the device.

Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided input.

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The Ivy Biomedical Model 7810 ("7810") is a basic cardiac monitor used to provide cardiac and respiratory trigger pulse outputs used by third-party systems that require ECG or respiratory synchronization. Cardiac and respiratory synchronization is commonly used in diagnostic imaging modalities (i.e., nuclear medicine, computed axial (CAT), or positron emission (PET) tomography) or other applications requiring such synchronization.

The 7810 is intended for use in pediatric and adult patients undergoing diagnostic imaging and related procedures in inpatient and outpatient centers under the supervision of licensed healthcare professionals.

The product is not intended for use as a life support, home monitoring, or magnetic resonance imaging (MRI) modality.

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I apologize, but the provided text from the FDA 510(k) summary for the Ivy Biomedical Systems, Inc. 7810 Cardiac and Respiratory Synchronization Monitor does not contain the specific details required to answer your full request regarding acceptance criteria and study design.

The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, intended use, and general controls, but it does not include a detailed scientific study, acceptance criteria, or performance metrics from such a study for the device itself.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not available. This type of study is typically for AI-assisted diagnostic tools, and the 7810 monitor is described as a basic cardiac monitor providing trigger pulse outputs for third-party systems.
6. If a standalone performance study was done: While the FDA clearance implies some testing was done to demonstrate substantial equivalence, the details of such a standalone performance study (including specific metrics and acceptance criteria) are not in this document.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable.

What the document does tell us:

• Device Name: 7810 Cardiac and Respiratory Synchronization Monitor
• Intended Use: "The Ivy Biomedical Model 7810 ("7810") is a basic cardiac monitor used to provide cardiac and respiratory trigger pulse outputs used by third-party systems that require ECG or respiratory synchronization. Cardiac and respiratory synchronization is commonly used in diagnostic imaging modalities (i.e., nuclear medicine, computed axial (CAT), or positron emission (PET) tomography) or other applications requiring such synchronization."
• Patient Population: Pediatric and adult patients undergoing diagnostic imaging and related procedures. The "Patient Population" section further states it's for "adult, geriatric, pediatric and neonatal patients."
• Contraindications: Not for life support, home monitoring, or MRI environment. Also, not for performing cardiac diagnostics.

To obtain the detailed performance data, acceptance criteria, and study information you're looking for, you would typically need to consult the complete 510(k) submission, the device's user manual, or scientific publications from the manufacturer (if any R&D studies were published). The provided document is merely the FDA's clearance letter.

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The Ivy Biomedical Model 7600 Cardiac Trigger Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization. The Model 7600 is limited to use by trained and qualified medical professionals. This product is not intended for home care monitoring.

The Ivy Biomedical Model 7600 Cardiac Trigger Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization.

Based on the provided text, the document is a 510(k) clearance letter for the Ivy Biomedical Model 7600 Cardiac Trigger Monitor. It confirms the device's substantial equivalence to a predicate device but does not contain information regarding detailed acceptance criteria, performance studies, or technical specifications of the device's performance.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. The document focuses on regulatory clearance, not the technical validation of the device's performance against specific metrics.

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