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The Cardiomedics, Inc., CardiAssist Counter Pulsation System - Series 4000 is intended to provide external Counterpulsation (ECP) for the treatment of ischemic heart disease by increasing perfusion during diastole in people with chronic angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure or myocardial infarction and may enhance coronary function.

The Cardiomedics CardiAssist External Counter Pulsation System - Series 4000 is a non-invasive circulatory assist device, which provides increased circulation via external counterpulsation (ECP) for the treatment of ischemic heart disease including congestive heart failure, chronic angina pectoris, acute myocardial infarction and cardiogenic shock. External counterpulsation therapy improves cardiac function by enhancing the perfusion of the coronary vasculature, the development of coronary collateral circulation, and by reducing the workload of the heart. The CardiAssist External Counter Pulsation System - Series 4000 consists of the portable console containing the computer and pumps with a touch screen for user interface, an integral patient chart printer, and leg cuffs and hoses. Additional components provided with the System include a finger plethysmograph and 5-lead ECG cable and leads (12 lead optional) and blood pressure cuff. This CardiAssist ECP System sequentially compresses the legs from the calves, thighs and buttocks, 40 milliseconds apart, by inflating three sets of flexible fabric cuffs during diastole. This results in movement of blood from the legs to the heart and entire upper body. Pressure, up to 310 mmHg, is applied with the timing and duration of each pulse, synchronized with the patient's ECG. When properly triggered, the pressure pulses applied to the vascular bed of the legs and buttocks transmit retrograde pressure through the entire vascular system. At the aorta, the aortic valve prevents retrograde flow into the left ventricle. Thus, a peak pulse of diastolic pressure occurs at or above systolic levels, which increases the driving pressure in the coronary vasculature.

The provided document is a 510(k) notification for the Cardiomedics CardiAssist Counter Pulsation System – Series 4000. This type of document is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device.

The document describes the device, its intended use, and its similarities to predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of the device. It is a regulatory submission for substantial equivalence.

Therefore, I cannot provide the requested information based on the given text.

The document does NOT contain:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
6. Information on a standalone (algorithm only) performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The CardioMedics, Inc., CardiAssist™ CounterPulsation System is intended to provide external counterpulsation (ECP) by increasing perfusion during diastole for the treatment of angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock and may enhance coronary function.

The CardioMedics CardiAssist™ ECP System is a non-invasive circulatory assist device which provides increased circulation via external counterpulsation (ECP) for the treatment of ischemic heart disease including congestive heart failure, angina pectoris, myocardial infarction and cardiogenic shock. External counterpulsation therapy improves cardiac function by enhancing the perfusion of the coronary vasculature, the development of coronary collateral circulation, and by reducing the workload of the heart. The CardiAssist ECP System consists of the portable console containing the computer and pumps with a touch screen for user interface, an integral strip chart recorder, and leg cuffs and hoses. Additional components provided with the System include a finger plethysmograph and 3-lead ECG cable and leads.

This CardiAssist™ ECP System sequentially compresses the legs from the calves, thighs and buttocks, 40 milliseconds apart, by inflating three sets of flexible fabric cuffs during diastole. This results in movement of blood from the legs to the heart and entire upper body. Pressure, up to 310 mmHg, is applied with the timing and duration of each pulse, synchronized with the patient's ECG. When properly triggered, the pressure pulses applied to the vascular bed of the legs and buttocks transmit retrograde pressure through the entire vascular system. At the aorta, the aortic valve prevents retrograde flow into the left ventricle. Thus, a peak pulse of diastolic pressure occurs at or above systolic levels which increases the driving pressure in the coronary vasculature.

The provided text is a 510(k) summary for the CardioMedics, Inc. CardiAssist Counterpulsation System Mark 3000. It focuses on demonstrating substantial equivalence to a predicate device for an expanded indication (treatment of non-chronic angina pectoris patients).

The submission does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:

• No acceptance criteria table or reported device performance is provided.
• No information about sample sizes (test or training set), data provenance, number or qualifications of experts, or adjudication methods is present.
• No mention of MRMC comparative effectiveness studies or standalone algorithm performance is made.
• The type of ground truth used is not specified.
• No details on how ground truth for a training set (if one existed, which is not stated) was established are given.

Instead, the submission primarily focuses on:

• Device Description: Explaining how the CardiAssist ECP System works (sequential compression of legs during diastole to enhance perfusion).
• Intended Use/Indications for Use: Listing the conditions the device is intended to treat (angina pectoris, congestive heart failure, myocardial infarction, cardiogenic shock).
• Comparison to Predicate Device: Stating that the new device is substantially equivalent in function and intended use to a previously cleared CardiAssist ECP System (K022107) and the Vasomedical EECP Therapy System Model TS3 (K020857). The key difference is an expanded indication to include non-chronic angina pectoris patients, with the claim that this does not change the safety or effectiveness.
• Regulatory Information: Including contact details, classification, and the FDA's clearance letter.

This type of 510(k) submission, especially for an expanded indication where technological and functional characteristics are identical to a predicate, often relies on demonstrating that the new indication does not introduce new questions of safety or effectiveness, rather than providing completely new performance study data if the core technology remains unchanged. The claim here is that the treatment of "all angina pectoris patients" (including non-chronic ones) "does not significantly change the safety or effectiveness of the device."

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The CardioMedics, Inc., CardiAssist CounterPulsation System is intended to provide external counterpulsation (ECP) for the treatment of ischemic heart disease by increasing perfusion during diastole in people with chronic angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure or myocardial infarction and may enhance coronary function.

The CardioMedics CardiAssist ECP System is a non-invasive circulatory assist device which provides increased circulation via external counterpulsation (ECP) for the treatment of ischemic heart disease including congestive heart failure, chronic angina pectoris, acute myocardial infarction and cardiogenic shock. External counterpulsation therapy improves cardiac function by enhancing the perfusion of the coronary vasculature, the development of coronary collateral circulation, and by reducing the workload of the heart.

The CardiAssist ECP System consists of the portable console containing the computer and pumps with a touch screen for user interface, an integral strip chart recorder, and leg cuffs and hoses. Additional components provided with the System include a finger plethysmograph and 3-lead ECG cable and leads.

This CardiAssist ECP System sequentially compresses the legs from the calves, thighs and buttocks, 40 milliseconds apart, by inflating three sets of flexible fabric cuffs during diastole. This results in movement of blood from the legs to the heart and entire upper body. Pressure, up to 310 mmHg, is applied with the timing and duration of each pulse, synchronized with the patient's ECG. When properly triggered, the pressure pulses applied to the vascular bed of the legs and buttocks transmit retrograde pressure through the entire vascular system. At the aorta, the aortic valve prevents retrograde flow into the left ventricle. Thus, a peak pulse of diastolic pressure occurs at or above systolic levels which increases the driving pressure in the coronary vasculature.

The difference between the new device and the predicate device is the indication. The indication is being expanded to include the treatment of congestive heart failure patients. The treatment of congestive heart failure patients with the CardiAssist ECP System does not require any changes in software, device design, or treatment regimen. The treatment of this patient population does not significantly change the safety or effectiveness of the device.

The provided text is a 510(k) summary for the CardioMedics CardiAssist Counterpulsation System Mark 3000. It focuses on demonstrating substantial equivalence to a predicate device and expanding the indication for use to include congestive heart failure.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing or clinical trials. The 510(k) process for this device relies on demonstrating substantial equivalence to a previously cleared device, not on new performance studies with acceptance criteria in the way you've described.

Therefore, I cannot populate the table or provide answers to most of your questions as the information is not present in the provided text.

Here's what I can extract regarding some of your questions, based on the nature of a 510(k) submission for substantial equivalence:

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

• Not Applicable. This document does not provide specific acceptance criteria or performance data for the device. The 510(k) summary focuses on demonstrating that the technological and functional characteristics of the new device are "identical" to a predicate device (K010261) and that the expanded indication for congestive heart failure "does not require any changes in software, device design, or treatment regimen" and "does not significantly change the safety or effectiveness of the device."

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

• Not Applicable. No new test set data is provided or discussed for the CardiAssist Counterpulsation System Mark 3000 in this 510(k) summary. The submission relies on the established safety and effectiveness of the predicate device.

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)

• Not Applicable. No ground truth establishment for a test set is mentioned.

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

• Not Applicable. No test set or adjudication method is mentioned.

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. This device is a medical device (a counterpulsation system), not an AI/imaging diagnostic device that would typically involve human readers or MRMC studies.

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

• Not Applicable. As above, this is not an AI/algorithm-based diagnostic device.

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

• Not Applicable. No new ground truth data is presented. The existing predicate device's safety and effectiveness (implicitly based on clinical understanding and possibly prior clinical data from its own clearance) serve as the foundation for equivalence.

8. The sample size for the training set

• Not Applicable. This document does not describe a training set as it's not a machine learning or AI device requiring such data.

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

• Not Applicable. As above.

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