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Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder, Model 1304, is a Non-Invasive device intended to acquire ambulatory 12 - Channel ECG signals from the upper body surfaces. Cardiac Rhythm is acquired via ECG signals.

Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter Recorder, Model 1303, is also a Non-Invasive device intended to acquire ambulatory 3 - Channel ECG signals from the upper body surfaces. Cardiac rhythm is also acquired via ECG signals.

The Holter Recorders are intended for adults and children who are over the age of six years.

The Models 1304 and 1303 work with the CB Series ECG Analysis Software which has been previously cleared under (K083820)

"The Intended Use of the modified devices as described in its labeling, has not changed as a result of the modifications".
The system is only for measurement, recording and display. It makes no diagnosis.

Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder and Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter Recorders are intended to be used as a Holter Ambulatory Electrocardiograph device for the purpose of screening ECG rhythms for periods up to 72 hours. Cardiac rhythm is acquired by 12 Channel or 3 Channel ECG signals.

The Recorders are portable, microprocessor based devices that are worn by a patient with the use of a supplied Carrying Case and Strap.

This 510(k) summary does not contain information typically found in a study or a clear set of acceptance criteria for the device performance beyond its substantial equivalence to a predicate device. The document primarily focuses on describing the device, its intended use, and comparing its technological characteristics to a previously cleared predicate device to establish substantial equivalence.

Based on the provided text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not provide a table of specific, quantifiable acceptance criteria (e.g., accuracy, sensitivity, specificity for cardiac event detection) or detailed reported device performance against such criteria. The core argument for clearance is "substantial equivalence" to a predicate device (Vasomedical-Biox, 3-Channel Ambulatory ECG Holter Recorder, Model 1305, K083820). The document states:

"Technological and functional characteristics of the devices listed in this Special 510(k) Notification for Modification are essentially the same as those of the Predicate device. The devices listed in this 510(k) Premarket Notification is therefore substantially equivalent to the predicate device."

The only "performance" reported are the device specifications in Table 1, which are hardware characteristics rather than clinical performance metrics.

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

The 510(k) summary does not mention any specific test set, clinical study, or patient data (retrospective or prospective) used to demonstrate performance for the devices (Model 1304 and 1303). The clearance is based on technological and functional equivalence to the predicate device (Model 1305).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since no specific test set or clinical study is mentioned for performance evaluation in this document, there is no information regarding experts used to establish ground truth.

4. Adjudication Method

No adjudication method is mentioned as no performance study is detailed in this document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or implied in this 510(k) summary. The devices (Holter recorders) are for data acquisition, recording, and display, and do not involve an AI component requiring human-in-the-loop performance evaluation in this context.

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

This refers to an ECG Holter recorder, which is a physical device for signal acquisition and recording. It is not an AI algorithm. Therefore, the concept of a "standalone" algorithm performance study without a human-in-the-loop does not directly apply in the way it would for diagnostic AI software. The performance of the recording hardware is typically assessed through technical specifications and verification/validation, rather than a standalone algorithm performance study in the AI sense. The document does not detail any such performance validation study.

7. The Type of Ground Truth Used

As no specific performance study is detailed, no type of ground truth (expert consensus, pathology, outcomes data, etc.) is mentioned. The clearance relies on substantial equivalence of the device's design and specifications, rather than a clinical performance study with established ground truth.

8. The Sample Size for the Training Set

The concept of a "training set" applies to machine learning or AI models. The devices described are hardware Holter recorders. Therefore, there is no training set applicable in this context.

9. How the Ground Truth for the Training Set was Established

Again, as these are hardware devices and not AI, there is no training set and thus no ground truth establishment for a training set.

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Vasomedical-Biox Model 2302 Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder is a Non-Invasive device intended to acquire Ambulatory 12 Channel ECG signals and non- invasive oscillometric Blood Pressure signals from the upper body surfaces. Cardiac rhythm is acquired via ECG signals.

Vasomedical-Biox Model 1804 Ambulatory BP Recorder is a non- invasive device intended to acquire ambulatory non-invasive oscillometric Blood Pressure signals from the upper body surfaces.

The Recorders are intended for adults and children who are over the age of six years.

The Models 2302 and 1804 work with the CB Series ECG and ABP Analysis Software which has been previously cleared under (k)092785

“The Intended Use of the modified devices as described in its labeling, has not changed as a result of the modifications”.

The system is only for measurement, recording and display. It makes no diagnosis.

Vasomedical-Biox Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder Model 2302 is intended to be used as a combined Holter Ambulatory Electrocardiograph device and a non-invasive Ambulatory Blood Pressure Monitor for the purpose of screening ECG rhythms and blood pressure measurements for periods to 24 hours. Blood Pressure measurements are obtained using oscillometric signals at intervals set by the physician or on demand. Cardiac rhythm is acquired by 12 Channel ECG signals. The Recorders are intended for adults and children over the age of six years old.

The Model 2302 Recorder is a modified version of Model 2301 which FDA granted clearance on April 2, 2010 (K092785), with 3-Channel ECG replaced by 12-Channel ECG.

Vasomedical-Biox Ambulatory Blood Pressure Recorder Model 1804 is intended to be used as a non-invasive ABP Monitor for the purpose of recording blood pressure measurements also for a period of 24 hours. The Recorders are intended for adults and children over the age of six years old.

The Model 1804 Ambulatory Blood Pressure Recorder is a modified version of Model 2301. Model 2301 records both ECG and BP signals and Model 1804 is a Blood Pressure only Recorder.

The Recorders are portable, microprocessor based devices that are worn by a patient with the use of a supplied Carrying Case and Strap.

The provided text is a 510(k) summary for the Vasomedical-Biox Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder Model 2302 and Ambulatory Blood Pressure Monitor (ABPM) Model 1804.

Based on the information provided, this submission primarily focuses on technical modifications (specifically increasing ECG channels from 3 to 12) and establishing substantial equivalence to a previously cleared predicate device (Vasomedical - Biox, 3 Channel Ambulatory ECG and Blood Pressure Recorder 2301, K092785).

The document does NOT contain a study or acceptance criteria in the typical sense of a clinical performance evaluation against specific metrics like sensitivity, specificity, or accuracy for diagnostic capability. This is because the device, as stated, "makes no diagnosis" and its intended use is for "measurement, recording and display" of ECG and blood pressure signals.

Therefore, the requested information elements cannot be fully populated as they pertain to clinical performance studies, which are not detailed in this 510(k) summary for this device. The summary emphasizes technological equivalence rather than new clinical performance data.

However, I can extract the relevant information that is present and indicate where information is not available based on the provided text.

Acceptance Criteria and Device Performance Study

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

The document does not explicitly state acceptance criteria in the form of performance metrics (e.g., accuracy, sensitivity, specificity) for diagnostic capabilities, nor does it report specific clinical performance results against such criteria. The focus is on demonstrating that the modified devices (Model 2302 and 1804) are substantially equivalent to the predicate device (Model 2301) in their technological and functional characteristics, and that "The Intended Use of the modified devices as described in its labeling, has not changed as a result of the modifications."

The "performance" documented here is primarily related to the device's technical specifications and intended function as a recorder, rather than a diagnostic tool.

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

This information is not provided in the 510(k) summary. The document does not describe a specific "test set" for performance evaluation in a clinical study. Substantial equivalence is asserted based on technological and functional characteristics, not new clinical data.

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 information is not provided in the 510(k) summary. No ground truth establishment by experts is described as part of this submission, as it focuses on technological equivalence rather than clinical diagnostic performance.

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

This information is not provided in the 510(k) summary. No adjudication method is described.

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

This information is not applicable / not provided. The device is an ECG and Blood Pressure recorder, not an AI-assisted diagnostic tool.

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

This information is not applicable / not provided. The device is a hardware recorder. While it works with "CB Series ECG and ABP Analysis Software," the submission explicitly states the system "makes no diagnosis" and the software was previously cleared (K092785). The current submission does not describe a standalone algorithm performance study for diagnostic purposes beyond the recording functionality.

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

This information is not provided. As no clinical performance study against a diagnostic ground truth is described, no ground truth type is mentioned. The ground truth for technical specifications would be engineering measurements and standards.

8. The sample size for the training set

This information is not applicable / not provided. The device is a recorder, not a machine learning algorithm that requires a training set in the typical sense.

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

This information is not applicable / not provided. (See #8)

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Vasomedical-Biox Combined Ambulatory ECG and Blood Pressure Recorder is a Non-Invasive oscillometric device intended to acquire Ambulatory 3 Channel ECG signals and non- invasive Blood Pressure signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG signals. The Recorders are intended for adults and children Who are over the age of six years.

Vasomedical-Biox Ambulatory ECG CB Series Analysis System Software allows transfer of ECG and Blood Pressure data from the Recorder to a Windows based PC-based computer program via a removable and large capacity storage card (SD) for the purpose of creating reports and printouts. The Software does not perform diagnostics. Physicians carry out diagnostic evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis.

Vasomedical's Ambulatory ECG and Blood Pressure Recorder is intended to be used as a combined Holter Ambulatory Electrocardiograph device and a non-invasive Ambulatory Blood Pressure Monitor for the purpose of screening ECG rhythms and blood pressure measurements for periods up to 24 hours. Blood Pressure measurements are obtained using oscillometric signals at intervals set by the physician or on demand. Cardiac rhythm is acquired by 3 channel ECG signals. The Recorders are intended for adults and children over the age of six years old.

The CB series AECG/BP Analysis system is a PC based diagnostic application running on a Microsoft Windows operating system. It is designed in conjunction with the CB series Holter Recorder and analyzes prerecorded patient's ECG and/or ABP data that has been stored by CB series Recorder, or other compatible Holter Recorders. The system provides multi-channel full disclosure for arrhythmia and ST events and synchronous three channel ECG and ABP pulses, and creates summary tables, statistics, trends, and final report regarding a variety of cardiac data indices. The cardiac data provided by the system is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.

The Recorders are portable, microprocessor based devices that are worn by a patient with the use of a carrying case and strap.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) Summary for the Vasomedical-Biox Combined Ambulatory ECG and Blood Pressure Recorder 2301 and its associated Analysis Software.

The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, not necessarily to prove it meets specific performance acceptance criteria through independent studies.

Here's what the document does state, and why it doesn't align with your request:

• Device Description and Intended Use: It describes the device's function (combined Holter ECG and non-invasive ambulatory blood pressure monitor for screening and measurement) and its intended users (adults and children over six years old).
• Predicate Devices: It lists two predicate devices: the SunTech Medical Instruments Inc., Automatic Blood Pressure Measurement System, Oscar 2, and the Vasomedical-Biox 1305, 3 Channel ECG Holter Monitor and CB Series Analysis Software. The document explicitly states: "Technological and functional characteristics of the device listed in this 510(k) Premarket Notification is essentially the same as those of the predicate devices. The device listed in this 510(k) Premarket Notification is therefore substantially equivalent to the predicate devices."
• No Performance Data: There is no mention of a study conducted to establish performance metrics, acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or adjudication methods for this specific device. The filing focuses on substantial equivalence to existing devices.
• Software Function: The software's role is described as transferring and analyzing pre-recorded data, providing multi-channel disclosure for events, summary tables, statistics, and trends. Crucially, it states: "The Software does not perform diagnostics. Physicians carry out diagnostic evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis." This indicates the software does not have an AI component for diagnosis that would typically require a study with performance acceptance criteria as you've outlined.

Therefore, I cannot provide the requested table and study details because the provided text does not contain this information. The 510(k) process for this device appears to rely on demonstrating substantial equivalence to predicate devices rather than presenting novel performance study data against specific acceptance criteria.

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The Ambulatory ECG Recorder described in this 510(k) Premarket Notification is a non-invasive device intended to acquire, record and store ambulatory three (3) channel ECG signals from the upper body surface of adults and children over the age of six years old for a minimum of 24 hours. It works in concert with the CB Series Analysis Software to playback, review, analyze, edit and print ECG data. The software does not perform diagnostics. These data are used by physicians for diagnostic evaluations.

Vasomedical's Ambulatory ECG Recorder Model 1305 is intended to be used as a Holter ambulatory electrocardiograph monitor for the purpose of screening ECG rhythms for periods up to 72 hours. Cardiac rhythm is acquired by 3 channel ECG signals. The recorders are intended for adults and children over the age of six years old. The recorders are portable, microprocessor based devices that are worn by a patient with the use of a carrying case and strap. Vasomedical's Ambulatory ECG CB Series Analysis System Software allows transfer of data from the recorder to a Windows based PC via a removable storage card for the purpose of creating printouts and reports. These data are used by physicians for diagnostic evaluations.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vasomedical Ambulatory ECG Recorder and Analysis Software:

Acceptance Criteria and Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria. Therefore, a direct table of acceptance criteria and reported device performance, in the way one might expect for a de novo device or a more rigorous performance study, is not explicitly provided.

However, the document does list the technical specifications and features of the device, which implicitly serve as performance characteristics that are intended to meet the standards of the predicate device.

Implicit "Acceptance Criteria" (Technical Specifications) and Reported Device Characteristics:

The study presented here is a substantial equivalence determination rather than a performance study with defined acceptance criteria and statistical analysis of device performance. The evidence for meeting criteria is primarily asserted through the direct comparison of technological and functional characteristics to known predicate devices that are already cleared.

Study Information:

Based on the provided K083820 510(k) summary, the following information is either not explicitly stated or not applicable because the submission method relies on substantial equivalence rather than independent performance evaluation against predefined criteria.

1. Sample size used for the test set and the data provenance: Not explicitly stated. The submission relies on demonstrating similarity to predicate devices. It doesn't describe a new test set with specific data provenance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. There is no information about an independent ground truth establishment process for the device's performance data.

3. Adjudication method for the test set: Not applicable, as there's no described independent test set or adjudication process for this 510(k) submission.

4. 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 document does not describe an AI-driven device or a MRMC study. The software functions as an analysis system for human review, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an "algorithm only" performance. The device is explicitly designed to work "in concert with the CB Series Analysis Software to playback, review, analyze, edit and print ECG data. These data are used by physicians for diagnostic evaluations." The software itself "does not perform diagnostics," indicating it's a tool for human interpretation rather than a standalone diagnostic algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated or outlined within this 510(k) summary. The submission focuses on substantial equivalence based on technical specifications and intended use matching predicate devices.

7. The sample size for the training set: Not applicable. This submission doesn't describe a machine-learning algorithm that would require a "training set."

8. How the ground truth for the training set was established: Not applicable, as there is no training set described.

Summary of this 510(k) Submission Approach:

The provided document is a 510(k) summary for a Class II medical device (Medical Magnetic Tape Recorder and Computer, Diagnostic, Programmable). The primary method for demonstrating safety and effectiveness relied on proving substantial equivalence to existing predicate devices (Huntleight Healthcare Cardiology Products Division Recorder Models MedilogAR4 and MedilogAR12; and Medilog Darwin software).

This means the submission's "study" wasn't a de novo clinical trial or performance study against specific acceptance criteria, but rather an engineering and functional comparison to prove that the new device's technical specifications and features are "essentially the same as those of the predicate devices" and "therefore substantially equivalent." There is no detailed information provided on the specific performance validation data (e.g., accuracy, sensitivity, specificity) against a ground truth dataset, which would typically be included in a de novo submission or a more complex device requiring specific performance metrics beyond equivalence.

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Vasomedical, Inc.'s Enhanced External Counterpulsation (EECP ) Therapy Systems are non-invasive external counterpulsation devices intended for use in the treatment of patients with stable or unstable angina, congestive heart failure, acute myocardial infarction, or cardiogenic shock

Vasomedical's EECP Therapy System Model TS3, Model TS3 with Pulse Oximetry and Model MC-2 have been previously described to FDA. The EECP® Therapy System Model TS4 with/without Pulse Oximetery is comprised of three major components, a Control Console, a Treatment Table, and a patient Cuff Set.

The Control Console accommodates the air compressor and reservoir, a signal module panel, a power module, a microprocessor with touch screen/keyboard interface, data storage drives and printer, and components for acquiring and processing ECG, finger plethysmograph and oxygen saturation signals. The signals are obtained non-invasively. The microprocessor is used to operate and monitor the system by means of proprietary custom software, with the operator using the touch screen/keyboard interface to control its operation. The screen displays information pertinent to operating the system, as well as treatment parameters and patient waveforms during use. Treatment pressure is selected by the operator and then monitored and maintained automatically. The touch screen employs "hardware-less keys" which the operator touches to select a function or execute a command and the keyboard enables alphanumeric text entries. An internal hard disk drive is used to store data on the system a printer is used to produce hard copy of site and patient identification and physiologic data.

The Treatment Table is a padded table assembly and is set at a height convenient for both patient and operator use. The valve assembly consists of three pairs of inflation/deflation valves that open and close on command to inflate or deflate the patient Cuff Set with air. The valve assembly is connected to the air compressor and reservoir components in the Control Console via connecting air hoses.

The electrocardiogram of the patient is detected to initiate triggering of the inflation/deflation valves at appropriate times during the cardiac cycle. External pressure is applied via a patient Cuff Set to the lower extremities of the patient in synchronization with the resting, diastolic phase of the heart cycle, i.e. the cuffs compress vascular beds in the calves, lower thighs and upper thighs/buttocks on inflation. This pressure is applied sequentially from the calves, to the lower thighs, to the upper thighs and buttocks, forcing blood back to the heart, increasing coronary arterial perfusion pressure and coronary arterial blood flow (diastolic augmentation), as well as venous return to the right side of the heart. Immediately before the heart begins to eject blood during the next systolic phase, the cuffs are rapidly deflated and all externally applied pressure is eliminated. The vasculature in the lower extremities reconforms and is able to receive the output of the heart with lessened resistance, thereby reducing systolic pressure and the workload of the heart (decreased afterload).

The provided text is a 510(k) summary for the Vasomedical EECP® Therapy System. It describes the device, its intended use, and states its substantial equivalence to a predicate device. However, this document does not contain information on acceptance criteria, a study proving the device meets those criteria, or any of the detailed performance metrics and study design elements requested in your prompt.

The document is a regulatory submission focused on establishing substantial equivalence, primarily by comparing technological characteristics and intended use to a previously cleared device. It does not include performance data or clinical study results in the manner you are asking for.

Therefore, I cannot fulfill your request for the table of acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, or ground truth information because that data is not present in the provided text.

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Vasomedical, Inc.'s EECP® Therapy System Model TS3 with Pulse Oximetry is a non-invasive external counterpulsation device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction, or cardiogenic shock.

The EECP® Therapy System Model TS3 with Pulse Oximetry is comprised of three major components, a Control Console, a Treatment Table, and a patient Cuff Set. The Control Console accommodates the air compressor and reservoir, a signal module panel, a power module, a microprocessor with touch screen/keyboard interface, data storage drives and printer, and components for acquiring and processing ECG, finger plethysmograph and oxygen saturation signals. The microprocessor is used to operate and monitor the system by means of proprietary custom software, with the operator using the touch screen/keyboard interface to control its operation. The screen displays information pertinent to operating the system, as well as treatment parameters and patient waveforms during use. Treatment pressure is monitored with an internal pressure sensor and the operator-selected set-point maintained by a closed-loop control system. The touch screen employs "hardware-less keys" which the operator touches to select a function or execute a command and the keyboard enables alphanumeric text entries. An internal hard disk drive is used to store data on the system, an internal floppy disk drive is used to record data onto transferable media, and a printer is used to produce hard copy of site and patient identifiers and physiologic data. The Treatment Table accommodates a motorized lifting mechanism, mattress and the pneumatic circuit valve assembly. The motorized lifting mechanism is used to move the mattress up and down, providing a convenient height for patient and operator use. The valve assembly consists of three pairs of inflation/deflation valves that open and close on command to inflate or deflate the patient Cuff Set with air. The valve assembly is connected to the air compressor and reservoir components in the Control Console via connecting air hoses. External pressure is applied via the patient Cuff Set to the lower extremities of the patient in synchronization with the heart, i.e. the cuffs compress vascular beds in the calves, lower thighs and upper thighs/buttocks on inflation. When the heart is in its relaxed state during the diastolic period, pressure is applied sequentially from the calves, to the lower thighs, to the upper thighs and buttocks, forcing blood back to the heart, increasing coronary perfusion pressure and coronary blood flow (diastolic augmentation), as well as venous return. Immediately before the heart begins to eject blood during the next systolic phase, the cuffs are rapidly deflated and all externally applied pressure is eliminated. The vasculature in the lower extremities reconforms and is able to receive the output of the heart with lessened resistance, thereby reducing systolic pressure and the workload of the heart (decreased afterload). Stretchable treatment pants comprised of cotton and Lycra (Spandex) are worn by the patient under the Patient Cuff Set to allow for greater comfort during treatment. The Model TS3 with Pulse Oximetry incorporates a noninvasive sensor and electronic module to acquire and process the patient's oxygen saturation. These same components functions can be used separately or simultaneously.

The provided text describes the Vasomedical EECP® Therapy System Model TS3 with Pulse Oximetry and mentions non-clinical and clinical tests. However, it does not explicitly state acceptance criteria or provide specific quantitative results of a study to demonstrate the device meets those criteria.

Instead, the documentation details:

• Non-clinical tests: Software verification and validation, including functional requirements, boundary values/stress testing, and safety requirements. It also mentions verification of system operation at both system and component levels, and biocompatibility testing. These are primarily focused on device functionality, safety, and software integrity rather than a quantitative performance metric against a defined clinical acceptance criterion.
• Clinical evaluation: A qualitative statement that "Clinical evaluation of EECP® in patients with congestive heart failure has been performed in multi-center, single center and registry-based clinical investigations. Results of these investigations have demonstrated clinical benefit in patients treated with Vasomedical EECP® Therapy Systems. Objective measures such as peak oxygen consumption, exercise duration and pre-load adjusted maximal left ventricular power are improved following EECP® therapy, as well as subjective measures of patient response to therapy, such as quality of life and functional ability measures."

Given this, I cannot construct the table of acceptance criteria and reported device performance as requested, nor can I provide specific details like sample sizes for test sets, data provenance, number/qualifications of experts, or adjudication methods, as these are not present in the provided text for a performance study.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not explicitly stated. The document details types of tests performed (software, safety, biocompatibility, clinical evaluation) but does not provide specific acceptance criteria or corresponding quantitative performance metrics from those tests.

Regarding the study proving the device meets criteria (based on the "Clinical Evaluation" section):

• Type of Study: Clinical evaluation (multi-center, single-center, and registry-based clinical investigations) of EECP® in patients with congestive heart failure.
• Study Purpose: To demonstrate clinical benefit in patients treated with Vasomedical EECP® Therapy Systems.
• Outcomes Measured:
  • Objective: Peak oxygen consumption, exercise duration, pre-load adjusted maximal left ventricular power.
  • Subjective: Quality of life, functional ability measures.
• Reported Finding: "Results of these investigations have demonstrated clinical benefit in patients treated with Vasomedical EECP® Therapy Systems." and that "Objective measures such as peak oxygen consumption, exercise duration and pre-load adjusted maximal left ventricular power are improved following EECP® therapy, as well as subjective measures of patient response to therapy, such as quality of life and functional ability measures."

Missing Information (not found in the provided text):

2. Sample size used for the test set and the data provenance:

• Not specified. The document mentions "multi-center, single center and registry-based clinical investigations" but provides no numbers for patient samples or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not specified. For a therapy system like EECP, the "ground truth" relates to clinical outcomes and physiological changes, which are measured directly rather than established by expert review of data/images. The document does not mention experts establishing ground truth in this context.

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

• Not applicable/Not specified. This typically applies to studies involving human interpretation (e.g., image reading), which is not the primary focus of the performance evaluation described here.

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:

• No. This is not an AI-assisted diagnostic device, but a therapy system. Therefore, an MRMC study is not relevant.

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

• Not applicable. This is not an algorithm-only device; it's a medical device used in a clinical setting by an operator.

7. The type of ground truth used:

• For the clinical evaluation, the "ground truth" would be the actual physiological measurements (peak oxygen consumption, exercise duration, pre-load adjusted maximal left ventricular power) and patient-reported outcomes (quality of life, functional ability measures) obtained during the investigations.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for the device would be its design, engineering, and software development based on medical principles and prior knowledge.

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

• Not applicable. See point 8.

In summary, while the document indicates that clinical evaluations were performed and demonstrated clinical benefits, it lacks the specific, quantifiable details regarding acceptance criteria and performance metrics that would typically be found in a robust study summary for a diagnostic or AI-powered device. The emphasis is on overall safety, functionality, and qualitative clinical benefit for a therapy delivery system.

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