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The Smartheart device is intended to condition an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology and cell-phone or communication device to a remote location. The Smartheart device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to enable review at a physician's office, hospital or other medical receiving center.

The Smartheart is a personal, hand-held battery powered. 12 lead ECG and rhythm strip device with Bluetooth connection. The Smartheart acquires ECG data via attached electrodes. The Smartheart transmits the data in real-time to a suitable Bluetooth communication device for forwarding it to a remote location and a certified medical professional capable of interpreting the results.

Here's a breakdown of the acceptance criteria and study information for the Smartheart device, extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria in a table format. However, it does outline the overall performance and equivalence claim.

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

The text mentions a "usability study" but does not specify the sample size used for the test set. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The text mentions that the Smartheart is designed to enable review at a "physician's office, hospital or other medical receiving center" by a "certified medical professional capable of interpreting the results." However, it does not specify the number or qualifications of experts used to establish ground truth specifically for the usability study mentioned.

4. Adjudication Method for the Test Set

The provided text does not describe any adjudication method used for the test set in the usability study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, no effect size for human readers with and without AI assistance is provided.

6. Standalone (Algorithm Only) Performance Study

The text describes the Smartheart as a device that transmits ECG signals for professional review. It does not describe a standalone (algorithm only) performance study or an AI component that would necessitate such a study. The device's function is data acquisition and transmission, not automated interpretation.

7. Type of Ground Truth Used

Based on the device's intended use to transmit ECGs for review by "certified medical professionals," the ground truth for evaluating the device's efficacy in data acquisition and transmission would likely be expert medical interpretation of the transmitted ECGs. However, the text does not explicitly state how ground truth was established for the usability study. Given the nature of the device, it would involve comparison of the transmitted ECGs to a reference standard (e.g., simultaneously acquired "gold standard" ECGs) and/or expert review of the quality and interpretability of the transmitted signals.

8. Sample Size for the Training Set

The provided text does not mention a training set or its sample size. This is consistent with the device being a data acquisition and transmission tool rather than an AI-powered diagnostic algorithm requiring a training phase for its core function.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned (since the device is a transmitter, not an AI interpreter), this information is not applicable and not provided in the text.

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The CardioSen'C device is intended to condition an electrocardiographic signal so that it can be transmitted acoustically via telephone and/or digitally over cellular network to a remote location. The CardioSen'C device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to a physician's office, hospital or other medical receiving center.

The CardioSen'C is a personal, battery powered, hand-held personal ECG transmitter, enabling an individual to immediately transmit a 12-lead ECG and a rhythm strip from a remote location, to a physician's office, hospital or monitoring center. The ECG data can be transmitted in real time via two communication methods. The CardioSen'C produces an ECG frequency modulated acoustical tone that can be coupled with and transmitted by a standard or a cellular telephone. The ECG data can also be transmitted digitally through the cellular network. Either one of these two transmissions methods permits the transfer of a 12-lead ECG and rhythm strip to the medical professional capable of interpreting the data.

The CardioSen'C device is a personal, battery-powered, hand-held personal ECG transmitter. It enables an individual to immediately transmit a 12-lead ECG and a rhythm strip from a remote location to a physician's office, hospital, or monitoring center. The ECG data can be transmitted in real-time via two communication methods: an ECG frequency modulated acoustical tone that can be coupled with and transmitted by a standard or cellular telephone, or digitally through the cellular network.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document states that the CardioSen'C device has been tested against various standards. However, it does not provide a specific table of acceptance criteria with corresponding performance metrics. It indicates adherence to general standards and a conclusion of safety and effectiveness.

• Compliance with ANSI/AAMI EC11-1991 (Diagnostic Electrocardiographic Devices)
• Compliance with IEC 60601-2-25 (1993) +A1:1999 requirements for the safety of electrocardiographs
• Ability to condition an electrocardiographic signal for transmission
• Ability to transmit 12-lead ECG and rhythm strip acoustically via telephone
• Ability to transmit 12-lead ECG and rhythm strip digitally over cellular network | The document broadly states that "Further IVD study has shown that the system meets its design specifications and is safe and effective for its intended use." It also concludes that "The results of tests studies and analyses performed with the CardioSen'C device demonstrate that the CardioSen'C device is as safe and effective as its predicate devices without raising any new safety and\or effectiveness concerns."
  Specifically, the device is reported to be capable of:
• "Conditioning an electrocardiographic signal so that it can be transmitted acoustically via telephone and/or digitally over cellular network to a remote location."
• "Transmitting a 12-lead ECG and rhythm strip in real-time to a physician's office, hospital or other medical receiving center." |
  | Substantial Equivalence:
• Same intended use as predicate devices.
• Capable of transmitting acoustically via customary telephones (like CardioBeeper® CB 12/12).
• Capable of transmitting digitally over cellular network (like River -1).
• No new safety and/or effectiveness concerns compared to predicate devices. | The CardioSen'C device is stated to have "the same intended use and is capable of transmitting the electrocardiographic signal acoustically via customary telephones as the CardioBeeper® CB 12/12. Further, the CardioSen'C can transmit digitally over cellular network to a remote location as the River -1 device. The results of tests studies and analyses performed with the CardioSen'C device demonstrate that the CardioSen'C device is as safe and effective as its predicate devices without raising any new safety and\or effectiveness concerns." |

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

The provided text mentions "Further IVD study has shown that the system meets its design specifications." However, no specific sample size for the test set or information regarding data provenance (e.g., country of origin, retrospective or prospective) is provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications. The device transmits ECG data to medical professionals capable of interpreting the data, implying their role in eventual interpretation, but this is distinct from establishing ground truth for a device validation study.

4. Adjudication Method for the Test Set

No information about an adjudication method for the test set is provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of how much human readers improve with AI vs. without AI assistance. The CardioSen'C is an ECG transmission device, not an AI-powered diagnostic tool in the sense of assisting human readers with interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document describes the device as a "transmitter" to be used by a patient to send data to a "medical professional capable of interpreting the data." This indicates that the device is not intended for standalone diagnostic interpretation (i.e., algorithm only without human-in-the-loop performance). Its function is to condition and transmit the signal for human interpretation.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any testing. Given the nature of the device as an ECG transmitter, the ground truth for its performance would primarily relate to the accuracy and fidelity of the transmitted ECG signal compared to the actual electrical activity of the heart. This would likely involve comparisons to a gold-standard ECG recording device, but the document does not elaborate on this.

8. Sample Size for the Training Set

No information about a training set or its sample size is provided. The device's validation focuses on its ability to accurately transmit ECG signals, which typically doesn't involve machine learning training sets in the way an AI diagnostic algorithm would.

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

As no training set is mentioned, there is no information on how its ground truth was established.

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The River-1 is indicated for the evaluation of patients who experience transient symptoms such as dizziness, palpitations, syncope, or chest pain that might suggest arrhythmia. The device is intended to record cardiac activity associated with those infrequent and transient symptoms. Once the data is recorded, the patient transmits this ECG data over the telephone or cellular network to a remote central receiving station to be reviewed by a healthcare professional.

The River-1 is a patient activated electrocardiograph (ECG) symptomatic event recorder and transmitter. The River is a looping type ECG recording device (it records the ECG continuously). When the patient presses the ECG Record Button to record an ECG, the device stores both the recently recorded ECG and the ECG, following activation. The recorded ECG can then be transmitted to a healthcare facility or receiving center via two distinct channels: digitally via cellular network or acoustically via any phone.

The River-1 is a portable programmable device which is worn on the belt of the patient. It features a simple LCD screen, key pad, and is powered by a rechargeable battery. It can accommodate up to three leads for the option of recording 1, 2, or 3 lead ECG data.

This 510(k) submission for the River-1 Electrocardiograph (ECG) Recorder and Transmitter is a premarket notification for a medical device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical study data with detailed performance metrics against specific acceptance criteria.

Therefore, the provided text does not contain the detailed information required to fill out the requested table regarding acceptance criteria and performance, nor does it describe a study that proves the device meets specific acceptance criteria in the way a clinical trial would.

Here's why and what information can be extracted or inferred:

• Focus on Substantial Equivalence: The core of a 510(k) is to show that a new device is as safe and effective as a predicate device already on the market. This often relies on technological comparisons, not necessarily new, extensive clinical studies with quantitative acceptance criteria for performance.
• Lack of Specific Clinical Study Details: The document mentions "Indications For Use" but does not detail a specific clinical study with a defined test set, ground truth, expert involvement, or statistical analysis of performance against pre-defined acceptance criteria, which would be typical for a PMA or a more rigorous clinical validation study.
• "Study that proves the device meets the acceptance criteria" Missing: There is no description of such a study in the provided text. The FDA's review in this context is about substantial equivalence, not typically about directly "proving" new performance against novel quantitative criteria.

Given these limitations, I will extract what can be inferred from the document and explicitly state what information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document does not describe a clinical test set for performance evaluation in the typical sense.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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

• MRMC Study: No. This device is an ECG recorder and transmitter, not an AI-powered diagnostic imaging tool that would typically involve a multi-reader, multi-case study to assess AI assistance. The "review by a healthcare professional" is mentioned as a human interpretation step after data transmission.
• Effect Size of AI Assistance: Not applicable.

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

• Standalone Performance: Not explicitly described for a specific algorithm. The device "records cardiac activity" and transmits it for review by a healthcare professional. This implies a human-in-the-loop system. The 510(k) for this type of device primarily ensures the accurate recording and transmission of ECG data, not independent algorithmic diagnosis.

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

• Type of Ground Truth: Not specified in relation to a performance evaluation study. For substantial equivalence, the "ground truth" implicitly aligns with the established performance of the predicate devices.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is not described as utilizing machine learning or AI that would require a "training set" in the conventional sense for algorithmic development. It's a recording and transmission device.

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

• How Ground Truth Established: Not applicable.

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VISUALIZATION AND MEASUREMENT OF ECG BY TRAINED USED RECORDINGS TO BE MEDICAL CONDITION. MON | TORING CARDIAC IN THE OF STAFF

The Cardio Vision software is a program which runs on a personal computer and is used for the display and storage of Electrocardiogram recordings. The software receives an input signal containing the ECG data from an ECG receiving center. The receiving center is connected to the computer on which the Cardio Vision software is running via a serial port. The ECG receiving center receives the ECG signal from an ECG recording device either via direct connection or via telephone. The software interprets the digital signal and displays it on the screen in real time as a single or multiple lead ECG plot.

The received ECG signal can be stored on the disk and can be compared to previous ECG recordings for that patient. In addition, measurements can be performed on the ECG plot.

The provided text describes the Cardio Vision Software, an ECG display and storage program. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific sample size for a "test set" in the context of clinical trials or an independent validation study. The "Bench Data" section refers to an "artificial signal" and "prepared files," which implies synthetic or pre-recorded data for testing specific functionalities. The "Clinical Data" section refers to "simultaneous ECG strip chart output," suggesting real patient data, but no further details on the number of patients, recordings, or their provenance (country, retrospective/prospective) are provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not detail any expert review process for establishing ground truth for a test set. The validation primarily relies on comparison with "original signals" (for bench data) and "simultaneous ECG strip chart output" (for clinical data), implying these were considered the ground truth references. There is no mention of human experts directly annotating or establishing ground truth for the purpose of evaluating the device.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned, as there is no indication of multiple independent expert reviewers establishing a ground truth that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The document does not describe any study involving human readers with and without AI assistance, nor does it provide an effect size for such a comparison.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies described are essentially standalone evaluations of the algorithm's performance.

• Bench Data: "An artificial signal was fed into the receiving center, and the resulting ECG data was displayed and written to a log file. Comparison of the log file with the original signal verified that the data sampling and data processing modules function properly." This is an algorithm-only test.
• Clinical Data: "The comparison of Cardio Vision Software printouts with simultaneous ECG strip chart output demonstrated that the Cardio Vision Software processes and presents ECG data consistently and accurately." This also evaluates the software's output against a reference without explicit human intervention in the interpretation of the software's output for evaluation purposes.

7. Type of Ground Truth Used

• Bench Data: The ground truth for the bench data was the "original artificial signal."
• Clinical Data: The ground truth for the clinical data was "simultaneous ECG strip chart output." This suggests the output from a traditional, established ECG recording method was used as the reference standard.

8. Sample Size for the Training Set

The document does not provide any information about a training set for the Cardio Vision Software. This suggests the software is primarily a display and storage tool, not an AI/ML-based diagnostic algorithm that learns from a training set. The descriptions focus on its functionality in processing and presenting data, rather than making automated interpretations or diagnoses.

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

As no training set is mentioned or implied, the establishment of ground truth for a training set is not applicable to this device description.

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