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This device is indicated for diagnostic evaluation of patients who experience transient symptoms such as:

• . Dizziness
• Palpitations .
• . Syncope
• Chest pain .

The KOH Express AF cardiac event recorder ("KOH" or "KOH Express AF" in short) is designed for the diagnostic evaluation of transient cardiac symptoms. The KOH is capable of storing up to 10 minutes of ECG recordings in solid state non-volatile memory. The device uses a two-wire lead set for single channel ECG acquisition. Using looping memory, the device captures ECG data; both before and after the patient experiences a cardiac symptom through auto-recording, or manually after the patient presses the RECORD button. ECG events are transmitted later in the form of an FM-modulated acoustic tone, when the SEND button is depressed. The device is configured in a compact sized case.

The provided text describes the "KOH Express AF cardiac event recorder" and outlines its performance validation. However, it does not contain specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity), sample sizes for test sets, data provenance, details on experts, adjudication methods, MRMC study results, or training set information.

The document indicates that "Final testing of the system included various performance tests and software validation tests designed to ensure that the device meets all of its functional and performance requirements and is fit for its intended use." It also states that "Arrhythmia Detection Algorithm Performance Validation" was performed, which implies that the device's ability to detect arrhythmia types (Tachycardia, Bradycardia, Atrial Fibrillation) was evaluated. However, the results of this validation are not provided in the given text.

Therefore, I cannot populate the table or provide specific details for most of the requested information. I can only extract what is explicitly mentioned.

Here's what can be extracted based on the provided text, with "N/A" for information 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: N/A (Not specified)
• Data Provenance: N/A (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: N/A (Not specified)
• Qualifications of Experts: N/A (Not specified)

4. Adjudication method for the test set

• Adjudication Method: N/A (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 Done: No. The device "records the ECG data and analyzes it for arrhythmias" [page 1]. This implies a standalone algorithm for detection, not an AI assistance tool for human readers.
• Effect Size: N/A

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

• Standalone Performance Study Done: Yes (implied). The text states "Arrhythmia Detection Algorithm Performance Validation" was performed [page 2], and the device "automatically detected" arrhythmias [page 1]. This indicates a standalone algorithmic performance evaluation. However, the specific results are not provided.

7. The type of ground truth used

• Type of Ground Truth: N/A (Not explicitly specified. For "Arrhythmia Detection Algorithm Performance Validation," it would typically be expert-adjudicated ECG tracings, but this is not confirmed in the text).

8. The sample size for the training set

• Sample Size for Training Set: N/A (Not specified)

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

• Ground Truth for Training Set Establishment: N/A (Not specified)

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The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm, or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.

The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is designed for selftesting by patients at home and for analysis by medical professionals at a remote Monitoring Center. The chest-worn sensor is used for the acquisition, recording, and transmission of the ECG signal. The device is equipped with 4 electrodes on a harness and it houses a 3.6V AA battery, a Bluetooth transceiver and a buzzer. The ECG signals are transmitted via Bluetooth to a handheld device with a proprietary interactive application, configured to process and transmit the ECG recordings. The handheld device is a mobile computing device with a display and a touch input such as a cell phone. It has sufficient memory and processing capability to run the proprietary application. When an arrhythmia event is detected, the handheld device transmits the recorded ECG information automatically via cellular link, to the Monitoring Center for professional analysis. When cellular service is unavailable the patient has an option to transmit via a landline telephone. The Patient and Physician manuals are being modified to change a warning to allow the use of the ACT-3L on patients with an Implanted Cardioverter Defibrillator (ICD) if specific precautions are observed.

The provided document is a 510(k) summary for the CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector. It primarily focuses on demonstrating substantial equivalence to a predicate device after a modification related to device labeling.

However, the document does not contain specific acceptance criteria, detailed results of a study proving the device meets acceptance criteria, sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, details of MRMC studies, standalone performance data, or training set information.

Instead, it states that the modification required "ACT-3L High Voltage Pulse Test, Card Guard document # ENTR-0112" and "ACT-3L EMC Dipole Antenna Test, Card Guard document # ENTR-0113" were performed to support the labeling change. It also indicates that the device conforms to various performance requirements and voluntary standards, including ANSI/AAMI EC57:1998 (R) 2008 for "Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms."

Without access to the specific internal Card Guard documents (ENTR-0112 and ENTR-0113) or detailed performance reports against standards like ANSI/AAMI EC57, it's impossible to fully answer your request.

Based only on the provided text, here's what can be extracted and what cannot:

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

The document mentions compliance with "applicable performance requirements contained in and referenced in this document" and voluntary standards. However, it does not explicitly list acceptance criteria or provide a table of reported device performance against those criteria. It only states that the device "conforms" to these standards.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text.

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 specified in the provided text. The document refers to "professional analysis" by a "Monitoring Center" and "medical practitioner for evaluation" in the context of device use, but not for establishing ground truth for a test set in a performance study.

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

Not specified in the provided text.

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: Not mentioned or implied in the provided text.
• Effect Size: Not applicable as an MRMC study is not indicated.

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

The document mentions the device "automatically generates an alarm triggered by an arrhythmia detection algorithm". Given the context of a 510(k) for an arrhythmia detector, it's highly probable that standalone algorithm performance was evaluated against standards like ANSI/AAMI EC57. However, the details of such a standalone study (e.g., specific metrics, dataset, outcomes) are not provided in this summary.

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

Not specified in the provided text. For arrhythmia detection, ground truth is typically established by expert cardiologists reviewing ECG waveforms. The reference to ANSI/AAMI EC57 implies such a standard methodology would be followed, but the specifics are not in this document.

8. The sample size for the training set

Not specified in the provided text. The document focuses on modifications to an existing device, and for the core arrhythmia detection algorithm, the training would have occurred much earlier for the predicate device.

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

Not specified in the provided text.

Ask a specific question about this device

The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm, or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.

CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center.

The chest-worn sensor is used for the acquisition, recording, and transmission of the ECG signal. The device is equipped with 4 electrodes on a harness and it houses a 3.6V AA battery, a Bluetooth transceiver and a buzzer.

The ECG signals are transmitted via Bluetooth to a handheld device with a proprietary interactive application, configured to process and transmit the ECG recordings. The handheld device is a mobile computing device with a display and a touch input such as a cell-phone. It has sufficient memory and processing capability to run the proprietary application.

When an arrhythmia event is detected the handheld device transmits the recorded ECG information automatically via cellular link, to the Monitoring Center or professional analysis. When cellular service is unavailable the patient has an option to transmit via a landline telephone.

The provided text describes the CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector, but it is a 510(k) Summary, not a detailed study report. Therefore, it does not contain the full details required to answer all aspects of your request comprehensively. Specifically, information regarding specific acceptance criteria values, reported device performance metrics against those criteria, detailed sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC study results (effect size), and training set ground truth establishment are largely absent or only broadly mentioned.

However, based on the information available, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the device was subjected to "extensive verification / validation testing" and "designed to ensure that the device meet all of its functional and performance requirements and is fit for its intended use." It also mentions conformance with the "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm, October 28, 2003" and ANSI/AAMI/ISO EC57:1998 (R) 2008 for "Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms."

Unfortunately, specific numerical acceptance criteria (e.g., sensitivity, specificity thresholds for arrhythmia detection) and the device's reported performance against these criteria are NOT provided in this summary. The summary only lists general categories of performance validation.

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

The document mentions "Arrhythmia Detection Algorithm Performance Validation" as part of the testing. However, it does not specify the sample size used for this validation or the data provenance (e.g., country of origin, retrospective/prospective nature of the data).

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

This information is not provided in the 510(k) summary. It only states that the monitoring center provides ECG data to the medical practitioner for evaluation, implying professional review, but it doesn't detail the ground truth establishment for the validation study itself.

4. Adjudication Method for the Test Set:

This information is not provided in the 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with AI assistance. The focus seems to be on the algorithm's standalone performance and the system's ability to transmit data to a monitoring center for professional analysis.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance evaluation of the algorithm was done. The document explicitly states: "Arrhythmia Detection Algorithm Performance Validation." This implies that the algorithm's ability to detect cardiac events (Atrial Fibrillation, Tachycardia, and Pause) was validated independently of a human interpreter at the point of detection, although human input at the monitoring center is part of the overall clinical workflow.

7. The Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for the algorithm validation. Given the nature of ECG monitoring and arrhythmia detection, it is highly probable that the ground truth would typically be established by expert consensus of cardiologists or electrophysiologists reviewing the ECG traces. However, this is an inference, not an explicit statement in the provided text.

8. The Sample Size for the Training Set:

The document does not provide any information regarding the sample size used for the training set of the arrhythmia detection algorithm.

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

The document does not provide any information regarding how the ground truth for the training set was established.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and outlines the general testing performed to meet regulatory guidance. It does not contain the detailed clinical study results and methodology typically found in a full clinical validation report.

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The CG-6108 ACT-1L Continuous ECG Monitor and Arrhythmia Detector are intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECC, automatically generates an alarm triggered by an arrhythmia detection algorithm, or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center.

The monitoring center provides the ECG data to the medical practitioner for evaluation.

CG-6108 ACT-1L Continuous ECG Monitor and Arrhythmia Detector is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center.

The chest-worn sensor is used for the acquisition, recording, and transmission of the ECG signal. The device is equipped with 3 electrodes on a harness and it houses a 3.6V AA battery, a Bluetooth transceiver and a buzzer.

The ECG signals are transmitted via Bluetooth to a handheld device with a proprietary interactive application, configured to process and transmit the ECG recordings. The handheld device is a mobile computing device with a display and a touch input such as a cell-phone. It has sufficient memory and processing capability to run the proprietary application.

When an arrhythmia event is detected the handheld device transmits the recorded ECG information automatically via cellular link, to the Monitoring Center or professional analysis. When cellular service is unavailable the patient has an option to transmit via landline telephone.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CG-6108 ACT-1L Continuous ECG Monitor and Arrhythmia Detector:

The provided text focuses on a 510(k) summary for a modified device (CG-6108 ACT-1L) and states that the technological characteristics and principles of operation are the same as the predicate device. This often means that the original predicate device's performance data and acceptance criteria are largely being referenced or assumed. The document does not contain a detailed de novo study demonstrating the performance of this modified device against specific, new acceptance criteria, but rather references validation against existing guidance and standards.

Therefore, many of the requested items (sample size, expert qualifications, etc.) are not explicitly provided for the modified device's performance study within these documents. The provided information focuses on conformance to standards and validation of software/hardware, rather than a clinical effectiveness study with an independent test set and ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

The document references existing performance standards and guidance. It does not provide a specific table of acceptance criteria for this particular submission or a direct report of device performance against such. Instead, it states conformance to:

• "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm, October 28, 2003"
• "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11 2005"
• ANSI/AAMI/ISO EC57:1998 (R) 2008: Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms
• ANSI/AAMI EC38:1998 Ambulatory Electrocardiograph

The document states: "Final testing of the system included various performance tests and software validation tests designed to ensure that the device meet all of its functional and performance requirements and is fit for its intended use."

Specific performance metrics of the device (sensitivity, specificity, accuracy for arrhythmia detection) are NOT provided in this document.

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

• Sample Size: Not specified in the provided document.
• Data Provenance: Not specified in the provided document. The device is manufactured in Israel, but the origin of any test data is not mentioned. It is unclear if it was retrospective or prospective.

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 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, an MRMC comparative effectiveness study is not mentioned in the provided document. This device is primarily a detector and transmitter of ECG data for medical professionals to evaluate, not a system assisting human readers directly in interpretation for a comparative effectiveness outcome as typically measured in an MRMC study. The device's algorithm detects events to trigger transmission, it doesn't provide a diagnostic interpretation for human readers to then improve upon.

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

• Standalone Performance: The document states: "Arrhythmia Detection Algorithm Performance Validation". This indicates that the algorithm's performance was validated, which would typically be a standalone assessment. However, specific metrics (e.g., sensitivity, specificity, PPV, NPV for Atrial Fibrillation, Tachycardia, and Pause) are not provided in this summary.

7. The type of ground truth used

• Type of Ground Truth: Not explicitly stated. For "Arrhythmia Detection Algorithm Performance Validation" and conformance to ANSI/AAMI/ISO EC57, the ground truth would typically be established by expert cardiologists reviewing the ECG tracings and labeling arrhythmias. The document does not specify if pathology or outcomes data were used, which is less common for arrhythmia detection algorithms unless used for long-term prognosis.

8. The sample size for the training set

• Training Set Sample Size: Not specified. The document focuses on validation rather than the development or training process.

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

• Training Set Ground Truth Establishment: Not specified.

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The HealthePod is a medical device designed for self-testing. It comprises the following medical features:

• ECG 1-lead .
• Heart rate .
• Body temperature ●

The Card Guard® CG-1411USB HealthePod is a medical and non-medical monitor designed for self-testing by patients. It contains 4 sensors designed to execute the following features:

• . ECG 1-lead
• . Heart rate
• . Ambient temperature
• Body temperature .
• Pedometer walking steps and walking distance, .
• Calorie Meter .
• Stopwatch, Count down, Alarm clock .
• Date/Time .
  HealthePod can communicate measured data and patient information to a PC with a receiving medical Application such as PMP4. Two dry electrodes are assembled on the device PCB. It features an LCD, three buttons and a USB connector for communication with PC.

The provided text does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance metrics. The document is primarily a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone performance study with detailed acceptance criteria and results.

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

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided text. The document states that "The HealthePod constitutes a safe and reliable device. Its material composition and operation present no adverse health effect or safety risks when used as intended. The device is as safe, as effective and performs as well as or better than its cleared predicate devices." This is a general statement of compliance and equivalence, not a table of specific performance metrics against defined acceptance criteria.

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

This information is not provided. The document does not describe any specific test set for performance evaluation, nor does it mention sample sizes, country of origin, or whether any testing was retrospective or prospective.

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

This information is not provided. As there's no mention of a specific test set or ground truth establishment process, the number and qualifications of experts are not discussed.

4. Adjudication Method for the Test Set

This information is not provided. An adjudication method would typically be relevant for studies involving human interpretation or expert review, which is not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not provided. There is no mention of an MRMC study or any assessment of human reader improvement with or without AI assistance. The HealthePod is described as a self-testing device with sensors, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not explicitly detailed in terms of performance metrics. While the device is a "self-testing" unit, indicating standalone operation, the document doesn't present a standalone performance study with quantitative results against specific criteria. It implies that the functionality (ECG 1-lead, heart rate, body temperature) works as intended and is equivalent to predicate devices.

7. The Type of Ground Truth Used

This information is not provided. Since no specific performance study with a test set is outlined, the type of ground truth used to validate performance (e.g., expert consensus, pathology, outcomes data) is not mentioned. For a device measuring physiological parameters, ground truth would typically come from established medical devices or clinical observations.

8. The Sample Size for the Training Set

This information is not provided. The document does not describe the development or training of any algorithms, so there is no mention of a training set or its size.

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

This information is not provided. As there is no mention of a training set, the method of establishing its ground truth is also not discussed.

Summary of Device and Equivalence Claim (from the document):

The HealthePod is a medical and non-medical monitor designed for self-testing. Its medical features include:

• ECG 1-lead
• Heart rate
• Body temperature

The device sought clearance based on substantial equivalence to the following predicate devices:

• Card Guard's CG-2206 K963725 (for one-lead feature and electronic design similarity)
• Card Guard's PMP4 SelfCheck ECG K042254 (for over-the-counter distribution and one-lead configuration)
• TaiDoc Technology Corporation Clever TD-1112 IR thermometer K061800

The conclusion states that the "HealthePod constitutes a safe and reliable device... The device is as safe, as effective and performs as well as or better than its cleared predicate devices." This implies that the performance is considered acceptable because it meets or exceeds the performance of already cleared devices, but the specific studies and acceptance criteria for this device are not detailed.

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The Easy2Check blood glucose and blood pressure monitoring system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions.

The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4"~13.8".

This system offers wireless communication function which is able to transmit the test result to other devices, such as PC.

PMP4 Easy2Check Personal Wireless Blood Pressure and Blood Glucose Monitor. The system measures glucose in fresh capillary whole blood and measures non-invasively the systolic and diastolic blood pressure and pulse rate. It has wireless communication function.

The provided document is an FDA 510(k) clearance letter for the "PMP Easy2Check Personal Wireless Blood Pressure and Blood Glucose Monitor". It does not contain a detailed study description with specific acceptance criteria and performance data. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This information is typically found in the 510(k) summary or the full 510(k) submission, which is not provided in these snippets. The document focuses on the FDA's regulatory decision, not on the detailed technical performance data of the device itself beyond its intended use.

Ask a specific question about this device

The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm, or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.

The CG-6108 ACT-3L is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center. It comprises a chest-worn ECG sensor and a handheld device with a proprietary application, configured to process and transmit the ECG recordings.

The chest-worn unit has 3 electrodes on a harness and it houses a battery, an ASIC and a Bluetooth transceiver for the acquisition, recording, and transmission of the ECG signal.

The ECG signals are transmitted via Bluetooth to the handheld device. When an event is detected it is wirelessly transmitted to the CG Monitoring Center for professional analysis. The handheld device is equipped with shared memory used to received from the sensor and to allow preand post processing options through the use of this memory in a dual memory loop configuration, both running in parallel. One loop is auto-triggered, with programmable that starts recording based on specific rhythms detected or manually activated by the patient. The second, and longer, recording loop is controlled to provide the physician with more information, when requested by the CG Monitoring Center.

The handheld device automatically transmits the recorded ECG, via cellular link, to the Monitoring Center. When cellular service is unavailable the patient can transmit via landline telephone.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector:

CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector: Acceptance Criteria and Study Details

The provided 510(k) summary (K081257) does not explicitly detail acceptance criteria or the specifics of a study proving the device meets those criteria, particularly regarding the arrhythmia detection algorithm's performance. It primarily focuses on the device's intended use, principles of operation, and its substantial equivalence to predicate devices, referencing compliance with various general medical device and quality management standards.

However, based on the information provided and common practices for arrhythmia detectors, we can infer some aspects and highlight what is missing.

Missing Information: A critical piece of information that is not present in this summary is a direct table of acceptance criteria for the arrhythmia detection performance (e.g., sensitivity, specificity for specific arrhythmias) and the corresponding reported device performance from a clinical or analytical study. The document states that "All Verification, Validation and Testing (VV&T) documents - although not included in this dossier, constitute a part of the device DMR and are available upon request." This indicates that such data exists but is not publicly available in this filing.

Inferred/Identified Information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, a specific table for acceptance criteria of the arrhythmia detection algorithm is not provided in this 510(k) summary. The document focuses on compliance with general medical device standards.

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

This information is not provided in the 510(k) summary. The document does not describe a performance study for the arrhythmia detection algorithm.

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

This information is not provided in the 510(k) summary.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

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

A MRMC comparative effectiveness study is not mentioned or described in the 510(k) summary. The document primarily focuses on the device's technical specifications and safety standards rather than human-in-the-loop performance studies.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study for the algorithm is not explicitly detailed in the 510(k) summary.
However, the "Arrhythmia Detector and Alarm Guidance for Industry and FDA Staff Class II Special Controls Guidance" and "ANSI/AAMI-EC 57:1998, Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms" are referenced as standards. These standards typically require performance metrics for arrhythmia detection. The absence of these results in the summary suggests they would be in the "VV&T documents" mentioned.

7. Type of Ground Truth Used

This information is not provided in the 510(k) summary. For arrhythmia detectors, ground truth is typically established by an expert cardiologist's review of the ECG recordings, sometimes with the aid of adjudicated annotations from multiple experts.

8. Sample Size for the Training Set

This information is not provided in the 510(k) summary.

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

This information is not provided in the 510(k) summary.

Summary of What Can Be Inferred/Found:

• Acceptance Criteria & Performance: Not explicitly stated for the arrhythmia algorithm. Compliance with general safety and electrical standards (IEC, EN, ISO) is stated, but these are not performance criteria for arrhythmia detection.
• Study Details (Test Set, Experts, Adjudication, MRMC, Standalone, Ground Truth): Not provided in this 510(k) summary. This information is likely contained within the "Verification, Validation and Testing (VV&T) documents" which were not part of the public dossier.
• Training Set Details: Not provided.
• Referenced Standards Indicating Expected Performance: The reference to "ANSI/AAMI-EC 57:1998, Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms" strongly suggests that the device's arrhythmia detection algorithm was tested against the performance metrics outlined in this standard (e.g., detection rates for various arrhythmias, false positive/negative rates). However, the results of such testing are not presented in this document.

Conclusion: The provided 510(k) summary (K081257) for the CG-6108 ACT-3L focuses on regulatory compliance and the device's technical description for establishing substantial equivalence. It does not contain specific details regarding the acceptance criteria or the results of a study demonstrating the device's performance for its arrhythmia detection algorithm. Such information would typically be found in the detailed V&V reports that were part of the full submission but not included in this public summary.

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The CG-6108 Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors a one lead ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.

The CG-6108 Continuous ECG Monitor and Arrhythmia Detector system is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center. It comprises a chest-worn ECG sensor and a handheld device with a proprietary application, configured to process and transmit the ECG recordings. The chest-worn unit includes 3 electrodes on a harness and it houses a battery, an ASIC and a Bluetooth transceiver for the acquisition, recording, and transmission of the ECG signal. The ECG signals are transmitted via Bluetooth to the handheld device. When an event is detected it is wirelessly transmitted to the CG Monitoring Center for professional analysis. The handheld device is equipped with shared memory used to record the signal received from the sensor and to allow pre- and post processing options through the use of this memory in a dual memory loop configuration, both running in parallel. One loop is auto-triggered, with programmable thresholds that starts recording based on specific rhythms detected or manually activated by the patient. The second, and longer, recording loop is controlled remotely to provide the physician with more information, when requested by the CG Monitoring Center. The handheld device automatically transmits the recorded ECG, via cellular link, to the Monitoring Center. When cellular service is unavailable the patient can transmit via landline telephone.

The provided document, a 510(k) Summary for the CG-6108 Continuous ECG Monitor and Arrhythmia Detector, does not contain specific acceptance criteria, performance metrics, or details of a study designed to prove the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device and describing the device's functionality and intended use. It lists referenced standards but does not report the device's performance against them.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication method.
• MRMC study details (effect size, improvement with AI).
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training set.
• How ground truth for the training set was established.

The document states: "The CG-6108 device constitutes a safe and reliable means for self-testing by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device is at least as safe, effective, and reliable as the cleared predicate devices." This is a conclusion about substantial equivalence, not a report of specific performance metrics against defined acceptance criteria from a study.

To obtain the information you're looking for, you would typically need access to the full 510(k) submission, including performance testing reports, which are not usually publicly disclosed in detail within the 510(k) summary document itself.

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The PMP4 Application is intended for: a) Patients wishing to acquire, display and transmit their vital signs to a medical professional via Webbased Call Center for analysis and obtain response b) Physicians for medical testing of patients' vital signs, display and analysis as well as follow up and response to patient's transmitted data

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The provided text is a 510(k) clearance letter from the FDA for the PMP4 Application, a network and communication physiological system. While it indicates the device is substantially equivalent to a predicate device and states its intended use, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for the detailed information outlined in points 1 through 9 based on the provided text. This document is a regulatory approval notice, not a study report.

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The Card Guard SelfCheck Gluco glucose test system is intended for use in the quantitative measurement of glucose in whole blood taken from the finger. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

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The provided text is an FDA 510(k) clearance letter for the SelfCheck™ Gluco glucose test system. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

Specifically, the document makes no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, or details about the study design.
• The number or qualifications of experts used for establishing ground truth.
• Any adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was conducted, or any effect sizes of human readers with/without AI assistance. (This is irrelevant for a glucometer as it's not an AI-assisted diagnostic imaging device).
• Whether a standalone (algorithm only) performance study was done. (Again, irrelevant for this type of device).
• The type of ground truth used (e.g., pathology, outcomes data). (For a glucometer, ground truth typically comes from lab reference methods).
• Sample size for the training set.
• How ground truth for the training set was established.

Therefore, I cannot provide the requested information from this document. The letter focuses on regulatory approval based on substantial equivalence, not on the detailed technical data of the performance study itself.

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