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To record infrequent and elusive ECG heart arrhythmia data. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review.

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This document describes the acceptance criteria and study proving a device's performance. However, there is no specific study described within the provided text that directly details acceptance criteria for a new AI/algorithm, a validation study with specific performance metrics (like sensitivity, specificity, or AUC), or a comparison against human readers.

The provided text describes a 510(k) summary for a hardware modification to an ECG event recorder (ER800 Series). The "Modification Background" section states: "In connection with the modification the device performance has been validated as reported herein. Note all devices meet the same performance standards of AAMI-EC38, EN60601-1-1, EN60601-1-2, and EN60601-2-47."

This indicates that the device's performance validation is against established electrical safety and performance standards for medical devices, not against a specific set of clinical performance metrics for an AI algorithm interpreting ECGs. The primary changes are hardware-related, with a reinstatement of existing arrhythmia functionality. The comparison table focuses on hardware features and basic functionalities like storage capacity, battery life, and on-board analysis.

Therefore, many of the requested points related to AI/algorithm validation, such as sample sizes for test sets, ground truth establishment, expert qualifications, and MRMC studies, cannot be directly answered from this document.

However, based on the information provided, here's what can be extracted and inferred:

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

Since the document refers to compliance with established medical device standards rather than a new algorithm's performance metrics, the "acceptance criteria" are the requirements outlined in those standards. The "reported device performance" is the statement that the device meets these standards. A direct table of numeric performance metrics is not provided for clinical outcomes like arrhythmia detection accuracy.

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

• Sample size: Not specified. The validation is against engineering and safety standards, which typically involve testing components or the full device under various conditions, rather than a clinical "test set" of patients or ECGs.
• Data provenance: Not applicable in the context of clinical data. For testing against electrical standards, testing would be conducted in a laboratory environment.

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

• Not applicable as this is not an AI/algorithm validation against clinical ground truth. Validation would be performed by qualified engineers or technicians in a laboratory setting.

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

• Not applicable.

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, an MRMC study was not done as this is a hardware modification of an existing device, not a new AI algorithm.

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

• The device has "On-board analysis: Yes" which implies some automated arrhythmia detection. The text states the modification "reinstates existing arrhythmia functionality." However, a standalone performance study report for this existing (not new) functionality is not provided in this excerpt. The focus of the submission is the hardware modification's continued compliance with general device standards, not a new or revalidated performance claim for its "on-board analysis."

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

• Not applicable for performance relative to electrical and safety standards. If the "on-board analysis" functionality's original validation (which is pre-existing) involved ground truth, that information is not in this document.

8. The sample size for the training set:

• Not applicable as this is not a new AI algorithm.

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

• Not applicable.

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The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently, the ECG is the most prominent and widely used non-invasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data which provides a powerful basis for evaluation of these biophysical signals. Twenty-four or forty-eight hour ECG recordings can be of great value in patient assessment.

Ambulatory (Holter) ECG intended use:

The DigiTrakPlus Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below.

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
3. Evaluation of patients for ST segment changes.
4. Evaluation of a patient's response after resuming occupational activities (e.g., after M.I. or cardiac surgery.)
5. Clinical and epidemiological research studies.
6. Evaluation of patients with pacemakers
7. Reporting of time and frequency domain heart rate variability
8. Reporting of QT Interval

The essence of this modification is a change of the digital Holter recorder hardware to a smaller configuration with reduced power consumption and the removal of ECG analysis capabilities from the device. In connection with this modification, the methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein. As a result of this modification, ECG analysis is not a part of this device, but rather is performed by software installed in the Holter Analyzer which is subject to independent 510(k) review, as in the Company's earlier filing (K990956).

The above changes do not affect the intended use of the device or alter the fundamental scientific technology of the device, as is demonstrated on the following pages.

The provided text describes a 510(k) submission for the DXP1000 Holter Recorder, focusing on modifications and demonstrating substantial equivalence to a predicate device (Biosensor Model #1005).

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

Acceptance Criteria and Reported Device Performance

Note: The primary focus of the modification and validation was the "pacemaker detection logic." The other attributes in the table represent direct comparisons of specifications between the modified device and the predicate.

Study Information

The provided text offers very limited details about the actual study conducted to validate the modified pacemaker detection logic. Here's what can be inferred:

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

   • Sample size: Not specified.
   • Data provenance: Not specified. It's unclear if the data was retrospective or prospective, or its country of origin.

2. 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):

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

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

   • Not specified.

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:

   • No, an MRMC comparative effectiveness study was not done. The document explicitly states that "ECG analysis is not a part of this device, but rather is performed by software installed in the Holter Analyzer which is subject to independent 510(k) review, as in the Company's earlier filing (K990956)." This indicates the DXP1000 is a recorder only, and any AI/analysis component would be in separate software. Therefore, there's no mention of human readers or AI assistance effect sizes for this specific device.

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

   • Yes, a standalone validation of the "pacemaker detection logic" was performed. The text states, "the methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein." This validation pertains to the device's inherent capability to detect pacemakers.

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

   • Not explicitly stated. Given it's pacemaker detection, the ground truth would likely involve expert review of ECG traces or potentially verified pacemaker presence/absence records coupled with ECG data where pacemaker spikes are either known to be present or absent.

7. The sample size for the training set:

   • Not specified. The document focuses on validation of a modified logic, implying existing development, but does not detail a training set for a new AI model.

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

   • Not specified. Assuming any "training" (if applicable, perhaps during the initial development of the pacemaker detection logic in the predicate device or an earlier iteration) involved expert review of annotated ECG waveforms.

In summary: The provided text is a 510(k) summary for a modified Holter recorder. It focuses on physical changes to the device and a slight modification to the pacemaker detection logic. While it states this logic was "validated," it provides minimal details regarding the methodology, sample sizes, ground truth establishment, or expert involvement in that validation study. The document explicitly differentiates this recorder from the ECG analysis software, which would be subject to separate review and where more detailed performance studies for algorithms might be expected.

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The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently, the ECG is the most prominent and widely used non-invasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data which provides a powerful basis for evaluation of these biophysical signals. Twenty-four or forty-eight hour ECG recordings can be of great value in patient assessment.

Ambulatory (Holter) ECG intended use:

The DigiTrakPlus Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below.

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.

2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.

3. Evaluation of patients for ST segment changes.

4. Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)

5. Clinical and epidemiological research studies.

• 6. Evaluation of patients with pacemakers
• 7. Reporting of time and frequency domain heart rate variability

8. Reporting of QT Interval

The essence of this modification is a change of the digital Holter recorder hardware to a smaller configuration with reduced power consumption and the removal of ECG analysis capabilities from the device. In connection with this modification, the methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein. As a result of this modification, ECG analysis is not a part of this device, but rather is performed by software installed in the Holter Analyzer which is subject to independent 510(k) review, as in the Company's earlier filing (K990956).

The provided text does not contain detailed information regarding acceptance criteria for device performance, nor a study proving the device meets said criteria in the format requested. The document is a 510(k) summary for a medical device (DigiTrakPlus Holter Recorder) indicating its substantial equivalence to a predicate device.

The summary focuses on:

• Modification Background: Changes to the device (smaller hardware, reduced power, removal of on-board ECG analysis) and validation of pacemaker detection logic.
• Comparison to Predicate Device (Model #1005): A table outlining differences in physical attributes and features.
• Regulatory Information: FDA’s determination of substantial equivalence and related regulatory details.
• Indications for Use: The intended applications for the Holter recorder.

Therefore, I cannot populate the table and answer the study-related questions as the information is not present in the provided text.

Specifically, the text is missing:

1. A table of acceptance criteria and reported device performance: While a comparison table to the predicate is given, it lists product attributes, not performance metrics against acceptance criteria.
2. Sample size used for the test set and data provenance: No information about a test set is provided.
3. Number of experts used to establish ground truth and their qualifications: Not mentioned.
4. Adjudication method: Not mentioned.
5. MRMC comparative effectiveness study: Not mentioned, and the device doesn't perform AI-assisted analysis.
6. Standalone performance (algorithm only): The device's on-board ECG analysis was removed. While "pacemaker detection logic has been modified slightly, and its performance validated," no specific performance metrics or standalone study details are given.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not mentioned.
9. How ground truth for the training set was established: Not mentioned.

The document states that the "methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein." However, the "reporting herein" refers to an attached document that is not provided.

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To RECORD INFREQUENT AND ELUSIVE ECG HEART ARREHYTHMIA DATA. ONCE THE EVENT IS RECORDED PATIENTS TRANSMIT THE RECORDED ECG DATA OVER THE TELEPHONE, OR, AS AN ALTER NATE, THE ER 700 SERIES ALLOWS THE ECG DATA To BE TRANSFERRED DIRECTLY To A HOST PC IF THE PATIENT RETURNS THE UNIT To THE CLINIC.

The ER700 Series is a family of patient-activated ambulatory electrocardiograph event recorders.

The provided text is a 510(k) summary for the Braemar ER700 Series Ambulatory ECG Event Monitor. It focuses on establishing substantial equivalence to a predicate device (Braemar ER300 Series) rather than detailing a study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance evaluation is not available in the given document.

However, I can extract the following information:

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

The document does not explicitly list acceptance criteria with corresponding performance data. Instead, it provides a comparison table between the ER700 Series and its predicate device (ER300 Series) based on device attributes for the purpose of demonstrating substantial equivalence.

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 document. The 510(k) summary focuses on comparing device specifications rather than reporting on a clinical trial or performance study with a test set.

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 document.

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

This information is not provided in the document.

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 provided in the document. The device described appears to be an ECG event monitor, not an AI diagnostic tool that would typically involve human readers interpreting AI outputs.

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

This information is not provided in the document. The ER700 Series is a patient-activated ambulatory ECG event recorder. While it records ECG data, the document doesn't discuss any specific algorithms for standalone diagnostic performance beyond data recording and transmission.

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

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Summary of what the document does provide regarding device evaluation:

The document serves as an FDA 510(k) premarket notification. Its primary purpose is to demonstrate that the Braemar ER700 Series Ambulatory ECG Event Monitor is substantially equivalent to a legally marketed predicate device, the Braemar ER300 Series (K923930). The evaluation provided is a comparison of attributes and intended use between the new device and the predicate.

The intended use of the ER700 Series is "To record infrequent and elusive ECG heart arrhythmia data. Once an event is recorded, patients transmit the recorded ECG data over the telephone, or, as an alternate, the ER700 Series allows the ECG data to be transferred directly to a host PC if the patient returns the unit to the clinic." This intended use is assessed against the predicate's intended use to ensure they are the same or very similar.

The document highlights differences and similarities in device features, such as the presence of an LCD, memory type, number of ECG channels, data transfer methods, and battery type. The rationale for substantial equivalence is based on these technical comparisons, implying that any differences do not raise new questions of safety or effectiveness.

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