Search Results

The HeartBeam AIMIGo™ System is a portable non-invasive recorder intended to record, store, and transfer a patient's 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional.

The HeartBeam AIMIGo™ System captures a 3-lead (in three-directions) electrocardiogram (ECG) recording of patients who have been prescribed a HeartBeam AIMIGo™ System for recording an ECG remotely. The HeartBeam AIMIGo™ System records and transmits the 3lead ECG signal which can be displayed as rhythm strips on a compatible ECG viewer. The HeartBeam AIMIGo™ System does not provide any analysis of the ECG data nor provide any recommendation toward a clinical diagnosis and is not intended to be used with automated ECG analysis systems. It reports a series of 3-lead ECG rhythm strips for manual interpretation. The hardware platform is designed to be functional and effective with any compatible software designed for the purpose of displaying ECG waveforms for clinical review. The HeartBeam AIMIGoTM System will be provided by prescription only.

The system allows the patient (or their caregiver or healthcare provider) the capability to perform the following:

• . Record a 3-lead (in three-directions) ECG with the recording device and accompanying mobile Patient Application
• Transmit the recorded 3-lead ECG signal to the cloud server, which can then be accessed ● by a clinician via the Clinician Portal for review and manual interpretation.

Filters applied may impact the ECG signal morphology, including significant attenuation of lowlevel atrial activity (P-waves / Flutter-waves), which may result in inability to discriminate certain types of arrhythmias (e.g., Atrial Fibrillation/Atrial Flutter).

The ECG report produced by HeartBeam AIMIGo is not intended for analysis of the T-wave or other morphological ECG evaluation.

The AIMIGo device is not intended for patients with tremors and/or those unable to place and maintain the device in the correct position for the duration of the recording.

The provided text addresses the clinical study, but lacks specific details on the acceptance criteria and the comprehensive study data. Based on the information available, here's a breakdown of what can be inferred and what is missing:

The HeartBeam AIMIGo™ System Clinical Study Summary

The HeartBeam AIMIGo™ System underwent two clinical studies to support its 510(k) submission, confirming its substantial equivalence to the predicate device (AliveCor KardiaMobile 6L) and a reference device (VectraCor Universal Smart ECG).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of acceptance criteria with corresponding performance metrics. It indicates that "All study endpoints were met" for both clinical studies, implying that the device's performance reached the predefined success criteria. However, the specific metrics and targets are not detailed.

Inferred Performance Goals (based on study objectives):

• Pivotal Study: To demonstrate clinical equivalence of ECG waveforms between AIMIGo 3-L VECG and reference standard 12-L ECG for interpretation of non-life-threatening arrhythmias. This implies high level of agreement or correlation in ECG waveform morphology and characteristics relevant for arrhythmia detection.
• Device Positioning Validation Study: To validate that within a predetermined range of distance, direction, and orientation from the recommended position, the AIMIGo 3L VECG output signal characteristics remain unaffected when compared to a simultaneously recorded standard 12L ECG signal, for interpretation of non-life-threatening arrhythmias. This suggests performance robustness under varied positioning.

Observed Device Performance:

• "All study endpoints were met" for both the Pivotal Study and the Device Positioning Validation Study. This is the only reported device performance.

Table Structure (Hypothetical, as specific criteria are not provided):

Ask a specific question about this device

The ASSURE Wearable ECG is indicated for adult patients who have been prescribed this device by a medical professional, who were previously prescribed the ASSURE WCD system, and who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, presyncope, syncope, fatigue, or anxiety. The signal acquired by the ASSURE Wearable ECG is not intended and should not be used for automated or semi-automated analysis. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support.

The ASSURE Wearable ECG is contraindicated for use in patients with an active implantable pacemaker or defibrillator.

The ASSURE Wearable ECG is a reusable, ambulatory electrocardiography-based, cardiac- and physiologicmonitoring, medical-electrical system whose intended purpose is to inform clinical management of options for diagnosing, monitoring and/or mitigating cardiac conditions after patient's improvement following ASSURE® Wearable Cardioverter Defibrillator (WCD) prescriptive use. The system utilizes the same five-electrode SensorFit™ Garment worn previously with the WCD prescription. The system continuously records ECG data and upon detection, it identifies and records episodes as high and low heart rate, as well as patient-triggered events. The system utilizes the same algorithm detection and episode reporting software marketed in the ASSURE WCD with high (Tachy) and low (Brady) capture for later transmission to the medical professional for interpretation. The system captures and stores ECG episodes, and non-ECG patient activity and wear information to be displayed and reported in counters and trends. Recorded events include ECG waveforms and reports identifying high and low heart rates, as well as patient-triggered events. The system uses a 3axis accelerometer to monitor non-ECG patient activity (steps and wear time).

The ASSURE Wearable ECG event reports do not contain diagnostic interpretation. The reported events are provided for review by the prescriber to assist in diagnosis of the recently transitioned WCD patient and to assess care options based on the healthcare professional's judgment and experience.

The ASSURE Wearable Cardiac ECG is a prescription use device. The ASSURE Wearable ECG is intended for use by a patient during their normal daily activities primarily in the home or community setting, but also hospitals, medical clinics, healthcare facilities and transport. The device is non-invasive, and intended to be used on one patient at a time.

The Wearable Cardiac ECG System is comprised of the following reusable patient-worn components:

• Monitor Cable Assembly
• Hub
• Alert Button
• Battery Pack
• SensorFit™ Garment
• Charger

The Kestra Medical Technologies, Inc. ASSURE Wearable ECG (K233864) does not appear to have an artificial intelligence/machine learning component that offers diagnostic interpretation. The provided text states, "The signal acquired by the ASSURE Wearable ECG is not intended and should not be used for automated or semi-automated analysis. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements, or provide for any life support." and "The ASSURE Wearable ECG event reports do not contain diagnostic interpretation." Therefore, the typical acceptance criteria and study designs for AI/ML devices might not be applicable in the usual sense.

However, based on the information provided, here's a breakdown regarding the device's technical performance and regulatory compliance, reinterpreting "acceptance criteria" through the lens of general medical device performance and safety standards:

1. Table of Acceptance Criteria and Reported Device Performance

Since the device explicitly states it does not perform automated or semi-automated analysis or provide diagnostic statements, traditional AI/ML performance metrics like sensitivity, specificity, or AUC against a ground truth would not be applicable here. Instead, the acceptance criteria are focused on the device's ability to reliably act as a continuous ECG monitor, data recorder, and transmitter, and its compliance with relevant safety and performance standards.

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

The provided text does not explicitly state the sample size for any clinical or technical test sets involving patient data. The performance section focuses on bench testing against recognized standards. There is no mention of a separate "test set" in the context of diagnostic accuracy from patient data, as the device doesn't provide diagnostic interpretation.

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

This information is not applicable as the device explicitly states it does not perform automated or semi-automated analysis or provide diagnostic statements. The "ground truth" here is primarily established by adherence to engineering and safety standards, and functional verification through bench testing. Clinical interpretation of the recorded ECG data is left to medical professionals.

4. Adjudication Method for the Test Set

This information is not applicable given the device's stated function and the type of performance testing described (bench testing against engineering standards, not diagnostic accuracy studies requiring expert adjudication).

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

No, a MRMC comparative effectiveness study was not conducted or described. The device's function is to record ECG data, not to interpret it or assist human readers in interpretation. There is no AI component in this device that provides diagnostic assistance to a human reader.

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

While the device uses an "embedded arrhythmia detection algorithm" for auto-triggering events (high and low heart rates), the submission explicitly states that the signal "is not intended and should not be used for automated or semi-automated analysis" and "does not deliver...interpretive or diagnostic statements." Therefore, a standalone performance study in the sense of evaluating the diagnostic accuracy of an AI algorithm was not performed because the device does not claim diagnostic capabilities. Its "algorithm detection and episode reporting software" is for capture and storage of events for later clinician review, not for automated diagnosis.

7. Type of Ground Truth Used

For the functional aspects (ECG monitoring, event triggering, data storage/transmission), the "ground truth" would have been established through instrumentation calibration, controlled simulated signals, and direct measurement during bench testing, verifying that the device accurately records ECG, identifies specified rate thresholds, and transfers data as intended. For the safety and performance standards (e.g., IEC 60601 series), the ground truth is adherence to the requirements and test methods outlined in those international standards.

8. Sample Size for the Training Set

This information is not applicable. The device, as described, does not utilize machine learning/AI for diagnostic purposes, and therefore would not have a "training set" in the context of developing a diagnostic algorithm. The "proprietary algorithm detection software" for event triggering, while an algorithm, is not presented as a machine learning model requiring a training set for diagnostic output.

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

This information is not applicable. As no machine learning-based diagnostic algorithm is described, there is no "training set" or corresponding ground truth establishment process mentioned.

Ask a specific question about this device

The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient's electrocardiogram. The recorder is intended to be used by either paediatric or adult patients suspected of cardiac arrhythmias in either a clinical setting or at home. The recorder does no cardiac analysis and is used with Spacelabs Ambulatory ECG Analysis Software.

The Eclipse MINI Model 98900 (Eclipse MINI) is an ambulatory electrocardiograph (ECG) recorder capable of providing a 3-lead recording. It is connected to the patient using a custom, disposable, single-patient only, 3-lead sensor patch that is adhesively attached to the patient's chest. The Eclipse MINI is powered by batteries that are integrated in the Eclipse Sensor Patch. These batteries are primary cells which cannot be recharged and power the recorder for up to 15 days. For an extended recording multiple Eclipse Sensor Patches may be required. The single patient event button allows the patient to indicate symptomatic episodes in the recording for correlation with the patient diary. The Eclipse MINI is fully sealed and waterproof. The Eclipse MINI is attached to the "holster" of the Eclipse MINI Sensor Patch by inserting the USB connector on the sensor patch into the USB receptacle on the bottom of Eclipse MINI housing. Patient data from the Eclipse MINI is downloaded to a PC upon which the Spacelabs Sentinel Cardiology Information Management System (Sentinel), cleared in 510(k) submission K152881, has been installed. This allows the clinician to download, view, and analyze patient data from the Eclipse MINI, and create reports. Further analysis of these patient data can be performed by using Spacelabs Pathfinder SL Holter Analyzer (cleared in 510(k) submission K110001) and/or Spacelabs Lifescreen PRO Analyzer (cleared in 510(k) submission K201921). Finally, a non-medical device mobile phone app is available for patient use as an electronic note taking option in lieu of a manual, written patient diary.

This is a 510(k) premarket notification for the Spacelabs Eclipse MINI Model 98900. A 510(k) submission generally aims to demonstrate substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study for a novel device. The document primarily focuses on demonstrating that the Eclipse MINI Model 98900 is substantially equivalent to the Reynolds Medical Ltd. Lifecard CF 7-Day Holter Recorder (K011837) based on technological characteristics and performance testing in accordance with regulatory standards.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, in the typical sense of a clinical trial for a new device, is not fully applicable or explicitly detailed in this 510(k) summary. The "acceptance criteria" here largely refer to meeting recognized standards for safety and performance to demonstrate substantial equivalence.

Here's an attempt to extract and interpret the information based on the provided document within the context of a 510(k) submission:

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

The document does not present a single table of "acceptance criteria" and "reported device performance" in the way one might expect for a specific clinical endpoint. Instead, the device's performance is demonstrated through compliance with various national and international standards and internal requirements, and by performing comparably to the predicate device.

The "Technology Comparison" table (page 5) lists various characteristics and indicates that the Eclipse MINI's performance is consistent with these standards and the predicate. The "Summary of Performance Testing" sections (pages 6 and 7) state that the device "complies with internal requirements, applicable Standards, and the guidance document."

Here is a summary of the broad performance areas and the reported compliance:

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 a way that relates to a "test set" for a diagnostic study. The performance testing described (shelf-life, biocompatibility, software V&V, electrical safety, EMC, bench performance) are engineering and laboratory tests, not clinical studies with a patient test set in the traditional sense. Therefore, details like "sample size used for the test set" and "data provenance" (country/retrospective/prospective) are not applicable or detailed for this type of submission.

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 device, the Eclipse MINI Model 98900, is an ECG recorder and "does no cardiac analysis" itself. It is used with "Spacelabs Ambulatory ECG Analysis Software" (which would have its own clearances, e.g., K152881, K110001, K201921). As such, it is not a diagnostic algorithm that provides an output requiring ground truth established by experts. Its function is to accurately record ECG data, and its performance is assessed against technical standards for signal acquisition and safety, not diagnostic accuracy. Therefore, this information is not applicable to the device described.

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

Not applicable, as there is no diagnostic "test set" and no "ground truth" adjudicated by experts for this recording device as described in the submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an ECG recorder and not an AI/CADe/CADx system. No MRMC study or AI assistance improvement is mentioned or relevant to the device's function.

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

Not applicable. This device is an ECG recorder, not an algorithm, and performs "no cardiac analysis."

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

Not applicable. As described in points 3, 4, 5, and 6, this device does not perform analysis that would require a ground truth for diagnostic accuracy. Its "ground truth" for performance is compliance with engineering and safety standards, and reliable recording of ECG data.

8. The sample size for the training set

Not applicable. This device is primarily hardware an embedded software for recording. It is not an AI/machine learning model that requires a training set. The software mentioned is developed through robust software development processes (as noted in the "Software" testing section) and validated against specifications, not "trained" on a data set in the ML sense.

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

Not applicable, as there is no training set for an AI/ML model for this device.

Ask a specific question about this device

The Biotres is indicated for use on adult patients 18 years or older who may be asymptomatic or who suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety and may require cardiac recording on a continuous basis for up to 30 days. The signal acquired by the Biotres is not intended and should not be used for automated or semi-automated analysis.

The Biotres system consists of 1) the Biotres Recorder, 2) a dedicated Biotres AC wall charger, 3) Biotres Gateway application for use on mobile devices using Android or iOS, and 4) Biotres Configured Secure Server. The Biotres Recorder is an ECG recording only device and does not include ECG analysis, alarms and is not a real time ECG monitor. The Biotres recorder is a small, lightweight, ambulatory, reusable 3 channel ECG recorder that is placed on the center of the chest. The Biotres Recorder has two buttons: 1) power button and 2) patient event marking button. There is an LED "status indicator light" in the middle of the patient event marking button that provides recorder status indications. The Biotres Recorder attaches to the patient's chest through three standard commercially available ECG electrodes. Biotres includes a Bluetooth modem to communicate with the Biotres Configured Secure Server through the Biotres Gateway Application. The Biotres Recorder integrated memory can store up to 30-days of ECG data. This data can be uploaded by the clinician to the Biotres Configured Secure Server. The dedicated Biotres AC Wall charger is used to charge the Biotres Recorder daily when disconnected from the patient. The ECG recorded data is transferred via the Biotres Gateway App via a Bluetooth connection and subsequently to the Biotres Configured Secure Server. Clinicians can use the Biotres Gateway Application using their privileged login credentials to connect Biotres Recorders to the Biotres Configured Secure Server so that patient studies may be started and completed. The Biotres Gateway Application can be used by the patient once registered (nonprivileged login credentials) and the patient can use the application to monitor the status indicators of the Biotres Recorder and to enter symptoms if the Event Marking Button is pressed on the recorder. The ECG recorded data from the Biotres Recorder can be transferred, by the clinician, from the Biotres Configured Secure Server when the recorder is connected to the Biotres Gateway App at the end of a patient study. The Biotres Configured Secure Server is an SFTP server that is configured to work with the Biotres System. The server enables the Clinician, through secured login, to command the Biotres Recorder (e.g. initiate ECG data collection) and to access uploaded MIT16 ECG data recordings when the ECG data collection is complete. Biotres does not provide the patient or clinician with diagnostic or interpretive statements based on the ECG data. Biotres ECG recordings can be viewed through the Bioflux Software II (K201040) by qualified medical personnel.

The provided text is a 510(k) summary for the Biotres device. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, this document does not contain the detailed clinical study information typically found when proving a device meets specific acceptance criteria through performance data.

The crucial piece of information for your request is that the Biotres device is not an AI or algorithmic analysis device. The text explicitly states: "The signal acquired by the Biotres is not intended and should not be used for automated or semi-automated analysis." Its purpose is to record ECG data for up to 30 days, which is then to be reviewed and interpreted by qualified medical personnel using an ECG viewer software.

Therefore, the concepts of acceptance criteria for algorithmic performance, sample sizes for AI test sets, expert ground truth establishment for AI, MRMC studies, or standalone algorithm performance do not apply to this device as described.

The performance testing mentioned (IEC 60601-2-47:2012) is a standard for basic safety and essential performance of ambulatory electrocardiographic systems, which typically involves testing electrical safety, signal quality, and functional parameters, not the accuracy of an AI algorithm in detecting or classifying conditions.

Given this, I cannot fill in the requested table and details for the points related to AI/algorithmic performance because the device, as described, does not perform automated or semi-automated analysis that would require such validation.

However, I can provide what is present in the document.

Based on the provided document, the Biotres device is a medical magnetic tape recorder (ECG recorder) and explicitly states it is NOT intended for "automated or semi-automated analysis." Therefore, the detailed acceptance criteria and study proving algorithmic performance (as typically seen in AI/ML medical devices) are not applicable or present in this 510(k) summary.

The device's performance is established through substantial equivalence to a predicate device (K211709) and compliance with relevant safety and performance standards for ECG recording devices.

Below is information that can be extracted or inferred from the document, with explanations for why certain requested fields cannot be filled:

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

   Given that this device is a recorder and not an analytical AI tool, there are no acceptance criteria for algorithmic performance (e.g., sensitivity, specificity, AUC for disease detection). The "performance" as described is its ability to record ECG data and meet general safety and essential performance standards.

   Acceptance Criteria (Inferred for a Recorder)	Reported Device Performance (Summary)
   Basic Safety and Essential Performance	Device passed IEC 60601-2-47:2012
   Ability to record 3-lead ECG data	Records 3-lead ECG, continuous
   Recording duration	Up to 30 days
   Defibrillator Protection	Not Defibrillator Proof (IEC 60601-1 passed)
   Data Transfer	Via Bluetooth to Biotres Gateway App, then to Secure Server
   Charging	Via dedicated AC wall charger; USB for charging
   Physical form factor	Small, lightweight, body-worn ambulatory cardiac monitor
   Interface	Power button, patient event marking button, LED indicator

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

   Not applicable in the context of AI/ML performance testing for this device. The document mentions general "performance and safety tests" (IEC 60601-2-47:2012) but does not detail a "test set" in the sense of a dataset for algorithmic validation. Device testing for hardware and basic functionality typically uses a limited number of physical units, not large patient datasets for performance metrics.

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

   Not applicable. Ground truth for algorithmic performance is not established because the device does not perform automated analysis. The interpretation of the ECG data recorded by Biotres is explicitly left to "qualified medical personnel" and "physician or trained healthcare professional."

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

   Not applicable, as there is no algorithmic test set requiring ground truth adjudication.

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. The device does not provide AI assistance for human readers. Its function is data recording.

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

   No. The device does not have a standalone algorithm for diagnostic performance.

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

   Not applicable, as there is no algorithmic performance claim that would require ground truth.

8. The sample size for the training set

   Not applicable, as there is no AI algorithm being trained by this device.

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

   Not applicable, as there is no AI algorithm being trained by this device.

Summary of Device Functionality Relevant to the 510(k) Summary:

The Biotres is a hardware device designed to continuously record 3-channel ECG data from adult patients for up to 30 days. It has buttons for power and patient event marking, an LED status indicator, and connects to mobile devices via Bluetooth for data transfer to a secure server. The recorded ECG data is intended for review and interpretation by qualified medical professionals using separate ECG viewing software (Bioflux Software II). The key point reiterated is that the device "is not intended and should not be used for automated or semi-automated analysis." Its 510(k) clearance is based on substantial equivalence to a previously cleared predicate device (K211709) and compliance with general medical device safety and performance standards.

Ask a specific question about this device

The Medicalgorithmics' Q Patch is intended to be used by patients who have a demonstrated need for extended cardiac monitoring and patients with symptoms that may be due to cardiac arrhythmias such as, dizziness, lightheadedness, shortness of breath, palpitations, dyspnea (shortness of breath), anxiety, syncope of unknown etiology in which arrhythmias are suspected or need to be excluded. It is indicated for use on adult patients. The sensor records single ECG channel for up to 15 days and can be used on patients with implanted pacemakers but is not intended to record pacemaker activity.

The Q Patch is a single channel ECG recorder. The device is intended to be placed on the sternum (in the middle of the chest). The Q Patch ECG recorder snaps onto the two off-the-shelf electrodes (Solid gel, Ag/AgCl) and records patient's ECG for up to 15 days powered from single disposable, non-rechargeable battery. The Q Patch Mobile Application is used to initiate recording session, for checking Q Patch status and to finish/stop the session if needed. When the recording is finished, the ECG data stored in Q Patch's memory can be downloaded through a USB port using the Q Patch Downloader (PC application).

The FDA 510(k) clearance document for the Q Patch (K210758) indicates that a clinical study and other performance tests were conducted to demonstrate substantial equivalence to the predicate device. However, the document does not contain a specific table of acceptance criteria and reported device performance metrics in numerical form (e.g., sensitivity, specificity, accuracy) for an algorithm's performance in detecting arrhythmias. This is largely because the Q Patch is described as an "Electrocardiograph, Ambulatory (Without Analysis)," meaning it primarily records ECG data and does not perform automated arrhythmia analysis.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not provide a table with quantitative acceptance criteria and specific algorithm performance metrics for arrhythmia detection (e.g., sensitivity, specificity). The Q Patch is explicitly stated not to include ECG analysis and visualization software as part of this specific product's clearance. It functions as a recorder, and its data can be integrated with third-party analysis software.

The acceptance criteria are implicitly defined by compliance with relevant electrical safety, EMC, software, usability, and biocompatibility standards, and demonstrating comparable performance to the predicate device in ECG recording quality.

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

• Clinical Study for ECG Signal Quality:

  • Sample Size: 30 participants.
  • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It mentions "Clinical study where ECG signals were recorded by the subject device and reference device simultaneously have been performed," which suggests a prospective data collection.

• Electrode Adherence Study:

  • Sample Size: 18 participants.

• Usability Testing:

  • Sample Size: 60 participants.

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

For the clinical study on ECG signal quality:

• The document states: "It has been demonstrated that non-standard ECG lead recorded by the Q Patch device is appropriate for ECG evaluation performed by the trained human interpreter."
• It further clarifies: "Potential patient cardiac abnormalities, must be confirmed by a qualified ECG technician or by a physician with other relevant clinical information."
• The number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") are not specified in the provided text for establishing ground truth within the clinical study. It generally refers to "trained human interpreter," "qualified ECG technician," or "physician."

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the clinical study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No MRMC study involving AI assistance: The document states that "The subject device acquires ECG data and does not perform automatic arrhythmia analysis." Therefore, a comparative effectiveness study involving AI assistance for human readers is not applicable as the cleared device does not have an AI analysis component.
• The clinical study compared the Q Patch's ECG signal quality against a "reference device" for human interpretation, not with or without AI assistance.

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

• No standalone algorithm performance study: As the device "does not perform automatic arrhythmia analysis," a standalone algorithm performance study is not applicable. The device's primary function is ECG recording.

7. The Type of Ground Truth Used

• For the ECG signal quality clinical study: The ground truth appears to be based on human interpretation of the ECG signals by "trained human interpreter," "qualified ECG technician," or "physician," potentially against findings from a "reference device." This implies a form of expert consensus or comparison to a gold standard from the reference device, though specific details are lacking.

8. The Sample Size for the Training Set

• The document does not indicate any training set as the Q Patch "does not perform automatic arrhythmia analysis" and is not an AI/algorithm-based diagnostic device. The studies described are for hardware performance, signal quality, usability, and biocompatibility.

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

• Not applicable, as there is no mention of a training set for an algorithm.

Ask a specific question about this device

The Biotres is indicated for use on adult patients 18 years or older who may be asymptomatic or who suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, fatigue, chest pain and/or anxiety and may require cardiac recording on a continuous basis for up to 30 days. The signal acquired by the Biotres is not intended and should not be used for automated or semi-automated analysis.

The Biotres system consists of 1) the Biotres Recorder, 2) a dedicated Biotres AC wall charger, 3) Biotres Gateway application for use on mobile devices using Android or iOS, and 4) Biotres Configured Secure Server.

Biotres Recorder: The Biotres Recorder is an ECG recording only device and does not include ECG analysis, an ECG viewer/EGG display, alarms and is not a real time ECG monitor. The Biotres recorder is a small, lightweight, ambulatory, reusable 3 channel ECG recorder that is placed on the center of the chest.

Biotres AC Wall Charger: The dedicated Biotres AC Wall charger is used to charge the Biotres Recorder daily when disconnected from the patient.

Biotres Gateway Application: The ECG recorded data is transferred via the Biotres Gateway App (Downloaded from the app store for iOS or Android respectively) via a Bluetooth connection and subsequently to the Biotres Configured Secure Server.

Biotres Secure Server: The Biotres Configured Secure Server is an SFTP server that is configured to work with the Biotres System. The server enables the Clinician, through secured login, to command the Biotres Recorder (e.g. initiate ECG data collection) and to access uploaded MIT16 ECG data recordings when the ECG data collection is complete.

This FDA 510(k) submission for the Biotres device does not include the detailed information required to describe acceptance criteria and associated study results for an AI/ML powered device. The Biotres is described as an ECG recording-only device that does not include ECG analysis, an ECG viewer/display, alarms, or real-time ECG monitoring. It explicitly states: "The signal acquired by the Biotres is not intended and should not be used for automated or semi-automated analysis."

Therefore, the following information cannot be extracted from the provided document:

1. A table of acceptance criteria and the reported device performance: Not applicable, as there are no automated analysis functionalities to evaluate.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on regulatory clearances, device description, comparison to a predicate device (ePatch), and performance testing related to electrical safety, electromagnetic compatibility, usability, and biocompatibility, as well as bench tests verifying ECG signal recording and transmission capabilities. These are standard tests for a medical device that records data but does not perform automated analysis.

Ask a specific question about this device

The Spacelabs Model 98700 is a portable non-invasive Holter recorder intended to record the patient's ambulatory electrocardiogram. The device is intended to be used by either pediatric or adult patients in either or at home. The device does no cardiac analysis and is used with a Holter Analysis System.

The Eclipse PRO Model 98700 (Eclipse PRO) is an ambulatory electrocardiograph (ECG) recorder capable of providing a true 12-channel recording for up to 72 hours or a 3-lead recording for up to 14 days. It is connected to the patient using Eclipse PRO-specific 3, 4, or 10 lead wire cables with the recorder located in a pouch on a lanyard.

The Eclipse PRO has a large, color display which allows the user to view recorder status, configure the recorder and to view ECG lead application.

It has an internal, fast-charge, long-life, rechargeable lithium-ion battery, which is charged when connected by a cable between the USB port of a personal computer (PC) or a USB charger, and the recorder's USB-C connector.

Two (2) arrow keys on the front of the Eclipse PRO are used to navigate and select options in the recorder's menu or as a patient event button when the patient desires to indicate symptomatic episodes in the recording.

The Eclipse PRO is fully sealed and waterproof.

Patient cables are attached to the Eclipse PRO using the USB connector on the bottom of the housing and protective cable retention loop.

Patient data from the Eclipse PRO is downloaded to a PC upon which the Spacelabs Sentinel Cardiology Information Management System (Sentinel), cleared in 510(k) submission K152881, has been installed. This allows the clinician to download, view, and analyze patient data from the Eclipse PRO, and create reports. Further analysis of these patient data can be performed by using Spacelabs Pathfinder SL Holter Analyzer (cleared in 510(k) submission K110001) and/or Spacelabs Lifescreen PRO Analyzer (cleared in 510(k) submission K201921).

Finally, a non-medical device mobile phone app is available for patient use as an electronic note taking option in lieu of a manual, written patient diary.

The Spacelabs Eclipse PRO Model 98700 is an ambulatory electrocardiograph (ECG) recorder. The provided text outlines its characteristics and the performance testing conducted to demonstrate its substantial equivalence to the predicate device, Reynolds Medical Ltd. Lifecard CF 7 Day (K011837).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly list "acceptance criteria" in a quantitative, metrics-based format for the overall device performance in recording ECGs. Instead, it focuses on demonstrating compliance with various regulatory standards and guidance documents, and technological equivalence to the predicate device. The performance testing section primarily reports that the device "complies" with these standards.

However, based on the "Technology Comparison" table, we can infer some functional acceptance criteria by comparing the proposed device against the predicate.

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

The provided document describes performance testing related to device functionality, electrical safety, EMC, software validation, and biocompatibility, but does not detail any clinical study or human subject trial for evaluating ECG recording performance. Therefore, there is no information on a "test set sample size" or "data provenance" related to patient data evaluation. The tests mentioned are primarily bench tests, engineering validations, and compliance checks against regulatory standards.

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)

As no clinical test set using patient data is described, this information is not applicable and not provided in the document. The performance evaluation focuses on technical compliance, not diagnostic accuracy requiring expert interpretation.

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

Since no clinical test set involving human interpretation of data is described, an adjudication method is not applicable and not provided.

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

The device described, Spacelabs Eclipse PRO, is a Holter recorder that "does no cardiac analysis" and is "used with a Holter Analysis System." The document explicitly states it's a recorder, not an analytical or AI-assisted diagnostic tool. Therefore, no MRMC comparative effectiveness study with AI assistance was performed or is relevant to this device.

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

As the device itself "does no cardiac analysis" and is a pure recorder, there is no algorithm for standalone performance to be evaluated. This question is not applicable to this device.

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

For the technical performance testing (biocompatibility, software, electrical safety, EMC, bench performance), the "ground truth" used is compliance with established international standards and FDA guidance documents (e.g., ISO 10993-1, IEC 62304, IEC 60601 series). For the functional comparison, the "ground truth" for substantial equivalence is the predicate device's characteristics and specifications. There is no clinical data 'ground truth' in the context of expert diagnosis or patient outcomes.

8. The sample size for the training set

Since this is a medical device (Holter recorder) and not an AI/ML-based diagnostic algorithm, there is no concept of a "training set" as would be applicable to machine learning.

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device

The Integrated CardioRespiratory (ICR) System, when used with ICR Acoustic Sensors and ECG Sensor Electrodes on the chest wall, is intended for use in acquiring and analyzing heart sound data and computing and reporting an estimate of left ventricle Ejection Fraction that is comparable to that derived by 2-D echocardiography. The device is not intended for continuous monitoring of Ejection Fraction.

The ICR System is not intended as a sole means of diagnosis. It does not supersede the judgment of the qualified medical personnel. The ICR System is intended to aid the physician in the evaluation of heart function. The interpretation of EF values offered by the ICR System are only significant when used in conjunction with physician over-read as well as consideration of all relevant patient data.

Indicated for use in adults only. The ICR System is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.

The Integrated CardioRespiratory (ICR) System is a non-invasive skin adhering sensors and computer based device that allows for measurement of Ejection Fraction (EF). The ICR System includes four acoustic sensors and ECG electrodes that are placed on the patient's chest to collect signals, which are combined to compute the EF percentage value. The ICR System performs signal processing computation to identify and characterize amplitude and time of event characteristics of S1 and S2 heart sounds. The computed EF percentage value is presented to the clinician on the ICR Patient Monitor display.

The ICR System consists of the following components:

1. ICR Acoustic Sensors
2. ECG Sensor Electrodes
3. ICR Sensor Application System
4. ICR Patient Monitor

Here's an analysis of the provided text to extract information regarding the acceptance criteria and the study proving the device meets them:

Disclaimer: The provided text is a 510(k) summary, which is a regulatory document. It summarizes the device, predicate devices, and testing performed to demonstrate substantial equivalence. It does not typically contain the detailed raw data or full study reports that would include specific acceptance criteria thresholds or comprehensive statistical results for every performance metric. Therefore, some information requested might not be explicitly present and can only be inferred or stated as "not specified."

Acceptance Criteria and Device Performance

The document broadly states that the device was evaluated for "equivalence to the Echocardiography method" and "agreement... to cardiac Magnetic Resonance Imaging (cMRI) EF measurements." However, specific numerical acceptance criteria (e.g., "within X% difference" or "sensitivity > Y%") for these comparisons are not explicitly stated in the provided text. The performance is summarized qualitatively as "comparable" and "low and acceptable variability."

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: "A total of 81 patients who arrived at the healthcare facility for some cardiac condition were enrolled."
   • Data Provenance:
     • Country of Origin: Not specified in the provided text.
     • Retrospective or Prospective: Not explicitly stated, but the phrase "patients who arrived at the healthcare facility for some cardiac condition were enrolled" suggests a prospective enrollment for the study.

2. 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: The ground truth methods were "2-D echocardiography" and "cardiac Magnetic Resonance Imaging (cMRI)". These procedures are performed and interpreted by trained medical professionals (e.g., cardiologists, sonographers, radiologists). The document refers to "qualified medical personnel" in the Indications for Use, but doesn't specify expert qualifications for ground truth establishment.

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

   • Not specified. The ground truth was established by comparison to echocardiography and cMRI, implying these methods served as the reference standard rather than human adjudication of the device's output.

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:

   • MRMC Study: No. The study described is a direct comparison of the device's output (EF) against established medical imaging methods (echocardiography and cMRI), not an evaluation of human reader performance with and without AI assistance.
   • Effect Size: Not applicable, as no MRMC study was performed to assess human reader improvement.

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

   • Yes. The "measurement validation study" evaluated the "equivalence of the ICR System to the Echocardiography method" and "agreement... to cardiac Magnetic Resonance Imaging (cMRI) EF measurements." This inherently describes the algorithm's performance in estimating EF independently, as its output (the EF percentage value) is directly compared to the reference standards. The device's output is "presented to the clinician on the ICR Patient Monitor display," meaning the algorithm generates the EF value.

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

   • The primary ground truths were 2-D Echocardiography and Cardiac Magnetic Resonance Imaging (cMRI) EF measurements. cMRI is explicitly stated as "considered the gold standard for EF assessment."

7. The sample size for the training set:

   • Not specified. The document only details the clinical study for the test set (81 patients). Information about the training set size or methodology is not included in this 510(k) summary.

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

   • Not specified. As the training set size and details are not provided, how its ground truth was established is also not mentioned.

Ask a specific question about this device

The NR recorder is intended for patients requiring: · Ambulatory (Holter) monitoring · Use within the physician office setting by the medical professional ECG monitoring (using Bluetooth communication) - Resting - Telemetry ECG monitoring (using Bluetooth communication) Such monitoring is most frequently used for the indications below: · Evaluation of symptoms suggesting arrhythmia or myocardial ischemia · Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients · Evaluation of patients for ST segment changes · Evaluation of a patient's response after resuming occupational activities (for example, after myocardial infarction or cardiac surgery) · Clinical and epidemiological research studies · Evaluation of patients with pacemakers · Reporting of time and frequency domain heart rate variability · Reporting of QT interval

NR Recorder

This FDA 510(k) clearance letter (K161062) for the Norav Medical GmbH NR Recorder does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria.

The document primarily focuses on:

• Approval of the 510(k) submission: Stating that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory compliance: Reminding the company of general controls provisions and other applicable regulations (e.g., registration, listing, labeling, adverse event reporting, good manufacturing practice).
• Indications for Use: Describing the intended clinical applications for the NR Recorder.

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

To fulfill your request, I would need a more detailed technical document, such as the full 510(k) summary or an associated clinical/performance study report submitted by Norav Medical GmbH to the FDA. These documents typically contain the specific performance metrics, study designs, sample sizes, and ground truth methodologies used to validate the device.

Ask a specific question about this device

The H3+ Holter recorder is intended to acquire, record and store continuous ECG data as directed by a clinician from adult, adolescent, pediatric, infant and neonate patient populations for a maximum recording time of 14 days in a hospital, clinic or home environment. The H3+ performs no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system which will analyze the recorded data. The H3+ data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis. The H3+ Holter Recorder is not a life-supporting device.

The H3+ Holter Recorder is part of a Holter Analysis system. The H3+ Holter Recorder provides multiple channels of continuous multi-day ECG data recording and pacemaker spike detection markers.

The H3+ Holter Recorder is extremely small and lightweight. The H3+ includes a display that allows the clinician to confirm patient identification, preview the waveform, and check the quality of lead connections during patient hook-up. The H3+ also has a patient activated event button which allows the insertion of event marks into the recorded data if directed by the clinician.

The H3+ uses a single battery and stores acquired data in digital form on internal, non-volatile memory. Stored data is then imported for analysis at a compatible Holter analysis system [ e.g. HScribe (K004017) or Vision (K945985)]. The recorded data will remain in memory until it has been cleared by the clinician.

The data provided by H3+ to the Holter Analysis system is used by trained medical personnel to assist in the diagnosis of patient conditions.

The provided text describes the H3+ Holter Recorder (K152626) and its substantial equivalence to a predicate device. However, a detailed study proving the device meets specific acceptance criteria with reported performance metrics is not included in this document. This submission primarily focuses on demonstrating substantial equivalence to a previous version of the H3+ Holter Recorder (K043010) by outlining technological characteristics and compliance with standards.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state acceptance criteria in a table format with reported device performance for specific clinical metrics. Instead, it compares the current device (H3+ version 3.0.0) with its predicate device (H3+ version 2.09) across various technical specifications. The changes are largely related to increased recording duration, updated standards compliance, and minor hardware modifications. The statement "The H3+ was designed and tested for compliance with the applicable clauses of the following standards" implies that meeting these standards serves as the acceptance criteria for technical performance, but no specific performance values are reported against them in this document.

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

The document primarily focuses on technical and regulatory compliance. It does not mention any specific sample size for a test set or clinical data. It explicitly states in Section 5, item 5: "The subject of this premarket notification did not require clinical data to support substantial equivalence." This implies that the testing performed was primarily non-clinical, focusing on engineering validation and adherence to standards. Therefore, information on data provenance (country, retrospective/prospective) is also not available.

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)

Since no clinical data or clinical test set was required for this submission, there is no information regarding the number of experts or their qualifications used to establish ground truth for a test set. The device's output (ECG data) is intended to be reviewed by "trained medical personnel for the purpose of forming a clinical diagnosis," suggesting that human experts interpret the device's output, but this is not part of the device's acceptance criteria study in this document.

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

As no clinical test set requiring adjudication was used for this submission, there is no information on any adjudication method.

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 document describes a Holter recorder, which acquires, records, and stores ECG data. It explicitly states the device "performs no analysis by itself." Therefore, it does not incorporate AI and no MRMC comparative effectiveness study with or without AI assistance was performed or would be relevant to this device's function.

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

The H3+ Holter Recorder is a data acquisition and recording device. It "performs no analysis by itself." Therefore, there is no standalone algorithm performance to report. Its function is to capture data that will then be analyzed by a separate Holter analysis system, with the final interpretation by trained medical personnel.

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

For the technical performance evaluations mentioned (e.g., related to standards compliance), the "ground truth" would be established by the definitions and requirements specified within those engineering and medical electrical equipment standards. For instance, frequency response or signal resolution are directly measurable against predefined norms. Since no clinical claims were made or clinical data was required for this submission, there is no ground truth related to clinical diagnoses (expert consensus, pathology, or outcomes data) established or reported for the device itself.

8. The sample size for the training set

Since this device does not perform analysis and does not incorporate AI or machine learning algorithms, there is no training set used for the device itself.

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

As there is no training set for this device, information on how its ground truth was established is not applicable.

Ask a specific question about this device