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Indications for Use:
The MAC 7 Resting ECG Analysis System is a non-invasive prescription device.

• The device is indicated for use to acquire, analyze, display and print electrocardiograms.
• The device is indicated for use to provide interpretation of the data for consideration by a physician.
• The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
• The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
• The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.

Intended Use:
The MAC 7 Resting ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult or pediatric populations. Basic system simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. Transmission and reception of ECG data and other clinical data to and from a central clinical information system is optional.

The MAC 7 Resting ECG Analysis System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital, medical professional's facility or wherever ECG testing is performed.

The MAC 7 Resting ECG Analysis System is a mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes.

The device can capture 3, 6, 12 or 15 lead electrocardiograms, provide interpretive analysis, and print reports.

The device can connect to a network, either through a wired LAN connection or via wireless WiFi access points. Once on the network, the device can optionally interface with cardiology information systems such as the GEHC MUSE® system to participate in a complete electrocardiology workflow.

The device provides state-of-the-art information technology security features and a contemporary user interface. Mobility is provided via an optional trolley.

The FDA 510(k) clearance letter for the MAC 7 Resting ECG Analysis System (K251670) does not contain a specific study proving the device meets acceptance criteria. Instead, it establishes substantial equivalence to predicate devices (K203786, K173830, K210560) based on similarities in intended use, indications for use, technology, and performance, along with compliance with voluntary standards and non-clinical testing.

Therefore, the following information is extracted from the provided text to fulfill your request:

1. Acceptance Criteria and Reported Device Performance

The document describes the device's characteristics and compares them to predicate devices, demonstrating substantial equivalence rather than explicit acceptance criteria with numerical performance targets. The "Discussion of Differences" column often highlights that a change does not significantly affect substantial equivalence, implying that the performance remains acceptable.

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

The document states: "Summary of Clinical Tests: The subject of this premarket submission, MAC 7 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence." This indicates that no specific test set data from clinical studies was used for performance evaluation in this submission. The "acceptance" is based on the device's technical characteristics aligning with or improving upon those of legally marketed predicate devices, supported by non-clinical testing and previous clearances for core components (like the 12SL™ analysis algorithm v24).

Therefore, details on sample size, country of origin, or retrospective/prospective nature of a clinical test set are not available in this document.

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

As no clinical studies were required for this submission to support substantial equivalence, there is no information provided regarding experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Given that no clinical studies were performed, there is no adjudication method described for a test set.

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 document does not mention any MRMC comparative effectiveness study. The focus is on establishing substantial equivalence to existing devices, not on demonstrating improved human reader performance with AI assistance.

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

The document states that the "Interpretive Statements are provided by 12SL (v24) ECG Analysis Program which was previously cleared under K221321." This implies that the performance of the 12SL™ algorithm itself (a standalone interpretation algorithm) would have been assessed during its prior clearance (K221321). However, the details of that standalone performance study are not included in this K251670 submission.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Since no new clinical studies were performed for this submission, there is no mention of the type of ground truth used for a test set. For the 12SL™ analysis algorithm (v24) which provides interpretation statements, the ground truth would have been established during its prior clearance (K221321), but those details are not provided here.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for any training set. As noted, the approval is based on substantial equivalence and non-clinical testing rather than specific training data for a new algorithm.

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

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

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HEARTBEAM AIMIGo SYSTEM:

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.

HEARTBEAM 12-L ECG SYNTHESIS SOFTWARE:

The HeartBeam 12-L ECG Synthesis Software synthesizes a 12-L ECG from the HeartBeam AIMIGo 3-Leads (in three-directions) recording device, producing a visual 12-L ECG representation that is similar, but not identical, to the same leads of a standard diagnostic 12-L ECG.

The synthesized 12-L ECG output is solely intended for manual assessment of normal sinus rhythm and the following non-life-threatening arrhythmias: sinus arrhythmia, sinus tachycardia, sinus bradycardia, atrial premature complexes, atrial fibrillation, and ventricular premature complex. The synthesized 12-L ECG output is not intended for the assessment of any other arrhythmia or conditions (including but not limited to: other atrial arrhythmias, ventricular arrhythmias, hypertrophy, conduction disorders, myocardial infarction or ischemia, pacemaker functions, localization of arrhythmia foci, ECG wave abnormalities, and/or any other disorder). The software does not conduct cardiac analysis and is not intended to replace a standard 12-L ECG. The 12-L ECG Synthesis Software is intended for adult use only.

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 3-lead 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 AIMIGo™ System is 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.

This submission includes a modification to the HeartBeam System involving the addition of a new software feature, the HeartBeam 12-L Synthesis Software. Like the HeartBeam AIMIGo system, the patient-activated recording of a 3-L ECG is obtained and the HeartBeam 12-L Synthesis Software can synthesize a 12-L ECG signal from the 3-lead ECG signal recorded from the HeartBeam AIMIGo Device of the cleared system. The synthesized 12-L ECG output signal is intended to be an adjunct set of ECG information that complements but does not replace a standard 12-L ECG, to aid in the manual assessment of non-life-threatening arrhythmias.

The synthesized 12-L ECG signal has not been studied or evaluated for safe and effective use for other cardiac conditions outside of manual non-life-threatening arrhythmias and is contraindicated for the assessment of any urgent, serious, or life-threatening conditions or arrhythmias.

The new software works with the HeartBeam system, which retains all functionalities and performance characteristics of the previously cleared system. No changes to the hardware, intended use, or fundamental technological characteristics were made to incorporate the new software. Additionally, the synthesis software works with the standard 12-L ECG system, the EDAN SE-1515 DX-12. The EDAN SE-1515 DX-12 systems provide a patient's compatible standard 12-L ECG signal, which is used as one of the inputs for the synthesis software to create the personalized transformation matrix for each patient.

N/A

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The MEMO Patch M is intended to record, transfer and store single-channel electrocardiogram via USB transmission to PC. The monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. The ECG data is intended to supplement other patient data and is not intended for automated analysis. The device has not been tested and it is not intended for pediatric use.

The MEMO Patch M is a continuous electrocardiogram (ECG) recording device to record, store, and transfer single channel ECGs and is designed for a fully retrospective review of data that was recorded over the specified wear period. The MEMO Patch M has Bluetooth module to verify ECG signals with mobile device and to authenticate the activation of MEMO Patch M. The device is in the form of an ECG patch that records ECG signals. As well the patch connects with a cradle and transmits ECG data via USB communication to PC. Healthcare professional actives the ECG patch, connects the patch with the cradle to the PC, and accesses raw ECG data on the ECG dataloader viewer. The MEMO Patch M includes a battery powered electronic unit that is used with off-the-shelf (OTS) disposable medical grade gel electrodes for long term monitoring. The adhesive electrodes should be replaced by the user every 24 hours or when it no longer adheres to skin. The device is only intended for manual interpretation, and does not provide any automated ECG analysis. The intended clinical use of the ECG is to display the waveforms of the P, QRS, and T waves of the measured electrocardiogram. The intended clinical use of the ECG waveform to be limited to the discrimination of normal sinus rhythm from easily identifiable, non-lethal arrhythmias. The device is not intended for additional analysis or the detection of specific cardiac conditions, such as ischemia, myocardial infarction, and ldft ventricular hypertrophy, etc. The Ambulatory ECG Monitor is intended to capture and continuous electrocardiogram information for long-term monitoring. The device records continuously for the entire wear period, up to 8 days. The MEMO Patch M is a prescription use device and the recorded ECG data is intended to be used with patient-triggered events. When a patient presses the event marking button during a symptom, this event is recorded and displayed on the PDF report of raw ECG data. However, there is no ability to detect specific cardiac events on the PDF report.

N/A

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The Hexoskin Medical System (HMS) is intended for use at home, or at a healthcare facility, on the order of a licensed medical professional, to record, display and store the following physiological data: a) 3 leads of electrocardiogram; b) heart rate; c) respiratory rate; and d) activity. The device is intended for use when the clinician decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The HMS ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The device does not produce alarms and is not intended for active patient monitoring (real-time). The device is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The device is not intended for use in the presence of a pacemaker.

The HMS consists of four main components - three physical components and one software user interface (UI) component. The physical components are the HMS Recorder, the HMS Shirt, and the Cable. The Recorder is a rechargeable data acquisition module that connects to the Shirt. The Shirt is available in a wide range of configurations, catering to diverse patient body types and builds. The Cable is a USB to micro-USB cable that connects to the Recorder for data transfer and charging. The UI component is a PC-based, stand-alone software that displays the recordings stored on the Recorder.

This device is not an apnea monitor. Users should not rely on its respiration monitoring for detecting cessation of breathing. The Hexoskin Medical System does not provide any automatic analysis or diagnosis.

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The Zio monitor is a prescription-only, single-use, ECG monitor that continuously records data for up to 14 days. It is indicated for use on patients, 18 years and older, who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, syncope, fatigue, or anxiety.

The Zio monitor is a non-sterile, single-use, continuously recording, long-term ambulatory ECG monitor that is adhered to a patient's left pectoral region in a modified Lead II orientation. The goal of the Zio monitor is to help physicians initiate long-term, patient-compliant ECG monitoring utilizing proprietary technology. The Zio monitor is applied and activated by the patient at home or at a clinic. Once activated, the device provides continuous, uninterrupted ECG recording into memory with minimal patient interaction. There is a button on the surface of the Zio monitor, which serves to activate the device and may be pressed by the patient during wear to indicate when he or she is experiencing a symptom. Additionally, there is a surface LED light that blinks green to confirm proper activation or that the device is working, and orange to indicate loss of connection with the skin or the presence of error conditions.

The Zio monitor utilizes firmware that captures single-channel ECG data into memory, there is no wireless transmission of data during the wear period of the device. After the prescribed monitoring period is complete, the Zio monitor is returned to iRhythm where the ECG data is then analyzed and annotated by the ZEUS System (K222389). ECG data is then presented to the Qualified Cardiac Technicians (QCT) at the Independent Diagnostic Testing Facility (IDTF) for review and subsequent creation and posting of the end-of-wear report with preliminary findings. Zio monitor device is not intended for real-time patient monitoring.

The provided text is an FDA 510(k) clearance letter and summary for the Zio® monitor. It details the device, its indications for use, comparison to a predicate device, and nonclinical testing performed to establish substantial equivalence. However, it explicitly states:

"No clinical testing was performed in support of this premarket notification."

Therefore, I cannot provide a table of acceptance criteria and reported device performance based on a clinical study, nor specific details about sample size, data provenance, ground truth establishment, expert qualifications, or MRMC studies, as these aspects relate to clinical testing which was not conducted for this submission.

Here's what I can extract and state based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, the acceptance criteria and device performance are established through nonclinical testing, demonstrating conformance to recognized standards and performance specifications, rather than through a clinical study with specific performance metrics like sensitivity or specificity for detecting arrhythmias.

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

• Sample Size for Test Set: Not applicable as no clinical testing was performed. The nonclinical testing would have used various test samples, components, or simulated data as appropriate for each specific engineering and performance test (e.g., system testing, electrical testing).
• Data Provenance: Not applicable for clinical data. For nonclinical testing, the data is generated in-house or by accredited testing laboratories as part of the device's design verification and validation.

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

• Not applicable as no clinical testing with human-established ground truth was reported. Ground truth in nonclinical testing refers to established engineering specifications or reference standards.

4. Adjudication method for the test set:

• Not applicable as no clinical testing requiring expert adjudication was performed.

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 MRMC comparative effectiveness study was done as no clinical testing was performed. The device, Zio monitor, is described as recording ECG data which is then "analyzed and annotated by the ZEUS System (K222389)" and "presented to the Qualified Cardiac Technicians (QCT) at the Independent Diagnostic Testing Facility (IDTF) for review." This implies an existing workflow with a human-in-the-loop, but this submission specifically states no clinical testing was performed to evaluate its effectiveness in combination with human readers.

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

• The document implies that the "ZEUS System (K222389)" performs initial analysis and annotation of the ECG data, but this specific 510(k) is for the Zio® monitor hardware device. Performance data for the ZEUS System itself would be found in its own 510(k) clearance (K222389). This submission does not provide standalone algorithm performance metrics.

7. The type of ground truth used:

• For the nonclinical testing, the ground truth would be based on:
  • Engineering Specifications: Device design requirements and intended performance.
  • Recognized Consensus Standards: Compliance with international standards (e.g., IEC 60601 series, ISO 10993 series).
  • Internal Product Specifications: How the device is designed to function and its measurable outputs.

8. The sample size for the training set:

• Not applicable. This submission is for a hardware device and relies on nonclinical testing for substantial equivalence, not a machine learning model's training set. While the ZEUS System (K222389) likely uses a training set, details for that system are outside the scope of this document.

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

• Not applicable as no training set for an algorithm is discussed in this submission for the Zio® monitor hardware.

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The VSH101 is designed to record, transmit, and store single channel electrocardiogram (ECG) data via Bluetooth communication to compatible Bluetooth enabled devices. The device is intended for use by healthcare professionals, individuals with known or suspected cardiac conditions, and health-conscious users. The ECG data serves as a supplementary source of patient information and is not intended for automated analysis.

VitalSigns 1-Lead Holter is an ambulatory and Bluetooth-based wireless communication ECG measurement solution designed to allow users to record, store, transmit, and display single-channel ECG data.

VitalSigns 1-Lead Holter consists of the following three components:

1. VS Electrode Patch "VSP101"
2. ECG Recorder Host "VSH101"
3. iOS APP "VSHealth"

When the ECG Recorder Host "VSH101" is fully charged and connected wirelessly via Bluetooth to the iOS app "VSHealth", it can instantly obtain the user's ECG data. VSHealth assists in transmitting, displaying, recording, and storing ECG data.

After the "VSH101" is fully charged, the device, through the VSHealth app, allows users to continuously use and record ECG data for 24 hours in their daily routines, whether at home or in a work environment.

The provided FDA 510(k) clearance letter and summary for the VitalSigns 1-Lead Holter (VSH101) primarily focus on demonstrating substantial equivalence to a predicate device through comparison of features and adherence to various safety and performance standards. However, it does not include explicit acceptance criteria tables or detailed study results for specific device performance metrics that would be typically found in a clinical or performance validation report.

The document states that "software validation, performance test and usability test have been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device. The subject device has also undergone all safety and performance tests, and the results complied with the test requirements." It also mentions "Performance testing - IEC 60601-2-47 test" and "Disposable ECG electrode test."

Given the information provided in the 510(k) summary, I will infer the acceptance criteria based on the mentioned compliance standards and the general nature of an ECG Holter device, and then describe what is stated about the testing.

Inferred Acceptance Criteria and Reported Device Performance

The 510(k) summary for the VitalSigns 1-Lead Holter (VSH101) does not provide a specific table of acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating compliance with relevant international standards and equivalence to a predicate device. Based on the mentioned standards (e.g., IEC 60601-2-47 for ambulatory ECG recorders, ANSI/AAMI EC12 for disposable ECG electrodes), the general acceptance criteria for such a device would relate to the accuracy, signal quality, and reliability of ECG signal acquisition.

Here's a table based on the inferred acceptance criteria from the context of ECG device standards and the information stated in the document:

Study Proving Device Meets Acceptance Criteria

The provided 510(k) summary describes that comprehensive testing was conducted, primarily focusing on compliance with recognized consensus standards and demonstrating substantial equivalence to a predicate device, rather than a single large-scale clinical/performance study with detailed outcome metrics.

Here's an analysis based on the information provided:

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

   • As detailed above, a direct table is not provided in the 510(k) summary. The acceptance criteria are inferred from the listed compliance standards (e.g., IEC 60601-2-47, ANSI/AAMI EC12). The reported performance is generally stated as "complied with the test requirements," "met its pre-defined criteria," or "confirmed compliance."

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

   • Sample Size: Not explicitly stated for performance testing. For compliance with standards like IEC 60601-2-47 or ANSI/AAMI EC12, testing typically involves a sufficient number of device units or electrodes to statistically demonstrate compliance with the standard's requirements (e.g., a batch of electrodes, multiple device samples). The document does not specify if patient data was used for performance testing beyond what is implied by the "24 hours" recording capability.
   • Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. Standard compliance testing is typically done in a lab setting rather than involving patient data in a "retrospective" or "prospective" clinical study design for 510(k) submissions unless a specific clinical performance claim needs to be proven. The focus here is on engineering verification and validation against standards.

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

   • This information is not provided in the 510(k) summary. The nature of the testing described (compliance with standards like IEC 60601-2-47 for signal quality, ANSI/AAMI EC12 for electrodes, and general electrical safety) suggests controlled laboratory testing and engineering validation, which typically does not involve human expert adjudication of ECG readings as a "ground truth" for device performance in this context. The device's indication for use explicitly states, "The ECG data serves as a supplementary source of patient information and is not intended for automated analysis," implying that human interpretation remains key. Therefore, ground truth establishment by experts for automated analysis is not applicable.

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

   • None is explicitly described. Based on the content, there was no clinical study described that would require a ground truth panel or adjudication method for ECG event interpretation. The testing focuses on technical performance compliance.

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 MRMC study was done or described. The device is a "1-Lead Holter" that records ECG data; it does not perform "automated analysis" or include AI assistance. Its purpose is to provide raw ECG data for supplementation of patient information, not for diagnostic interpretation by an algorithm. Therefore, an MRMC study assessing AI assistance is not relevant to this device's claims or function.

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

   • Based on the indication for use, "The ECG data serves as a supplementary source of patient information and is not intended for automated analysis," there is no algorithm for diagnostic interpretation. Therefore, no standalone algorithm performance study was done or described.

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

   • As noted above, for the type of device and the presented summary, complex ground truth derived from expert consensus, pathology, or outcomes data is not applicable for the performance testing described. The "ground truth" for compliance testing is largely defined by the technical specifications and requirements within the IEC/AAMI standards themselves (e.g., known input signals for signal quality, chemical assays for biocompatibility).

8. The sample size for the training set:

   • Not applicable / Not provided. The device records raw ECG data and does not perform automated analysis using a trained algorithm. Therefore, no "training set" for AI/ML model development is mentioned or required for this type of device based on its intended use.

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

   • Not applicable. As there is no AI/ML model for automated analysis that requires a training set, the establishment of ground truth for such a set is not discussed.

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The Frontier X Plus device is an ambulatory monitoring device intended to record, store, and transfer single-channel (ECG) rhythms for monitoring and evaluation. The Frontier X Plus system also displays ECG waveforms and ECG rhythm analysis; detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, inconclusive and unreadable rhythm. The Frontier X Plus is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms requiring cardiac monitoring. The device has not been tested for pediatric use. The Frontier X Plus is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.

The Frontier X Plus is an ECG (electrocardiogram) event recorder that records, stores and transfers single-channel electrocardiogram rhythms. The device utilizes a proprietary algorithm, to analyze single-channel ECG. The Frontier X Plus hardware transmits the ECG signal from a dry electrode array embedded in the Frontier X Plus chest strap to the embedded Frontier X Plus firmware, integrated with the HeartKey ECG algorithm to be analyzed and presented to the user. All ECGs are synced with the user's account.

The provided document describes the FDA 510(k) premarket notification for the Frontier X Plus device. It does not contain a specific table of acceptance criteria with reported device performance results, nor does it detail a multi-reader, multi-case (MRMC) comparative effectiveness study or provide effect sizes for human readers with AI assistance.

However, based on the Clinical Testing Summary section on pages 10-11, we can infer information about the study design that proves the device meets certain performance criteria.

Here's an attempt to structure the available information per your request:

Acceptance Criteria and Device Performance Study

The document doesn't explicitly state "acceptance criteria" in a quantitative table format. Instead, it describes a clinical investigation designed to demonstrate "substantial equivalence" to a predicate device, focusing on the ability of the device's algorithm to accurately detect and classify ECG rhythms.

Inferred Acceptance Criteria & Reported Device Performance (Qualitative)

Study Details:

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

   • Test Set Sample Size: A total of 832 users were included in the Study population for the clinical investigation.
   • Data Provenance: The document does not specify the country of origin for the data. It seems to be a prospective study as it describes the conduct of a clinical investigation where ECGs "were collected and analyzed at various time points."

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

   • The document implies that the ground truth for the rhythm analysis (Atrial Fibrillation, Normal Sinus Rhythm, Tachycardia, Inconclusive, noisy/unreadable signals) was established by comparison to a "standard 12-lead ECG device."
   • It also states that the "reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience." This suggests that physicians (likely cardiologists or electrophysiologists) were the experts, but the number of experts and their specific qualifications (e.g., years of experience) are not explicitly stated for ground truth establishment within the study.

3. Adjudication Method for the Test Set:

   • The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the test set. It suggests that the 12-lead ECG served as the reference standard.

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, a MRMC comparative effectiveness study was not explicitly described or summarized in this document. The study focused on the device's (algorithm's) performance against a reference standard, not on how human readers' performance might improve with the device's assistance.

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

   • Yes, a standalone performance evaluation of the algorithm appears to have been a primary component of the clinical investigation. The study "evaluated the reliability of the Frontier X Plus ECG rhythm analysis software algorithm by assessing its ability to detect and classify Atrial fibrillation, Normal Sinus Rhythm, Tachycardia, Inconclusive and noisy/unreadable signals, from all the ECG recordings obtained on the subject device, when compared to simultaneously acquired signals from a standard 12-lead ECG device." This describes the algorithm's performance independent of human readers.

6. The Type of Ground Truth Used:

   • The primary ground truth used was simultaneously acquired signals from a standard 12-lead ECG device. This can be considered a form of clinical standard/reference data. The document also mentions that a "physician who will render a diagnosis based on clinical judgment and experience" reviews the reported information, implying physician interpretation as a ground truth for final diagnosis.

7. The Sample Size for the Training Set:

   • The document does not provide information on the sample size used for the training set of the algorithm. It only discusses the clinical investigation/test set.

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

   • The document does not provide information on how the ground truth for the training set was established, as it focuses on the validation study and not the algorithm development process.

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The Zio AT device is intended to capture and transmit symptomatic and asymptomatic cardiac events and record continuous electrocardiogram (ECG) data for long-term monitoring. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. It is not intended for use on critical care patients.

The Zio AT® Electrocardiogram (ECG) Monitoring System is intended for continuous, long-term monitoring of a patient's ECG data with the ability to provide symptomatic and asymptomatic transmissions of potential arrhythmias during wear time. The Zio AT ECG Monitoring System enables ambulatory Mobile Cardiac Telemetry (MCT) services for non-critical care patients by providing the following devices for use. The Zio AT device consists of the Zio AT patch and Zio AT wireless gateway. The Zio AT patch is a single-use ECG monitor applied to the patient's chest, in-clinic or at home, and worn for up to 14 days without any required patient interaction for maintenance, such as replacing or charging a battery. The patch continuously records ECG data and transmits symptomatic and asymptomatic cardiac events through the Zio AT wireless gateway during the wear period. After the wear period concludes, the patient removes and returns the patch to the monitoring center, an Independent Diagnostic Testing Facility (IDTF), for analysis and end-of-wear reporting. The Zio AT wireless gateway securely receives ECG data from the Zio AT patch using Bluetooth technology. The gateway securely transmits ECG data through cellular technology for subsequent processing. The Zio AT device is designed to be used with the interoperable Zio ECG Utilization Service (ZEUS) SaMD which provides an arrhythmia detection algorithm for analysis and reporting.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Zio AT device, organized as requested:

Device: Zio AT® device (A100A1001)

This premarket notification (K240177) is for an updated version of an already cleared device (Zio® AT ECG Monitoring Device [K240029]). Therefore, the submission primarily focuses on demonstrating substantial equivalence to the predicate device through non-clinical testing rather than presenting new clinical study data with detailed acceptance criteria and performance metrics for the device's diagnostic capabilities. The document explicitly states: "No clinical testing was performed in support of this premarket notification."

As such, many of the requested details related to clinical performance, such as detailed acceptance criteria tables, sample sizes for test sets, expert qualifications, and MRMC studies, are not available in this 510(k) summary. The acceptance criteria described here pertain to safety and engineering standards, not clinical accuracy for arrhythmia detection.

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

Since this is a 510(k) for substantial equivalence based on non-clinical testing for an updated device, the "acceptance criteria" are predominantly for engineering and safety standards, and the "reported performance" is that the device conforms to these standards.

Regarding the study that proves the device meets the acceptance criteria:

The study referenced is a comprehensive set of nonclinical performance testing. The document states: "All necessary performance testing was conducted on the Zio AT device to ensure performance as intended per specifications and to support a determination of substantial equivalence to the predicate device."

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

• Sample Size for Test Set: Not applicable/not provided for clinical performance. The nonclinical testing involves evaluating the physical device and its software against engineering standards. The sample size would refer to the number of devices or components tested to ensure compliance with specific technical standards (e.g., a certain number of units for electrical safety testing, material samples for biocompatibility), but specific quantities are not detailed in this summary.
• Data Provenance: Not applicable, as this is nonclinical (engineering/safety) testing.

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 applicable, as this document focuses on nonclinical testing and substantial equivalence, not clinical diagnostic performance requiring expert interpretation as ground truth.

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

Not applicable, as this document focuses on nonclinical testing, not clinical performance where adjudication of "ground truth" labels would be necessary.

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 MRMC comparative effectiveness study was done or reported in this 510(k) summary. This submission explicitly states "No clinical testing was performed in support of this premarket notification." The Zio AT device uses an arrhythmia detection algorithm (provided by the interoperable ZEUS SaMD), but the evaluation here is for the physical device's safety and engineering, not the diagnostic performance of the AI component.

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

This document does not provide details on standalone algorithm performance. The "Zio AT device is designed to be used with the interoperable Zio ECG Utilization Service (ZEUS) SaMD which provides an arrhythmia detection algorithm for analysis and reporting." While an algorithm exists, its performance is not detailed or assessed in this specific 510(k) submission as the focus is on the physical hardware's substantial equivalence to a predicate. Evaluations of the ZEUS SaMD's algorithm (which likely includes standalone performance) would have been part of previous submissions for that software.

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

For the nonclinical testing described, the "ground truth" would be the defined standards and specifications (e.g., a device passes the electrical safety test if it meets the voltage and current limits specified in IEC 60601-1). This is not clinical ground truth.

8. The sample size for the training set

Not applicable/not provided. This submission does not discuss the training of any AI algorithm, as it's a 510(k) for an updated physical device and primarily addresses nonclinical performance and substantial equivalence based on engineering and safety standards.

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

Not applicable/not provided for the same reasons as #8.

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The Zio AT device is intended to capture and transmit symptomatic and asymptomatic cardiac events and record continuous electrocardiogram (ECG) data for long-term monitoring. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. It is not intended for use on critical care patients.

The Zio AT® Electrocardiogram (ECG) Monitoring System is intended for continuous, long-term monitoring of a patient's ECG data with the ability to provide symptomatic and asymptomatic transmissions of potential arrhythmias during wear time. The Zio AT ECG Monitoring System enables ambulatory Mobile Cardiac Telemetry (MCT) services for non-critical care patients by providing the following devices for use. The Zio AT device consists of the Zio AT patch and Zio AT wireless gateway. The Zio AT patch is a single-use ECG monitor applied to the patient's chest, in-clinic or at home, and worn for up to 14 days without any required patient interaction for maintenance, such as replacing or charging a battery. The patch continuously records ECG data and transmits symptomatic and asymptomatic cardiac events through the Zio AT wireless gateway during the wear period. After the wear period concludes, the patient removes and returns the patch to the monitoring center, an Independent Diagnostic Testing Facility (IDTF), for analysis and end-of-wear reporting. The Zio AT wireless gateway securely receives ECG data from the Zio AT patch using Bluetooth technology. The gateway securely transmits ECG data through cellular technology for subsequent processing.

The provided document, a 510(k) Summary for the Zio AT® device (K240029), states that no clinical testing was performed in support of this premarket notification. The submission relies solely on nonclinical testing to demonstrate substantial equivalence to the predicate device (Zio® AT ECG Monitoring Device [K163512]).

Therefore, based on the provided text, I cannot provide details regarding acceptance criteria, reported device performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance that would typically be associated with clinical studies.

The document indicates that the device's acceptance criteria were based on its conformance to established performance specifications and FDA-recognized consensus standards. The study that proves the device meets these acceptance criteria is the nonclinical testing described.

Here's an overview of the information available:

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

The document does not provide a specific table of quantitative acceptance criteria and reported device performance metrics in the format typically seen with clinical study results (e.g., sensitivity, specificity, accuracy for arrhythmia detection). Instead, it states that "All necessary performance testing was conducted on the Zio AT device to ensure performance as intended per specifications and to support a determination of substantial equivalence to the predicate device."

The acceptance criteria implicitly relate to the successful completion of the following nonclinical tests and their conformance to specified standards:

• System performance testing: This would ensure the device functions as designed in various operational aspects.
• Biocompatibility testing: This confirms the materials used in the device are safe for contact with the human body.
• Firmware verification testing: This validates the software operating the device.
• Electrical safety and EMC testing: This ensures the device is electrically safe and does not interfere with other electronic devices, and vice versa.

The reported device performance, in this context, is that the device "meets the requirements of established conformance standards and performance specifications necessary for its intended use."

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

Not applicable, as no clinical testing was performed. The nonclinical testing would use various test samples and equipment as dictated by the specific standards and internal protocols, but these are not disclosed in terms of number or provenance in the provided summary.

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 applicable, as no clinical testing with expert ground truth establishment was performed.

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

Not applicable, as no clinical testing requiring adjudication was performed.

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, as no clinical testing or MRMC study was performed. The Zio AT device itself functions as a monitoring and transmission system, not an AI-powered diagnostic aid that assists human readers in real-time interpretation.

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

The device is described as "intended to capture and transmit symptomatic and asymptomatic cardiac events and record continuous electrocardiogram (ECG) data." While it transmits events, the overall system for diagnosis involves a monitoring center for analysis and end-of-wear reporting, which would typically involve human oversight. The provided text does not suggest a standalone algorithm-only diagnostic performance evaluation in a clinical setting. The nonclinical testing focused on the device's functional performance and compliance with relevant standards.

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

Not applicable, as no clinical testing that would require such ground truth for diagnostic accuracy was performed. For nonclinical tests, the "ground truth" would be the specified parameters and expected outputs defined by the relevant engineering and safety standards.

8. The sample size for the training set

Not applicable, as no clinical testing or development of an AI algorithm based clinical data was detailed as part of this submission for demonstrating substantial equivalence. The device is an updated version of a previously cleared device, focusing on hardware and firmware changes.

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

Not applicable for the same reasons as #8.

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CareConsole is intended to be used in conjunction with biometric health care measuring devices, mobile applications, and questionnaires to collect and store data, and for clinician-scheduled monitoring at home and/or in medical facilities. The CareConsole platform securely sends data from a patient monitoring device to a central electronic log of patient information, from which notifications, alerts, and reports can be generated and data can be securely viewed by healthcare professionals, authorized caregivers, and patients. Clinicians would then determine how and when to best treat their patients in response to the notifications, alerts, and biometric data. For use by individuals 12 years and older who do not have an emergency health care condition.

· Data can be sent via intranet networks, the internet, landline telephones, and other mobile devices.

· The software supports communication between patients and clinicians, caregivers, or researchers, such as through bidirectional audio and video e-visits, telephone calls, and mobile text messages.

CareConsole is intended for use in capturing remote patient monitoring data from non-invasive remote monitoring devices and to provide remote hospital-at-home level of care where determined necessary by a health care professional. CareConsole is not intended for use in emergency situations or by a patient in an acute care medical facility.

The CareConsole ("CareConsole") is a software only device. CareConsole enables clinicians and patients to conduct bidirectional audio-video conversations and collects patient-reported outcomes and self-care activities via assessment questionnaires. Biometric measurements, using third party devices, can be taken by the patient while being observed over videoconference by a clinician who is located remotely, or measurements can be made by the patient at any time, without being observed by a clinicians can also use CareConsole to exchange messages with patients by text or telephone.

The system is indicated when health professionals wish to directly interact with patients via video, voice and/or text, and/or view reports of medical parameters collected from patients with non-acute conditions using remote biometric measuring devices and questionnaires. The AMC system is not intended for use in emergency situations.

The provided text describes the regulatory clearance of the AMC Health CareConsole, a software-only device for remote patient monitoring. However, it does not contain specific details about acceptance criteria, the methodology of a study proving the device meets those criteria, or performance metrics from such a study.

The document mainly focuses on:

• Regulatory information: FDA clearance, regulation numbers, product codes, and general controls.
• Device description and intended use: How CareConsole functions (collects, stores, and transmits biometric data, facilitates communication) and its target users (individuals 12+, not for emergency situations).
• Predicate devices comparison: It asserts the substantial equivalence of the CareConsole to its predicate devices in terms of intended use and technological specifications, mainly through a comparison table.
• Compatibility with third-party devices: A list of integrated biometric devices.
• General statement on performance: Mentions that "validation and verification testing were performed under the company's Design Control Process" and "The testing has confirmed the device's conformity with specifications."

Therefore, based only on the provided text, I cannot complete the requested information about acceptance criteria and detailed study results. The document states that performance validation was done to meet regulatory requirements but does not provide the specifics of that validation.

Here's what I can extract or infer, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing: Specific quantitative acceptance criteria or performance metrics (e.g., accuracy percentages, latency times, success rates for data transmission, etc.). The document states that testing confirmed conformity but doesn't provide the results of that conformity testing.

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

• Missing: No information on specific sample sizes for any test sets.
• Data Provenance: Not specified (e.g., country of origin). The document implies the data is gathered remotely from patients using the system. It states "The CareConsole platform securely sends data from a patient monitoring device to a central electronic log of patient information." and lists various third-party devices, suggesting data would come from these sources. It's unclear if a specific "test set" with a defined provenance was used for a formal clinical performance study, or if "testing" refers to internal software validation.
• Retrospective/Prospective: Not specified.

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

• Missing: The document does not describe a study involving expert readers/evaluators for establishing ground truth, as it is a data aggregation and communication platform, not an AI diagnostic imaging device. The "ground truth" here would relate to the successful and accurate transfer, storage, and display of biometric data. The closest mention of experts is "Clinicians," "healthcare professionals," and "authorized caregivers" who view the data.

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

• Missing: Not applicable or not described, as the device is not an imaging AI requiring multiple reader 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:

• Missing: Not applicable. The CareConsole is a data management and communication system, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned or implied.

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

• Partially Addressed/Inferred: The device is "software only." Its primary function is automated data collection, transmission, storage, and presentation. Thus, its core performance is "standalone" in terms of these automated processes. The "human-in-the-loop" aspect comes in with clinicians viewing the data and interacting with patients, but the device's fundamental data handling is algorithmic. However, there are no specific standalone performance metrics provided (e.g., "algorithm achieved X% accuracy in data transmission"). The document states the "testing has confirmed the device's conformity with specifications."

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

• Inferred: For a device like CareConsole, the "ground truth" would likely be the accuracy and integrity of the data captured from the third-party devices, its faithful transmission, secure storage, and correct display. This would typically be verified against the direct output of the connected biometric device or a known, verified standard. There's no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the device's technical performance.

8. The sample size for the training set:

• Missing: No information provided about a training set, as this is a traditional software system, not described as a machine learning/AI model that typically requires a distinct training set. The "testing" mentioned refers to software verification and validation.

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

• Missing: Not applicable, as no training set for an AI model is described.

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