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Configuration 1) Holter Mode: The MobileECG 2 BT is intended to record continuous data for 30+ days for the detection of arrhythmias in ambulatory patients. Such monitoring is frequently used for patient symptoms such as: Palpitations, shortness of breath, chest pain, syncope, evaluating pacemakers, heart rate variability's, and clinical studies. The MobileECG 2 BT device transmits all collected data to a call center for interpretation using the TM eCloud ECG Analysis System at the end of the completed study.

Configuration 2) Mobile Cardiac Telement Mode: The MobileECG 2 BT is intended to continuously monitor, transmit, and record data for up to 30 days for patient transient symptoms that may suggest cardiac arrhythmia. The MobileECG 2 BT device continuously transmits data to a call center for interpretation of ECG data using the TM eCloud ECG Analysis System.

Configuration 3) Event Mode: The MobileECG 2 BT is intended to monitor and record patient activated data for up to 30 days for patient transient symptoms that may suggest cardiac arrhythmia. The MobileECG 2 BT device transmits all patient event activated data to a call center for interpretation of ECG data using the TM eCloud ECG Analysis System.

The MobileECG 2 BT is intended for use in adults and children of any age from birth upwards.

The MobileECG 2 BT and the TM eCloud ECG Analysis System interpretation software is not intended as sole means of diagnosis and is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.

The MEMTEC MobileECG 2 BT digital Monitor provides high resolution recording of patient ECG data and pacemaker spike detection for a period of up to 30 Days. The 3 in 1 Multi - Function BT monitor provides Holter, Event, and MCT ambulatory use. The data is stored on a removable Micro SD Card and no data compression is used. The data can be downloaded by a USB 3.0 cable, BT, or removable Micro SD Card. The BLE 4.1 (Bluetooth) sends patient data to cell phone continuous for 30 days for use as an Event or MCT Monitor. The patient ID/Date/Time is stamped on the recording every 2 minutes preventing the mixing of data with another patients data. The large LCD provides real time patient ECG signals and confirms lead hook-ups. In Holter Mode the unit has selectable sample rates of 250, 500, or 1000 samples per second with resolution of 12bits. The MobileECG 2 BT operates on a single "AAA" alkaline or "AAA" lithium battery.

Configuration 1 (Holter Mode): MobileECG 2 BT is used with the TM eCloud Analysis System (K142349) for Holter monitoring. In Holter usage, data is recorded for the prescribed duration and then uploaded and analyzed after the recording period has ended. The TM eCloud algorithm suite is used to analyze and interpret the ECG data.

Configuration 2 (MCT Mode): MobileECG 2 BT is combined with a special purpose cell phone and Android APP to store and transmit real-time ECG to the TM eCloud Analysis System (K142349) to provide Mobile Cardiac Telemetry (MCT). The TM eCloud algorithm suite is used to analyze and interpret the ECG data.

Configuration 3 (Event Mode): MobileECG 2 BT is combined with a special purpose cell phone and Android APP to store and transmit real-time ECG on patient activated events to the TM eCloud Analysis System (K142349). The TM eCloud algorithm suite is used to analyze and interpret the ECG data.

The Memtec Corporation's MobileECG 2 BT device underwent testing to demonstrate its substantial equivalence to predicate devices. The study information is extracted from the provided text.

1. Acceptance Criteria and Reported Device Performance

The provided document describes a comparison of technical specifications and indications for use between the subject device (MobileECG 2 BT) and two predicate devices (Preventice BodyGuardian and Memtec Corporation Model 950-12L). The primary acceptance criteria for establishing substantial equivalence were that differences in technological specifications should not raise any new issues of safety or effectiveness. The document concludes that "the differences in the above "Technological Specifications" between the devices do not raise any new issues of safety or effectiveness, demonstrating that the subject device is as safe and as effective as the predicated devices."

A table comparing the technical specifications of the MobileECG 2 BT with the predicate devices is provided in the source document. Since the reported performance is largely a qualitative statement of "Same" or "Different" with a justification for why the difference does not affect safety or effectiveness, a direct quantitative comparison of acceptance criteria vs. specific reported device performance values for each technical specification is not explicitly detailed in a pass/fail format within this document. The conclusion states all criteria were met to establish substantial equivalence.

Conclusion: The provided document states that the MobileECG 2 BT's performance testing results demonstrate that the differences in "Technological Specifications" do not raise any new safety or effectiveness issues, and that the "Indications For Use" are substantially equivalent to the predicate devices.

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

The provided document does not specify a separate test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The assessment of substantial equivalence relies on comparison of technical specifications and indications for use against predicate devices validated against recognized FDA standards. The non-clinical tests mentioned are conformance to these standards.

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

The document does not mention the use of experts to establish ground truth for a test set. Substantial equivalence was determined through comparison to predicate devices and conformance to recognized standards.

4. Adjudication Method

The document does not mention any adjudication method as no expert review or human evaluation of a test set is described.

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

The document does not describe an MRMC comparative effectiveness study, nor does it provide information on human reader improvement with or without AI assistance. The device is a data acquisition system that transmits data to an existing analysis system (TM eCloud ECG Analysis System, K142349).

6. Standalone Performance Study

The document does not describe a standalone (algorithm only without human-in-the-loop performance) study for the MobileECG 2 BT itself in terms of diagnostic accuracy. Instead, it states that "The MobileECG 2 BT and the TM eCloud ECG Analysis System interpretation software is not intended as sole means of diagnosis and is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG." The MobileECG 2 BT is primarily a data acquisition device, and its performance is evaluated through its conformity to established medical device standards and comparison of its technical specifications to predicate devices. The TM eCloud ECG Analysis System is a referenced device (K142349), suggesting its own performance would have been established separately.

7. Type of Ground Truth Used

For the MobileECG 2 BT device itself, the ground truth for performance assessment seems to be derived from compliance with FDA-recognized consensus standards (e.g., ANSI/AAMI ES60601-1-2005, IEC 60601-1-2:2014, ANSI/AAMI-IEC 60601-2-47-2012, ANSI/AAMI EC53:1995). The document does not describe a clinical study with pathology or outcomes data specifically for the MobileECG 2 BT's diagnostic performance for arrhythmias, as it functions as a data recorder for an analysis system.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. The MobileECG 2 BT is a hardware device for ECG data acquisition; it does not explicitly describe an AI algorithm or model that would require a training set. The referenced "TM eCloud ECG Analysis System" (K142349) would be the component that uses algorithms and would likely have had its own training set.

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

As no training set is described for the MobileECG 2 BT, there is no information provided on how its ground truth would have been established.

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ScioCardio ECG transmitter is a physiological ECG acquisition module. It records and transmits the data acquired, to a compatible mobile phone via Bluetooth low energy link, for visualization without making any analysis or filtering to the data acquired.

ScioCardio ECG transmitter acquires Lead III ECG signals meeting the AAMI/ANSI/IEC standards for ambulatory ECG acquisition, via three electrodes attached to the patient's body.

ScioCardio ECG transmitter is a battery powered wearable device which allows the patient to be free to moving while wearing the device.

ScioCardio ECG transmitter transmits the acquired physiological signals in real-time to a compatible mobile phone where ScioCardio Mobile App is installed. ECG data is stored in the mobile phone verbatim without any sampling adjustment or any other modifications and also is displayed in the Mobile App.

ScioCardio ECG transmitter is a prescription only device which is intended for use under the supervision of a physician or those knowledgeable in all aspects of ECG morphology, rhythm and arrhythmia.

ScioCardio ECG transmitter and ScioCardio Mobile App are intended to be used on adult patients only.

ScioCardio ECG transmitter is a battery powered wearable device, capable of continuously capturing a body surface ECG from the patient, storing and transmitting the data to an external device or a system wirelessly. ECG signals are captured from the conventional solid gel electrodes worn on the body using a 3 lead ECG system. Raw ECG data is stored and transmitted wirelessly to any compatible device with Bluetooth Low Energy capability. This allows visualization, analysis and interpretation which can be used for a variety of applications such as ECG monitoring, heart rate monitoring, arrhythmia detection and analysis, out-patient monitoring etc. Other than the ECG data, ScioCardio ECG transmitter also captures, stores and transmits patient's motion data from an IMU sensor providing information about the patient's activities which can also be used in above mentioned analysis and interpretations. ScioCardio ECG transmitter is an always-on device. Data acquisition, storing and transmission are all done automatically and require no patient intervention other than initializing the device. ScioCardio ECG transmitter is small in form factor and has a higher battery life, making it possible for the user to wear the device comfortably for longer durations as per specific requirements.

The ScioCardio ECG Transmitter is a physiological ECG acquisition module that records and transmits ECG data to a compatible mobile phone via Bluetooth Low Energy. The device acquires Lead III ECG signals and is intended for use on adult patients under the supervision of a physician.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for performance in a tabular format. Instead, it demonstrates substantial equivalence through comparison to predicate devices and adherence to relevant standards. The performance aspects discussed indirectly serve as acceptable performance levels.

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

The document describes non-clinical performance testing and states that clinical performance testing was not required to establish substantial equivalence. Therefore:

• Sample size for the test set: Not applicable for clinical data. For non-clinical tests, specific sample sizes (e.g., number of devices tested for battery life) are not provided, but the tests were "successfully conducted" or "successfully performed."
• Data provenance: Not applicable for clinical data. For non-clinical device performance, the testing was conducted by SYNERGEN Technology Labs LLC. The country of origin of the data is implicitly the USA (where the company is based), but not explicitly stated. The tests are prospective as they were performed to validate the device.

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

Not applicable, as clinical performance testing was not required or submitted for this 510(k) summary. The device transmits raw data and does not perform analysis itself.

4. Adjudication Method for the Test Set

Not applicable, as clinical performance testing was not required or submitted for this 510(k) summary.

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

No MRMC study was done. Clinical performance testing was not required. The device's function is to acquire and transmit raw ECG data; it does not include AI for interpretation or diagnosis that would typically warrant a comparative effectiveness study with human readers.

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

Not applicable. The ScioCardio ECG Transmitter is a hardware device for acquiring and transmitting raw ECG signals. It explicitly states it transmits data "without making any analysis or filtering to the data acquired." Therefore, there is no embedded algorithm for diagnosis or interpretation that would require a standalone performance study.

7. The Type of Ground Truth Used

• For non-clinical performance (e.g., battery life, transmitter range, operability): The ground truth was based on engineered specifications and successful operation against those specifications (e.g., battery lasted longer than 120 hours, transmitter range was "successfully conducted").
• For standards compliance: The ground truth is the requirements outlined in the specified international and FDA recognized standards (e.g., AAMI / ANSI ES60601-1). The device was tested and found compliant with these standards, implying it met the specified performance metrics within those standards.
• For clinical data / algorithm performance: Not applicable, as clinical performance testing was not required and there's no diagnostic algorithm in the device.

8. The Sample Size for the Training Set

Not applicable, as the device does not employ machine learning or AI algorithms requiring a training set.

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

Not applicable, as the device does not employ machine learning or AI algorithms requiring a training set.

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The CardioLogs ECG Analysis Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in subjects over 18 years of age. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices when assessment of the rhythm is necessary. The Cardiologs ECG Analysis Platform can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as an ECG management system. The Cardiologs ECG Analysis Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, ORS feature extraction, interval measurement, heart rate measurement, and rhythm analysis. The Cardiologs ECG Analysis Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices.

The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.

Cardiologs ECG Analysis Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

CardioLogs ECG Analysis Platform is made up of:

• An interface which provides tools to measure, analyze and review numerous ECGs;
• An automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide physicians supportive information for ECG analysis.

CardioLogs ECG Analysis Platform can be accessed through a network connection/wireless device when the electrocardiograph allows for digital ECG upload, or locally (stand-alone algorithm).

CardioLogs ECG Analysis Platform works in the following sequence:

• 1. Upload of digital ECG file to CardioLogs' secured hosting databases (for health data i.e. HIPAA compliant);
  • Manual upload: via the web-interface which allows the selection of files to upload on the evaluating user's computer
  • Direct upload: with no manual intervention, in the specific cases where the user's hardware is already connected to the CardioLogs' Application Programming Interface (or API): the ECG is automatically sent to CardioLogs' servers.
• 2. Processing of the uploaded ECG file;
• 3. Analysis of the uploaded ECG performed by CardioLogs' proprietary algorithm, which labels the ECG;
  • Delineation (detection of at least P waves, QRS complexes and T waves on the ECG signal). The output format is a sequence of elements "wave type/start time/ end time";
  • Abnormality labels: the algorithm provides probability scores on a predefined set of abnormality labels (multi-label classification);
• 4. CardioLogs ECG Analysis Platform displays the resulting analysis, along with the original ECG signal and a variety of tools (ruler, zoom, etc.). Results are made available either on the CardioLogs interface if the user's hardware allows for digital ECG upload, or on an API in cases where the service is available as part of a package with an ECG machine;
• 5. CardioLogs ECG Analysis Platform then allows for editing and/or confirmation of the measurements and parameters by the analyzing physician.

The resulting information is stored on a secured database.

The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria in a format that allows for the extraction of all requested data points. While it mentions performance evaluation and compliance with standards, and that "All clinical input requirements were validated against a gold standard," it does not specify the numerical acceptance criteria or the specifics of the study design, sample sizes, expert qualifications, or adjudication methods for that validation.

Therefore, I can only provide limited information based on the text.

Here's a summary of what can be extracted:

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

The document mentions that the device performs:

• Heart rate determination for non-paced adult
• QRS Detection
• Non-paced arrhythmia interpretation for adult patients
• Non-paced ventricular arrhythmia calls
• Intervals measurements
• Ventricular ectopic beat detection

It also states, "All clinical input requirements were validated against a gold standard," implying that the device's performance for these functionalities met certain (unspecified) acceptance criteria as compared to a gold standard. However, the specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and the reported device performance metrics are not provided in the text.

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

• Sample size for the test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified. The term "gold standard" is used without elaborating on how it was established or by whom.

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

• Adjudication method: Not specified.

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

• The document does not mention an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is described as providing "supportive information for ECG analysis" and its "interpretation results are not intended to be the sole means of diagnosis," suggesting an assistive role, but no study details for this are given.

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

• The document describes the device as having "An automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide physicians supportive information for ECG analysis." It also states, "CardioLogs ECG Analysis Platform then allows for editing and/or confirmation of the measurements and parameters by the analyzing physician." This implies a standalone capability for analysis before physician review, but no specific study reporting standalone performance metrics is detailed.

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

• The text states, "All clinical input requirements were validated against a gold standard." The specific nature of this "gold standard" (e.g., expert consensus, pathology, follow-up outcomes) is not specified.

8. The sample size for the training set:

• Sample size for the training set: Not specified.

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

• How ground truth was established: Not specified, as details about the training set or its ground truth establishment are absent.

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