Search Results

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.

Ask a specific question about this device

The MobileECG System is intended to provide an interpretation of the resting 12 lead ECG in all situations, whether in a hospital or primary care setting. It is capable of diagnosing all commonly recognized ECG abnormalities such as myocardial infarction (MI), including acute MI, ventricular hypertrophy, abnormal ST-T changes and common abnormalities of rhythm.

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

The MobileECG System's 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 System is an electrocardiograph consisting of Model 950-12LR HHC module and CardioVu interpretation software.

The Model 950-12LR HHC module is a small, light weight, single battery, wireless module designed to transmit 12Lead electrical heart activity of a patient to a computer. This module will transmit a patient's ECG wirelessly to a laptop, netbook, tablet, or desktop computer containing the CardioVu interpretation software from up to 100 feet away.

Elimination of the cable reduces a source of artifact resulting in high-quality ECG tracings. Wireless dedicated and secure communication links the Model 950-12LR HHC module to CardioVu interpretation software.

The CardioVu software receives, displays, and stores the patients ECG data wirelessly on a laptop, netbook, tablet, or desktop computer in "real time". The software also has the data using ECG algorithms for review by a physician or other qualified medical professional as an advisory basis only in conjunction with the physician's knowledge of ECG. The wireless feature allows the patient not to be tethered to the computer or a bulky box thus reducing motion artifacts caused by movement of the connecting cables and providing comfort to the patient.

The provided 510(k) summary for the Memtec Corporation's MobileECG System (K103427) does not describe an extensive study (clinical or analytical) with specific acceptance criteria and performance metrics for the device's diagnostic capabilities. Instead, it focuses on non-clinical testing for substantial equivalence to predicate devices based on applicable standards.

Therefore, many of the requested details about acceptance criteria, study sizes, expert qualifications, and ground truth establishment cannot be extracted from this document as such a study is not presented.

Here's a breakdown of what can be inferred from the document regarding comparative effectiveness and analytical performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of diagnostic accuracy (e.g., sensitivity, specificity) for its ECG interpretation software. The assessment is based on demonstrating equivalence to predicate devices through compliance with technical standards.

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

No clinical test set is described. The "non-clinical tests" focused on standards compliance, not diagnostic performance on a patient dataset.

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

Not applicable, as no clinical test set with expert-established ground truth is described. The software's interpretation is "an advisory basis only in conjunction with the physician's knowledge of ECG."

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set for diagnostic performance is described.

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 is mentioned. The device's software is described as providing "interpretation software... on an advisory basis only," suggesting it's an aid, but no study on human performance improvement with this aid is presented.

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

The document states, "The software also has the data using ECG algorithms for review by a physician or other qualified medical professional as an advisory basis only." While algorithms are present, a formal standalone performance study (e.g., sensitivity/specificity of the algorithm alone against a gold standard) is not described or quantified in this 510(k) summary.

7. The Type of Ground Truth Used:

Not applicable, as a study requiring ground truth for diagnostic performance is not described.

8. The Sample Size for the Training Set:

The document does not provide any information about a training set for the ECG interpretation algorithms.

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

Not applicable, as no training set or its ground truth establishment is described.

Summary of what the 510(k) does convey:

The document primarily demonstrates substantial equivalence to predicate devices through non-clinical testing against relevant industry standards (e.g., electrical safety, electromagnetic compatibility, ECG performance requirements like filtering and lead accuracy). It asserts that the device's technical specifications and intended use are similar to those of previously cleared devices, making it equally safe and effective from a manufacturing and functional standpoint, rather than providing a detailed clinical validation of its diagnostic algorithm's accuracy.

Ask a specific question about this device

The Model 950-12L Holter recorder is intended to record continuous data for up to 120 hours 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
• Evaluating medications
• Clinical studies
  This is a prescriptive device and is to be used by trained physicians and other licensed medical professionals only.
  The Memtec Model 950-12L recorder does not perform diagnostics. The data provided shall be used by physicians for diagnostic evaluations.
  The Memtec Model 950-12L recorder is not intended for infants weighing less than 22 Lbs. (10 Kg).

The Model 950-12L is a small, light weight, single battery device designed for the recording of ECG data collected from ambulatory patients. The device can record and store multiple of channels of data for up to 120 hours on a SD Card. The device has a resolution of 12-bits with a fundamental sampling frequency of 6K (SPS) per channel with selectable storage rates of 128, 256, 512, or 1024 SPS and is stored un-compressed on a removable SD or SDHC Storage Card. The data can be downloaded via USB 2.0 or removable of SD Card. Data integrity is provided by including Patient ID/Date/Time Stamps and a CRC-16 check on the recording every 2 minutes. The large LCD provides real time patient ECG signals enabling lead placement confirmation during patient hook-up. The Model 950-12L provides up to 48 hours of continuous operation using one AA alkaline or 120 hours using a Lithium "AA" battery.
The recorder is not capable of any diagnosis, nor can it provide any interpretation of the data. The device accommodates compatibility with various OEM Holter playback systems.

The provided document is a 510(k) summary for the Memtec Model 950-12L Holter Monitor, which is a device for recording ECG data. The submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing and general safety and effectiveness.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of algorithm performance.

The device itself is described as a "Holter Monitor (Without Analysis)" and explicitly states: "The recorder is not capable of any diagnosis, nor can it provide any interpretation of the data." and "The Memtec Model 950-12L recorder does not perform diagnostics. The data provided shall be used by physicians for diagnostic evaluations."

Therefore, many of the requested points in your prompt are not applicable to this type of device and submission. This is a hardware device intended for data acquisition, not an AI or algorithm-driven diagnostic tool.

Here's a breakdown of the applicable information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document implies that the acceptance criteria are adherence to specific industry standards for medical devices and performance equivalent to existing predicate devices. No quantitative performance metrics for disease detection or diagnosis are presented because the device does not perform these functions.

  • Standards Cited:
    • ANSI/AAMI EC38 (Performance standard for cardiac monitors, heart rate meters, and alarms)
    • IEC60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - requirements and tests)
    • IEC61000-4-2, 3, 6, and 8 (Electromagnetic compatibility (EMC) testing standards)

• Reported Device Performance: The "Conclusions From Non-clinical Testing" state: "After comparing predicated devices to the Memtec Model 950-12L, results show that with the intended use, the Model 950-12L is equivalent in safety and effectiveness." This is a qualitative statement of equivalence based on meeting the mentioned standards, not a quantitative performance metric for diagnostic accuracy.

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

• Not Applicable. The device does not perform diagnostic algorithms, so there is no "test set" of patient data in the context of evaluating algorithm performance for disease detection. The testing mentioned (non-clinical) would involve device-level electrical, mechanical, and safety testing, not clinical data sets for diagnostic accuracy evaluation.

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

• Not Applicable. See point 2. There's no ground truth for diagnostic performance established for this device as it doesn't make diagnoses.

4. Adjudication Method for the Test Set

• Not Applicable. See point 2.

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. This is not an AI-assisted diagnostic device. It's a data recorder.

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

• No. There is no diagnostic algorithm in this device.

7. The Type of Ground Truth Used

• Not Applicable. For a device without diagnostic capabilities, "ground truth" related to disease outcomes or pathology is not relevant to its 510(k) submission. The "ground truth" in this context would be whether the device meets electrical safety, EMI/EMC, and recording performance specifications as defined by the cited standards.

8. The Sample Size for the Training Set

• Not Applicable. There is no machine learning "training set" for this hardware device.

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

• Not Applicable. See point 8.

Ask a specific question about this device

Ask a specific question about this device