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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.

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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.

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