(329 days)
The ECG Holter device, MICROVIT MT-100, is a recording device used to record long term Electrocardiographs for the diagnostics of symptomatic and asymptomatic arrhythmias, i.e. bradycardia, tachycardia, diagnostic of arrhythmias in patients with coronary artery disease, in patients after reanimation, in patients with different diseases such as cardiomyopathy, high blood pressure, long QT syndrome. A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of dizziness or for controlling medical therapies, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic ischemias.
The ECG Holter device, MICROVIT MT-100, is a recording device used to record long term Electrocardlographs for 24 hours, on two channels.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what's available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Braemar DL 700 Holter Monitor K945130) by meeting recognized standards. The "acceptance criteria" are implied by adherence to these standards and the comparison table.
| Acceptance Criteria (Implied by Standards/Comparison) | Reported Device Performance (MICROVIT MT-100) |
|---|---|
| Electrical Safety and Reliability: | |
| Conformity to ANSI/AAMI EC 38-1994 (Ambulatory Electrocardiographs Type 1 Devices) | All tests passed |
| Conformity to IEC 601-1:1988 (General Safety of Medical Electrical Equipment) | All tests passed |
| Conformity to IEC 801-1:1984, 801-2:1991, 801-3:1984 (EMC Test, ESD, RF Electromagnetic Field) | All tests passed |
| Input Impedance (> 5 MOhm for predicate) | > 10 MOhm (conforms to AAMI EC38-1994, superior to predicate) |
| DC Offset (± 300mVDC max for predicate) | SAME (± 300mVDC max) |
| Common Mode Rejection (60dB for predicate) | > 80dB (conforms to AAMI EC38-1994, superior to predicate) |
| Recording Bandwidth (0.05 Hz to 50 Hz for predicate) | 0.05Hz to 40 Hz (conforms to AAMI EC38-1994) |
| Environmental Testing: | |
| Conformity to MIL-STD-81D (Environmental Conditions, Mechanical, Climate) | All tests passed |
| Operating Temperature (0 to 70 °C for predicate) | +10 to +40 °C (conforms to MIL-STD-81D) |
| Storage Temperature (-40 to +50 °C for predicate) | -10 to +50 °C (conforms to MIL-STD-81D) |
| Relative Humidity (10% to 90% non-condensing for predicate) | 25% to 95% non-condensing (conforms to MIL-STD-81D) |
| Electromagnetic Compatibility (EMC): | |
| Conformity to EN 55011 class B (Electromagnetic radiation) | All tests passed |
| Conformity to IEC 801-1 (Electromagnetic susceptibility) | All tests passed |
| Conformity to IEC 801-2 (Electrostatic Discharge) | All tests passed |
| Conformity to IEC 801-3 (Radio Frequency Electromagnetic Field) | All tests passed |
| Electro Static Discharge (Fully functional below 4 kV, no damage below 8kV for predicate) | SAME |
| Radiated Emissions (Less than 30 dB Microvolts for predicate) | SAME |
| Radiated Immunity (Less than 3 Volts per meter for predicate) | SAME |
| Software Quality: | |
| Reviewed against "reviewer guidance for computer controlled medical devices undergoing 510(k) review" | Software requirements, structure, development, revision, identification, verification, validation, and testing described. |
| Data Transmission Accuracy: | |
| Maximum deviation between original and transmitted/restored ECG signal | Less than 20 microvolts |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" in terms of patient data for clinical evaluation. The testing described is primarily non-clinical, involving the device itself against engineering standards.
- Data Provenance: Not applicable for patient data. The "tests" were conducted in a lab setting to verify device compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a non-clinical, engineering-centric evaluation against established standards, not a clinical study involving ground truth established by medical experts on patient data.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication process on patient data is described. The tests were objective measurements against predefined standards.
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, an MRMC comparative effectiveness study was not done. The device is a Holter recorder, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device is a recording device. Its performance is evaluated based on its ability to accurately record and transmit ECG signals, not as an algorithm performing a diagnostic task. The "standalone" performance is implied by the successful completion of the electrical, environmental, and EMC tests against established medical device standards.
7. The Type of Ground Truth Used
The "ground truth" for this submission are the established engineering and medical device standards (e.g., ANSI/AAMI EC 38-1994, IEC 601-1, MIL-STD-81D, IEC 801 series, EN 55011). The device's performance was compared against the requirements specified in these standards and the performance characteristics of the predicate device.
8. The Sample Size for the Training Set
Not applicable. The device is a physical recorder and does not utilize a "training set" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).