(192 days)
The QT ECG System is intended to acquire, record and process an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology to a cell-phone or mobile device, then to a remote location. The QT ECG System is indicated for use on infants, children and adults. It is designed to be operated by adults in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing facilities), to record and transmit a 12-lead ECG and rhythm strip in near real-time to enable review at a physician's office, hospital or other medical receiving centers.
The OT ECG system is a non-defibrillator-proof, hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity. The OT ECG system consists of 5 major components:
- ·The QT ECG Recorder—Compact device that records 12-lead, resting electrocardiograms, then transmits the recorded data to a mobile device (smartphone, tablet, etc.) paired via Bluetooth. A Bluetooth-enabled mobile device (not included) is needed to operate the QT ECG Recorder, and to send the recoded rhythm strip to a cardiologist or licensed physician for review.
- . The QT ECG Electrode Strip-Disposable, patented electrodes that are prepositioned on a self-adhesive strip.
- The QT ECG App - Software that lets the user uses their mobile device to operate the QT ECG recorder, then send the recorded data via cloud to a certified medical professional for review.
- . Analysis - The analysis module provides ECG measurement from the collected data. It does not make any interpretation of the intervals provided based on factors such as heart rate, ORS duration, etc.
- . Web Service — The web service provides an interface for communication.
The recorded ECG data is saved temporarily on the mobile device until it is transferred via the Internet to the cloud server. The QT ECG System does not have monitoring capabilities and does not have diagnostic alarm function. The QT ECG System is intended for use on infants, children and adults patients to acquire ECG signals to be transmitted wirelessly via Bluetooth to a mobile device, and then over the Internet to a web service. The QT ECG System is designed to be used by a patient to record and transmit ECG data to a physician's office, hospital or other medical receiving center for review.
The provided text is a 510(k) Summary for the QT Medical, Inc. QT ECG device (K220795). This document primarily focuses on establishing substantial equivalence to a predicate device (K180157) and outlines various non-clinical testing performed to show safety and performance. However, it does not contain the detailed clinical study information typically required to describe acceptance criteria and the study that proves the device meets those criteria for an AI/ML enabled medical device.
The document states:
- "All the test results demonstrate OT ECG meets the requirements of its pre-defined acceptance criteria and indication for use, and is substantially equivalent to the predicate device." (Page 5)
- "Although there are some different specifications between two devices, the 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 requests." (Page 14)
These statements indicate that acceptance criteria exist and were met through testing. However, the document lists these tests as "Non-clinical Testing" including biocompatibility, software validation, cybersecurity, electromagnetic compatibility, electrical safety, performance (of electrode and recorder, durability, wireless interference), and human factors (usability). These are engineering and regulatory compliance tests, not a clinical study proving diagnostic or predictive performance against specific clinical acceptance criteria for an AI/ML algorithm's output.
The device description on page 5 explicitly mentions:
- "Analysis - The analysis module provides ECG measurement from the collected data. It does not make any interpretation of the intervals provided based on factors such as heart rate, QRS duration, etc."
- "The QT ECG System does not have monitoring capabilities and does not have diagnostic alarm function." (Page 5)
This indicates that the "Analysis module" performs basic ECG measurements (e.g., intervals, durations) but does not provide diagnostic interpretations or AI-driven insights that would require validation through a clinical study with expert ground truth. The device's function is data acquisition and transmission, not automated diagnosis or interpretation. Therefore, a clinical study of the device's diagnostic performance, as might be done for an AI/ML device that provides interpretations, is not described because it appears not to be within the scope of this device's intended use or capabilities.
Given the information provided in the document, I cannot create the requested table or answer most of the questions because the device does not include an AI/ML component for diagnostic interpretation and the detailed clinical study information is not present. The "performance test" mentioned in the non-clinical testing section likely refers to technical specifications for ECG signal acquisition and transmission, not clinical outcome or interpretative accuracy.
Therefore, the following table and answers are based on the absence of such information in the provided document, reflecting that this device's clearance did not hinge on an AI/ML diagnostic performance study.
Acceptance Criteria and Device Performance (Based on available information)
The provided submission does not detail acceptance criteria related to AI/ML diagnostic performance as the device's "Analysis module" performs raw ECG measurement without interpretation or diagnostic capabilities. The acceptance criteria mentioned are general for device functionality, safety, and substantial equivalence to a predicate device.
| Acceptance Criteria Category | Specific Criterion (if available from this document) | Reported Device Performance (if available from this document) |
|---|---|---|
| AI/ML Diagnostic/Interpretative Performance | Not applicable; device performs measurement, not interpretation. | Not applicable; device performs measurement, not interpretation. |
| Biocompatibility | - (Met predefined criteria) | "test results demonstrate OT ECG meets the requirements of its pre-defined acceptance criteria." |
| Software Validation & Cybersecurity | - (Met predefined criteria) | "test results demonstrate OT ECG meets the requirements of its pre-defined acceptance criteria." |
| Electromagnetic Compatibility & Electrical Safety | - (Met predefined criteria) | "test results demonstrate OT ECG meets the requirements of its pre-defined acceptance criteria." |
| Performance (general device) | - (Met predefined criteria for electrode, recorder, durability, measurement, wireless interference) | "test results demonstrate OT ECG meets the requirements of its pre-defined acceptance criteria." |
| Human Factors (Usability) | - (Met predefined criteria) | "test results demonstrate OT ECG meets the requirements of its pre-defined acceptance criteria." |
| Substantial Equivalence | Demonstrated equivalence to K180157 | "QT ECG is substantially equivalent to the predicate device." |
Answers to Specific Questions (Based on available information):
-
A table of acceptance criteria and the reported device performance:
(See table above. Note: This device is not described as having an AI/ML diagnostic component, so the clinical performance criteria typically associated with such devices are not present.) -
Sample sizes used for the test set and the data provenance:
The document mentions general "validation activities" and "performance tests" but does not specify sample sizes for test sets related to clinical performance or diagnostic accuracy. The data provenance (e.g., country of origin, retrospective/prospective) for any specific performance testing is also not provided. The testing described appears to be primarily engineering and regulatory compliance testing rather than clinical study data. -
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/Not provided. Since the device states it "does not make any interpretation" and "does not have diagnostic alarm function," there's no indication that expert-established ground truth for diagnostic or interpretative performance was required or used in this submission. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable/Not provided. No clinical diagnostic test set or adjudication method is described in this document. -
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 does not appear to provide AI assistance for human interpretation, as its analysis module only provides measurements, not interpretations. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No standalone diagnostic performance study was done or described as the device's analysis module explicitly states it "does not make any interpretation." -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable/Not provided regarding diagnostic ground truth, for reasons stated above. The ground truth for the non-clinical performance tests would be defined by engineering standards and specifications. -
The sample size for the training set:
Not applicable/Not provided. As the device's "Analysis module" performs measurements rather than AI-driven interpretations, there's no mention of a training set for a machine learning algorithm. -
How the ground truth for the training set was established:
Not applicable/Not provided. (See answer to question 8).
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).