FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

ECGxxx(z)(+) is a high-performance, multi-channel, interpretative resting electrocardiograph.
The ECG signal is acquired with a 10-wires patient cable and is displayed in real time on a LCD screen integrated in the device. The electrocardiograph can analyse and store the ECG traces, send them to an external peripheral via network or via USB, print the 12 lead ECG in automatic or manual mode by means of a thermal printer.
ECGxxx(z)(+) is intended for assessment and diagnosis of cardiac functions. In any case the results of analysis performed by the electrocardiograph must be validated by a Physician.
ECGxxx(z)(+) is intended for use in hospitals, in medical clinics and doctor's offices of any size.

The device is indicated for use to acquire, analyse, display and print electrocardiograms.
The device is intended to provide the physician with an automatic interpretation of the ECG to be reviewed by a physician.
The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data.
The device is indicated for use on adult and pediatric populations.
The device is not intended to be used as a vital signs physiological monitor.

Device Description

ECGxxx(z)(+) is a family of high-performance, multi-channel, interpretative resting electrocardiograph. ECG100+ and ECG200+ are two models of that electrocardiographs family.
The device is a 12-lead diagnostic electrocardiograph which displays, acquires, prints and stores EGG tracings for adults and children. It also calculates the main overall ECG parameters.
The device can be supplied with the optional 12-lead Glasgow resting ECG interpretation algorithm, with specific criteria by age, sex and race. If this option is enabled, the algorithm can provide an over-reading physician with a second opinion generating diagnostic messages in the ECG report.
For further information on the resting ECG interpretation algorithm, see the Guidance for the physician on the application on adults and children (see accessories list)
The device can be configured with a larger memory, with bidirectional connectivity (LAN) and with DICOM® functionality.
The device can be powered by battery or the electrical mains.
The printing formats supported include: standard or Cabrera 3, 3+1, 3+3, 6 or 12 channels in automatic mode and 3, 6 or 12 (only for ECG200+) channels rhythm strip printing.
The ECG signal is acquired with a 10-wires patient cable and is displayed in real time on a LCD screen integrated in the device. The electrocardiograph can analyze and store the ECG traces, send them to an external peripheral via network or via USB, print the 12 lead ECG in automatic or manual mode by means of a thermal printer.
ECGxxx(z)(+) is intended for control and diagnosis of cardiac functions. In any case the results of analysis performed by the electrocardiograph must be validated by a Cardiologist.
ECGxxx(z)(+) is intended for use in hospitals, in medical clinics and offices of any size.
ECGxxx(z)(+) is a family of electrocardiographs which are a 12-lead diagnostic electrocardiographs and which are intended to displays, acquires, prints and stores ECG tracings for adults and children. It also calculates the main overall ECG parameters.
The devices have the following characteristics:

mains and internal battery operation
manual and automatic acquisition of the 12 Standards Leads
simultaneous acquisition of the 12 Standards Leads
internal storage up to 100 ECGs. Can storage up to 1000 ECGs optionally
multichannel ECG printout on thermal paper:
- a) (for ECG100+) 3, 6 channels, 5/10/25/50 mm/s
- b) (for ECG200+) 3, 6 or 12 channels, 5/10/25/50 mm/s
high resolution thermal printer:
- a) (for ECG100+) 8 dot/mm 108mm; Z-fold 100x150mm
- b) (for ECG200+) 8 dot/mm 216mm; A4 Z-fold
for autoprint mode:
- a) (for ECG100+) Standard or Cabrera; 3, 3+1, 6 channels Patient Demographic, Global Measurements, Optional Interpretation (Glasgow University - Prof. MacFarlane) Adult, Paediatric, STEMI
- b) (for ECG200+) Standard or Cabrera; 3, 3+1, 6, 12 channels Patient Demographic, Global Measurements, Optional Interpretation (Glasgow University - Prof. MacFarlane) Adult, Pediatric, STEMI
display:
- a) (for ECG100+) Backlit, colour LCD display, 4.3" ECG waveform real-time tracing
- b) (for ECG200+) 7" backlit LCD colour display, displays the ECG waves in real time
Keyboard (for both devices): Mechanical keypad with alphanumeric keys and special function keys -
filters (for both devices): diagnostic fully digital high pass filter; adaptive digital AC interference filter (50/60 Hz); digital low pass filter muscular filter 25 and 40 Hz (only for display and printing)
connectivity (for both devices): USB device and LAN (optional)
patient cable (for both devices): standard 15D, 10-wires
-Data export (for both devices): SCP (standard format), XML-PDF-GDT (included in standard connectivity option), DICOM (included in DICOM connectivity option), HL7 (optional).
More specifically, the equipment family is based on two model variants characterized by different print and display capabilities.
Both devices offers full ECG acquisition meeting the standards used in clinical and diagnostic applications (AAMI, ANSI, AHA, ACC). When battery powered both devices have a duration of more than 500 ECGs and the recharging time is 4 hours to 85% of full charge.
The package includes (for both devices):
1. Patient cable
1. AC Power supply (100-240 VAC 50/60 Hz)
1. Paper
1. Pack of electrodes
1. Banana/clip adapter set
1. Guidance for the physician on the application on adults and children (with interpretative key)
1. User manual
  The common family name is ECGxxx(z)(+). Where:
  xxx = printer size
- = model with network connectivity
z = models with different interfaces
(refer to Technical File for more details)
The results of the analysis must always be validated by qualified, trained medical personnel and the devices are intended for use in a medical environment. ECG100+ and ECG200+ are intended to be used on adult and all pediatric patients. The devices must be handled with care by taking all the necessary precautions in order to prevent and avoid shocks, vibrations, heat sources, liquids and anything else that may damage it.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Cardioline ECG100+ and ECG200+ electrocardiographs. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's diagnostic algorithm performance.

Therefore, many of the requested details about acceptance criteria, specific study designs, and ground truth establishment for an AI performance study are not present in this document. The document describes the device's physical and functional performance, as well as its safety and EMC compliance, but not the clinical performance of its automatic interpretation algorithm in a standalone or MRMC study.

Here's a breakdown of what can be extracted and what is not available:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of clinical accuracy or diagnostic performance for the ECG interpretation algorithm. Instead, it demonstrates compliance with relevant safety and performance standards for electrocardiographs.

The performance aspects highlighted are related to the physical and electrical functioning of the device, not the diagnostic accuracy of its interpretation algorithm.

Acceptance Criteria (Standards Compliance)	Reported Device Performance
Safety:
IEC 60601-1	Full compliance
IEC 60601-2-25	Full compliance
CB scheme	Full compliance
Defibrillation protection	Compliant
Energy reduction test	Compliant
Overload tolerance	Compliant
Indication of inoperable ECG	Compliant
LEAD representation, nomenclature & def.	Compliant
Goldberg and Wilson LEADS	Compliant
Recovery time	Compliant
Input impedance	Compliant
Common mode rejection	Compliant
Filters	Compliant
Noise level	Compliant
Channel crosstalk	Compliant
High frequency response	Compliant
Low frequency (impulse) response	Compliant
Linearity and dynamic range	Compliant
Recording speed	Compliant
Time and amplitude ruling	Compliant
Use with cardiac pacemakers	Compliant
EMC:
EN 60601-1-2 standard	Full compliance

Information Not Found in the Document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document does not contain information about a dedicated test set for evaluating the diagnostic performance of the interpretation algorithm. The "performance data" section focuses on hardware and electrical aspects, not clinical algorithm accuracy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no dedicated test set for diagnostic accuracy is described. The document states that the interpretations must be validated by a Physician/Cardiologist.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no specific test set requiring adjudication is described.
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 interpretation algorithm (Glasgow ECG system) is presented as an "optional interpretation" intended to "provide the physician with an automatic interpretation of the ECG to be reviewed by a physician." It explicitly states: "The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data." This indicates it's an assistive tool, but no study on its effectiveness in improving human reader performance is provided.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies the algorithm provides an interpretation, but no standalone performance study results (e.g., sensitivity, specificity for specific conditions) are provided. Its role is clearly defined as "not intended as a sole means of diagnosis" and requiring "a physician over-read."
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified for the interpretation algorithm's development or validation.
The sample size for the training set:
- The document mentions the device can be supplied with the "optional 12-lead Glasgow resting ECG interpretation algorithm." The training set size for this pre-existing algorithm (developed by Glasgow University - Prof. MacFarlane) is not discussed in this submission.
How the ground truth for the training set was established:
- As with the training set size, the method for establishing ground truth for the Glasgow algorithm is outside the scope of this 510(k) submission and not detailed here.

Summary of what the document does provide regarding the interpretation algorithm:

Algorithm Name: Glasgow resting ECG interpretation algorithm (adult and pediatric).
Provider: Glasgow University - Prof. MacFarlane.
Function: Provides a "second opinion" or "diagnostic support" to the physician.
Limitation: "Interpretation Statements must be overviewed and approved by trained Physician's. Interpretation statements just represent a partial qualitative and quantitative information of the general patient cardiovascular condition: no therapy or drugs can be subministrated based solely on Interpretation statements." Also, "It is not intended as a sole means of diagnosis." and "must be validated by a Physician."
Target Population: Adult and pediatric.

This 510(k) submission focuses on demonstrating that the new Cardioline ECG devices are substantially equivalent to existing, legally marketed ECG devices in terms of general function, safety, and physical performance, including the capability to run a similar interpretation algorithm. It does not provide the detailed validation study of the embedded Glasgow interpretation algorithm itself.

Summary

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).