(184 days)
The intended use of this device is to acquire and record 3 different types of heart bio-signals (ECG, PCG, MCG) and combine the results into a contiguous presentation as an aid to diagnostic interpretation by a Physician in a clinical setting.
The indication for use is as ...
a. a Standard 12 Lead Diagnostic ECG
b. an aid to identify events in the cardiac cvcle
c. an aid to detect S1 & S2 hearts sounds and murmurs.
Not intended for use in pediatrics. Not intended for patients in the intensive care units. Intended population: Males and females greater than or equal to 20 years of age.
Any diagnostic interpretation is only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.
The Cardio-TriTest is on a prescription basis by a Certified Medical Practitioner.
The Cardio-TriTest is three devices in one, combining a 12-Lead Electrocardiograph (ECG), a Phonocardiograph and a Mechanocardiograph. The device will acquire all three types of bio-signals during the same non-invasive test procedure. The three types of signals are synchronized and outputted on the same timeline making it easier and more visual for general practitioners to visually determine a patient's current heart symptoms.
The ECG component is a Standard 12-Lead ECG, conformant with IEA60601-2-25 standards.
The Cardio-TriTest device for catching ECG signals uses Standard 12-Lead FDA/CE approved ECG cables by Sino-Hero Company.
The PCG component consists of 4 electronic stethoscopes combined into one Phono recording device.
PCG/MCG sensors are with FDA/CE approved diaphragms and soft non chill rings manufactured by the Riester Company from Germany.
The MCG component consists of 4 MCG recording devices.
The MCG signal validation is in the Annex B of this application.
The PCG and MCG sensors are housed in common sensor housing for the purpose of being positioned/located on the thoracic wall in the same four (4) primary and standard auscultation points.
The combined PCG/MCG sensors are correctly positioned on the four primary auscultation points on the thoracic wall via a purpose designed harness.
The provided text describes the Cardio-TriTest device, a 3-in-1 device combining Electrocardiograph (ECG), Phonocardiograph (PCG), and Mechanocardiograph (MCG) functionalities. It aims to acquire and record three types of bio-signals and combine them into a contiguous presentation to aid diagnostic interpretation by a physician.
Here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices. For parts of the device where specific standards apply (like the ECG), it states compliance.
Reported Device Performance:
The document primarily focuses on establishing "substantial equivalence" based on technological characteristics and safety. It states:
- ECG Component: "The ECG component is a Standard 12-Lead ECG, conformant with IEA60601-2-25 standards." and "In accordance with FDA guidelines, the ECG component is conformant with IEA 60601-2-25 (2014) Diagnostic ElectroCardiographs (ECG)."
- MCG Component: "The MCG functionality... is substantially equivalent to the DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300."
- PCG Component: "The PCG functionality... is substantially equivalent to the Zargis Acoustic Cardioscan-ZAC."
- Safety: "Being a 3-in-1 device, the safety of the device meets the Standard as per IEA60601-1, in accordance with the standards set in 60601-2-25 for Diagnostic ECG and applies equally to the two other functional aspects of the device." And "The Cardio-TriTest device has passed all the required safety standards and has also been subjected to extensive safety, environmental and performance testing."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a test set or the data provenance for performance evaluation. The focus is on demonstrating compliance with standards and substantial equivalence rather than a clinical performance study with a specific test set.
3. 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)
This information is not provided in the document. The document refers to "physician over-read" for diagnostic interpretation but does not detail how ground truth for any testing was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
An MRMC comparative effectiveness study is not mentioned in the document. The device is presented as an aid to diagnostic interpretation, but no study comparing human readers with and without the device's assistance is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is explicitly stated as an "aid to diagnostic interpretation by a Physician" and that "Any diagnostic interpretation is only significant when used in conjunction with physician over-read." This indicates it's not intended for standalone (algorithm-only) performance, and no standalone performance study is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not describe the type of ground truth used for any performance evaluation.
8. The sample size for the training set
The document does not mention a training set or its sample size. The description centers on the device's technological characteristics and comparison to predicate devices, not on a machine learning model that would typically require a training set.
9. How the ground truth for the training set was established
Since no training set is mentioned, the method for establishing its ground truth is not provided.
Summary of what's provided related to device performance and criteria:
The document focuses on establishing the Cardio-TriTest's substantial equivalence to existing legally marketed devices based on:
- Compliance with recognized standards:
- ECG component: IEA60601-2-25 (2014) Diagnostic ElectroCardiographs (ECG).
- Overall safety: IEA60601-1 and related collateral standards (IEC 60601-1-2, IEC 60601-1-6, EC53, ISO 13485, ISO 14971).
- Technological characteristics comparison: Detailed feature-by-feature comparison with predicate devices (DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 and Zargis Acoustic Cardioscan-ZAC), demonstrating that differences "do not raise any significant concern with respect to the safety or on the effectiveness of the operating results."
- Signal validation/comparison documents: "The MCG signal validation is in the Annex B of this application." and "The PCG signal comparison document to the Reference device is in Annex A of this application." and "The MCG signal comparison document to the CTT PCG part is in Annex B of this application." (Note: these annexes are referenced but not included in the provided text).
In essence, the "study" proving the device meets acceptance criteria appears to be a demonstration of compliance with relevant safety and performance standards for its individual components (ECG, PCG, MCG) and a detailed comparison of its technological features to predicate devices to establish substantial equivalence, rather than a clinical trial with specific performance metrics against a defined ground truth.
§ 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).