(74 days)
The intended use of the device is to acquire and record the 3 different types of heart bio-signals (ECG, PCG, and 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 cycle
c. an aid to detect S1 & S2 hearts sounds and murmurs.
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 v6.5 (CTT) is three devices in one; combining a 12-Lead Electrocardiograph (ECG), a 4 Lead Phonocardiograph and a 4 lead 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 for general practitioners to visually determine a patient's current heart health.
The ECG component is a Standard 12-Lead ECG, conformant with EN IEC 60601-2-25 standards.
The CTT v6.5 device uses approved Standard 12-Lead FDA/CE cables.
The CTT includes 4 Kombi-Sensors that include combine PCG/MCG functionality.
The PCG component consists of 4 electronic stethoscopes into one Phono recording device.
PCG sensors are equipped with diaphragms and non-chill rings.
The MCG component consists of 4 MCG recording devices integrated into the Kombi-Sensor housing (PCG and MCG in same Sensor Housing).
The PCG and MCG signal verification can be found in Annex E - Signal Testing.
The PCG and MCG sensors are housed in common sensor housing, Kombi-Sensor, this allows the Kombi-sensor of being positioned/located in one of the 4 standard auscultation points on the thoracic wall.
The combined PCG/MCG sensors record their signals when positioned on the four primary auscultation points on the thoracic wall.
The provided text describes the Cardio-TriTest v6.5 device and its substantial equivalence to a predicate device (Cardio-TriTest v5.5) but does not contain information about a specific study designed to prove the device meets acceptance criteria related to its diagnostic performance (e.g., accuracy of identifying cardiac events or heart sounds).
The document focuses on:
- Device Description and Intended Use: The device acquires and records three types of bio-signals (ECG, PCG, MCG) and combines them for diagnostic interpretation by a physician.
- Technological Characteristics and Equivalence: It compares the v6.5 device to its predicate (v5.5), highlighting features and functions.
- Safety and Performance (General): It states that the device meets safety standards (IEC 60601-1, EN IEC 60601-2-25) and has undergone "extensive safety and performance testing" and "software validation."
Missing from the text is a detailed account of a study specifically designed to establish acceptance criteria for the diagnostic interpretation aid and subsequent performance evaluation against those criteria. Therefore, most of the requested information cannot be extracted directly from the provided document.
However, based on the general statements about safety and performance, and the comparison to the predicate device, we can infer some aspects and highlight what's missing.
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity for detecting cardiac events or murmurs). It mentions that the ECG component is conformant with EN IEC 60601-2-25 standards, which implies compliance with the technical requirements of that standard. Similarly, it states the device "has passed all the required safety standards and has also been subjected to extensive safety and performance testing." However, specific performance metrics against defined acceptance criteria are not reported for its diagnostic aid function.
| Acceptance Criteria (Implied/Inferred) | Reported Device Performance |
|---|---|
| ECG Functionality: | |
| Conformity to EN IEC 60601-2-25 | "Conformant with EN IEC 60601-2-25 standards." |
| Electrical Safety (IEC 60601-1) | "Has passed all the required safety standards." |
| EMC (EN IEC 60601-1-2) | Compliance met. |
| Usability (IEC 60601-1-6) | Compliance met. |
| Overall Device Safety: | |
| Compliance with IEC 60601-1 | "meets the Standard as per IEC 60601-1" |
| PCG/MCG Functionality: | |
| Signal verification | "Signal verification can be found in Annex E - Signal Testing." (Details not provided in this extract) |
| Performance against predicate | "substantially equivalent to their corresponding FDA cleared predicate device" |
| Software Validation: | |
| Functional and performance specifications met | "software validation corresponding to each functional aspect of the device, to ensure that all safety and performance specifications were met." |
| Intended Use (Aid to Diagnosis): | No specific quantitative diagnostic performance metrics or acceptance criteria are provided. The device is described as an "aid to diagnostic interpretation by a Physician." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. While "extensive safety and performance testing" is mentioned, details about specific test sets for evaluating diagnostic aid performance are absent.
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. The document states that "Any diagnostic interpretation is only significant when used in conjunction with physician over-read," implying human interpretation, but does not detail how ground truth was established for performance testing of the aid itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 study is not explicitly mentioned or described. The document focuses on substantial equivalence based on technological characteristics and general safety/performance, not on comparative effectiveness against humans with or without the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is positioned as an "aid to diagnostic interpretation by a Physician." This implies it is not intended for standalone diagnostic use. Therefore, a standalone performance study for diagnosis (without human-in-the-loop) is unlikely to be relevant to its intended use and is not described in the document. The "software validation" mentioned focuses on meeting "safety and performance specifications," likely referring to technical signal acquisition and processing rather than diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.
8. The sample size for the training set
This information is not provided. The document mentions "software validation" but does not detail machine learning models or their training data.
9. How the ground truth for the training set was established
This information is not provided.
§ 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).