(238 days)
The Cardio Q50 / Cardio Q70 ECG Analysis System is intended to acquire, analyze, display and record ECG information from adult and pediatric populations.
- Bionet Algorithm - 3 years or older / Glasgow Algorithm - 0 years or older
The system provides 12-lead ECG and interpretive analysis.
The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical professional along with other relevant clinical information.
Sending and receiving ECG data to and from the Hospital Information System is optional.
The Cardio Q50 / Cardio Q70 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.
In addition, the Cardio Q50 / Cardio Q70 is intended for prescription use only to perform spirometry diagnostic tests in adults and pediatric patients aged 5 and older in general practice, specialist and hospital settings. The device is intended to be used what measures patient respiratory parameters including FVC, FEV1/FEV6, SVC, MVV.
Cardio Q50 / Cardio Q70 is a 12-channel ECG (Electrocardiogram) recording equipment that measures and records the patient's ECG. It not only provides parameters necessary for diagnosis, patient's ECG record and automatic diagnosis, but also increases chart management efficiency by providing ECG records and printing reports when patient or user information is entered. At the same time, it can transmit the saved data to a PC for file management. Its useroriented design enables ECG examination with a single push of a button. It saves, transfers and prints the data that has been acquired by automatic diagnosis.
It provides the user with the necessary parameters, which are necessary for patient diagnosis, along with the spirometry record. After spirometry tests, you can print out a report on A4/letter paper together with the spirometer record to efficiently manage the patient's or user's chart. The stored data is forwarded to a PC that is in charge of managing digital files. In addition, the battery pack, which can be stored inside as an optional component, ensures high portability and makes it possible to inspect or use the equipment in an emergency.
The provided document is a 510(k) summary for the Cardio Q50 and Cardio Q70 ECG Analysis System, which includes both ECG and spirometry functions. The document primarily focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner you've requested.
However, based on the information provided, I can infer some aspects related to acceptance criteria and how the device's performance is demonstrated:
1. A table of acceptance criteria and the reported device performance
The document does not provide a direct table of acceptance criteria with reported device performance metrics in terms of accuracy, sensitivity, specificity, etc., for the diagnostic algorithms. Instead, it states that the device complies with certain international standards. Compliance with these standards implicitly serves as the acceptance criteria for various aspects of the device's functionality and performance.
| Acceptance Criteria (Implied from Standards Compliance) | Reported Device Performance (Implied from Compliance Statement) |
|---|---|
| ECG Functionality: | |
| Electrical Safety & Essential Performance (IEC 60601-1 Ed 3.2) | Complies |
| Electromagnetic Compatibility (IEC 60601-1-2 Ed 4.1) | Complies |
| Usability (IEC 60601-1-6 Ed 3.1) | Complies |
| Specific Safety for Electrocardiographs (IEC 60601-2-25: 2011) | Complies |
| Performance for Ambulatory ECG Recorders (ANSI AAMI EC53) | Complies |
| Spirometry Functionality: | |
| Spirometers for Forced Expired Volumes (ISO 26782:2009) | Complies |
| Peak Expiratory Flow Meters (ISO 23747:2009) | Complies |
| Software: | |
| Software Development Process & Validation (FDA Guidance) | Software developed, verified, and validated |
| Cybersecurity Management (FDA Guidance) | Implied compliance by citing guidance |
| Biocompatibility: | |
| Cytotoxicity (EN ISO 10993-5) | Complies by reference to standards used |
| Sensitization (EN ISO 10993-10) | Complies by reference to standards used |
| Intracutaneous Reactivity (ISO 10993-10) | Complies by reference to standards used |
2. Sample size used for the test set and the data provenance
The document does not provide details on sample size, data provenance (e.g., country of origin, retrospective/prospective), or demographic information for any test sets used to validate the performance of the Bionet or Glasgow ECG analysis algorithms. It mentions "Non-Clinical Test Summary" and "Clinical Test Summary" but states "Clinical testing is not required." This implies that the device's performance regarding the ECG interpretation algorithm itself was likely established based on prior validation of the algorithms (Bionet algorithm V 3.26 and Glasgow algorithm V 30.4) outside the scope of this specific 510(k) submission, or that the FDA did not require new clinical data for this particular clearance due to substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document because no specific clinical study data is presented for the ECG analysis algorithm. The document mentions that the interpretive analysis "must be confirmed by a qualified medical professional along with other relevant clinical information." This highlights the human-in-the-loop nature of the device's intended use rather than providing details on ground truth establishment for an algorithm's validation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided as no specific clinical study data (including ground truth establishment) is detailed 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
The document does not indicate that an MRMC comparative effectiveness study was performed or refer to any such study demonstrating the effect size of human readers improving with AI assistance. The device's clearance is based on substantial equivalence to existing devices and compliance with relevant standards, not on a demonstrated improvement in human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
While the document states that the ECG interpretation algorithm provides analytical information that "must be confirmed by a qualified medical professional," it also includes the algorithm as a feature. The compliance with standards like ANSI AAMI EC53 (Ambulatory ECG Recorders) might implicitly cover some standalone algorithm performance metrics, but no specific standalone performance metrics (e.g., sensitivity, specificity, accuracy of the algorithms) are explicitly provided in this 510(k) summary. The document focuses on the safety and essential performance of the electrocardiograph system as a whole, rather than the isolated diagnostic performance of its interpretive algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used for the validation of the Bionet or Glasgow ECG analysis algorithms, as details of a specific validation study are not included in this submission. For ECG interpretation algorithms, ground truth is typically established through expert consensus by multiple cardiologists, often aided by correlation with other clinical data and patient outcomes.
8. The sample size for the training set
The document does not provide information on the sample size for the training set of the ECG analysis algorithms.
9. How the ground truth for the training set was established
The document does not describe how the ground truth for the training set was established. This information would typically be part of the algorithm's development and validation, which precedes the 510(k) submission for a device incorporating a previously developed or updated algorithm. The document only states the versions of the Bionet (V 3.26) and Glasgow (V 30.4) algorithms being used, implying their prior establishment and validation.
§ 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).