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The Cardio10 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations.

Pediatric population is defined as patients between the ages from 3 and less than 16 years.

Basic systems deliver 12 lead ECG's, interpretive analysis, and can be upgraded to provide software analysis options such as a high resolution signal averaging of QRS and P wave portions of the electrocardiogram. The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.

Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.

The Cardio10 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

Cardio10 is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients. 5 years and older, in general practice, specialty physician, and hospital settings. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, COPD, SVC, MVV.

Cardio 10 is a device to measure and record ECG of a patient as an ECG recording machine with 12 channels.

It provides parameters required for the diagnosis. ECG records of a patient, and automatic diagnosis and prints ECG records and output report if entering patient or user information and efficiently use them for the chart management. At the same time, it is possible to transmit saved data to the PC connected to the network and manage digital files.

In addition, it is possible to measure ECG by pressing the button only once in consideration of the convenience of a user as much as possible and save, transmit, and print data all at once after completing the automatic diagnosis.

Parameter and automatic diagnosis required on the spirometer record and diagnosis of patients are provided to users while printing the A4 size and Letter size report along with the spirometer records by entering the information of patients or users for the efficient management of chart. At the same time, saved data are delivered to the PC connected to the network managing digital files.

In addition, the battery can be internally saved as an optional component making it feasible to carry and use for checkup while moving.

The provided document is a 510(k) summary for the Cardio10 device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results in the same way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain the kind of detailed information about acceptance criteria for device performance, the specific study design (beyond general non-clinical testing for safety and EMC), sample sizes for test sets where ground truth was established, expert qualifications, or multi-reader multi-case studies as you requested.

The document states: "Clinical testing is not required." This indicates that the manufacturer did not conduct a clinical study to prove the device meets specific performance acceptance criteria in human subjects for the purpose of this 510(k) submission.

However, based on the information provided, I can extract the following details regarding the non-clinical testing performed to support substantial equivalence:

Acceptance Criteria and Device Performance (Non-Clinical Testing Summary)

The Cardio10 device was tested to comply with several international and national standards related to electrical safety, electromagnetic compatibility, usability, and specific requirements for electrocardiographs and spirometers. The acceptance criteria essentially refer to meeting the requirements of these standards. The device is reported to comply with these standards.

Missing Information:

The document does not provide the following information as it was not a clinical study designed to demonstrate performance against specific clinical acceptance criteria:

1. Sample size used for the test set and data provenance: Not applicable for the non-clinical validation studies described.
2. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable for the non-clinical validation studies described.
3. Adjudication method for the test set: Not applicable.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was conducted. The document explicitly states "Clinical testing is not required."
5. Standalone (algorithm only without human-in-the-loop performance): While the device includes interpretive algorithms, the document does not provide a specific standalone performance study report for these components. The claim is substantial equivalence to a predicate device that also has interpretive analysis, and that algorithm analysis "must be confirmed by a physician."
6. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for the non-clinical validation studies described.
7. Sample size for the training set: Not applicable, as this is not a study about an AI model's training performance, but rather a regulatory submission for a device incorporating software.
8. How the ground truth for the training set was established: Not applicable.

Summary of what the document does indicate regarding "studies":

The "study" that proves the device meets the (non-clinical) acceptance criteria consists of various engineering and validation tests to demonstrate compliance with recognized national and international standards for electrical safety, electromagnetic compatibility, usability, and specific device types (ECG and spirometer). Software validation was also performed, indicating that the firmware was developed, verified, and validated according to a software development process. Biocompatibility testing was also conducted. These are all non-clinical evaluations aimed at establishing safety and performance relative to predicate devices and recognized standards, but they are not clinical trials demonstrating diagnostic accuracy or effectiveness in human subjects with specific clinical endpoints.

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