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The CardioMem® CM 3000-12BT is a Hotter recorder which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality.

The CM 3000-12BT is a Holler recorder designed to be used in conjunction with the evaluation software GardioDay® (K051471). This recorder is not capable of any diagnosis nor can it provide any interpretation of the clata. The CM 3000-12BT acquires, digitizes and stores data to be analyzed by CardioDay®. The CM 3000-12BT uitlizes a 10-lead electrode hookup and placement to provide CardioDay" with 12 channels of full disclosure for Holler analysis. The cardiac data provided by CardioDay® is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns. The CM 3000-12BT Holter recorder stores 12 ECG channels continuously for up to 48-hours including the detection of pacemaker pulses. A keyped is available to set up system contiguration, to enter patient's ID and name, to check lead quality during hook-up, and to start the recording. During the recording, the keypad can be used to enter event markers. The CM 3000-12BT has a LCD screen to allow ECG display during the hook-up, lead quality check, system configuration and various messages for the hock-up technician. The CM 3000-12BT uses one or two AA batterles, and a removable memory card for data storage.

ECG data and palient data can be Iransmitted via a Bluetooth connection (BT module from Amber wireless GmbH) from the CM 3000-12BT to CardidDay" and also from CardioDay® to the CM 3000-12BT

Here's an analysis of the provided text regarding the CardioMem CM 3000-12BT, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list specific quantitative acceptance criteria or detailed performance metrics from a test study. Instead, it relies on a comparison to predicate devices and adherence to relevant standards. The "New/Modified Device" column serves as the "reported device performance" in this context, compared against the "Legally Marketed Device" columns.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Clinical testing was not required to demonstrate substantial equivalence of safety and effectiveness." This implies that there was no specific "test set" of patient data used in a clinical study as would be typical for many medical devices. The evaluation for this 510(k) focused on non-clinical testing and comparison to predicate devices. The data provenance would therefore be from the technical specifications and performance characteristics of the device itself and the predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical testing with a "test set" was performed, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical testing was not required."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is an ECG recorder, not an algorithm that performs analysis. It acquires, digitizes, and stores data to be analyzed by separate evaluation software (CardioDay®) and "trained medical personnel." Therefore, the concept of a "standalone" algorithm performance study is not directly applicable to this device, which is a data acquisition unit. Its performance is related to its ability to accurately record physiological signals. Non-clinical testing focused on this aspect.

7. Type of Ground Truth Used

The ground truth for the device's technical specifications and electrical performance would be established through engineering measurements, laboratory testing, and adherence to established industry standards (e.g., IEC 60601 series, ANSVAAMI EC 38). For example, the A to D sample rate and resolution would be verified against internal specifications and industry benchmarks for Holter recorders.

8. Sample Size for the Training Set

Not applicable. This device is a hardware recorder, not an AI/ML algorithm that requires a training set. The "training" in this context would refer to the device's design, engineering, and manufacturing process.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this hardware device. The device's functionality is based on its engineering design and adherence to technical requirements, which are verified through non-clinical testing against established industry standards.

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