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The CardioMem® CM 3000-12 digital Holter recorder is intended to continuously record up to 48 hours of ECG data on a digital flash memory card. The CardioMem® CM 3000-12 performs no cardiac analysis by itself and is intended to be used with the analysis evaluation software CardioDay®. The recorded data are downloaded to a PC for analysis and following evaluation by a trained physician or health care professional.

Federal law restricts CardioMem® CM 3000-12 to use on order of a physician.

This device is available only upon the order of a physician or other licensed medical professional.

The CardioMem® CM 3000-12 is a Holter 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 3000-12 is a Holter recorder designed to be used in conjunction with the evaluation software CardioDay® (not included in this 510(k)). This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. The CM 3000-12 acquires, digitizes and stores data to be analyzed by CardioDay". The CM 3000-12 uiliizes a 10-lead electrode hookup and placement to provide CardioDay® with 12 channels of full disclosure for H 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 3000-12 Holter recorder stores 12 ECG channels continuously for up to 48-hours. A keypad is available to set up system configuration, 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 3000-12 has a LCD screen to allow ECG display during the hook-up, lead quality check, system configuration and various messages for the hook-up technician. The CM 3000-12 uses one or two AA batteries, and a removable memory card for data storage.

The provided document is a 510(k) summary for the CardioMem® CM 3000-12 Holter recorder. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

The device, CardioMem® CM 3000-12, is a Holter recorder that acquires, digitizes, and stores ECG data. Crucially, the document states: "This recorder is not capable of any diagnosis nor can it provide any interpretation of the data." and "The CardioMem® CM 3000-12 performs no cardiac analysis by itself and is intended to be used with the analysis evaluation software CardioDay®."

Therefore, the "acceptance criteria" and "device performance" in this context do not refer to diagnostic accuracy or clinical effectiveness metrics, but rather to the recorder's technical specifications and compliance with regulatory standards for device safety and electrical performance. The study described is not a clinical performance study but a series of tests to confirm safety and efficacy based on technical standards.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document implicitly defines "acceptance criteria" through comparison with predicate devices and adherence to regulatory standards (IEC and AAMI). The "reported device performance" is essentially that the device meets these technical specifications and standards.

2. Sample size used for the test set and the data provenance

The document does not describe a clinical "test set" in the traditional sense involving patient data for diagnostic evaluation. The "tests" mentioned are primarily engineering and electrical safety tests, not performance on a clinical dataset. Therefore, there is no sample size of patients or data provenance (country, retrospective/prospective) for a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As this is not a clinical performance study involving diagnostic outputs, there was no ground truth for a test set established by medical experts. The device explicitly states it performs no analysis or diagnosis.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication is described.

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

Not applicable. This device is a Holter recorder, not an AI analysis tool. It does not perform analysis itself, nor does it involve human readers interpreting AI-assisted outputs.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a data acquisition and storage tool, not an algorithm performing standalone analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this device's acceptance is its adherence to technical specifications and safety standards, rather than diagnostic accuracy against clinical ground truth.

8. The sample size for the training set

Not applicable. This document is about a hardware device, a Holter recorder, not an AI or analytical algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

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