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The CardioMem® Models CM 4000/CM 4000B are Holter recorders which are 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 CardioMem® Models CM 4000/CM 4000B digital Holter recorders are intended to continuously record ECG data. The CM 4000/CM 4000B perform no cardiac analysis by themselves and are intended to be used with a Holter ECG Analysis Software package. The recorder supports the user throughout all phases of recording Holter ECGs, from applying the electrodes and entering patient demographic data up to inspecting the ECG waveforms. The digital recorders CardioMem® Models CM 4000/CM 4000B devices allow a qualified trained physician or health care professional to record the patient's ECG for the long term. The data is then downloaded to a computer containing a Holter ECG Analysis Software package. This data is then reviewed by a qualified health professional or a physician.

The only difference between the two CM 4000 models CM 4000 and CM 4000B is the battery size. The CM 4000 has a AAA battery compartment whereas the CM 4000B has a AA battery compartment, which results in a different shape of the weight of the recorder.

Here's a breakdown of the acceptance criteria and study information for the CardioMem® Models CM 4000/CM 4000B, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for performance metrics like sensitivity, specificity, or accuracy. This is likely because the device is a Holter recorder that doesn't perform cardiac analysis itself. Its primary function is to continuously record ECG data for later evaluation by software and a physician.

Instead of performance metrics, the acceptance criteria are implicitly related to demonstrating substantial equivalence to predicate devices through non-clinical testing and ensuring the device performs its intended function safely and effectively.

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

• Sample Size for Test Set: Not applicable / Not explicitly stated for a clinical test set. The provided document emphasizes non-clinical testing.
• Data Provenance: The non-clinical testing (Electromagnetic compatibility, Electrical safety, and Software validation) was performed by GETEMED Medizin- und Informationstechnik AG (Germany). The original device name is CardioMem® Models CM 4000/CM 4000B, manufacturer based in Germany. The data is retrospective in the sense that it's reported by the manufacturer for the specific device being submitted.

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

• Not applicable. No clinical test set with human ground truth labeling was used as "No clinical testing was performed in order to support safety or effectiveness."

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication was used.

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

• No. This type of study was not conducted. The device is a Holter recorder, not an AI-powered analysis tool. It records data for later use with existing ECG analysis software, which may or may not incorporate AI. The submission focuses on the recorder itself.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Yes, in spirit, but not in the context of an "algorithm" as typically defined for AI. The "standalone" performance was assessed through the non-clinical tests (EMC, electrical safety, software validation) to ensure the device's hardware and software components function correctly as a standalone recorder. However, it's crucial to reiterate that the device itself performs "no cardiac analysis."

7. The Type of Ground Truth Used

• For the non-clinical tests:
  • Regulatory Standards: Ground truth was established by relevant international standards for electromagnetic compatibility (IEC 60601-1-2) and electrical safety (IEC 60601-1).
  • Software Design Specifications/Requirements: For software validation, the ground truth would be the defined software requirements and specifications.
  • Predicate Device Performance: Implicitly, the performance and safety profile of the predicate devices (CardioMem® CM 3000-12 BT and CardioMem® CM 3000) served as a benchmark for "ground truth" concerning acceptable levels of safety and effectiveness for a Holter recorder.

8. The Sample Size for the Training Set

• Not applicable. The device is a medical device hardware (Holter recorder) and associated operating software, not an AI or machine learning algorithm that requires a "training set" in the conventional sense.

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

• Not applicable. As noted above, there is no "training set" for this type of device.

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