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The CardioTag device is a tool that can be used to record, display and transfer vibrational waveforms produced by the heart contractions and transmitted to the chest as well as single-channel electrocardiogram (ECG) rhythms and heart rate. It also measures pulse waveform and pulse rate by photoplethysmograph (PPG). The CardioTag may be used as a tool to measure the timing of the aortic valve opening and closing in the cardiac cycle. The CardioTag is intended for spot-checking of adult patients in clinics or at home under the care of a physician. The data from the CardioTag is intended for use by healthcare professionals as an aid to diagnosis and treatment.

The CardioTag device consists of a rechargeable wearable that is responsible for collecting raw cardiac signals from a single patient, and produces a spot-check report of a patient's electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG) signals and heart rate. To generate the report, the user places the wearable on the sternum and starts a 2 minute recording session for waveform output and heart rate /pulse rate calculation. The wearable contains electrodes to measure single-lead ECG, light sources and optical sensor arrays to measure PPG, and an accelerometer to measure vibrational waveforms from the heart's contractions transferred to the chest wall (SCG). Sensor data is then transferred for storage and processing to a cloud-based backend). The backend uses the recording to calculate heart rate and pulse rate and then visualizes the waveforms and heart rate in the format of a downloadable PDF report for the clinician. The SCG signal is intended to be used for manual interpretation by the clinician in conjunction with other information from the device. The device may be used as a tool to measure the timing of the aortic valve opening and closing in the cardiac cycle.

The provided FDA 510(k) clearance letter and supporting documentation for the CardioTag device does not contain enough information to fully answer all aspects of the acceptance criteria and study design, specifically regarding the detailed performance metrics, sample sizes for test and training sets, expert adjudication details, and the specific ground truth establishment methods.

However, I can extract and infer information from the available text to address as many points as possible.

Here's a breakdown of the acceptance criteria and study details based on the provided document:

Acceptance Criteria and Device Performance

The document states that "The primary endpoints for the CardioTag study were all met. The study results demonstrated that the CardioTag performs at an acceptable level when compared to commercially available devices with high accuracy." While this confirms the device met its performance criteria, the specific metrics and numerical targets are not explicitly stated in the provided text.

Based on the device's functions, the implied acceptance criteria would relate to the accuracy of:

• ECG waveform recording and display
• Heart rate calculation (from ECG)
• PPG waveform recording and display
• Pulse rate calculation (from PPG)
• SCG waveform recording and display
• Measurement of aortic valve opening and closing timing (from SCG)

Since the document states "The primary endpoints for the CardioTag study were all met," we can infer that the reported device performance met or exceeded the (unspecified) acceptance thresholds for these functions, demonstrating high accuracy when compared to commercially available devices.

Table of Acceptance Criteria and Reported Device Performance (Inferred/General)

Study Proving Device Meets Acceptance Criteria

The document describes a clinical study that was conducted to validate the CardioTag device.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: The exact numerical sample size for the clinical study is not specified in the provided document. It only states, "The CardioTag device has been clinically tested and validated in the US."
   • Data Provenance: The data was collected from subjects recruited in the US. The study was prospective as it involved recruiting subjects for clinical testing. It also states, "subjects were recruited based on US demographics to present proper race and ethnicity to ensure diverse representation."

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • The document does not specify the number of experts or their qualifications used to establish ground truth for the clinical study. It only mentions that the data is "intended for use by healthcare professionals as an aid to diagnosis and treatment" and the SCG signal is for "manual interpretation by the clinician." This implies that expert interpretation would be crucial for ground truth, but the details are missing.

3. Adjudication Method for the Test Set:

   • The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • The document does not mention a specific MRMC comparative effectiveness study. The study "compared [CardioTag] to commercially available devices" to demonstrate accuracy, which suggests a comparative element, but not necessarily an MRMC study assessing human reader performance with and without AI assistance.
   • Therefore, no effect size for human reader improvement with AI vs. without AI assistance is reported in this document.

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

   • The document does not explicitly describe a standalone algorithm-only performance study. The description of the device heavily emphasizes the output for "manual interpretation by the clinician" and "aid to diagnosis and treatment by healthcare professionals," suggesting a human-in-the-loop workflow.
   • However, the validation of "ECG Validation," "PPG Validation," and "SCG Validation" in the performance testing section, which were "Bench-testing (non-clinical)," might imply a component of standalone algorithm evaluation of signal quality and derived parameters. The clinical study, by nature of validating against commercially available devices, would involve the device's outputs without necessarily detailing a separate "algorithm only" performance metric without human review.

6. Type of Ground Truth Used:

   • The document implies that ground truth was established by comparison to "commercially available devices" which served as the reference standard. This suggests a clinical comparator ground truth rather than pathology or long-term outcomes data. For parameters like heart rate and pulse rate, the ground truth would likely come from validated measurements by the comparator devices. For waveform interpretation (ECG, SCG), expert consensus or comparison to gold-standard clinical systems would be the likely ground truth, though not explicitly stated.

7. Sample Size for the Training Set:

   • The document does not specify the sample size used for the training set.

8. How the Ground Truth for the Training Set Was Established:

   • The document does not specify how ground truth for the training set was established. Given the nature of a 510(k) submission, this information might be in a more detailed study report not included in this summary.

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