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CardeaScreen records and measures a resting ECG from the adult and pediatric (age ≥ 14) body surface. It provides automatic ECG interpretations which are identified as "Unconfirmed" by the product until they have been overread and confirmed by a clinician.

CardeaScreen is intended for use on apparently healthy individuals and on symptomatically stable patients with known or potential cardiac conditions.

This device is intended for use under the direct supervision of a licensed health care clinician.

The CardeaScreen™, developed by Cardea Associates, Inc. (Cardea), is small, lightweight, portable electrocardiograph, designed for collection of resting (nonambulatory) electrocardiographic (ECG) data.

The CardeaScreen device system is composed of 2 main components:

• . ECG Transmitter - this type of device is also referred to in the medical community as a "ECG recorder", or "ECG data acquisition unit". The CardeaScreen ECG transmitter is about the size of a small paperback book (~6" x 4" x 1.5") and ~11 ounces. The transmitter is battery powered or it can also be powered via AC mains power by using the medical grade power supply supplied as part of the CardeaScreen system.
  A patient cable with 10 lead wires is attached to the transmitter. The lead wires terminate in connectors that are attached to commercially available ECG electrodes selected by the clinician for use. The electrodes (not part of the CardeaScreen system) adhere to the patient's skin in the chest region and are used for detecting a patient's ECG.

• . CardeaScreen Software - the software is installed by the clinician on the clinician's personal computer (PC). The software controls the ECG transmitter's use. The transmitter cannot function in any manner to collect ECG, without the software.
  Collected ECG data is transferred from the ECG transmitter to the PC using wireless (Bluetooth) transmission. The software can be used for subsequent analysis of the patient's ECG data.

Here's an analysis of the provided text regarding the CardeaScreen™ device's acceptance criteria and the supporting study, structured according to your request:

Acceptance Criteria and Device Performance

The provided document, a 510(k) Summary of Safety and Effectiveness, focuses primarily on establishing substantial equivalence to predicate devices rather than defining specific performance-based acceptance criteria with quantitative thresholds. The "Testing" section broadly describes verification and validation activities.

Therefore, the table below will reflect the types of testing performed, implying that acceptable results from these tests constitute the criteria for regulatory acceptance. There are no specific quantitative performance metrics reported in this document that can be directly mapped to the common acceptance criteria for diagnostic devices (e.g., sensitivity, specificity, accuracy).

Study Details

Based on the provided K123217 510(k) summary, the "study" conducted for the CardeaScreen™ is a series of verification and validation (V&V) tests to demonstrate compliance with recognized standards and to establish substantial equivalence, rather than a clinical performance study with detailed metrics like sensitivity/specificity.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated for any of the tests. The document broadly refers to "testing" and "assessments." For the "Firmware/Software (including ECG analysis algorithm) verification/validation testing," it can be inferred that a set of ECG data was used, but the size is not specified.
   • Data Provenance: Not specified. It is not clear if it was prospective or retrospective data, or its country of origin.

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

   • Not applicable/Not specified. The document does not describe a process where experts established ground truth for a test set in the context of diagnostic performance (e.g., labeling ECGs for rhythm abnormalities). The "ECG analysis algorithm" is mentioned, and its interpretations are "Unconfirmed" until overread by a clinician, implying a human confirmation step in clinical use, but not for establishing ground truth during the described V&V.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not specified. As no expert-derived ground truth process is detailed, an adjudication method is not mentioned.

4. 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 MRMC comparative effectiveness study is mentioned in this document. The device provides "automatic ECG interpretations which are identified as 'Unconfirmed' by the product until they have been overread and confirmed by a clinician," suggesting it's intended to assist, but no study on the impact of this assistance on human reader performance is provided.

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

   • The document implies that the "ECG analysis algorithm" was part of the firmware/software verification/validation testing. However, no specific standalone performance metrics (like sensitivity, specificity, accuracy) for this algorithm are reported. The "automatic ECG interpretations" are explicitly stated to be "Unconfirmed" until overread, suggesting the standalone interpretation is not intended as a final diagnosis.

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

   • Not explicitly stated for the "ECG analysis algorithm" testing. For the physical and technical tests (electrical safety, EMC, etc.), the "ground truth" would be compliance with the respective standards, confirmed by test results meeting predefined thresholds.

7. The sample size for the training set:

   • Not specified. The document does not detail the development or training of the ECG analysis algorithm.

8. How the ground truth for the training set was established:

   • Not specified. No information is provided regarding the training set or its ground truth establishment.

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