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KardiaMobile 6L is intended to record, store and two-channel electrocardiogram (ECG) rhythms. In single channel mode, KardiaMobile 6L can record Lead-I. In two channel mode, KardiaMobile 6L can record Lead-I and Lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. KardiaMobile 6L also displays ECG rhythms and output of ECG analysis from AliveCor's KardiaAI platform including detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, and others. KardiaMobile 6L is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested and is not intended for pediatric use.

KardiaMobile 6L is a trans-telephonic (transmission by smartphone) electrocardiogram (ECG) event recorder that records, stores, transfers, and analyzes single-channel or two channel ECG rhythm recordings. KardiaMobile 6L provides output of one or six ECG leads, including Lead I, Lead II, Lead III, aVL, aVR and aVF. The device utilizes the computing power of iOS-based or Android-based devices (referred to as "Mobile Computing Platforms" (MCP) within this 510(k)) to record and analyze ECG signals. KardiaMobile 6L consists of KardiaMobile 6L Hardware (portable small wireless hardware with electrodes) and the Kardia Core app. which is installed on an MCP (i.e., iOS or Android devices). KardiaMobile 6L Hardware uses Bluetooth to transmit the ECG signal from the electrodes to the Kardia Core app on the MCP, which then displays the recorded ECG on the MCP's screen. The device is intended to be used by patients with known or suspected heart conditions and health conscious individuals as well as by healthcare professionals (HCPs) who want to remotely monitor their patient's heart health. The device is available for Over-the-Counter (OTC) as well prescription use. The Kardia Core app provides the complete ECG recording and analysis workflow, from acquisition of the signal from the KardiaMobile 6L hardware, to the display of the ECG and analysis results, to printing of the ECG rhythm strip. The app utilizes KardiaAI (K181823, K201985) to provide ECG analysis, which includes the determinations of Normal Sinus Rhythm, Atrial Fibrillation, Bradycardia, Tachycardia, or Unclassified to OTC users and additionally, Sinus Rhythm determinations (Sinus Rhythm with Wide ORS, Sinus Rhythm with Supraventricular Ectopy, and Sinus Rhythm with Premature Ventricular Contractions) for prescription-use only users.

The document provided is a 510(k) summary for the AliveCor KardiaMobile 6L device. It describes the device, its intended use, and its substantial equivalence to a previously cleared predicate device.

Based on the provided information, the current submission (K220350) is for a minor modification (software reorganization and API addition) to an existing device (K210753, KardiaMobile 6L). Therefore, the study described here is primarily focused on demonstrating that these software changes do not adversely affect the device's safety or effectiveness as previously established.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the subject device (K220350) is being compared to its predicate (K210753). The performance criteria are implicitly met by demonstrating that the changes do not raise new questions of safety or effectiveness, as stated in the "Nonclinical Testing Summary" and "Conclusions" sections.

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

The document states: "No clinical testing was required for the minor changes made to the software." This implies that the current submission (K220350) did not involve a new clinical test set with human subjects to prove performance, but rather relied on nonclinical testing, specifically software verification activities.

Therefore, information on the sample size for a test set (e.g., number of ECGs, number of patients) or data provenance (country of origin, retrospective/prospective) directly related to a new clinical performance study for K220350 is not provided as it was explicitly deemed not required. The performance is being established by comparing to the predicate and ensuring the software changes did not introduce new risks. The previous predicate devices (K210753, K183319) would have had their own clinical data.

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

Not applicable, as no new clinical testing was performed for this specific submission (K220350). The performance claims are based on the substantial equivalence to the predicate, K210753, which would have established its own ground truth using experts.

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

Not applicable, as no new clinical testing was performed for this specific submission (K220350).

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. The document states "No clinical testing was required for the minor changes made to the software." This submission is not an MRMC study and does not evaluate AI assistance for human readers. It focuses on software reorganization and API addition.

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

The device description indicates that the Kardia Core app utilizes KardiaAI (K181823, K201985) to provide ECG analysis, detecting conditions like Normal Sinus Rhythm, Atrial Fibrillation, Bradycardia, Tachycardia, or Unclassified. This implies a standalone algorithmic analysis component. However, the current submission (K220350) primarily focuses on the software reorganization and API addition and explicitly states no new clinical testing was required. The performance of these AI determinations would have been established in the previous predicate clearances (K181823 and K201985), not in this particular submission.

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

Not directly addressed for this specific submission (K220350), as no new clinical data was collected. For the underlying KardiaAI platform (K181823, K201985), the ground truth for ECG analysis typically involves expert consensus of cardiologists reviewing the ECGs.

8. The sample size for the training set:

The document does not provide details of the training set size, as this submission is not about training a new AI model but rather a software modification to an already cleared device that utilizes existing AI algorithms (KardiaAI K181823, K201985). The training data for those AI algorithms would have been described in their respective 510(k) submissions.

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

Not directly addressed for this specific submission (K220350), as it pertains to the training of the underlying KardiaAI algorithms (K181823, K201985) rather than the software reorganization. For such algorithms, ground truth for training is typically established by expert adjudication/consensus of ECG interpretations by qualified medical professionals (e.g., cardiologists).

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AliveCor QT Service analyses 30 seconds of a previously acquired electrocardiogram (ECG) from AliveCor designed 6-Lead ambulatory ECG devices analyzed as normal sinus rhythm for QT interval measurements.

AliveCor OT Service is intended for use in a professional medical facility, such as a hospital, clinic, or doctor's office by a qualified health care professional, including trained ECG technician.

AliveCor QT Service is indicated for use on adult patients (older than 18 years). The device has not been tested for and is not intended for pediatric use. The service is not intended for use in life supporting, or sustaining systems, or continuous ECG monitors, or cardiac alarm devices, or OTC use only devices.

AliveCor QT Service is a cloud-based Software as a Medical Device (SaMD) that is used to measure the QT and heart-rate corrected QT ("QTc") interval measurements from electrocardiograms (ECG) recorded from adult patients (older than 18 years) using AliveCordesigned 6-Lead ambulatory ECG devices. AliveCor QT Service provides QT and QTc interval measurements only on ECGs analyzed as Normal Sinus Rhythm by KardiaAI (K201985).

AliveCor QT Service is a prescription (Rx) use only device intended for use by qualified healthcare professionals, including trained ECG technicians. Healthcare professionals can access AliveCor OT Service over the internet from patient management and ECG storage Medical Device Data Systems (MDDS), or from other prescription-use only medical data software devices. These devices provide a previously recorded ECG from an AliveCor-designed 6-Lead ambulatory ECG device, such as the KardiaMobile 6L (K210753), in a compatible format using the AliveCor QT Service's REST-based application program interface (API). REST or REpresentational State Transfer is a software methodology that defines rules for creating web services to access resources over Hypertext Transfer Protocol (HTTP). AliveCor QT Service responds to the analysis request with the following measurements:

• QT interval, measured from the first 30 seconds of the ECG
• Heart-rate corrected QT (QTc) interval based on the Bazett's formula and the Fridericia's ● formula

AliveCor QT Service utilizes various internal algorithms including deep neural networks (DNN) to analyze an ECG to compute the QT interval. AliveCor QT Service also includes algorithms to compute the RR-interval, which is used to provide both the Bazett's and Fridericia corrected OTc intervals. These algorithms were trained and validated on datasets with ECGs from patients representative of the device's intended use. The training included more than 750K ECGs from over 250K patients. The training dataset included more than 200K ECGs with approximately 49% data from females, approximately 70% from subjects who were reported as whites, 3% nonwhites, and 27% from those who did not report their race The validation was conducted on two datasets. The first dataset included more than 34K ECGs with approximately 51% data from females, approximately 80% from subjects who were reported as whites, 3.6% non-whites, and 1 7% from those who did not report their race. The second dataset included 226 ECGs with approximately 60% data from females, approximately 87% from subjects who were reported as whites, 3.2% non-whites, and 10% from those who did not report their race.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the AliveCor QT Service:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) summary provides a high-level summary of the performance testing. While the acceptance criteria are stated, the precise numerical results for the mean and standard deviation of the interval differences are not explicitly detailed in this public document, beyond the assertion that the device "performs to its specifications" and achieves "substantially equivalent performance."

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

• Test Set (Validation Datasets):
  • First Dataset: More than 34,000 ECGs
    • Provenance: Not explicitly stated (e.g., country of origin). Appears to be retrospective, as it's described as a "validation was conducted on two datasets."
    • Demographics: Approximately 51% females, ~80% whites, 3.6% non-whites, and 17% did not report their race.
  • Second Dataset: 226 ECGs
    • Provenance: Not explicitly stated (e.g., country of origin). Appears to be retrospective.
    • Demographics: Approximately 60% females, ~87% whites, 3.2% non-whites, and 10% did not report their race.
• Data Provenance: The document does not specify the country of origin for the validation datasets, only that they contain ECGs from "patients representative of the device's intended use." The testing was "nonclinical" and involved "standards-based and AliveCor proprietary ECG databases." It implies retrospective data collection.

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

The document mentions "expert annotated reference interval from a supine, diagnostic bandwidth, 12-lead ECG" as the ground truth. However, it does not specify the following:

• The exact number of experts used.
• The specific qualifications of those experts (e.g., "radiologist with 10 years of experience" - for ECGs, this would typically involve cardiologists or electrophysiologists).
• The process for their annotation (e.g., independent reviews, consensus).

4. Adjudication Method for the Test Set

The document does not specify an explicit adjudication method (e.g., 2+1, 3+1, none) for the expert annotations used to establish ground truth for the test set. It simply states "expert annotated reference interval."

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

• Was an MRMC study done? No. The document explicitly states: "No clinical testing was required to establish substantial equivalence." This indicates that the study focused on device performance against a predefined ground truth in a non-clinical setting, rather than a human-in-the-loop comparative effectiveness study for human readers.

6. Standalone (Algorithm Only) Performance

• Was a standalone performance study done? Yes. The entire nonclinical testing section describes the performance of the "AliveCor QT Service" (the algorithm) independently against expert-annotated ground truth. The acceptance criteria relate directly to the algorithm's output (mean and standard deviation of interval differences).

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was expert consensus / expert annotated reference interval. Specifically, it states "expert annotated reference interval from a supine, diagnostic bandwidth, 12-lead ECG."

8. Sample Size for the Training Set

• Training Set Sample Size: The training included more than 750,000 ECGs from over 250,000 patients.
  • Demographics: More than 200,000 ECGs within this set had demographic data: ~49% females, ~70% whites, 3% non-whites, and 27% did not report their race.

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

The document states that the algorithms (including deep neural networks) were "trained and validated on datasets with ECGs from patients representative of the device's intended use." However, it does not explicitly detail how the ground truth for the training set was established. It is common practice for such large datasets to be assembled from institutional databases or clinical trials where ECGs might have pre-existing annotations or be reviewed by a panel of experts, but the specific methodology for establishing ground truth for the training set is not provided in this summary.

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KardiaMobile 6L is intended to record, store and two-channel electrocardiogram (ECG) rhythms. In single channel mode, KardiaMobile 6L can record Lead-I. In two channel mode, KardiaMobile 6L can record Lead-I and Lead-II simultaneously and derive Lead-III and unipolar limb leads aVE. KardiaMobile 6L also displays ECG rhythms and output of ECG analysis from AliveCor's KardiaAI platform including detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, and others. KardiaMobile 6L is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested and is not intended for pediatric use.

KardiaMobile 6L is a trans-telephonic (transmission by smartphone) electrocardiogram (ECG) event recorder that records, stores, transfers, and analyzes single-channel or two channel ECG rhythm recordings. KardiaMobile 6L provides output of one or six ECG leads, including Lead I, Lead II, Lead III, aVL, aVR and aVF. The device utilizes the computing power of iOS-based or Android-based devices (referred to as "Mobile Computing Platforms" (MCP) within this submission) to obtain and analyze ECG signals. KardiaMobile 6L consists of KardiaMobile 6L Hardware (portable small wireless hardware with electrodes) and the Kardia App, which is installed on an MCP (i.e., iOS or Android devices). KardiaMobile 6L hardware uses Bluetooth to transmit the ECG signal from the electrodes to the Kardia App on the MCP. KardiaMobile 6L displays thus record their ECG and additionally provides ECG analysis using the KardiaAI (K181823, K201985) ECG analysis suite, which includes the determinations of Atrial Fibrillation, Normal Sinus Rhythm, Bradycardia, Tachycardia, or Unclassified. The device is intended to be used by patients with known or suspected heart conditions and health conscious individuals as well as by healthcare professionals (HCPs) who want to remotely monitor their patient's heart health. Patients can forward the recorded ECG to their HCP, who can review the ECG for rhythm and to measure the QT interval. The device is available for Over-the-Counter (OTC) purchase and for purchase with a prescription. The Kardia App is also comes in an alternate variant, called the KardiaStation App that is exclusively used within hospitals and clinics; this app is identical to the Kardia App with the exception of incorporating patient administration workflows.

Here's a summary of the acceptance criteria and study details based on the provided text, focusing on the expanded use case of QT interval measurement for healthcare professionals:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document specifically addresses the expanded use case for healthcare professionals to measure the QT interval. It compares the KardiaMobile 6L's ability to measure QT intervals against a gold standard 12-lead diagnostic ECG device.

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

• Sample Size: 313 subjects.
• Data Provenance: Not explicitly stated regarding country of origin, but the study design suggests prospective data collection as ECG recordings were "taken comparison" and included "both healthy volunteers and patients suspected of long QT syndrome or other genetic heart disease."

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

• The document states that a "core lab used to provide precise QT measurements for Thorough QT studies was utilized to measure the QT and heart-rate corrected QTc in each ECGs."
• Number of Experts: Not specified.
• Qualifications of Experts: Implied expertise in QT measurement for Thorough QT studies, indicating highly specialized cardiac electrophysiology expertise.

4. Adjudication Method for the Test Set

• The document mentions that the core lab measured QT and QTc "in a randomized and blinded order, using standard measurement techniques." This suggests a robust, independent assessment, but a specific "adjudication method" (e.g., 2+1, 3+1) is not explicitly stated.

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

• No, a MRMC comparative effectiveness study was not explicitly described for the expanded QT interval measurement use. The study focused on the equivalence of QT measurements from the device compared to a gold standard, not on the improvement of human readers with AI assistance. The "human readers" in this context were the core lab experts establishing ground truth, not users of the device whose performance was being evaluated for improvement with AI.

6. Standalone (Algorithm Only) Performance

• No, an explicit standalone (algorithm only without human-in-the-loop performance) study for QT interval measurement was not described. The study validated that "a healthcare professional can review and measure the QT interval reliably using an ECG recorded using KardiaMobile 6L." While the device records the ECG, the measurement itself is performed by a human expert/core lab. The device's role here is data acquisition for human interpretation.
• It's important to note that the KardiaAI platform (K181823, K201985) does run algorithms for detecting Atrial Fibrillation, Normal Sinus Rhythm, Bradycardia, Tachycardia, or Unclassified rhythms, and these would have had standalone performance studies in their original clearances. However, for the expanded QT interval measurement claim, the study focuses on the reliability of the ECG recording for human measurement.

7. Type of Ground Truth Used

• Expert Consensus / Highly Specialized Core Lab Measurement: The QT and heart-rate corrected QTc measurements were performed by a "core lab used to provide precise QT measurements for Thorough QT studies." This represents a high-level, specialized form of expert consensus and measurement standard.

8. Sample Size for the Training Set

• Not provided. The document focuses on the clinical validation study for the QT interval measurement claim, which is a test set evaluation. Information about the training set for any underlying algorithms is not included in this 510(k) summary.

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

• Not provided. As the training set size is not mentioned, neither is the method for establishing its ground truth.

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