(140 days)
The heartEVENT^T is indicated for use by patients as directed by a physician, who experience transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities or other rhythm disturbances that may result in shortness of breath, pre-syncope or palpitations.
The heartEVENT* is a battery operated transtelephonic ECG event recorder and transmitter that is capable of storing multiple electrocardiograms. The transmission of these recordings is by telephone to a receiving system.
The heartEVENTAT has two operating modes – manual and automatic trigger.
In the manual mode, the heartEVENT^T stores the ECG before and after the 'record' button is depressed. The recording period is preset up to 80 seconds with 2 manually activated recordings stored.
The heartEVENTAT also has an automatic triggering function where recording is automatically activated when the user experiences a cardiac symptom. Cardiac symptoms captured by the auto-trigger function include bradycardia, pause and atrial fibrillation.
The heartEVENT^T is configured with 'pre' and 'post' event memories with a total ECG recording time for up to 320 sec.
The stored ECGs are transmitted by acoustic output by coupling the telephone mouthpiece over the heartEVENTAT by manually depressing the 'send' button.
This 510(k) submission (K072385) for the heartEVENTAT ECG Recorder with Auto-Trigger does not contain the detailed information necessary to answer all parts of your request about acceptance criteria and study proving device meets them.
The document is a summary for a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (KING OF HEARTS EXPRESS + AF MONITOR, K020825). While it states that the heartEVENTAT shares similar technology and "indicated no adverse indications or results" based on testing, it does not provide the specifics of those tests, acceptance criteria, or performance metrics in the way you've outlined.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Explicitly Stated in Document) |
|---|---|
| N/A - Not explicitly stated | "heartEVENTAT indicated no adverse indications or results" |
| "Same or better specifications and characteristics" than the predicate device | "heartEVENTAT has the same or better specifications and characteristics and is substantially equivalent to the KING OF HEARTS EXPRESS + AF MONITOR (K020825)." |
| Device is "safe and effective" | "It is our determination that the heartEVENTAT is safe and effective, performing within its design specifications..." |
Missing Information: The document does not provide specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy, detection rates for specific cardiac events) or corresponding numerical performance results for the device. The claims are qualitative and based on comparison to the predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document makes no mention of a specific clinical "test set" with a defined sample size. It refers to "testing" in a general sense, but no details of the number of patients, recordings, or the nature of the data (e.g., retrospective vs. prospective, country of origin) are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Missing Information: Since no explicit clinical test set or study is detailed, there is no information on experts used to establish ground truth or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: No adjudication method is mentioned as there is no detailed information on a test set or ground truth establishment process.
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
Missing Information: This device is a direct-to-patient ECG event recorder with an auto-trigger function, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable and not mentioned in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Information Provided: The device has an "automatic triggering function where recording is automatically activated when the user experiences a cardiac symptom." This implies a standalone algorithm for detecting specific cardiac events (bradycardia, pause, and atrial fibrillation) to initiate recording.
Missing Information: While the device has an auto-trigger algorithm, the document does not present a standalone performance study with specific metrics (e.g., sensitivity, specificity for AF detection) for this algorithm. It only states that the device is "safe and effective, performing within its design specifications."
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Missing Information: The document does not specify the type of ground truth used, as no detailed study or validation is described. For devices like this, ground truth would typically be established by physician review of ECG recordings.
8. The sample size for the training set
Missing Information: No information is provided about a "training set" or any machine learning model training process. This implies that the auto-trigger functions were likely implemented using more traditional signal processing and rule-based algorithms rather than modern large-scale machine learning, or details are simply not included in this summary.
9. How the ground truth for the training set was established
Missing Information: As no training set is mentioned, there is no information on how its ground truth was established.
In summary: This 510(k) submission is a high-level summary primarily focused on demonstrating substantial equivalence to a predicate device. It does not contain the granular detail about acceptance criteria, specific study designs (like randomized controlled trials or large-scale validation studies), sample sizes, expert qualifications, or detailed performance metrics that your request seeks. This level of detail is typically found in full study reports or more comprehensive technical documentation, which are not usually included in a public 510(k) summary.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).