(336 days)
The DeepRhythm Platform is intended for use by qualified healthcare professionals for the assessment of arthythmias using ECG data in adult patients.
The product supports downloading and analyzing data recorded in compatible formats from 1-channel and 2-channel ambulatory ECG recording devices used for the arthythmia diagnostics such as Holter, event recorder or other similar devices when retrospective assessment of the rhythm is necessary.
The DeepRhythm Platform is intended for the storage, analysis, visualization, review and reporting of arthythmias. The DeepRhythm Platform utilizes DeepRhythmAl (FDA-cleared device) for QRS and arrhythmia detection on the received signal. The DeepRhythm Platform provides further ECG signal annotations processing on a beat-by-beat basis, heart rate measurement and rhythm analysis, for both symptomatic and asymptomatic events.
The DeepRhythm Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. The product can be integrated with computerized ECG monitoring devices compatible with DeepRhythmAI.
The DeepRhythm Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
The DeepRhythm Platform system is a cloud-based software with microservice architecture and browser-based user interface. It provides arrhythmia diagnosis process and monitoring session management capabilities.
The DeepRhythm Platform's functionality consists of:
- enrolling a patient for an ECG monitoring session in a medical facility (performed . by Healthcare Professionals users),
- receiving the signal from a compatible monitoring device worn by the patient, .
- using an external AI service for signal analysis and classification (not a part of the . subject device),
- processing signal and annotations received from the external Al service, including . statistics computation,
- · reviewing the signal and annotations by an ECG Technician user,
- generating and publishing a report for a single ECG episode (Urgent report) and . for the entire monitoring session (End of Study report), performed by an ECG Technician user,
- reviewing a published report back at the medical facility that ordered the monitoring . session in the first place (performed by a Physician user).
The provided text does not contain detailed acceptance criteria or a comprehensive study report proving the device meets specific performance criteria. It primarily focuses on the regulatory submission information for FDA 510(k) clearance, asserting substantial equivalence to a predicate device.
Therefore, I cannot populate all the requested information. However, I can extract what is available and note the missing information.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with corresponding performance metrics. It generally states that "All necessary testing was conducted on the DeepRhythm Platform to support a determination of substantial equivalence to the predicate device. Test results confirm that DeepRhythm Platform meets its intended use."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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)
This information is not provided in the document. The document mentions that the DeepRhythm Platform "utilizes DeepRhythmAI (FDA-cleared device) for QRS and arrhythmia detection on the received signal." This suggests that the AI component's ground truth establishment might have been part of its own prior clearance, but details for the DeepRhythm Platform's specific testing are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The DeepRhythm Platform's role is described as "interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only." This suggests it's an assistive tool, but a comparative effectiveness study with human readers is not detailed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states that "DeepRhythm Platform utilizes DeepRhythmAI (FDA-cleared device) for QRS and arrhythmia detection on the received signal." This implies that the core algorithmic performance for detection is handled by the pre-cleared DeepRhythmAI. The DeepRhythm Platform "provides further ECG signal annotations processing on a beat-by-beat basis, heart rate measurement and rhythm analysis," and processes statistics from DeepRhythmAI. However, specific standalone performance metrics for the DeepRhythm Platform's unique contributions (beyond DeepRhythmAI) are not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The type of ground truth used for this specific submission's testing is not explicitly stated. Given that it leverages a previously cleared AI for detection, the ground truth for the DeepRhythmAI algorithm itself would have been established during its clearance, likely through expert consensus with ECG interpretation. For the DeepRhythm Platform's own capabilities (processing, visualization, reporting), it would likely involve verification against established ECG processing standards and internal validation, but the ground truth method is not described.
8. The sample size for the training set
The document states that the DeepRhythm Platform "utilizes DeepRhythmAI (FDA-cleared device) for QRS and arrhythmia detection on the received signal." This means the training of the core AI algorithm (DeepRhythmAI) would have been done prior to this submission as part of its own clearance. The sample size for the training of DeepRhythmAI is not provided in this document.
9. How the ground truth for the training set was established
As in point 8, the ground truth for the DeepRhythmAI algorithm's training would have been established during its separate FDA clearance. Details on this ground truth establishment are not provided in this document.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).