(282 days)
The River-1 is indicated for the evaluation of patients who experience transient symptoms such as dizziness, palpitations, syncope, or chest pain that might suggest arrhythmia. The device is intended to record cardiac activity associated with those infrequent and transient symptoms. Once the data is recorded, the patient transmits this ECG data over the telephone or cellular network to a remote central receiving station to be reviewed by a healthcare professional.
The River-1 is a patient activated electrocardiograph (ECG) symptomatic event recorder and transmitter. The River is a looping type ECG recording device (it records the ECG continuously). When the patient presses the ECG Record Button to record an ECG, the device stores both the recently recorded ECG and the ECG, following activation. The recorded ECG can then be transmitted to a healthcare facility or receiving center via two distinct channels: digitally via cellular network or acoustically via any phone.
The River-1 is a portable programmable device which is worn on the belt of the patient. It features a simple LCD screen, key pad, and is powered by a rechargeable battery. It can accommodate up to three leads for the option of recording 1, 2, or 3 lead ECG data.
This 510(k) submission for the River-1 Electrocardiograph (ECG) Recorder and Transmitter is a premarket notification for a medical device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical study data with detailed performance metrics against specific acceptance criteria.
Therefore, the provided text does not contain the detailed information required to fill out the requested table regarding acceptance criteria and performance, nor does it describe a study that proves the device meets specific acceptance criteria in the way a clinical trial would.
Here's why and what information can be extracted or inferred:
- Focus on Substantial Equivalence: The core of a 510(k) is to show that a new device is as safe and effective as a predicate device already on the market. This often relies on technological comparisons, not necessarily new, extensive clinical studies with quantitative acceptance criteria for performance.
- Lack of Specific Clinical Study Details: The document mentions "Indications For Use" but does not detail a specific clinical study with a defined test set, ground truth, expert involvement, or statistical analysis of performance against pre-defined acceptance criteria, which would be typical for a PMA or a more rigorous clinical validation study.
- "Study that proves the device meets the acceptance criteria" Missing: There is no description of such a study in the provided text. The FDA's review in this context is about substantial equivalence, not typically about directly "proving" new performance against novel quantitative criteria.
Given these limitations, I will extract what can be inferred from the document and explicitly state what information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Metric | Acceptance Threshold | Reported Device Performance | Comments |
|---|---|---|---|---|
| Not provided in the document. The 510(k) focuses on substantial equivalence to predicate devices, not on explicit, quantitative acceptance criteria for performance in a new clinical study. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document does not describe a clinical test set for performance evaluation in the typical sense.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: No. This device is an ECG recorder and transmitter, not an AI-powered diagnostic imaging tool that would typically involve a multi-reader, multi-case study to assess AI assistance. The "review by a healthcare professional" is mentioned as a human interpretation step after data transmission.
- Effect Size of AI Assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not explicitly described for a specific algorithm. The device "records cardiac activity" and transmits it for review by a healthcare professional. This implies a human-in-the-loop system. The 510(k) for this type of device primarily ensures the accurate recording and transmission of ECG data, not independent algorithmic diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified in relation to a performance evaluation study. For substantial equivalence, the "ground truth" implicitly aligns with the established performance of the predicate devices.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is not described as utilizing machine learning or AI that would require a "training set" in the conventional sense for algorithmic development. It's a recording and transmission device.
9. How the ground truth for the training set was established
- How Ground Truth Established: Not applicable.
§ 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).