(164 days)
To RECORD INFREQUENT AND ELUSIVE ECG HEART ARREHYTHMIA DATA. ONCE THE EVENT IS RECORDED PATIENTS TRANSMIT THE RECORDED ECG DATA OVER THE TELEPHONE, OR, AS AN ALTER NATE, THE ER 700 SERIES ALLOWS THE ECG DATA To BE TRANSFERRED DIRECTLY To A HOST PC IF THE PATIENT RETURNS THE UNIT To THE CLINIC.
The ER700 Series is a family of patient-activated ambulatory electrocardiograph event recorders.
The provided text is a 510(k) summary for the Braemar ER700 Series Ambulatory ECG Event Monitor. It focuses on establishing substantial equivalence to a predicate device (Braemar ER300 Series) rather than detailing a study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance evaluation is not available in the given document.
However, I can extract the following information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list acceptance criteria with corresponding performance data. Instead, it provides a comparison table between the ER700 Series and its predicate device (ER300 Series) based on device attributes for the purpose of demonstrating substantial equivalence.
| Attribute | ER700 Series | ER300 Series |
|---|---|---|
| Liquid Crystal Display (LCD) | Yes | No |
| Looping memory | Yes | Yes |
| Memory type | Flash (non-volatile) | Solid State (volatile) |
| Number of ECG channels | One or two | One or two |
| Transtelephonic data transfer | Yes | Yes |
| Belt clip | Yes | Yes |
| Direct Data Transfer | Yes | No |
| Battery | Two AAA | One 9V |
2. Sample size 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. The 510(k) summary focuses on comparing device specifications rather than reporting on a clinical trial or performance study with a test set.
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.
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 device described appears to be an ECG event monitor, not an AI diagnostic tool that would typically involve human readers interpreting AI outputs.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The ER700 Series is a patient-activated ambulatory ECG event recorder. While it records ECG data, the document doesn't discuss any specific algorithms for standalone diagnostic performance beyond data recording and transmission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary of what the document does provide regarding device evaluation:
The document serves as an FDA 510(k) premarket notification. Its primary purpose is to demonstrate that the Braemar ER700 Series Ambulatory ECG Event Monitor is substantially equivalent to a legally marketed predicate device, the Braemar ER300 Series (K923930). The evaluation provided is a comparison of attributes and intended use between the new device and the predicate.
The intended use of the ER700 Series is "To record infrequent and elusive ECG heart arrhythmia data. Once an event is recorded, patients transmit the recorded ECG data over the telephone, or, as an alternate, the ER700 Series allows the ECG data to be transferred directly to a host PC if the patient returns the unit to the clinic." This intended use is assessed against the predicate's intended use to ensure they are the same or very similar.
The document highlights differences and similarities in device features, such as the presence of an LCD, memory type, number of ECG channels, data transfer methods, and battery type. The rationale for substantial equivalence is based on these technical comparisons, implying that any differences do not raise new questions of safety or effectiveness.
§ 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).