(241 days)
The Neteera 130H-Plus device is intended for spot and continuous measurement of heart rate and respiration rate in adult patients (in healthcare facilities and home monitoring) and inform on bed exit.
The indications provided are to be used by health care professionals and are intended to be reviewed by clinicians to inform patient care.
The Neteera device is not intended to be used as an alarm system for potentially acute life-threatening situations in which medical intervention is necessary (e.g., ICU).
Neteera 130H-Plus device is a modification of the predicate device Neteera 130H (K212143). It is a contact-free vital-signs monitor based on a high frequency (122.25-123 GHz) micro-radar on-chip and algorithm, capable of detecting Respiration Rate (RR) and Heart Rate (HR) during rest or subject's mild body movement, with the additional capability of identifying and notifying on bed exit.
Neteera's micro- radar-based solution enables remote measurement, in real-time, in a non-invasive and contact-free manner. The system works by measuring only the ballistocardiograph micro-movements of of the skin (BCG) through nonmetallic materials such as furniture and clothing at a high resolution, and it has several different mounting options and measuring ranges.
This FDA 510(k) summary provides information on the Neteera 130H-Plus Vital Sign Monitoring Sensor, which is a modification of a previously cleared device. The summary primarily focuses on demonstrating substantial equivalence to the predicate device rather than detailing comprehensive acceptance criteria and a standalone study for the current device. However, it does provide some clinical validation details.
Here's an attempt to extract and interpret the information based on your requested format:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for HR, RR, or bed exit detection. It states that "all outcomes met the same pre-specified performance criteria" from the predicate device's clearance, but these criteria are not detailed in this submission. To fully answer this, one would need to refer to the K212143 submission for the predicate device.
However, based on general expectations for vital sign monitors, the reported measurement ranges can be inferred as indirectly related to performance.
| Parameter | Acceptance Criteria (Inferred/Referenced) | Reported Device Performance (Implied) |
|---|---|---|
| Heart Rate (HR) | Within range of 40-160 Beats Per Minute with performance comparable to FDA-cleared ECG reference. | Met pre-specified performance criteria. |
| Respiration Rate (RR) | Within range of 5-40 Breaths Per Minute with performance comparable to FDA-cleared Capnograph reference. | Met pre-specified performance criteria. |
| Bed Exit Detection | New feature; performance criteria not specified in this summary. | Functioned as intended (implied by clearance). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Clinical Validation): 46 subjects.
- Data Provenance: The study was a "GCP-compliant confirmatory clinical validation study under Independent Ethical Committee approval." This implies a prospective study. The country of origin is not explicitly stated, but the sponsor, Neteera Technologies Ltd., is based in Jerusalem, Israel, which might suggest the study was conducted there.
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 ground truth was established by "FDA-cleared devices ECG and Capnograph," which are considered reference standards, not human experts for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the ground truth was established by FDA-cleared reference devices (ECG and Capnograph), not through human expert adjudication.
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, an MRMC comparative effectiveness study was not done. This device is a standalone vital signs monitor, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Yes, the clinical validation study was for the standalone performance of the Neteera 130H-Plus device, comparing its measurements directly against FDA-cleared reference devices (ECG and Capnograph). The device is described as "contact-free vital-signs monitor based on a high frequency (122.25-123 GHz) micro-radar on-chip and algorithm."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Measurements from FDA-cleared reference devices: ECG (for Heart Rate) and Capnograph (for Respiration Rate).
8. The sample size for the training set
This information is not provided in the 510(k) summary. The summary focuses on the clinical validation of the modified device, not its initial algorithm development or training data.
9. How the ground truth for the training set was established
This information is not provided in the 510(k) summary.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).