(446 days)
The Neteera 130H/131H device is intended for spot and continuous measurement of heart rate and respiration rate in adult patients (in healthcare facilities and home monitoring).
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/131H device 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 a variety of parameters: Respiration Rate (RR), Heart Rate (HR), during rest or subject's mild body movement.
Neteera's micro radar-based solution enables measuring the micro-motions of the skin (BCG-Ballistocardiograph) remotely, in a real-time, non-invasive, and non-contact manner, through non-metallic materials such as furniture and clothing at a high resolution.
The Neteera 130H/131H Vital Signs Monitoring Sensor is intended for "spot and continuous measurement of heart rate and respiration rate in adult patients (in healthcare facilities and home monitoring)." The following details describe the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the performance metrics reported, specifically the percentage of measurements falling "under 10% error" or meeting "5% or 5bpm Criteria" for HR, and "under 10% error or 2brpm" for RR. These thresholds represent the satisfactory performance levels.
| Parameter | Subgroup | Num. Setups HR | Num. Setups RR | Spot HR under 10% error | Spot HR 5% or 5bpm Criteria | Spot RR under 10% error or 2brpm | Continuous HR under 10% error | Continuous HR 5% or 5bpm Criteria | Continuous RR under 10% error or 2brpm |
|---|---|---|---|---|---|---|---|---|---|
| Chair Back | Total | 130 | 130 | 98.46% | 96.92% | 96.15% | 97.44% | 95.96% | 93.1% |
| Chair Front | Total | 130 | 131 | 98.46% | 96.92% | 96.95% | 98.7% | 97.33% | 93.52% |
| Above Bed | Part 2 | 34 | 34 | 97.06% | 97.06% | 91.18% | 96.44% | 95.28% | 93.1% |
| All Front (Chair & Bed) | 164 | 165 | 98.17% | 96.95% | 95.76% | 98.26% | 96.94% | 93.44% |
2. Sample Size for the Test Set and Data Provenance
The clinical validation study involved 170 subjects in total across two parts.
- Part 1: 100 subjects from Israel.
- Part 2: 70 subjects from the US population, specifically recruiting subjects with cardiopulmonary and metabolic medical disorders.
The study was prospective as it was a "GCP-compliant clinical study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
No information is provided about the number of experts or their qualifications used to establish ground truth.
4. Adjudication Method for the Test Set
No information is provided about an adjudication method for the test set. Given that the ground truth for vital signs is typically established through direct measurement with reference devices, complex adjudication methods like 2+1 or 3+1 are typically not applicable.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The Neteera 130H/131H is a direct measurement device for vital signs, rather than an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance study was done. The performance results presented in the table are for the Neteera device's measurements compared to a reference device, indicating its standalone accuracy in measuring HR and RR. The device is described as "a high frequency (122.25-123 GHz) micro-radar on-chip and algorithm," implying autonomous measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance testing was established using a reference medical device. Specifically, the "MindRay Patient Monitor, model ePM 10M (K200015)," which is an FDA-cleared device.
8. The sample size for the training set
The document does not specify the sample size for the training set. The provided clinical study data (170 subjects) appears to be for validation/testing, not training.
9. How the ground truth for the training set was established
The document does not provide information on how the ground truth for the training set, if any, was established. It only mentions the reference device used for validation.
§ 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).