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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.

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.

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The RespArray™ patient monitor is intended to be used for monitoring, storing, of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments.
The monitor is for prescription use only.
The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), and carbon dioxide (CO2).
The arrhythmia detection and ST Segment analysis are intended for adult patients.
The SpO2 (NellcorTM) module is intended to be used for spot-check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR), in motion conditions, and in patients who are well or poorly perfused.
The MicrostreamTM capnography module is intended for continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath (etCO2) and respiration rate (RR).
The monitor also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is not intended for patients up to the age of one year. Allr and ODI are intended for ages 22 and up.
The monitors are not intended for MRI environments.

The RespArray patient monitor (hereinafter called RespArray) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.

The provided text is a 510(k) Premarket Notification summary for the "Patient Monitor: RespArray" device. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical trials for de novo clearance or PMA approval. Therefore, the details requested about acceptance criteria, specific study design (like MRMC studies, sample sizes, expert ground truth establishment for AI/algorithm performance), and training set information are not typically found in these types of submissions, as the FDA review here centers on comparing the new device's specifications and performance to an existing, already cleared device.

The document primarily highlights the device's technical specifications and how they compare to a predicate device (Edan Instruments, Inc, Patient Monitor Model X8, X10, X12 - K192514), along with compliance with relevant electrical safety, EMC, and performance standards. It explicitly states "Clinical data: Not applicable."

Given this, I will extract the information that is present in the document and indicate where the requested information is not applicable or not provided within the scope of a 510(k) submission focused on substantial equivalence.

Analysis of the Provided Document for Device Acceptance Criteria and Study Proof

The provided document is a 510(k) premarket notification. For devices cleared via a 510(k), the primary "acceptance criterion" is often substantial equivalence to a legally marketed predicate device, demonstrated through comparative testing and adherence to recognized standards. Direct, explicit "acceptance criteria" presented as quantitative performance targets with a detailed study to prove they are met (as might be seen in AI/ML clearances for algorithms with novel functionalities) are typically not included in this type of submission for a patient monitor.

The "study" that proves the device meets the acceptance criteria is primarily non-clinical performance testing (bench testing) and software verification/validation to show that the device performs as intended and is as safe and effective as its predicate.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of explicit acceptance criteria/performance targets with quantitative results in the way one might expect for a new AI/ML algorithm. Instead, it demonstrates performance by stating compliance with recognized consensus standards and by comparing the subject device's specifications to those of its predicate device, showing "similar design features and performance specifications."

The closest representation of "performance" and "acceptance" is the "Predicate Device Comparison" table (pages 5-6). This table implicitly acts as the performance comparison against the predicate device that serves as the "acceptance" benchmark for substantial equivalence.

The document concludes that "the subject and predicate devices have similar design features and performance specifications. The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness."

2. Sample size used for the test set and the data provenance

The document states "Clinical data: Not applicable." Therefore, there isn't a "test set" in the sense of patient data used for clinical validation of, for example, an AI algorithm's performance. The "testing" primarily refers to non-clinical bench testing.

• Sample size: Not applicable for patient data test set. For bench testing, samples would be physical devices, components, or simulated signals, but a "sample size" in terms of patient numbers is not provided.
• Data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as no clinical data test set was used/provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Since no clinical data test set was described and "Clinical data: Not applicable" is stated, there was no need for expert ground truth establishment for a test set. This type of information would be relevant for AI/ML device clearances where human expert annotation is part of the ground truth creation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set requiring adjudication of ground truth was described.

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

No. The document explicitly states "Clinical data: Not applicable." MRMC studies are typically for evaluating the impact of AI algorithms on human reader performance, which is not the scope of this 510(k) submission for a patient monitor.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a patient monitor with various physiological parameter measurements and alarms. Its "performance" is inherent in its ability to accurately measure these parameters and detect events like arrhythmias. The non-clinical bench testing demonstrated its standalone performance by showing compliance with relevant standards (e.g., IEC 60601-2-27 for ECG, IEC 80601-2-30 for NIBP, ISO 80601-2-61 for pulse oximeter).

While not explicitly called "standalone algorithm performance" in the AI/ML sense, the "Performance testing-Bench" section (page 8) confirms that "Edan has conducted functional and system level testing to validate the performance of the results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards." This demonstrates the device's functional performance in isolation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical bench testing, the "ground truth" would be established by:

• Reference instruments or calibrated signals (e.g., precise electrical signals for ECG, known pressure values for NIBP, calibrated gas mixtures for CO2).
• Standardized measurement protocols defined by the cited IEC/ISO standards.
• Accuracy specifications found within those standards or the device's own specifications.

There's no mention of expert consensus, pathology, or outcomes data as "ground truth" because this is a measurement and alarm device, not a diagnostic imaging AI algorithm, and no clinical data was used for validation in this submission.

8. The sample size for the training set

Not applicable. This device is a patient monitor, not an AI/ML algorithm that undergoes a distinct training phase on a dataset. The underlying algorithms for parameter measurement (e.g., NIBP oscillometric algorithm, arrhythmia detection) are established engineering designs, not typically "trained" in the machine learning sense with large datasets.

9. How the ground truth for the training set was established

Not applicable, as there is no specific "training set" for an AI/ML algorithm described. The "ground truth" for the development and calibration of the monitor's measurement algorithms would have been established through engineering principles, laboratory testing with calibrated instruments, and referencing physiological models and data, but this is part of the device's fundamental design and not a separate "training set" as understood in current AI/ML contexts.

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BeneVision N12/N15/N17/N19/N22

The BeneVision N12N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Bispectral Index (BIS), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

· BIS, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring, PNP, and PNC are intended for adult and pediatric patients only:

· C.O. monitoring and A-Fib are intended for adult patients only;

• ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.

· rSO2 monitoring is intended for use in individuals greater than 2.5kg.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport. hospital ambulance, or home use.

BeneVision N1 Patient Monitor:

The BeneVision N1 Patient Monitor is intended for monitoring, displaying, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• PAWP, PNP, and PNC are intended for adult and pediatric patients only;
• A-Fib is intended for adult patients only;

The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

The subject BeneVision N Series Patient Monitors includes six monitors:

• BeneVision N12 Patient Monitor
• BeneVision N15 Patient Monitor
• BeneVision N17 Patient Monitor ●
• . BeneVision N19 Patient Monitor
• . BeneVision N22 Patient Monitor
• BeneVision N1 Patient Monitor ●

Mindray's BeneVision N Series Patient Monitors provide a flexible software and hardware platform to meet the clinical needs of patient monitoring.

The provided document describes the BeneVision N Series Patient Monitors and their clearance by the FDA based on substantial equivalence to predicate devices, particularly focusing on changes and new features. The document details the device's intended use, technological comparisons, and performance data from various tests. However, it does not explicitly provide a table of acceptance criteria and reported device performance in the format requested. Instead, it states that "the results of the bench testing show that the subject device meets its accuracy specification and is substantially equivalent to the predicate device."

Specifically regarding "Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm)" which is the relevant regulation name for the product code MHX (used by the BeneVision N Series Patient Monitors), the document states:
"Add arrhythmia detection for neonatal patients when used with the MPM 3.0 module." (Page 9, Table 2 ECG section; Page 22, Table 3 ECG section).
And references "K200015 - ePM series Patient Monitors...: provided as reference devices for ECG algorithm supporting arrhythmia detection in neonate that has been added to the subject BeneVision N Series Patient Monitors." (Page 6, Section 4).

Given the information in the document, here's a structured response:

Acceptance Criteria and Device Performance Study for Arrhythmia Detection in Neonates

The provided FDA 510(k) summary (K202405) for the BeneVision N Series Patient Monitors primarily focuses on demonstrating substantial equivalence to a predicate device (K192972) and a reference device (K200015) for the new feature of neonatal arrhythmia detection. While it explicitly states that the device meets its accuracy specifications, it does not provide a specific table of acceptance criteria or detailed reported performance metrics for neonatal arrhythmia detection. Instead, it relies on general statements about meeting specifications and compliance with standards.

However, based on the document's information and common regulatory expectations for such devices, we can infer the type of acceptance criteria and the nature of the study.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table for the acceptance criteria and reported device performance for neonatal arrhythmia detection. It states that the device "meets its accuracy specification." For arrhythmia detection systems, typical performance metrics and acceptance criteria, often derived from standards like IEC 60601-2-27, would generally include:

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