FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The BeneView T Series patient monitors including models BeneView T8, BeneView T6 and BeneView T5 are intended to be used for monitoring, displaying, storing and alarming of multiple physiological parameters including ECG(3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST Segment analysis, Heart Rate(HR), Respiration Rate(RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS) and respiration mechanics (RM).

The arrhythmia detection, ST Segment analysis, BIS and RM monitoring are not intended for neonatal patients. The ICG is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 159kg. Other parameters can be applied to a single adult, pediatric or neonatal patient.

The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport, hospital ambulance, or home use.

Device Description

The BeneView T Series patient monitors (including models BeneView T8, T6 and T5) are Mindray's new generation monitoring product family with ergonomic and flexible design in platform of both software and hardware to meet the clinical needs of standard vital signs, high-acuity and anesthesia monitoring.

BeneView T8, BeneView T6 and BeneView T5 have same design principle and technical characteristics:

Same system framework and components.
Same Hardware design principle in main unit.
Same parameters measurement subsystems (including parameters modules and accessories).
Same peripheral equipments or accessories (including mouse, keyboard and printer, etc.)
Same host software and modules software.

The difference between BeneView T8 and BeneView T6 is the size of display screen. And the differences between BeneView T8 and BeneView T5 are the appearance and interior structure in main unit.

AI/ML Overview

The provided text describes the BeneView T Series patient monitors and states that "testing has been conducted to validate and verify that meet all design specifications." However, it does not explicitly define acceptance criteria or provide specific reported performance metrics for the device against those criteria in a tabular format.

Furthermore, the document primarily focuses on verifying compliance with existing standards and the device's substantial equivalence to predicate devices, rather than a detailed study designed to independently prove specific performance metrics against defined acceptance criteria.

Therefore, much of the requested information cannot be extracted from the given text.

Here's a breakdown of what can and cannot be provided based on the input:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in the document. The text mentions "all design specifications" and "compliance with the requirements of various published standards," but these specifications and standards are not detailed, nor are specific numerical acceptance thresholds provided.
Reported Device Performance: No specific numerical performance metrics (e.g., sensitivity, specificity, accuracy, error rates) are reported for the various physiological parameters. The document broadly states that the testing demonstrated that the devices are "as safe and effective as the legally marketed predicate devices."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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)

Not specified. The document only mentions "clinical and/or bench performance testing," but does not detail how ground truth was established or if experts were involved in a formal capacity for a test set.

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

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

No mention of an MRMC study or AI assistance. This device is a patient monitor, not an AI-powered diagnostic tool, and the date of the document (2008) predates widespread adoption of AI in medical devices as described in the prompt's context.

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

This question is not applicable in the context of a patient monitor, which inherently involves human observation and intervention. The testing described is for the device's ability to measure and display physiological parameters, which is a "standalone" function in terms of the device's internal algorithms, but not in the sense of a diagnostic algorithm replacing human interpretation without human review.

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

Not specified. The document mentions "clinical and/or bench performance testing," which implies direct comparison to a reference standard, but the nature of that standard (e.g., whether it's expert consensus, another highly accurate device, or simulated data) is not detailed.

8. The sample size for the training set

Not applicable as this is a patient monitoring device and the document does not suggest an AI/machine learning component that would involve a "training set" in the modern sense.

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

Not applicable (see point 8).

Summary

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.