(67 days)
Patient Monitors, M9500 / AnyView A8 / AnyView A6, are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. They are not intended for helicopter transport or hospital ambulance.
The proposed devices are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. They have the alarming function with audio and visual alarming, which may raise the user attention of system error and exceeding the pre-set limit of physiological parameter, and data storage function, which can replay the data and alarming event. The device is driven by AC or DC power supply.
The provided text describes a 510(k) summary for a patient monitor and focuses on regulatory compliance rather than detailed device performance studies or specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, and ground truth establishment is not explicitly available in the provided document.
Here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria or specific numerical performance metrics for the patient monitor's physiological parameter measurements (e.g., accuracy ranges for SpO2, NIBP, etc.).
The "Test Summary" section states: "Per the risk management during the design change control, the verification tests performed demonstrated that risks of each hazard are reduced to acceptable region." This is a general statement about meeting risk management objectives but does not quantify performance.
It also notes the device was tested against:
- IEC 60601-1:1988+A1:1991+A2:1995 (Medical electrical equipment - Part 1: General requirements for safety)
- IEC 60601-1-2:2001+A1:2004 (Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests)
These are safety and electromagnetic compatibility standards, not performance standards for the physiological parameters themselves.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text does not describe a clinical study with a specific test set of patients or data provenance details.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. As no clinical performance study details are given, there's no mention of experts establishing ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and safety standards, rather than comparative clinical performance with human readers.
6. Standalone Performance Study
The document does not describe a standalone (algorithm only without human-in-the-loop performance) study for physiological measurement accuracy. The "verification tests" mentioned are related to safety and EMC standards.
7. Type of Ground Truth Used
Given the absence of a detailed clinical performance study, the type of ground truth used for specific physiological measurements is not described. The focus is on compliance with general safety and EMC standards, and substantial equivalence to a predicate device.
8. Sample Size for the Training Set
This information is not applicable. The device described is a patient monitor, not an AI/ML algorithm that typically requires a training set of data for development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a training set for an AI/ML algorithm.
Summary of what is present:
- Device: Patient Monitors, M9500, AnyView A8 and AnyView A6.
- Intended Use: Monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters (ECG, HR, RESP, SpO2, PR, NIBP, IBP, CO2, TEMP) for adult, pediatric, and neonatal patients in healthcare facilities.
- Studies Mentioned: Verification tests against IEC 60601-1 and IEC 60601-1-2 for risk management, safety, and electromagnetic compatibility.
- Conclusion: The devices are Substantially Equivalent (SE) to the predicate device, M9000 Patient Monitor (cleared in K100046), with respect to effectiveness and safety. This "substantial equivalence" is the primary justification for market clearance, implying that the new device meets similar performance and safety levels as the predicate device. However, the exact performance metrics compared are not detailed in this summary.
§ 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.