(103 days)
The YM6000 monitor is intended to be used to monitor electrocardiography, heart rate, pulse rate, noninvasive blood pressure (systolic, diastolic and mean arterial pressures), functional arterial oxygen saturation, invasive blood pressure, respiration, capnography (EtCO2 and InCO2) and temperature for adult, pediatric a nd neonate patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist.
The YM6000 patient monitor is to monitor electrocardiography (ECG), Arrhythmia, ST segment, heart rate (HR), pulse rate, noninyasive blood pressure (systolic, diastolic and mean arterial pressures); functional arterial oxyge n saturation, invasive b lood pressure, respiration, capnography (EtCO2 and InCO2) and temperature for adult, pediatric and neonate in patients in general hospital and alternate ca re facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.
The YM6000 patient monitor is a lightweight and compact device (341 × 305 × 172 (mm) (W × H × D) and 5.5 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on TFT-LCD displays.
The provided text is a 510(k) summary for a patient monitor. It focuses on establishing substantial equivalence to predicate devices rather than presenting detailed performance studies with specific acceptance criteria and detailed study results in the format requested.
Therefore, many of the requested categories cannot be directly extracted from the provided text. The document primarily describes the device, its intended use, and argues for its equivalence based on shared modules and compliance with industry standards.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with corresponding reported device performance values in a quantifiable manner for each parameter. Instead, it states that various modules (ECG, NIBP, SpO2, Respiration, Thermometry, Capnography) used in the YM6000 are identical to those in predicate devices and comply with relevant standards (AAMI SP-10, IEC60601-2-30, ISO9919, IEC60601-2-34). For example, it says: "all devices comply with the AAMI performance standard SP-10 & IEC60601-2-30 and have same measurement technology" for NIBP.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not explicitly stated in the document. The text mentions "The Mediana patient monitor, Model YM6000 substantially have been tested in accordance with the system V & V plan (#P AA00-00005) and summary included with the submission using production equivalent units prior to release to market." This indicates testing was performed, but details about sample size, data type (retrospective/prospective), or origin are not provided.
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. The document focuses on technical equivalence and compliance with standards rather than human-expert-based ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This is not an AI-powered device, but a physiological patient monitor. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a patient monitor. Its performance is inherent to its functional modules, which operate "standalone" in recording physiological parameters. The document primarily focuses on the technical specifications and standards compliance of these modules.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for a patient monitor like the YM6000 would generally be based on:
- Reference measurement devices/standards: For parameters like NIBP, SpO2, ECG, etc., the accuracy is typically verified against highly accurate reference devices or simulated signals that meet specific industry standards.
- Compliance with performance standards: The document frequently refers to compliance with standards like AAMI SP-10, IEC60601-2-30, ISO9919, IEC60601-2-34. These standards define the acceptable range of error and performance characteristics.
The document does not explicitly state "expert consensus," "pathology," or "outcomes data" as ground truth methods for the device's fundamental physiological measurements.
8. The sample size for the training set
This information is not provided. For a patient monitor, there isn't typically a "training set" in the machine learning sense. The device's algorithms for physiological parameter measurement are developed based on established physiological principles and signal processing, and then validated against a range of inputs/patients.
9. How the ground truth for the training set was established
As there's no mention of a "training set" in the AI/machine learning context, this question is not applicable. The ground truth for developing and testing the device's measurement algorithms would be based on established medical and engineering principles, known physiological ranges, and comparison with highly accurate reference equipment under controlled conditions.
§ 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.