(146 days)
The VS 9/VS 8/VS 8A Vital Signs Monitors are intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon Dioxide (CO2). All the parameters can be monitored on single adult, pediatric, and neonatal patients.
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 VS 9/VS 8A Vital Signs Monitors are not intended for helicopter transport, hospital ambulance, or home use.
The subject VS series Vital Signs Monitors includes three monitors:
- VS 9 Vital Signs Monitor
- VS 8 Vital Signs Monitor
- VS 8A Vital Signs Monitor
The VS series Vital Signs Monitors are for use for adult, pediatric, and neonatal patients. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. The monitors should only be used by persons who have received adequate training in their use.
The provided text is a 510(k) summary for the Shenzhen Mindray Bio-Medical Electronics Co., LTD VS Series Vital Signs Monitors. It describes the device, its intended use, comparison to predicate devices, and the performance data submitted to demonstrate substantial equivalence.
However, the provided document does not describe an AI/ML software device or a study validating its performance. The "Product Code: MWI, CCK, DQA, DXN, FLL" and "Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm)" indicate traditional vital signs monitors. The 'software verification and validation testing' mentioned refers to general software engineering practices for medical devices, not specific performance criteria for an AI/ML algorithm.
Therefore, I cannot provide the requested information because the document does not contain details about:
- Acceptance criteria for an AI/ML algorithm.
- A study proving an AI/ML device meets acceptance criteria.
- Sample sizes for test sets used for AI/ML validation.
- Ground truth establishment methods for AI/ML datasets.
- MRMC studies for AI/ML.
- Standalone performance for AI/ML algorithms.
- Training set details for AI/ML.
The document discusses validation for a physical medical device (vital signs monitor) including:
- Biocompatibility Testing: For NIBP cuffs due to an ink change.
- Software Verification and Validation Testing: General software V&V for the device's embedded software, not an AI/ML algorithm.
- Electrical safety and electromagnetic compatibility (EMC): Compliance with relevant standards.
- Bench Testing: Functional and system level testing to validate device performance.
- Clinical Data: NIBP measurement accuracy validated according to ISO 81060-2:2018 in neonate, infant, child, and adult populations.
If you have a document describing an AI/ML medical device, please provide that, and I will be able to answer your questions.
§ 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).