(125 days)
This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric (but not neonatal) patients. With the functions of real-time recording and displaying parameters, such as ECG, heart rate(HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration rate (RESP), body temperature (TEMP), end-tidal CO2 concentration (EtCO2), it allows comprehensive analysis of patient's physiological conditions.
This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.
This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric (not neonatal) patients. With the functions of real-time recording and displaying parameters, such as ECG, pulse rate (PR), noninvasive blood pressure (NIBP), functional oxygen saturation (SpOz), respiration rate (RESP), body temperature (TEMP), end-tidal CO2 concentration (EtCO2), it allows comprehensive analysis of patient's physiological conditions.
This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.
There are three versions of the K serial Patient Monitor, K10, K12 and K15. The primary difference is physical dimension and display TFT size; all other specifications remain unchanged. All versions have the same indications for use.
This document, a 510(k) summary for the Shenzhen Creative Industry Co., Ltd. Patient Monitor, Models K10, K12, and K15, primarily focuses on demonstrating substantial equivalence to a predicate device (Shenzhen Creative Industry UP-7000 Patient Monitor, K123711) rather than detailing the specific acceptance criteria and study proving performance for a novel AI/software device.
Therefore, much of the requested information regarding AI device performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training) is not applicable or present in this document. This document describes a traditional medical device (patient monitor) and its components, and the "study" referred to is non-clinical and clinical testing to ensure compliance with relevant performance standards for vital sign monitoring.
However, I can extract the information that is applicable based on the provided text, particularly focusing on the performance criteria for the integrated vital sign modules.
Here's an analysis based on the provided text:
Device: Patient Monitor, Models K10, K12, K15
Indications for Use: Monitoring the vital physiological signs of adult and pediatric (but not neonatal) patients, including ECG, heart rate (HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration rate (RESP), body temperature (TEMP), and end-tidal CO2 concentration (EtCO2). Applicable for use in hospitals and clinical institutions, operation by qualified professionals only.
Study Type: This is a 510(k) submission seeking substantial equivalence to a predicate device. The "studies" involve non-clinical (safety and performance) and clinical (NIBP validation) testing against recognized standards rather than a comparative effectiveness study of a novel AI algorithm's diagnostic performance.
1. Table of acceptance criteria and the reported device performance:
The document lists performance specifications for each physiological parameter module, often directly comparing them to the predicate device. The acceptance criteria are implicitly that the devices meet or are substantially equivalent to the established performance requirements of the predicate device and relevant industry standards.
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) | Difference Discussion (Relevance) |
|---|---|---|---|
| SpO2 Accuracy | Adult & Pediatric: ±3% (70%-100%), Undefined (0-70%) | Adult & Pediatric: ±3% (70%-100%), Undefined (0-70%) | No change. |
| Pulse Rate Accuracy (SpO2) | ±2 bpm or ±2% (whichever is greater) | ±2 bpm or ±2% (whichever is greater) | No change. |
| CO2 Accuracy (0-40 mmHg) | ±2 mmHg | ±2 mmHg | No change. |
| CO2 Accuracy (41-70 mmHg) | ±5% of reading | ±5% of reading | No change. |
| CO2 Accuracy (71-100 mmHg) | ±8% of reading | ±8% of reading | No change. |
| CO2 Accuracy (101-150 mmHg) | ±10% of reading | ±10% of reading | No change. |
| Respiration Rate Accuracy (CO2) | ±2 rpm | ±2 rpm | No change. |
| Heart Rate Precision (ECG) | ±1% or ±2 bpm, whichever is greater | ±1% or ±2 bpm, whichever is greater | No change. |
| RESP Rate Accuracy | ±2% or ±2 rpm, whichever is greater | ±2% or ±2 rpm, whichever is greater | No change. |
| NIBP BP Accuracy (Mean Deviation) | ±5 mmHg | Max. mean deviation values: ±5 mmHg | Identical. |
| NIBP BP Accuracy (Standard Deviation) |
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).