Search Results

C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. It's used for monitoring, reviewing and storing of multiple physiological parameters as following: ECG, heart rate (HR), respiration (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single patient. All parameters can be applied to adult, pediatric or neonate. The Patient Monitor is not intended to be used on the patients with pacemaker.

The monitor is used for monitoring the clinical patients, so only the doctors and nurses who are qualified through training can use these monitors.

C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is intended to be used for monitoring, reviewing and storing of multiple physiological parameters as following: ECG, heart rate (HR), respiration (Resp), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single patient. Other parameters can be applied to adult, pediatric or neonate.

The provided text is a 510(k) Summary for the Shenzhen Comen Medical Instruments Co., Ltd. Multi-parameter Patient Monitor, Model C30. It describes the device's characteristics, intended use, and comparisons to legally marketed predicate devices.

However, the document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and the results of a specific clinical study for the device's performance in isolation. The testing mentioned is primarily related to electrical safety, electromagnetic compatibility, and adherence to performance standards, along with some clinical verification for NIBP and respiration rate accuracy.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of an AI algorithm's performance (such as sensitivity, specificity, or reader improvement) is not directly available or applicable to this type of medical device submission. This document describes a traditional multi-parameter patient monitor, not an AI-powered diagnostic device.

Based on the provided text, here's what can be extracted and what cannot be provided:

1. A table of acceptance criteria and the reported device performance:

The document lists various performance characteristics for each parameter (ECG, Respiration, Temperature, SpO2, Pulse Rate, NIBP, CO2) as part of the technological comparison to predicate devices, including measurement ranges and accuracies. These can be considered the de facto performance criteria. While the document states the device was "tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards," it does not provide a specific table of acceptance criteria with corresponding measured performance for each parameter from a single comprehensive study report. Instead, it infers compliance through comparison to predicate device specifications and adherence to standards.

2. Sample size used for the test set and the data provenance:

• NIBP Clinical Study: The document states "According to ISO 81060-2:2013, NIBP clinical accuracy was verified." This standard specifies requirements for Non-Invasive Sphygmomanometers, including clinical investigation procedures. However, the exact sample size for this specific study and the data provenance (country, retrospective/prospective) are not given in this summary.
• Respiration Rate Clinical Study: "To verify respiration rate (RR) accuracy, Clinical study was conducted comparing the RR from the subject device with that from capnography." The exact sample size and data provenance are not given.
• For other parameters, bench testing and compliance with standards are mentioned, but no specific clinical test sets or sample sizes are detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided as this is not an AI diagnostic device and does not inherently involve expert image interpretation or similar processes for ground truth establishment. Clinical studies mentioned (NIBP, RR) would likely use reference measurements from other validated medical devices as a "ground truth" or comparator, but details on expert involvement are absent.

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

This information is not applicable/provided. Adjudication methods are typically used in studies involving subjective assessments, especially common in AI diagnostic imaging where multiple readers reconcile disagreements. This device is a physiological monitor measuring objective parameters.

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 information is not applicable/provided. This is a physiological monitoring device, not an AI-powered diagnostic tool intended to assist human readers in interpreting complex medical data or images. Therefore, an MRMC study is beyond the scope of this type of device.

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

This information is not applicable/provided. This device is a multi-parameter patient monitor that measures physiological signals directly rather than an AI algorithm performing a standalone diagnostic function. The device's performance is its direct measurement output, which is then used by healthcare professionals.

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

For the NIBP and Respiration Rate clinical studies, the "ground truth" would likely be established through reference measurements from other validated medical devices or established clinical methods. For example, NIBP accuracy usually compares the device's readings to those obtained through an invasive arterial line or another highly accurate, validated NIBP device. For respiration rate, capnography (a precise measurement of CO2 in exhaled breath) was explicitly mentioned as the comparator.

8. The sample size for the training set:

The device described is a traditional patient monitor developed through engineering and design principles, not a machine learning or AI model that requires a "training set." Therefore, this concept is not applicable to this product.

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

As above, the concept of a "training set" and "ground truth for the training set" is not applicable to this traditional medical device.

Ask a specific question about this device