(264 days)
The Patient Status Engine is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes heart rate, heart rate variability (R-R interval), ECG derived respiration rate data (EDR), skin temperature, activity, posture and optional SpO2 and non-invasive Blood Pressure (BP). Data is transmitted wirelessly from the sensors to the Patient Gateways and from the Patient Gateways to a central Server where it is stored for analysis. The Patient Status Engine can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.
The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information.
The data from the Patient Status Engine is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients nor replace standard monitoring and/or routine care.
The Patient Status Engine (PSE2) is a wireless data collection system that monitors physiological data and consists of the following components / subsystems and optional third party devices as listed below:
Components and Subsystems:
Patient Gateway (Samsung Tablet) – Manufactured by Samsung
Patient Gateway Software – Manufactured by Isansys Lifecare Ltd
Lifetouch Blue Sensor – Manufactured by Isansys Lifecare Ltd
Lifetemp Sensor– Manufactured by Isansys Lifecare Ltd
Lifeguard Server Software – Manufactured by Isansys Lifecare Ltd
Additional third party Accessories:
Pulse Oximeter 3150– Manufactured by Nonin
Blood Pressure Monitor UA767– Manufactured by A&D Medical
Skintact ECG Electrodes – Manufactured by Leonhard Lang
Ambu White Sensors – Manufactured by Ambu Inc.
At the subsystem level the Patient Gateway, Lifetouch Blue Sensor and Lifetemp Sensor are collectively identified as the Patient Digitisation Engine (PDE2). The inclusion of the Lifeguard Server completes the Patient Status Engine (PSE2).
The provided text is a 510(k) summary for the Isansys Lifecare Ltd Patient Status Engine. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it does not contain a specific study that proves the device meets explicit acceptance criteria in the format requested.
The document states that no human clinical testing was required to support the medical device, as its indications for use are equivalent to the predicate device. It relies instead on non-clinical performance tests against applicable standards. Therefore, an analysis of acceptance criteria and proven device performance as typically found in clinical studies (e.g., sensitivity, specificity, AUC) is not present.
Below is an attempt to structure the available information regarding "acceptance criteria" based on the non-clinical performance data provided.
1. Table of Acceptance Criteria and Reported Device Performance
Given that no clinical study with specific performance metrics (like accuracy, sensitivity, specificity) against a ground truth is provided, the "acceptance criteria" here refer to compliance with various electrical, electromagnetic, biocompatibility, risk management, and software standards.
| Acceptance Criteria (Reference Standard) | Reported Device Performance (Result) |
|---|---|
| Electrical safety (BS EN 60601-1:2006+A12:2014) | Passed |
| Electromagnetic compatibility (BS EN 60601-1-2: 2007) | Passed |
| Homecare environment (BS EN 60601-1-11:2010) | Passed |
| Electrocardiographic monitoring equipment (BS EN 60601-2-27:2014) | Passed |
| Biocompatibility (BS EN ISO 10993-1:2009) | Passed |
| Risk Management (BS EN ISO 14971:2012) | Passed |
| Software (BS EN 62304:2006+A1:2015) | Passed |
| Usability (BS EN 62366-1:2015) | Passed |
2. Sample size used for the test set and the data provenance
Not applicable. The "tests" were non-clinical performance and engineering validation tests, not tests on a dataset of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for clinical performance studies (e.g., diagnoses by experts, pathology reports) was not established for patient data in this submission. The "ground truth" for the non-clinical tests was compliance with international standards, which is evaluated by test engineers and accredited laboratories.
4. Adjudication method for the test set
Not applicable, as no external test set requiring expert adjudication was used.
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
Not applicable. This device is a remote monitoring system, not an AI-assisted diagnostic tool that would typically involve human readers. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The evaluation was for the entire system's compliance with safety and performance standards for a monitoring device, not a standalone AI algorithm.
7. The type of ground truth used
The "ground truth" for this submission was the compliance with established international and national standards for medical device safety, electromagnetic compatibility, biocompatibility, software development, usability, and risk management.
8. The sample size for the training set
Not applicable. No machine learning model or "training set" is mentioned in the context of this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable, as there was no training set.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).