(85 days)
The N2000 Base Station is intended to be used in conjunction with the N2001 Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional.
The N2000 Base Station is intended to be used upon prescription of an authorized healthcare provider, by patients where regular monitoring of vital signs information is indicated.
The N2000 Base Station is intended to be used as a means to collect and transmit patient vital signs information over standard telephone lines between the patient, typically at home, and a health care professional at the health care provider's site. The information includes: blood pressure, pulse rate, blood oxygen saturation, blood glucose level, temperature, weight, and heart, lung and bowel sounds. The information is collected upon request of the healthcare provider.
The device is not indicated for diagnostic purposes. The device does not send any real-time alarms. Clinical judgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
The HomeCare Information Network System (HINS) consists of two components: the N2000 Base Station installed typically in a patient's home; and the N2001 Nurse Station located in the provider or professional caregiver's office. The two components communicate with each other through modems over standard telephone lines and transmit real-time video, audio and data between them.
The real-time video and audio communications allow the patient and the caregiver to view and speak with each other.
With existing legally marketed vital signs measurement devices integrated with the N2000 Base Station, the N2000 Base Station is designed to monitor the patient's blood pressure, pulse rate, blood oxygen saturation, blood glucose level, temperature, weight and/or heart, lung and bowel sounds, and transmit this data to the N2001 Nurse Station. The real-time data is displayed to the caregiver operating the N2001 Nurse Station and also automatically recorded in a patient information database. The heart, lung and bowel sounds are recorded from the electronic stethoscope supplied with the system.
Vital signs measurement devices integrated in the HINS are FDA approved devices and have received 510(k) approval. The N2000 may be configured for use with one to five devices.
The N2001 Nurse Station consists of two sub-components, the N2001 Nurse Station PC, which is a standard PC with supporting peripherals, and the N2001 Nurse Station Data Client, which provides the video and audio communications and monitoring functions for the Nurse Station. The N2001 Nurse Station PC can operate as a standalone device for patient data management and record keeping functions.
The provided text contains a 510(k) Summary for the Neptec Homecare Information Network System (HINS). This document predominantly focuses on regulatory compliance, outlining the device's description, intended use, and substantial equivalence to predicate devices, rather than a detailed performance study with specific acceptance criteria and their verification.
Therefore, many of the requested details, such as a table of acceptance criteria with reported device performance, sample sizes for test and training sets, expert qualifications, and adjudication methods, are not available in the provided text.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Functional Performance | "Testing was performed to validate the functional performance of the HINS." |
| Vital Signs Measurement Device Integration | "Testing was performed with each vital signs measurement device to show that they operated as independent devices." |
| Environmental Compliance | The device was subjected to performance testing and emissions in compliance with: |
- IEC 601-1 (Medical Electrical Equipment)
- CAN/CSA-C22.2 (Medical Electrical Equipment)
- UL 2601-1 (Safety of Medical Electrical Equipment)
- FCC Part 15, Subpart C (FCC Rules and Regulations) |
| Accuracy of collected vital signs data | Not explicitly stated. The document implies accuracy through the integration of FDA-approved vital signs devices, but no direct performance metrics for the HINS system itself are provided regarding data accuracy. |
| Real-time video, audio, and data transmission | "The real-time video and audio communications allow the patient and the caregiver to view and speak with each other... transmit this data to the N2001 Nurse Station." |
| Absence of real-time alarms | "The device does not send any real-time alarms." (This is a design feature, not directly a performance metric.) |
| Not for diagnostic purposes | "The device is not intended to be used for diagnostic purposes." (This is an intended use/limitation, not a performance metric.) |
| Not a substitute for medical care/emergency intervention | "The device is not intended as a substitute for medical care or emergency intervention." (This is an intended use/limitation, not a performance metric.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Available. The document mentions "performance testing" and "testing was performed," but does not specify any sample sizes (e.g., number of patients, number of vital sign readings, duration of testing) or the nature of the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Available. The primary purpose of this system is to transmit vital signs data from existing FDA-approved devices. The study described focuses on functional performance and regulatory compliance, not on clinical interpretation or diagnostic accuracy where expert ground truth would be established for the HINS itself. The document states: "Clinical judgement and experience are required to check and interpret the information transmitted." This implies that the interpretation is done by healthcare professionals, but they are not establishing ground truth for the device's performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Available. As no expert-based ground truth establishment for diagnostic or interpretative tasks is described for the HINS device, an adjudication method is not mentioned.
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
- No. An MRMC study was not described. The HINS is a "Tele Homecare System" for transmitting vital signs and enabling communication, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Partially Applicable, but not for "algorithm only" in the modern sense. The N2001 Nurse Station PC (part of the HINS) "may also operate as a standalone device for patient data management and record keeping functions." This refers to its ability to function without the N2000 Base Station for certain administrative tasks, not as an "algorithm only" performance evaluation similar to AI models. The HINS itself is designed as a system requiring human oversight and interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implicitly established by integrated devices. The "ground truth" for the vital signs data transmitted by the HINS is implicitly established by the FDA-approved vital signs measurement devices that are integrated with the N2000 Base Station. The HINS system's performance is based on its ability to accurately and reliably transmit data from these already validated devices, not on generating its own diagnostic ground truth.
8. The sample size for the training set
- Not Available. The document does not describe any training set, as it is not a machine learning or AI-based device in the context of this 510(k) summary.
9. How the ground truth for the training set was established
- Not Applicable. No training set is described.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).