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QuietCare-Networked is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. QuietCare-Networked recognizes and monitors certain patterns of activity including but not limited to bathroom and bedroom activity, residence entry/exit, and interaction with food and medication storage.

Caregivers are provided with information and notification about the occurrence of, and changes in, these monitored activity patterns and environmental conditions. Noteworthy occurrences and changes are communicated to caregivers through direct notification (pager, voice alert, email) as well as a secure Internet website.

Data from QuietCare-Networked should not be relied on as medical advice or clinical diagnosis. Caregivers should always rely on licensed medical professionals in making all health decisions and should use the information provided by QuietCare as a resource in that process.

Caregivers should not rely solely on the use of QuietCare-Networked for care management of clients/residents. Caregivers should use standard care practices established within their care organization to ensure the safety and wellness of senior clients/residents.

Care Innovations QuietCare-Networked uses advanced motion sensors to monitor Activities of Daily Living for senior residents who require care assistance. It provides alerts and reporting information to care givers when conditions or trends are detected that indicate the senior resident may need care intervention.

The Intel-GE Care Innovations QuietCare-Networked device is a Class I Bed-Patient Monitor that uses motion sensors to monitor Activities of Daily Living for senior residents.

This submission explicitly states that clinical performance data was not used to demonstrate safety and efficacy. The device's equivalency was established by comparing its technological characteristics to predicate devices. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and adjudication methods is not applicable to this particular 510(k) submission.

The device was deemed substantially equivalent based on similarities in software functionality, data collection methods, sensor types, communication methods, connectivity, communication protocol, and display method to existing commercially distributed predicate devices.

Here's a breakdown of why many of your excellent questions cannot be answered from the provided document:

• Acceptance Criteria & Reported Device Performance: Not provided as no clinical performance study was conducted.
• Sample Size (Test Set) & Data Provenance: Not applicable as there was no test set or clinical study.
• Number of Experts & Qualifications: Not applicable as there was no ground truth establishment by experts for a clinical study.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this type of study was not conducted or presented.
• Standalone Performance (Algorithm Only): Not performed as a separate clinical study.
• Type of Ground Truth Used: Not applicable, as no clinical ground truth was established for performance evaluation.
• Sample Size for Training Set: Not applicable, as no training set for a clinical algorithm was mentioned.
• How Ground Truth for Training Set was Established: Not applicable.

Summary from the provided 510(k) Notification:

Study Details:

The 510(k) submission for the Intel-GE Care Innovations QuietCare-Networked did not rely on an assessment of clinical performance data to demonstrate safety and efficacy. Instead, substantial equivalence was claimed based on a comparison of technological characteristics with predicate devices.

Therefore, the following details are not applicable in this context:

• Sample size used for the test set and data provenance: N/A (no test set/clinical study performed).
• Number of experts used to establish the ground truth for the test set and their qualifications: N/A (no ground truth established for a clinical study).
• Adjudication method for the test set: N/A.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No standalone performance study was described.
• The type of ground truth used: N/A (no clinical ground truth was established).
• The sample size for the training set: N/A (no training set for clinical performance was mentioned).
• How the ground truth for the training set was established: N/A.

The submission concluded that the device introduces no new questions concerning safety or efficacy because its technological characteristics (software functionality, data collection, sensor types, communication methods, connectivity, communication protocol, and display method) are substantially equivalent to the predicate devices.

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Intel-GE Care Innovations Connect RCM is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also engage in videoconferences with caregivers and answer the caregivers' questions by participating in surveys.

Care Innovations Connect RCM is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required.

Care Innovations Connect RCM is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

Care Innovations Connect RCM will be available for over the counter use.

Care Innovations™ Connect RCM is a software application for use with measurement devices commercially available for home use. The software executes on a web server and is accessed via a browser from the patient's COTS personal computing device. A small validated software application known as Device Connector runs on patients' home COTS platforms. Off the Shelf (OTS) software is also used with the internally developed software to provide functionality such as: setting & receiving email and text-based notifications, creating & editing calendar entries, playing Learn More videos, and holding a video conference with a clinician.

Care Innovations™ Connect RCM is a software application for use with measurement devices commercially available for home use. Connect RCM provides the same client capabilities of collecting and transmitting patient data to the clinician database system as the predicate devices, and uses the existing clinician database system in the Intel-GE Care Innovations 10 Guide (K130290). No changes were required to the existing clinician database system to support the new client software.

Patients can also enter measurement data manually entered data is stored in the backend clinician database as well as the Personal Health Data Record. It is flagged as manually entered data.

The provided document, K130821, states that the "Connect RCM does not rely on an assessment of clinical performance data." It asserts that "The device will conform to FDA 's recognized consensus standards and relies on its conformity to demonstrate the safety and efficacy." Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices and conformity to recognized consensus standards for safety and efficacy.

Given this, I cannot fill out the requested table or answer most of the follow-up questions because the submission explicitly states that clinical performance data was not used.

Here's what I can provide based on the document:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of clinical studies. The "acceptance criteria" for this device appear to be its conformity to FDA recognized consensus standards and its substantial equivalence to predicate devices.

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

Not applicable. The device does not rely on clinical performance data for its 510(k) submission.

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

Not applicable. No clinical test set described.

4. Adjudication method

Not applicable. No clinical test set described.

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. The device is a remote patient monitoring system, not an AI-assisted diagnostic tool, and no such study was performed or described.

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

Not applicable. The device is software for collecting and displaying patient data, not an algorithm for standalone performance evaluation in a clinical sense.

7. The type of ground truth used

Not applicable. No clinical performance data was used for the 510(k) submission. The "ground truth" for regulatory approval appears to be the documented functionality of the predicate device and the adherence to safety standards.

8. The sample size for the training set

Not applicable. No machine learning model or training set is described in the context of clinical performance for this 510(k).

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

Not applicable. No training set is described.

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The Intel-GE Care Innovations Guide is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys.

The Intel-GE Care Innovations Health Care Management Suite allows the caregiver to review patient data and initiate video conferencing with patients, or select and send educational content to patients.

The Intel-GE Care Innovations Guide is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required.

The Intel-GE Care Innovations Guide is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

The Intel-GE Care Innovations Guide is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. The Intel-GE Care Innovations Guide is a software application running on a Commercial Off The Shelf (COTS) Personal Computer (PC). It collects measurements captured on commercially available wireless or tethered medical devices which are designed for home use and connection to a COTS PC. It displays the collected measurement on the PC, and securely stores the collected information locally on a memory device installed in the PC. Intel-GE Care Innovations Guide also stores the information remotely on a host server, where the caregiver can view the measurement via the host server once synchronization between the host server and Intel® Health Guide Express has been completed. Intel-GE Care Innovations Guide can be used to display educational and motivational content from the caregiver and can facilitate communication between the caregiver and patient via health wellness surveys and optional video conferencing.

The Intel-GE Care Innovations Guide is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. It is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered. The Intel-GE Care Innovations Guide system consists of the:

Intel-GE Care Innovations Guide software application: (1)

The software application captures, stores, displays and transmits information to a secure database on a host server running the Intel-GE Care Innovations Health Care Management Suite software via a standard telephone line or internet connection. The Intel-GE Care Innovations Guide software runs on a Commercial Off The Shelf (COTS) Personal Computer (PC).

Intel-GE Care Innovations Health Care Management Suite software application: (2)

The software application runs on a host server and allows caregivers to review patient vital signs on the secure website. The Intel-GE Care Innovations Health Care Management Suite allows for predefining upper and lower limits and, when either limit is exceeded, the system emails and/or pages the caregiver.

The provided text describes a 510(k) submission for a modification to the Intel-GE Care Innovations Guide, a remote patient monitoring system. However, the document explicitly states that "The Intel-GE Care Innovations Guide does not rely on an assessment of clinical performance data."

Therefore, it is not possible to describe acceptance criteria or a study that proves the device meets those criteria, as such information is not present in the provided text.

Specifically, the document states:
"The Intel-GE Care Innovations Guide does not rely on an assessment of clinical performance data. The device conforms to FDA's recognized consensus standards and relies on its conformity to demonstrate the safety and efficacy. The device introduces no new questions concerning the safety or efficacy and is, therefore, substantially equivalent to the predicate device."

This means the submission for this device did not include a clinical study with acceptance criteria to demonstrate performance. Instead, it relied on conformity to recognized standards and substantial equivalence to a predicate device (Intel-GE Care Innovations Guide, K103276).

Since there is no performance study described, all sections of your request related to study details (acceptance criteria table, sample sizes, experts, adjudication, MRMC, standalone performance, ground truth, training set) cannot be fulfilled from the provided text.

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