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The Intel® Health Guide Express 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® Health Care Management Suite allows the caregiver to review patient data and initiate video conferencing with patients, or select and send educational and motivational content to patients.

The Intel® Health Guide Express 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® Health Guide Express 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® Health Guide Express is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. The Intel® Health Guide Express 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. The Intel® Health Guide Express 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. The Intel® Health Guide Express 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® Health Guide Express 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® Health Guide PHS Express system consists of the:

• Intel® Health Guide Express software application: (1)
  The software application captures, stores, displays and transmits information to a secure database on a host server running the Intel® Health Care Management Suite software via a standard telephone line or internet connection. The Intel® Health Guide Express software runs on a Commercial Off The Shelf (COTS) Personal Computer (PC).

Intel® 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® 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 Intel® Health Guide Express is a remote patient monitoring system. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting them in the way clinical studies for diagnostic accuracy often do.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of diagnostic accuracy or a specific performance study. Instead, it demonstrates substantial equivalence to a predicate device (Intel® Health Guide PHS6000) based on technological characteristics and functional similarities. The key performance aspect is the ability to collect, store, display, and transmit vital sign measurements, and this is compared to the predicate device's capabilities and compatibility with various peripherals.

Essentially, the "acceptance criteria" here are that the new device performs its intended functions (collecting and transmitting data) and is at least as safe and effective as the predicate device, given its specific use case as a communication tool and not a diagnostic device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a specific "test set" or a study involving patient data for performance evaluation in the context of diagnostic accuracy or a similar clinical measurement. The device is a "Remote Patient Monitoring System" that collects data from other commercially available medical devices.

The assessment is primarily a technical comparison and declaration of substantial equivalence to a predicate, not a clinical trial evaluating the performance on a patient cohort or a specific dataset. There is no mention of data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as there is no mention of a "test set" requiring ground truth established by experts for performance evaluation. The device's function is data capture and transmission, not interpretation or diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. No test set requiring expert adjudication for ground truth establishing is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC comparative effectiveness study was not done. The device is a data collection and communication tool, and its primary purpose is not to assist human readers in interpretation or diagnosis. Therefore, a study of improved human reader performance with AI assistance is not relevant to this type of device.

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

No, a standalone study in the context of algorithmic performance for diagnosis/interpretation was not described. The device is a software application running on a COTS PC that interacts with other medical devices. Its performance is assessed in terms of its ability to correctly capture, store, transmit data, and its compatibility with hardware, rather than standalone diagnostic accuracy. The safety and efficacy claims "do not rely on an assessment of clinical performance data" but on conformity to recognized consensus standards.

7. The Type of Ground Truth Used

Not applicable. As stated earlier, the submission focuses on substantial equivalence based on technological characteristics and safety standards, not on evaluating diagnostic accuracy against a ground truth. The device itself is "not interpretive, nor is it intended for diagnosis."

8. The Sample Size for the Training Set

Not applicable. This device is a remote patient monitoring software system. There is no mention of a "training set" for an AI algorithm in the context of diagnosis or prediction.

9. How the Ground Truth for the Training Set was Established

Not applicable. For the same reasons as point 8, there is no mention of a training set or ground truth establishment relevant to an AI model's training.

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The Intel® Health Guide PHS6000 is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. It collects measurements captured on commercially available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host server. Caregivers can review the transmitted information and select education and reminders for patients using a caregiver software interface to the host server. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also optionally engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys.

The Intel® Health Guide PHS6000 is not 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® Health Guide PHS6000 is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. It collects measurements captured on commercially available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host server. Caregivers can review the transmitted information and select education and reminders for patients using a caregiver software interface to the host server. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also optionally engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys.

The Intel® Health Guide PHS6000 system consists of the:

• Intel® Health Guide PHS6000 hardware: The physical component of the Intel® Health Guide PHS6000 is an electronic device contained in a plastic enclosure with a touch screen, video camera with privacy screen, microphones, speakers and a reminder light which is mounted into the top of the case. On the back of the device is a power socket, a headphone socket, a Broadband (high-speed) internet socket for connection to a broadband network. The device has medical device sockets for connection to specific physiological monitors, and may optionally have a phone socket for modem connection to a standard phone line.
• Intel® Health Guide software application: The software application captures, stores, and transmits information to a secure website via a standard telephone line or a LAN/WAN connection.
• Intel® Care Management Suite software application: The application allows caregivers to review patient vital signs on the secure website. The Intel® Care Management Suite allows for predefining upper and lower limits and, when either limit is exceeded, the system emails and/or pages the caregiver.
• Processor software application: The processor software application manages the interface between the Intel® Health Guide PHS6000 software application and the secure website.

The Intel® Health Guide PHS6000 is not 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 device is contraindicated for patients requiring direct medical supervision or emergency intervention. The device 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 provided document is a 510(k) summary for a modification to the Intel® Health Guide PHS6000, a remote patient monitoring system. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical performance through new studies.

Therefore, the document explicitly states: "The Intel® Health Guide PHS6000 does not rely on an assessment of clinical performance data."

Consequently, the information requested regarding acceptance criteria and a study proving the device meets those criteria cannot be found in this document. The submission relies on conformity to FDA recognized consensus standards to demonstrate safety and efficacy, and on the substantial equivalence to its predicate device (Intel® Health Guide PHS6000 - K080798 & K083115).

Here's why each specific point cannot be addressed by this document:

1. A table of acceptance criteria and the reported device performance: Not provided. The device does not rely on clinical performance data for this submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable as no clinical performance study demonstrating acceptance criteria was conducted or reported in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable as no clinical performance study demonstrating acceptance criteria was conducted or reported in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical performance study demonstrating acceptance criteria was conducted or reported in this submission.
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 patient monitoring system, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as no clinical performance study demonstrating acceptance criteria was conducted or reported in this submission.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no clinical performance study demonstrating acceptance criteria was conducted or reported in this submission.
8. The sample size for the training set: Not applicable as no machine learning algorithm requiring a training set is discussed or implied to be part of a new clinical performance study for this modification.
9. How the ground truth for the training set was established: Not applicable as no machine learning algorithm requiring a training set is discussed or implied to be part of a new clinical performance study for this modification.

In summary, this 510(k) submission for the Intel® Health Guide PHS6000 modification relies on demonstrating substantial equivalence to a previously cleared device and conformity to recognized consensus standards, rather than presenting new clinical performance data or studies against specific acceptance criteria.

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The Intel® Health Guide PHS6000 is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. It collects measurements captured on commercially available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host server. Caregivers can review the transmitted information and select education and reminders for patients using a caregiver software interface to the host server. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also optionally engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys.

The Intel® Health Guide PHS6000 is not 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® Health Guide PHS6000 is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. It collects measurements captured on commercially available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host server. Caregivers can review the transmitted information and select education and reminders for patients using a caregiver software interface to the host server. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also optionally engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys.

The Intel® Health Guide PHS6000 system consists of the:

• Intel® Health Guide PHS6000 hardware: The physical component is an electronic device with a touch screen, video camera with privacy screen, microphones, speakers and a reminder light. It has a power socket, headphone socket, Broadband internet socket, medical device sockets, and optionally a phone socket.
• Intel® Health Guide software application: Captures, stores, and transmits information to a secure website.
• Intel® Care Management Suite software application: Allows caregivers to review patient vital signs on the secure website and set limits for alerts.
• Processor software application: Manages the interface between the Intel® Health Guide PHS6000 software application and the secure website.

The Intel® Health Guide PHS6000 is not 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 device is contraindicated for patients requiring direct medical supervision or emergency intervention. The device 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 provided text describes a 510(k) Notification Submission for a modification to the Intel® Health Guide PHS6000. However, it explicitly states that clinical performance data was not used to demonstrate safety and efficacy.

Therefore, I cannot provide information on acceptance criteria or a study proving the device meets those criteria from the given text.

Here's why and what the document does say:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on demonstrating substantial equivalence to a predicate device, not on specific performance metrics or acceptance criteria for the modified device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no clinical study or test set data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no clinical study or ground truth establishment is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical study or adjudication is 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: Not applicable. The device is a "Remote Patient Monitoring System" and is not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The document states: "The Intel® Health Guide PHS6000 is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data." and "Clinical judgment and experience by a caregiver are required to check and interpret the information delivered." This indicates a human-in-the-loop system, but not one that evaluated "algorithm only" performance. Furthermore, no performance study of any type is detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical study or ground truth establishment is mentioned.

8. The sample size for the training set: Not applicable, as no machine learning algorithm training is described within the context of a clinical study.

9. How the ground truth for the training set was established: Not applicable, as no machine learning algorithm training with ground truth is described.

What the document states regarding safety and efficacy:

The document explicitly states in "Safety and Efficacy":
"The Intel® Health Guide PHS6000 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 indicates that the regulatory clearance for this modification was based on demonstrating substantial equivalence to an existing predicate device (Intel® Health Guide PHS6000, K080798) and adherence to recognized consensus standards, rather than through a clinical study with specific acceptance criteria and performance data.

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The Intel® Health Guide PHS6000 is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. It collects measurements captured on commercially available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host server. Caregivers can review the transmitted information and select education and reminders for patients using a caregiver software interface to the host server. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also optionally engage in video conferences with caregivers and answer the caregivers` questions by participating in surveys.

The Intel® Health Guide PHS6000 is not 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* Health Guide PHS6000 is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. It collects measurements remotely access vitar ago available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host scrver. Caregivers can review the transmitted information and select education and reminders for patients using a caregiver software interface to the host server. Patients can review the stored vital sign measurement information and receive Screef. Fattents can review the pregivers. Patients can also optionally engage in cultianonia and morractorers and answer the caregivers` questions by participating in surveys.

The Intel" Health Guide PHS6000 system consists of the:

• Intel* Health Guide PHS6000 hardware: (1)
  The physical component of the Intel® Health Guide PHS6000 is an electronic device contained in a plastic enclosure with a touch screen, video camera with privacy screen, microphones, speakers and a reminder light which is mounted into the top of the case. On the back of the device is a power socket, a headphone socket. a Broadband (high-speed) internet socket for connection to a broadband network. The device has medical device sockets for connection to specific physiological monitors, and may optionally have a phone socket for modem connection to a standard phone line.

• Intel " Health Guide software application: (2)
  The software application captures, stores, and transmits information to a secure website via a standard telephone line or a LAN/WAN connection.

• Intel* Care Management Suite software application: (3)
  The application allows caregivers to review patient vital signs on the secure website. The Intel® Care Management Suite allows for predetining upper and lower limits and, when either limit is exceeded, the system emails and/or pages the caregiver.

• Processor software application: (4)
  The processor software application manages the interface between the Intel® Health Guide PHS6000 software application and the secure website.

The Intel® Health Guide PHS6000 is not 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 device is contraindicated for patients requiring direct medical supervision or emergency intervention. The device 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.

This 510(k) summary does not contain information regarding specific acceptance criteria, a study proving the device meets those criteria, or the detailed methodology typically associated with performance studies for medical devices that directly assess efficacy or safety through clinical data.

The Intel® Health Guide PHS6000 is described as a "communication tool" for remote patient monitoring. The submission explicitly states:

"The Intel® Health Guide PHS6000 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 devices."

This indicates that the submission for this device primarily focused on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and adherence to recognized consensus standards, rather than presenting a performance study with specific acceptance criteria related to a novel clinical claim or a direct assessment of clinical performance.

Therefore, the requested information cannot be extracted from the provided text as it is not present. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, or the nature of prospective/retrospective data.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes for human reader improvement with AI.
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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