(36 days)
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:
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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.
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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.
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical study or adjudication is mentioned.
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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.
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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.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical study or ground truth establishment is mentioned.
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The sample size for the training set: Not applicable, as no machine learning algorithm training is described within the context of a clinical study.
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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.
§ 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).