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The Optum TeleHealth Application is a software application designed to retrospectively monitor vital signs. The following vital signs are collected: noninvasive blood pressure, pulse rate, weight, temperature, and blood glucose. The Optum TeleHealth Application collects, displays, and transmits vital sign measurements captured from commercially available FDA cleared medical devices designed for home use, or via manual input by the patient. Collected measurement data from the Optum TeleHealth Application can be transmitted via a secure communication mechanism to a central health data repository. Data can be viewed and analyzed via the Optum TeleHealth Web Application.

The Optum TeleHealth Application is not intended for emergency use or real-time monitoring.

The client application is available in three configurations:

• stand-alone application for both Android and iOS operating systems
• pre-loaded on an Android tablet

The Optum TeleHealth Application is client/server software application which collects and transmits patient vital signs, and physiological data for review, and analysis by clinicians. The software consists of a web based application for clinician use, the client application for member use, and web services. Standard data communication protocols are used. The server hosts the web based application for user management, and patient information and care management. The client application is designed to work with Android devices (OS 4.0 and higher) and Apple devices (iOS 9 and higher), and allows for data input from external biometric measuring devices, review of clinician advice, response to clinician questions, and viewing of graphed data.

The client application is available in two configurations:

• stand-alone application for both Android and iOS operating systems .
• . pre-loaded on an Android tablet

The device is used in combination with various Class I 510(k) exempt devices and FDA cleared biometric measuring devices, including, but not limited to:

• A&D Medical, UA-767PBT Digital Blood Pressure Monitor (K043217) .
• . A&D Engineering Inc., UC-321PBT Weight Scale (510(k) exempt)
• TaiDoc Technology Corporation, Fora W310 Weight Scale (510(k) exempt) .
• . TaiDoc Technology Corporation, Fora IR20b Ear Thermometer (K090395)
• TaiDoc Technology Corporation, Fora P20 Blood Pressure Monitor (K092106) ●
• Nonin Medical Inc Onyx II Model 9560 Finger Pulse Oximeter (K081285) ●

The provided document is a 510(k) premarket notification letter and summary for the Optum TeleHealth Application. It describes a software application designed to collect, display, and transmit vital sign measurements for retrospective monitoring. As such, it is a data handling and transmission device, not a diagnostic or prognostic medical imaging AI device.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving device performance as typically expected for a medical imaging AI device. Specifically, it does not include:

• A table of acceptance criteria with reported device performance (e.g., sensitivity, specificity, AUC).
• Details on sample size, data provenance, ground truth establishment, or expert involvement for a test set designed to evaluate diagnostic or prognostic performance.
• Information on MRMC studies or standalone algorithm performance.

Instead, the document focuses on:

• Indications for Use: Retrospective monitoring of vital signs (noninvasive blood pressure, pulse rate, weight, temperature, blood glucose). It explicitly states it's not intended for emergency use or real-time monitoring.
• Technological Characteristics: How it collects data (manual input, Bluetooth from external devices) and transmits it to a central repository.
• Predicate Devices: Claiming substantial equivalence to a previously cleared Optum TeleHealth Application (K130971).
• Pre-Clinical Testing: A generic statement that "Bench testing, including software validation, was performed to ensure that the product works as intended." and "Results of bench testing show that the product is safe, and effective for use." This implies functional verification and validation of the software, rather than clinical performance evaluation against a diagnostic ground truth.

In summary, this device's function is data aggregation and transmission, not medical image analysis or diagnosis. The typical performance metrics and study designs (like MRMC, standalone performance, or detailed ground truth establishment for diagnostic accuracy) are not applicable or described for this type of device in the provided document.

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The CipherOx CRI Tablet is indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), and the Compensatory Reserve Index (CRI), which trends changes in intravascular volume relative to the individual patient's response to hypovolemia.

For patients with a finger thickness of 0.3" to 1" in hospital and pre-hospital settings.

CRI trends with changes in intravascular volume relative to the individual patient's response to hypovolemia, and should only be used by qualified medical providers as an adjunct to rather than as a replacement for traditional hemodynamic measures. CRI is indicated for adults (19-36 years old) in the supine position under non-motion conditions and without cardiovascular disease. CRI has not been studied in trauma patients.

The CipherOx CRI Tablet consists of a Nonin Onyx II Model 9560 finger pulse oximeter (previously cleared under K081285) that communicates by Bluetooth with a Cybernet CyberMed T10 tablet PC. The CipherOx CRI Tablet is a continuous, multi-parameter monitor that displays SpO2, Heart Rate (HR), photoplethysmograph (PPG) waveform images, and the Compensatory Reserve Index (CRI) value and historical trend-line.

CRI is an index related to the physiologic changes induced by intravascular fluid loss and ranges from 0 to 1, where 1 indicates a normal subject and 0 indicates a subject who has undergone significant physiological effects from loss of fluid volume.

Here's a breakdown of the acceptance criteria and study information for the CipherOx CRI Tablet, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criterion for the CipherOx CRI Tablet appears to be the accurate estimation of CRI values, specifically the root-mean-squared error (RMSE) between estimated and reference CRI.

Study Information

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

• LBNP Verification Study: 20 healthy participants.
  • Data Provenance: The text does not explicitly state the country of origin, but the development and studies seem to be conducted by Flashback Technologies in Boulder, Colorado. The data is prospective, gathered specifically for the study.
• Blood Draw Validation Study: 42 healthy participants (ages 19 to 36).
  • Data Provenance: Similar to the LBNP study, the country of origin is not explicitly stated but implied to be the US. The data is prospective, gathered specifically for the study.

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

The text does not mention the use of experts to establish a "ground truth" in the traditional sense (e.g., diagnosis by radiologists). Instead, the ground truth for CRI was established physiologically:

• LBNP Study: Reference CRI values were defined as CRI = 1 - LBNPcurrent / LBNPcollapse, where LBNPcollapse refers to the LBNP pressure level at the point a subject either had a precipitous fall in systolic blood pressure below 80 mmHg and/or voluntary subject termination due to discomfort or expression of presyncopal symptoms (or until completion of -100 mmHg). This relies on objective physiological measurements (blood pressure) and subjective patient reporting (presyncopal symptoms).
• Blood Draw Study: The "ground truth" for the blood draw study was the actual volume of blood removed and the observation of symptoms (e.g., systolic blood pressure

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LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healtheare professionals. It consists of a hosted web server, a hosted database server and two types of client interfaces - one that is provided by Windows client and one that is provided by a web client interface.

LifeStream software's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, dispensed medicine, ECG, peak flow, prothrombin time and retrospective PERS messages.

LifeStream retrospectively displays the data, user-defined data alerts for review and interpretation by a healthcare professional. LifeStream is not intended for emergency use or real-time monitoring.

LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healthcare professionals. It consists of a hosted web server and two types of client interfaces, one that is provided by Windows client and one that is provided by a web client interface. LifeStream 5, like the predicate LifeStream 4.0, is configured to accept patient data that is acquired periodically and displayed retrospectively from Honeywell HomMed Patient Monitors (e.g. Genesis Touch). LifeStream 5 can also interface with 3nd party compatible medical device data systems (e.g. Govsphere TV). LifeStream 5 has the same intended use as the predicate, LifeStream 4.0. LifeStream 5, like LifeStream 4.0 is not intended for emergency use or real-time monitoring. Both are designed to retrospectively receive, display and store scheduled vital sign parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, ECG, peak flow, prothrombin time and retrospective PERS messages.

The Honeywell HomMed LifeStream™ 5 is a software program designed to retrospectively receive, display, and store monitored vital signs parameters and related data for review and interpretation by healthcare professionals. It is not intended for emergency use or real-time monitoring.

Here's an analysis of its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific quantitative acceptance criteria for performance. The "acceptance criteria" here are implied by the claim of substantial equivalence in intended use, users, use environment, technological characteristics, and safety to the predicate device, LifeStream™ 4.0.

The performance reported is qualitative, stating that LifeStream 5 is substantially equivalent to LifeStream 4.0 and that differences "do not affect the relative safety and/or effectiveness."

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

The document does not specify a "test set" in the context of clinical performance evaluation using patient data. This 510(k) submission primarily relies on demonstrating substantial equivalence through non-clinical performance testing (bench testing) and comparison of technological characteristics with a predicate device.

Therefore, there is:

• No specific sample size for a test set of patient data mentioned.
• No data provenance (country of origin, retrospective/prospective) related to a clinical test set.

The "validation testing of complete systems" and "black box testing" likely used simulated data or internal test cases, but no details on their size or origin are provided.

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

Since there is no mention of a clinical test set requiring expert ground truth, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

As there is no clinical test set with expert ground truth mentioned, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technical and functional comparison to a predicate device and non-clinical testing, not on comparative effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a "standalone, prescription-based software program" for retrospective display and storage of vital signs, intended for use by healthcare professionals for review and interpretation. The "Performance / Bench Testing" section describes functional, validation, automated regression, black box, localization, and deployment testing, along with "External evaluation by Honeywell clinical team." This evaluation represents the standalone performance of the software in its intended function of receiving, displaying, and storing data correctly, as it is a device intended to assist human professionals, not to make diagnoses autonomously. However, these are engineering/software tests, not clinical performance studies measuring diagnostic accuracy of an algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance/bench testing, the "ground truth" would be established by the expected behavior and output defined in the software's functional specifications and requirements. For example:

• Functional Testing: The "ground truth" is that the software correctly performs its intended function (e.g., displaying specific vital sign data accurately, registering alerts based on defined thresholds).
• Validation Testing: The "ground truth" is that the complete system meets all specified requirements.
• Automated Regression Testing: The "ground truth" is that previously corrected defects remain fixed and new changes haven't introduced new errors.

There is no mention of pathology, outcomes data, or expert consensus serving as ground truth for a clinical dataset in this submission.

8. The Sample Size for the Training Set

Not applicable. This submission describes a medical device, LifeStream™ 5, which is a software system for managing vital signs data. It is not an AI/Machine Learning algorithm that typically requires a "training set" of data to learn patterns or make predictions. The software's functionality is pre-programmed based on defined rules and specifications.

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

Not applicable, as there is no training set for an AI/Machine Learning algorithm. The software's "ground truth" for its development would be its functional and system requirements.

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The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and mobile environments.

The subject device, MightySat Rx, is a fingertip pulse oximeter that includes Masimo SET technology for the measurement of functional oxygen arterial hemoglobin (SpO2) and pulse rate in adults and pediatrics. The device is a spot check pulse oximeter and does not include alarms. The device has the combined function of a pulse oximeter monitor and a reusable sensor. It includes an OLED color display, enclosed by plastic housing and powered by two alkaline AAA batteries. The MightySat Rx also includes optional Bluetooth wireless technology for the wireless transfer of patient data to mobiles devices, such as a smartphone.

The mobile device functions as a secondary display and it is not required for the intended use of pulse oximetry measurements. After measurements are made by the subject device, the data can be transferred to the mobile device via Bluetooth for the display and/or storage of the data.

Here's a breakdown of the acceptance criteria and study information for the Masimo MightySat Rx Fingertip Pulse Oximeter, based on the provided document:

Acceptance Criteria and Device Performance

Note: The document also lists acceptance criteria for Pulse Rate (No motion, Motion, Low Perfusion) and SpO2 (Low Perfusion) in the "SPECIFICATION" table on page 5, but the reported clinical testing results only explicitly state the SpO2 accuracy under no motion and motion conditions. It does state that the device "meets the accuracy requirement" for SpO2, implying other parameters were also met (e.g., 2% Arms for SpO2 Low Perfusion), but specific values are not provided for those.

Study Information

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

• Sample Size: 14 healthy adult male and female volunteers (with at least a total of 356 blood samples).
• Data Provenance: Not explicitly stated regarding country of origin, but it's a clinical study conducted. The study is prospective as it describes the validation of the SpO2 measurement "in accordance with ISO 80601-2-61" carried out on human volunteers.

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

• The ground truth was established "against a laboratory CO-Oximeter." This implies the CO-Oximeter itself is the "expert" or standard, not human experts. Therefore, the concept of "number of experts" or their qualifications for establishing ground truth as typically understood in image-based AI studies does not apply here.

4. Adjudication method for the test set:

• Not applicable/Not explicitly mentioned. The ground truth was established by a laboratory CO-Oximeter, which provides a direct measurement, not an interpretation requiring human adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a standalone measurement device (pulse oximeter), not an AI-assisted diagnostic tool that would typically involve human readers.

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

• Yes, a standalone performance study was done. The clinical testing described validates the accuracy of the device's functional oxygen saturation and pulse rate measurements as performed by the device itself against a laboratory standard, without human intervention in the measurement process after initial placement.

7. The type of ground truth used:

• Ground Truth Type: Laboratory CO-Oximeter measurements of functional oxygen saturation.

8. The sample size for the training set:

• The document does not specify a separate "training set" sample size. This type of device relies on established physiological principles and signal processing, rather than machine learning models that require distinct training and test sets in the same way. The clinical testing described is primarily for validation (test set).

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

• Not applicable, as a distinct "training set" with established ground truth as commonly understood in AI/ML contexts is not described for this device. The device's operation is based on its integrated Masimo SET technology and established algorithms for pulse oximetry, which would have been developed and refined through engineering and earlier research, not necessarily through a formal "training set" in the context of this 510(k) submission.

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The Optum TeleHealth Application is a software application designed to retrospectively monitor vital signs. The following vital signs are collected: noninvasive blood pressure, pulse oximetry, pulse rate, weight, temperature, and blood glucose. The Optum TeleHealth Application collects, displays, and transmits vital sign measurements captured from commercially available FDA cleared medical devices designed for home use, or via manual input by the patient. Collected measurement data from the Optum TeleHealth Application can be transmitted via a secure communication mechanism to a central health data repository. Data can be viewed and analyzed via the Optum TeleHealth Web Application.

The Optum TeleHealth Application is not intended for emergency use or real-time monitoring.

The client application is available in two configurations:

• stand-alone application .
• pre-loaded on an Android tablet .

The Optum TeleHealth Application is client/server software application which collects and transmits patient vital signs, and physiological data for review, and analysis by clinicians.

The software consists of a web based application for clinician use, the client application for member use, and web services. Standard data communication protocols are used. The server hosts the web based application for user management, and patient information and care management. The client application is designed to work with Android tablets (Android OS 4.0 and higher), and allows for data input from external biometric measuring devices, review of clinician advice, response to clinician questions, and viewing of graphed data.

The client application is available in two configurations:

• stand-alone application .

• pre-loaded on an Android tablet .
  The device is used in combination with various Class I 510(k) exempt devices and FDA cleared biometric measuring devices, as listed below:

• A&D Medical, UA-767PBT Digital Blood Pressure Monitor (K043217)

• A&D Engineering Inc., UC-321PBT Weight Scale (510(k) exempt)

• TaiDoc Technology Corporation, Fora W310 Weight Scale (510(k) exempt) .

• TaiDoc Technology Corporation, Fora IR20b Ear Thermometer (K090395) .

• TaiDoc Technology Corporation, Fora P20 Blood Pressure Monitor (K092106) .

• Nonin Medical Inc Onyx II Model 9560 Finger Pulse Oximeter (K081285) .

The Optum TeleHealth Application is a software application designed to collect, display, and transmit patient vital signs and physiological data for review and analysis by clinicians. The device is not intended for emergency use or real-time monitoring.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of a clinical study with patients. The testing performed was "Bench testing, including software validation." This typically involves internal testing by developers rather than a separate patient-based test set for performance evaluation. Therefore, information on data provenance (country of origin, retrospective/prospective) is not applicable.

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

This information is not applicable as the testing described is limited to "bench testing" and "software validation," not a clinical study requiring expert-established ground truth.

4. Adjudication method for the test set

This information is not applicable as the testing described is limited to "bench testing" and "software validation," not a clinical study requiring adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The device is a data collection and transmission application, not an AI-powered diagnostic tool requiring human reader interpretation improvements.

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

The device itself is a standalone software application in the sense that it operates independently to collect and transmit data. However, its intended use inherently involves a "human-in-the-loop" (clinicians reviewing and analyzing the data). No study focused on "algorithm only without human-in-the-loop performance" was explicitly mentioned, other than software validation.

7. The type of ground truth used

For the "bench testing" and "software validation," the ground truth would likely be established through predefined software requirements, expected output values for simulated inputs, and adherence to communication protocols. It would not typically involve expert consensus, pathology, or outcomes data in the way a diagnostic device would.

8. The sample size for the training set

The document does not mention a "training set." This type of testing is characteristic of traditional software validation, not machine learning model training as understood in current AI contexts.

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

Not applicable, as no training set for a machine learning model was identified. The device's validation relied on traditional software testing methodologies.

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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 Sharp Pulse Oximeter Model BM-500 and BM-510 is a non-invasive pulse oximeter indicated for use in the spot-check measurement and display of arterial blood oxygen saturation (SpO2) and pulse rate in hospitals or primary care settings.

The Sharp Pulse Oximeter is a multi-parameter module comprising of a main unit (BM-500) and the SpO2 Sensor (BM-510) connected via the sensor cord. The device operates continuously to provide spot-check measurements of oxygen saturation and pulse when a patient's finger is inserted into the sensor and the ON button is depressed.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 12 subjects
• Data Provenance: The information provided does not specify the country of origin of the data, but the submitter is Sharp Corporation based in Japan.
• Retrospective/Prospective: The study appears to be prospective, as hypoxia was "induced to different levels of oxyhemoglobin saturation" in subjects for the purpose of the study.

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

• Number of Experts: Not applicable. The ground truth was established by a blood gas analyzer, not human experts.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The ground truth was established by objective medical equipment (blood gas analyzer).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The study involved comparing the device against a blood gas analyzer, not against human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, a standalone performance study was done. The device's SpO2 accuracy and pulse rate accuracy were assessed by comparing its readings directly with a blood gas analyzer.

7. The Type of Ground Truth Used:

• Ground Truth: Objective medical equipment (blood gas analyzer). This serves as a direct, gold-standard measurement of arterial blood oxygen saturation.

8. The Sample Size for the Training Set:

• The document does not explicitly mention a separate "training set" or its size. The clinical data description focuses on the evaluation of the device's accuracy with 12 subjects. While device development involves internal testing, the provided summary focuses on the clinical validation data.

9. How the Ground Truth for the Training Set Was Established:

• Since a distinct "training set" is not detailed in the provided information, the method for establishing its ground truth is not described. The clinical validation ground truth was established by a blood gas analyzer.

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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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