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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® 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 Zargis Acoustic Cardioscan, (ZAC) is an electronic auscultatory device, intended to provide support to the physician in the evaluation of heart sounds in patients.

The product will acquire and record the acoustic signals of the heart and analyze these signals. The analysis procedure will identify specific heart sounds. that may be present. Identified sounds include S1, S2, and suspected murmurs.

The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.

The interpretations of heart sounds offered by the Zargis Acoustic Cardioscan are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.

The ZAC is an electronic auscultatory device intended to acquire, record, and analyze heart sounds.

The complete system is a CD comprising software and instructions for use with an included USB transceiver for connection with a PC and capable of wireless communication with a Bluetooth-enabled electronic stethoscope.

Here's an analysis of the acceptance criteria and study information for the Zargis Acoustic Cardioscan (ZAC), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (K083309) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and performance metrics for a novel technology. Therefore, specific quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) and corresponding numerical performance results are not explicitly stated in this document.

The document broadly states: "non-clinical performance testing has been conducted to demonstrate the performance of the modified ZAC device and that it meets its intended use." and "A clinical software validation was performed to insure the performance of the enhanced software algorithm."

Based on the limited information, we can infer the implied performance goal is to "identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs." However, no specific metrics for the accuracy of this identification are provided.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "A clinical software validation was performed," but does not provide the number of cases or patients included in this validation.
• Data Provenance: Not explicitly stated. The document does not mention the country of origin of the data or whether it was retrospective or prospective.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The device's intended use emphasizes "physician over-read" and "consideration of all other relevant patient data," implying medical professionals are involved in the overall diagnostic process, but their role in establishing ground truth for the validation study is not detailed.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not explicitly stated. The document does not describe how discrepancies in ground truth or interpretation were resolved, if multiple experts were involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• MRMC Study: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study.
• Effect Size: Therefore, no effect size of human readers improving with AI assistance is provided. The device is intended to "provide support to the physician" and is "not intended as a sole means of diagnosis," requiring "physician over-read." This implies human-in-the-loop, but a comparative study assessing its impact is not described.

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

• Standalone Performance Study: The document does not explicitly present standalone (algorithm-only) performance metrics such as sensitivity or specificity. While "analysis procedure will identify specific heart sounds," the performance of this identification in isolation is not separately quantified. The emphasis is on its use "in conjunction with physician over-read."

7. The Type of Ground Truth Used:

• Type of Ground Truth: Not explicitly stated. Given the nature of heart sound analysis, it's highly probable that the ground truth would have been established by expert clinical assessment (e.g., cardiologists interpreting auscultation, possibly combined with other diagnostic tests like echocardiography), but this is an inference, not a direct statement from the document.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not mentioned or provided in the document.

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

• Ground Truth for Training Set Establishment: Not mentioned or provided in the document.

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The Nox T3 device is intended for ambulatory recording of physiological signals during sleep. The recorded signals are then downloaded to a PC where the signals can be viewed and analyzed by use of the Nox T3 application (Noxturnal). The Nox T3 system is indicated for use in patients greater than 2 years of age.

The Nox T3 system is NOT intended for any patient monitoring or automatic diagnosis.

The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including patient's home.

The Nox T3 system is used for patients suspected of suffering from Sleep Disordered Breathing (SDB) or Periodic Limb Movement Disorder (PLMD).

The Nox T3 is an ambulatory recording system. It includes a recording device, respiratory effort sensors, clip straps, filter tube connector and an USB cable for data download and the Nox T3 application (Noxturnal).

The Nox T3 device is a pocket size battery powered digital recorder that incorporates electronics to record and store up to three nights of physiological parameters. The Nox T3 device is worn on the patient's chest by snapping it to the thoracic respiratory effort sensor belt and securing its position with the clip straps. It has a display for status indication, signal integrity and preliminary results, and buttons for control.

The Nox T3 device records signals from five external sensors and three built-in sensors. The external sensors that can be used with the device are abdominal and thoracic respiratory effort sensors, oximeter (via wireless transmission), and two leads of the following: ECG, EMG, EEG or EOG. The built-in sensors include a pressure transducer allowing either recording of nasal pressure (via nasal cannula) or mask pressure and measuring of snoring, a three dimensional acceleration sensor for measure of patient's position and activity, and a microphone for true audio recording capabilities.

The Nox T3 device includes a class II Bluetooth transmitter/receiver to allow for wireless transmission of data from Nonin´s Model 4100 Patient Oximeter Module.

The Nox T3 application (Noxturnal) is used to configure the device for recording, and downloading, viewing and analyzing of recorded data on a PC.

Here's an analysis of the acceptance criteria and study detailed in the provided document for the Nox T3 device:

The document (510(k) summary) describes the Nox T3 as an ambulatory recording system for physiological signals during sleep. The primary goal of the "performance testing summary" is to demonstrate substantial equivalence to predicate devices, rather than establishing specific performance metrics against a predefined acceptance criterion. The key performance claims for this device focus on its ability to record reliable signals and the accuracy of its automated scoring software (Noxturnal) compared to manual scoring.

Here's the breakdown as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the comparisons "do not raise new questions of safety and effectiveness and demonstrate the same effectiveness and safety as that of the predicates." This implies that the 'acceptance criteria' are primarily based on demonstrating equivalence rather than achieving absolute performance thresholds.

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

• Sample Size for Automatic Scoring Comparison: 1057 Embla N7000 recordings.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the data consisted of "Embla N7000 recordings." Embla is a brand associated with sleep diagnostics, and both Medcare Flaga (the predicate's manufacturer) and Nox Medical are based in European countries (Medcare Flaga in the past was associated with Iceland, though it might have had broader presence; Nox Medical is in Iceland). Given the context of a 510(k) submission to the FDA, it's highly probable that the data was collected from clinical settings, likely retrospectively as they were "recordings which had all gone through the process of being manually scored."

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

• Number of Experts: Not explicitly stated as a specific number. The ground truth was established by "Sleep Technicians with RPSGT certification" and "then reviewed by a Physician." This suggests at least one technician and one physician per recording, but doesn't give an aggregate count of unique individuals.
• Qualifications of Experts:
  • Sleep Technicians: "RPSGT certification" (Registered Polysomnographic Technologist).
  • Physician: "reviewed by a Physician." (Specific specialization like a sleep physician is implied but not explicitly stated.)

4. Adjudication Method for the Test Set

• The method described is sequential: "manually scored by Sleep Technicians with RPSGT certification, and then reviewed by a Physician." This implies a form of hierarchical review, where the technician's scoring is the initial pass, followed by a physician's oversight. It is not explicitly stated if there was a consensus process (e.g., 2+1, 3+1) if the physician disagreed with the technician, or if the physician's review constituted the final ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

• No, a MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not performed or reported in this summary. The study reported compared the device's standalone automatic scoring (Noxturnal application) against manual scoring by human experts. The study's focus was on the performance of the automated algorithm, not on improving human reader performance.

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

• Yes, a standalone performance evaluation of the algorithm was done. The "Analysis comparison was performed to validate the quality of the automatic scoring performed by the Noxturnal application compared to manual scoring of full PSG data." This directly assesses the algorithm's performance without a human in the loop during the scoring process.

7. The Type of Ground Truth Used

• The ground truth used was expert consensus/manual scoring. Specifically, "manual scoring of full PSG data" performed by "Sleep Technicians with RPSGT certification" and "then reviewed by a Physician."

8. The Sample Size for the Training Set

• The document does not specify a sample size for the training set. It only mentions the "recordings used consisted of 1057 Embla N7000 recordings" for the validation study. It is common for 510(k) summaries to omit details about training data, but its absence here means we cannot ascertain the training set size from this document.

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

• The document does not provide information on how the ground truth for the training set was established. Given the lack of detail on the training set itself, this information is not available in the provided text.

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