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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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Care Pal (Model no. CPW-10X) is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.

The product is not intended to provide automated treatment decisions nor for use as a substitute for a health care professional's judgement.

The Care Pal ("CP") remote patient monitoring system is for use in non-clinical settings as an accessory device to collect and transmit historical patient information to healthcare providers. It is intended to be used in combination with a variety of external devices. The CP remote patient monitoring system serves as the remote communication link between compatible external devices and the compatible healthcare facility at another location. The product is not intended to provide automated treatment decisions nor for use as a substitute for a health care professional's judgment.

The CP appliance contains software that can be activated to function with specific medical devices (including blood glucose meter, blood pressure and weight scale). The CP appliance with device connectivity retrieves data from a specific medical device and transmits to a remote healthcare provider using standard digital communication technologies. The CP appliance is not used directly on the patient, and poses no significant risk to the patient or other people within the patient's home.

Care Pal provides interfaces to the following connecting peripheral devices and back end server as well a. BT

Selected device (Brand/Model): weight scale, A&D/UC-321PBT

• b. USB
  Selected device (Brand/Model): glucose meter, Johnson & Johnson LifeScan / OneTouch Ultra II (K053529)

c. RS-232 (Serial Port) Selected device (Brand/Model): blood pressure meter, A&D UA-787PC (K012013)

d. Internet (Ethernet/wireless) connection to backend server

The provided text describes the 510(k) summary for the "Care Pal" device (Model no. CPW-10X). However, it does not contain specific acceptance criteria for device performance or a detailed study demonstrating how the device meets those criteria in the way typically expected for an AI/ML medical device submission (e.g., accuracy, sensitivity, specificity studies).

Instead, this document focuses on substantial equivalence to a predicate device based on intended use, technological characteristics, and conformance to safety and EMC standards.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• The document primarily references general performance summaries related to operating specifications, safety, and EMC requirements.
• It states that the device conforms to applicable standards, including IEC 60601-1 and IEC 60601-1-2 requirements. These are general safety and electromagnetic compatibility standards for medical electrical equipment.
• It also states that "bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." However, specific acceptance criteria for this bench testing (e.g., data transfer accuracy percentage, successful connection rate) and the detailed results are not provided in this summary.

Without the actual study report, it's impossible to create a precise table. Based on the summary, a conceptual table would look like this:

Missing Information (Crucial for an AI/ML device, but this isn't one):

• Specific quantitative performance metrics like accuracy, sensitivity, specificity, or F1-score.
• Thresholds for passing these metrics.

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

• Not applicable / Not specified. This device is a data management/transmission system, not an AI/ML algorithm that predicts or diagnoses based on a test dataset. The "bench testing" mentioned would focus on the device's ability to connect and transmit data reliably, not on a "test set" of patient data for diagnostic evaluation.
• The document mentions "historical medical information" being transmitted, but this refers to the type of data the device handles, not a dataset used for performance evaluation of the device itself.

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

• Not applicable / Not specified. As a data transmission device, ground truth for diagnostic or prognostic purposes is not established by experts for its functional evaluation. The "ground truth" for this device would likely be the accurate transfer of data from the peripheral device to the server, which would be verified through technical means rather than expert clinical review.

4. Adjudication method for the test set:

• Not applicable / Not specified. No clinical test set requiring expert adjudication is described in this summary.

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 not an AI algorithm designed to assist human readers or perform diagnostic tasks. It's a data transmission system.

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

• Not applicable. This is not an algorithm, but a hardware and software system for data collection and transmission. Its "standalone" performance would relate to its ability to perform its transmission function independently, which would be covered under bench testing and EMC/safety compliance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable / Not specified in detail. For this type of device, ground truth would relate to the successful and accurate transmission of data. For instance, if a glucose meter reads "120 mg/dL," the ground truth for the Care Pal's performance would be that "120 mg/dL" is accurately received by the remote server. This is typically verified through technical validation, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

In summary:

The provided document describes a "Care Pal" device which is a data management/transmission system, not an AI/ML diagnostic or therapeutic device. Therefore, it does not contain the types of performance data (e.g., accuracy, sensitivity, specificity, expert ground truth, sample sizes for training/test sets) that are typically associated with AI/ML device approval. The "study" mentioned is "bench testing" and compliance with general safety and EMC standards, aimed at demonstrating substantial equivalence to a predicate device rather than statistical performance on a clinical dataset.

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The OneTouch® UltraLink™ Blood Glucose Monitoring System is intended to be used for self-testing outside the body (in vitro diagnostic use) for the quantitative measurement of glucose in fresh capillary whole blood obtained from the finger, forearm or palm. The OneTouch® UltraLink™ System is intended for use by people with diabetes in a home setting and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.

The OneTouch® UltraLink™ Blood Glucose monitor may be used to transmit glucose values to appropriate MiniMed Paradigm® and Guardian® REAL Time devices using radio frequency communication.

The OneTouch® UltraLink Blood Glucose Monitoring System is a modification to the OneTouch® Ultra® 2 Blood Glucose Monitoring System, retaining the features, functions, and user interface of the OneTouch® Ultra® 2 meter while introducing a feature allowing Radio-Frequency transmission of blood glucose results to compatible Medtronic MiniMed, Inc. devices. The OneTouch® UltraLink™ Blood Glucose Monitoring System is composed of the OneTouch® UltraLink™ Blood Glucose meter, OneTouch® Ultra® Test Strips, OneTouch® Ultra® Control Solution, OneTouch® Lancing device, OneTouch® UltraSoft® Lancets, and meter carrying case. System modifications were made only to the blood glucose meter, carrying case, and instructions for use.

Here's a breakdown of the acceptance criteria and the study information for the OneTouch® UltraLink™ Blood Glucose Monitoring System, based on the provided text:

Acceptance Criteria and Device Performance

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