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Health Buddy® Appliance 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 Health Buddy appliance is a communications product that connects to a telephone line. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional(s) between office visits. The Health Buddy appliance contains software that can be activated to function with specific medical devices (including blood glucose meters, non-invasive blood pressure cuffs, patient weight scales, peak flow meters and pulse oximeters). The Health Buddy appliance retrieves data from a specific medical device and stores it for transmission to a healthcare provider. The physiologic patient parameters available for retrospective display and evaluation include blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements, and blood oxygen saturation (%SpO₂) and pulse rate using a digital pulse oximeter. The Health Buddy receives connections from these medical devices, and through the data port, wireless hub, or infrared device, downloads readings from the identified attached device and transmits the responses over the phone lines at predetermined times to the patient's health care professional.

The Health Buddy appliance is a simple, user-friendly device that connects to the patient's standard home telephone line. The device connects to a Data Center via a toll-free number to send patient responses since the previous data transfer and to retrieve the new dialogue.

The screen displays information and asks questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient responses are sent to the patient's health care provider.

Here's an analysis of the provided text regarding the Health Buddy® Appliance, addressing your requested information:

Key Takeaway: The provided 510(k) summary for the Health Buddy® Appliance is for a special 510(k) of device modifications. This means it is based on modifications to an already cleared device and demonstrates substantial equivalence to predicate devices. As such, it does not contain a new study with acceptance criteria and device performance results in the way you might expect for an initial clearance or a comprehensive clinical trial. The focus is on demonstrating that the modifications do not introduce new questions of safety or effectiveness.

Therefore, many of your requested items (like a table of acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance studies) are not present or applicable to this specific type of submission as described.

Summary of Requested Information from the Provided Text:

1. A table of acceptance criteria and the reported device performance

• Not applicable/Not provided in this document. This special 510(k
  ) submission focuses on demonstrating substantial equivalence of modifications to an existing device, rather than presenting a de novo performance study against new acceptance criteria. The document asserts that the safety and effectiveness are "reasonably assured" based on equivalence to predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not provided. No specific test set or data provenance is mentioned as this is a modification submission based on substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. No ground truth establishment for a test set is discussed in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. No test set or adjudication method is discussed.

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/Not provided. This device is a data management system/accessory, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

• Not applicable/Not provided. The device's function is to collect and transmit historical data from other medical devices to healthcare professionals. It does not perform an "algorithm only" diagnostic function that would typically be evaluated in a standalone performance study. Its role is as an accessory and communication tool. The indication explicitly states it is "not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment."

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

• Not applicable/Not provided. As there is no new performance study described, there is no explicit mention of ground truth types. The device transmits historical data from other medical devices, so the "ground truth" for the data itself would derive from the accuracy of those connected medical devices (e.g., blood glucose meter, blood pressure cuff).

8. The sample size for the training set

• Not applicable/Not provided. The document describes a medical device for data transmission, not an AI/ML algorithm that would typically require a training set.

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

• Not applicable/Not provided. See the explanation for point 8.

Detailed Information from the Provided Text (Relevant to Device Description and Predicate):

Acceptance Criteria & Device Performance (Indirect):

Since this is a Special 510(k) for modifications, the "acceptance criteria" are generally understood to be that the modifications do not alter the fundamental operation or intended use such that the device is no longer substantially equivalent to its predicates, and that the modifications do not raise new questions of safety or effectiveness. The "performance" is implicitly deemed acceptable because it maintains substantial equivalence to already cleared devices.

Predicate Devices (Form the Basis of Equivalence, not a "study"):

• Health Buddy® appliance with Device Connectivity (#K063612, #K060843, #K050567, #K042273, #K040086)
• Health Buddy® with Buddylink (#K993128)
• CareMatix Wellness System (#K040966)
• Philips TeleMonitoring System, (#K041674)

Indication for Use:

"Health Buddy® Appliance 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."

Conclusion from the 510(k) Summary:

"The Health Buddy Appliance is substantially equivalent in technology, features, and indications for use to devices cleared under the Federal Food. Drug and Cosmetic Act. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance of this modified device."

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Health Buddy® Appliance 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 Health Buddy appliance is a communications product that connects to a telephone line. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional(s) between office visits. The Health Buddy appliance contains software that can be activated to function with specific medical devices (including blood glucose meters, non-invasive blood pressure cuffs, patient weight scales, peak flow meters and pulse oximeters). The Health Buddy appliance retrieves data from a specific medical device and stores it for transmission to a healthcare provider. The physiologic patient parameters available for retrospective display and evaluation include blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements, and blood oxygen saturation (%SpO₂) and pulse rate using a digital pulse oximeter. The Health Buddy receives connections from these medical devices, and through the data port, wireless hub, or infrared device, downloads readings from the identified attached device and transmits the responses over the phone lines at predetermined times to the patient's health care professional.

The Health Buddy appliance is a simple, user-friendly device that connects to the patient's standard home telephone line. The device connects to a Data Center via a toll-free number to send patient responses since the previous data transfer and to retrieve the new dialoque.

The screen displays information and asks questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient responses are sent to the patient's health care provider.

The provided text describes a 510(k) premarket notification for a modification to the Health Buddy® Appliance. However, it does NOT contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

The submission focuses on establishing substantial equivalence to previously cleared devices for a modification to the software to support the connection of additional medical devices. This is a regulatory pathway that relies more on demonstrating that the changes do not introduce new questions of safety or effectiveness, rather than providing new performance data for the device as a whole.

Therefore, many of the requested details are not present in the provided document.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) submission for this device modification focuses on establishing substantial equivalence rather than presenting new performance data against specific acceptance criteria. The document explicitly states: "This submission represents a modification to the software in the Health Buddy® Appliance to support the connection of additional medical devices."

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

This information is not provided in the document. No specific test set or study details with sample sizes are mentioned.

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

This information is not provided in the document. There is no mention of experts or ground truth establishment for a test set.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

This information is not applicable/provided. The Health Buddy Appliance is a data management and communication system for physiological parameters, not an AI-assisted diagnostic tool that would typically involve an MRMC study comparing human readers with and without AI. It collects and transmits historical data for healthcare professionals to support patient management.

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

This information is not provided in the document. The device primarily functions as a data conduit and communication tool, not an autonomous algorithm requiring standalone performance evaluation in the typical sense of a diagnostic or therapeutic algorithm.

7. The Type of Ground Truth Used

This information is not provided in the document. Given the nature of the device as a data transmission system, the "ground truth" would likely relate to the accuracy of data transmission and correlation with the attached medical devices, but specific details are not outlined.

8. The Sample Size for the Training Set

This information is not provided in the document. There is no mention of a training set for an algorithm.

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

This information is not provided in the document.

Summary of the Device and its Regulatory Review:

The Health Buddy® Appliance is a communication product that connects to a telephone line. It functions by retrieving data from various medical devices (blood glucose meters, blood pressure cuffs, scales, peak flow meters, pulse oximeters) and transmitting this historical patient information to healthcare professionals. It also allows healthcare providers to send questions and educational messages to patients.

This specific 510(k) submission (K063612) is a modification to the software of an already cleared Health Buddy® Appliance to support the connection of additional medical devices. The regulatory review relies on demonstrating substantial equivalence to previously cleared Health Buddy versions and other similar telemonitoring systems.

The core assertion for clearance is that the modified device is "substantially equivalent in technology, features, and indications for use to devices cleared under the Federal Food, Drug and Cosmetic Act," and therefore its "safety and effectiveness are reasonably assured." This implies that the performance characteristics (e.g., accuracy of data transmission, reliability of communication) of the modified device are considered to be comparable to those of the predicate devices without requiring new, extensive performance studies to define new acceptance criteria and prove them.

Ask a specific question about this device

Health Buddy® Appliance 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 Health Buddy appliance is a communications product that connects to a telephone line. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional(s) between office visits. The Health Buddy appliance contains software that can be activated to function with specific medical devices (including blood glucose meters, non-invasive blood pressure cuffs, patient weight scales, peak flow meters and pulse oximeters). The Health Buddy appliance retrieves data from a specific medical device and stores it for transmission to a healthcare provider. The physiologic patient parameters available for retrospective display and evaluation include blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements, and blood oxygen saturation (%SpO₂) and pulse rate using a digital pulse oximeter. The Health Buddy receives connections from these medical devices, and through the data port, downloads readings from the identified attached device and, at predetermined times, transmits the responses over the phone lines to the patient's health care professional.

The Health Buddy appliance is a simple, user-friendly device that connects to the patient's standard home telephone line. The device connects to a Data Center via a toll-free number to send patient responses since the previous data transfer and to retrieve the new dialoque.

The screen displays information and asks questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient responses are sent to the patient's health care provider.

The provided text describes a 510(k) submission for modifications to the Health Buddy® Appliance. However, it does not contain any information about acceptance criteria or a study designed to prove the device meets those criteria.

The document focuses on:

• Regulatory Authority and Company Information
• Device Name and Classification
• Predicate Devices: Identifying previously cleared devices that the modified device is substantially equivalent to.
• Device Description: Explaining what the Health Buddy appliance is and how it functions as a communication tool for collecting and transmitting physiological data from various medical devices.
• Indication for Use Statement: Defining the intended purpose of the device.
• Substantial Equivalence Comparison: Arguing that the modified device is substantially equivalent to existing cleared devices.
• Conclusion: Stating that safety and effectiveness are reasonably assured due to substantial equivalence.
• FDA Correspondence: The FDA's letter granting 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide the requested information about acceptance criteria or a study that proves the device meets them because this information is not present in the provided text.

In a real-world scenario for a medical device requiring performance testing, the requested information would typically be found in a separate section detailing verification and validation activities, including test protocols, acceptance criteria, and specific study results. This document bypasses such a detailed study by asserting substantial equivalence to previously cleared devices for modifications that are primarily software-related to support additional medical device connections.

Ask a specific question about this device

Health Buddy® Appliance 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 Health Buddy appliance is a communications product that connects to a telephone line. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional(s) between office visits. The Health Buddy appliance contains software that can be activated to function with specific medical devices (including blood glucose meters, non-invasive blood pressure cuffs, patient weight scales and peak flow meters). The Health Buddy appliance retrieves data from a specific medical device and stores it for transmission to a healthcare provider. The physiologic patient parameters available for retrospective display and evaluation include blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements. In this submission, software changes are made to support hardware replacement to components no longer available in the Health Buddy. In addition, the operating system has changed. The Health Buddy device has data ports that allow it to download readings from identified attached devices, activated only upon appropriate patient enrollment.

The Health Buddy appliance is a simple, user-friendly device that connects to the patient's standard home telephone line. The device connects to a Data Center via a toll-free number to send patient responses from the previous day and to retrieve the current day's dialoque.

The screen displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient information is sent to the patient's health care provider.

The Health Buddy® is an accessory device, intended to be a communication tool to enable healthcare providers to receive historical patient information. The product is used in conjunction with Health Hero Network's Online Service, a communication tool to enable health care providers to educate, motivate, and receive patient information. Health Buddy Appliance is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

The provided document is a 510(k) premarket notification for a modification to the Health Buddy® Appliance. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving safety and efficacy through new, independent studies with acceptance criteria in the traditional sense.

Therefore, many of the requested categories (acceptance criteria, specific study design, sample sizes for test and training sets, ground truth establishment for novel algorithms, MRMC studies, and standalone performance) are not applicable to this type of submission.

Here's an breakdown based on the provided text, explaining why certain information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable. This 510(k) is for modifications to an already cleared device (Health Buddy® Appliance) and focuses on demonstrating substantial equivalence to its predicates. It does not present new acceptance criteria or new performance metrics with specific thresholds that a study would aim to meet, as would be the case for a novel device or a device with new clinical indications. The "performance" here is primarily about maintaining the functionality and safety of the original device despite hardware and OS changes.

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

• Not Applicable. No explicit "test set" in the context of an algorithm's performance on a specific dataset is mentioned. The changes are to hardware components and the operating system of an existing communication device. The "testing" would have focused on ensuring the modified device continues to perform its intended functions (collecting and transmitting data from attached medical devices) as reliably as the original, in line with its cleared indications. This would likely involve engineering verification and validation, not a clinical study on a patient data set.

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

• Not Applicable. As there's no explicit "test set" involving diagnostic or interpretative tasks, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

• Not Applicable. No test set requiring expert adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Applicable. An MRMC study is typically conducted for diagnostic devices where human readers interpret medical images or data. The Health Buddy® Appliance is a data collection and transmission device, not an interpretive diagnostic tool. There is no AI component that would "assist" human readers in the way an MRMC study evaluates.

6. Standalone (Algorithm Only) Performance Study

• Not Applicable. The Health Buddy® Appliance acts as a communication tool and an accessory to other medical devices (blood glucose meters, blood pressure cuffs, etc.). It does not contain a standalone "algorithm" for making medical decisions or interpretations, nor does it perform any diagnostic functions independently. Its software updates are related to hardware compatibility and the operating system, not to a novel clinical algorithm.

7. Type of Ground Truth Used

• Not Applicable. Given the nature of the device (a data communication system), the concept of "ground truth" as it applies to diagnostic accuracy (e.g., pathology, clinical outcome) is not relevant. The device's function is to accurately transmit data, not to interpret it.

8. Sample Size for the Training Set

• Not Applicable. This device does not use machine learning algorithms that require a "training set" of data for learning or model development. The software changes are related to hardware drivers and the operating system.

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

• Not Applicable. As no training set is described (see point 8), there is no ground truth establishment for a training set.

Summary of the 510(k) Submission:

The provided document describes a Special 510(k) submission for modifications to the "Health Buddy® Appliance." The key points are:

• Device Type: A communication product that connects to a telephone line, used by patients to answer questions and transmit data from specific medical devices (blood glucose meters, blood pressure cuffs, scales, peak flow meters) to healthcare professionals.
• Modifications: Software changes to support hardware replacement due to components no longer being available, and an update to the operating system.
• Indication for Use: "Health Buddy® Appliance 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." It explicitly states it is not intended for automated treatment decisions or as a substitute for professional healthcare judgment.
• Predicate Devices: The submission claims substantial equivalence to previously cleared versions of the Health Buddy® (K042273, K040086, K993128) and other similar telehealth monitors/systems (CareMatix Wellness System K040966, Viterion 100 TeleHealth Monitor K030419).
• Conclusion: The changes maintain the technological features and indications for use, thus demonstrating substantial equivalence to cleared devices, assuring safety and effectiveness.

This 510(k) is a regulatory filing for a device modification, not a report on a clinical study establishing new performance metrics for a novel algorithm or diagnostic capability. The "study" here is essentially the demonstration that the modified device maintains its previously cleared functionality without raising new questions of safety or effectiveness.

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