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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 or Ethernet connection. 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 pulse rate, blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements, and blood oxygen saturation (%SpO2). 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 telephone or Ethernet connection 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 or an Ethernet connection to send patient responses since the previous data transfer and to retrieve the new dialogue.

The screen displays information sent by the patient's healthcare provider and asks questions about vital signs, symptoms and behaviors, 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 the Health Buddy® Appliance, which is a communication product designed to collect and transmit patient data from various medical devices to healthcare professionals.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that "Verification and validation testing activities were conducted to establish the performance, functionality and reliability characteristics of the Health Buddy Appliance." And concludes that "The Health Buddy Appliance performed as intended."

The core "performance" of this device is its ability to communicate and transmit data correctly. The acceptance criteria, therefore, would be that these functions work as expected.

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

The document does not specify the exact sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "Verification and validation testing activities."

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

The document does not mention using experts or establishing ground truth in the context of clinical performance for the test set. This device is an accessory for data transmission, not a diagnostic tool requiring expert interpretation of results. Its performance is evaluated based on its technical functionality (e.g., proper data relay), rather than clinical accuracy adjudicated by experts.

4. Adjudication Method for the Test Set:

Given that the device's function is data transmission and not diagnostic interpretation, an adjudication method for a test set (like 2+1 or 3+1) is not applicable and not mentioned in the document.

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

A MRMC comparative effectiveness study is not applicable and not mentioned. The Health Buddy Appliance is not an AI-powered diagnostic tool that assists human readers in interpreting medical images or data. Therefore, there is no "human readers improve with AI vs without AI assistance" effect size to report.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone performance study focused on the algorithm itself was implicitly done through the "Verification and validation testing activities." The software within the Health Buddy Appliance was tested to ensure it correctly handled data retrieval, storage, and transmission. However, the document doesn't quantify this performance with typical standalone metrics like sensitivity or specificity because the device's primary function is communication, not diagnostic interpretation. Its "standalone" performance is its ability to perform its communication tasks correctly.

7. Type of Ground Truth Used:

For the Health Buddy Appliance, the "ground truth" would be related to the correctness of data transmission and device functionality. This would involve:

• Known input data: Inputting specific physiological data from medical devices and verifying that the exact same data is received by the healthcare professional's system.
• Functional specifications: Verifying that all programmed features (e.g., displaying questions, receiving button presses, responding with messages, connecting via Ethernet/phone) work according to their design specifications.
• Electrical and environmental standards: Compliance with relevant industry standards for electrical safety and electromagnetic compatibility.

This is not "expert consensus," "pathology," or "outcomes data" in the traditional clinical sense, but rather a verification against defined technical and functional requirements.

8. Sample Size for the Training Set:

The Health Buddy Appliance appears to be a rule-based or firmware-driven device for data transmission, not an AI/machine learning product that requires a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable and not mentioned in the document.

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

As there is no mention of a training set for an AI/ML algorithm, the method for establishing its ground truth is not applicable and not mentioned.

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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.

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The purpose of the Telephone based BL Healthcare Remote Care Management System is to collect and transmit medical information such as weight, blood pressure and pulse rate, blood glucose, SPO2, FEV1 and PEF from the patients on completion of their testing and transmit these results to their healthcare provider at another facility. This system is installed by or with support from trained professionals. This device is not intended to provide time sensitive data or alarms. This system may not be used as a substitute for direct medical intervention or emergency care. Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional.

Telephone based BL Healthcare Remote Care Management system serves as the communication link between compatible devices and the server software at a compatible healthcare facility. The purpose of the system is to collect and transmit patient vital signs and other physiological data and transmit these results to their healthcare provider at another facility. The healthcare provider is able to access the data for retrospective review and monitoring.

Here's an analysis of the provided text regarding the BL Healthcare Remote Care Management System (K052608), focusing on acceptance criteria and the study proving it:

Important Note: The provided document is a 510(k) Summary and the corresponding FDA clearance letter. It is a regulatory submission, not a detailed scientific study report. As such, it focuses on demonstrating "substantial equivalence" to predicate devices rather than providing in-depth performance studies with acceptance criteria, sample sizes, and ground truth establishment in the way a clinical trial would.

Therefore, many of the requested details (especially quantitative performance metrics, sample sizes, ground truth specifics, and MRMC studies) are not present in this type of document. The 510(k) process for this device type primarily relies on demonstrating that the new device's technology, intended use, and performance are similar enough to legally marketed devices that it doesn't raise new questions of safety or effectiveness.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for a remote monitoring system, the "acceptance criteria" are more conceptual regarding functionality and safety rather than specific diagnostic performance metrics found in imaging or AI device clearances. The "reported device performance" is framed in terms of achieving substantial equivalence.

Study Details

The document refers to "Non-clinical testing" as the study that demonstrates substantial equivalence.

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

   • Sample Size: Not specified. This typically involves technical testing of the device's components and system functionality, rather than patient data in the sense of a clinical trial.
   • Data Provenance: Not specified. It would be internal testing by BL Healthcare.
   • Retrospective or Prospective: Not applicable in the context of this type of non-clinical testing. It would be a prospective test of newly manufactured devices/software.

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

   • Not applicable/specified. For a device like this, ground truth would relate to the accuracy of data transmission and device connectivity, confirmed by engineering and quality assurance personnel, not medical experts establishing a diagnosis.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods (like 2+1) are for human interpretation of data, often in diagnostic imaging, not for testing the fundamental data transmission and connectivity of a remote monitoring system.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. An MRMC study is designed to compare the performance of human readers, typically in diagnostic tasks, with and without the assistance of AI. This device is a data transmission system, not an AI for diagnostic interpretation.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, in spirit. The "Non-clinical testing" assessed the device's technical functionality (its ability to collect and transmit data) in a standalone manner, without requiring a human medical professional to be in the loop of the testing itself to achieve the functional goal. The output of the device (the transmitted data) is intended for human review, but the device's core function of transmission is tested independently.

6. Type of Ground Truth Used:

   • Technical Specifications/Predicate Device Equivalence. The ground truth for this device's performance would be successful data collection and transmission as verified against internal engineering specifications and, importantly, by demonstrating that its performance is equivalent to that of the predicate devices in terms of its ability to perform its stated functions.

7. Sample Size for the Training Set:

   • Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data in the conventional sense. It's a communication system.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" referenced in the 510(k) is "Non-clinical testing." This testing was conducted to demonstrate that the functionality of the Telephone based BL Healthcare Remote Care Management system is "substantially equivalent" to its predicate devices (BL Healthcare Remote Care Management Systems, Zymed EasyView telemetry system, Motion Media Care Station 126S Videophone, and Carematix Modified System). This equivalence means it performs the same intended functions (collecting and transmitting vital signs like weight, blood pressure, pulse rate, blood glucose, SpO2, FEV1, and PEF) without introducing new questions of safety or effectiveness.

The explicit details typically found in an AI/ML or diagnostic device study (like specific performance metrics, clinical sample sizes, physician ground truth, etc.) are absent because the device's classification and the 510(k) pathway rely on demonstrating equivalence for a data communication and remote monitoring system, not on proving de novo diagnostic accuracy for an algorithm. The acceptance criteria are broadly met by showing that the device works as intended for its specified functions and is comparable to existing cleared devices.

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The Hermes System is intended to be used by out-of-hospital patients as a means to collect and transmit medical measurements (such as blood glucose level, weight, and blood pressure) to their healthcare provider and to receive returned educational and motivational messages to help them better understand and manage their chronic condition. The Hermes System is to be used only upon prescription of a licensed physician or other authorized healthcare provider.

The Hermes System is an accessory device that collects data from a range of supported monitoring devices. The data is collected and sent using standard wireless technologies and maintained on an associated database server located within the healthcare facility. Based on patient specific parameters set by the healthcare provider, educational and motivational messages are returned to the patient.

The Hermes System is not intended for emergency calls or for transmission or indication of any real-time alarms or time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.

Hermes is not intended to provide automated treatment decisions, nor to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

The Hermes System is an accessory device that collects data from a range of supported measurement devices. The data is collected and sent using standard wireless technologies and maintained on an associated database server located within the healthcare facility. Based on patient specific parameters set by the healthcare provider, educational and motivational messages are returned to the patient. Hermes is used by the patient to collect data from one or more off-the-shelf measurement devices. Hermes currently supports a glucometer, a noninvasive blood pressure cuff and a weight scale.

Hermes is a software system composed of two components, a Collector module and a Server module. The Collector module is a software program that runs on a cell phone and provides the data collection, transmission and message display capabilities. The Server module is a software program that runs on standard web server hardware. The Server module receives the data sent to it by the Collector module and provides the set-up, data management, and message delivery capabilities.

Hermes messages remind the user of good health habits such as taking all prescribed measurements and maintaining a healthy lifestyle. Hermes can send email to the patient's doctor and/or guardian if good habits are not maintained.

The provided text describes a medical device called "The Hermes System" and its intended use, but it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance.
• Sample sized used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

What the document does state regarding testing:

The document briefly mentions safety and effectiveness testing in Section 6:

"An extensive collection of tests has been conducted and successfully completed, including usability and pilot studies, software unit, integration, system and load/performance testing and document verification."

However, this is a general statement and does not provide any specific acceptance criteria, performance metrics, or details about the methodology, sample sizes, ground truth, or expert involvement in these tests. The conclusion infers that these tests support substantial equivalence, but doesn't present the data itself.

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