(297 days)
This medical device is indicated for use by patients with known or suspected hypertension or diabetes that a physician wants to monitor blood pressure, pulse, and/or blood glucose at home.
This medical device is a software based device which runs on a Windows based Computer or netbook. This medical device receives readings from supported FDA approved devices in the home and serves as a remote communication link between the home and the physician or qualified medical provider. The physician or qualified medical provider will review the patient information from a web interface and may make medication changes and transmit those changes back to the patient for display on the Home Medical Station(HMS).
This medical device receives blood pressure, heart rate and blood glucose readings from the supported FDA approved medical devices via USB or serial connection to the HMS. The HMS communicates with the server via standard wireless or wired communication protocols such as cellular data, and wired or wireless internet.
HMMS has been tested to work with Homedics BPA-260-CBL, Omron HEM-7901T and OneTouch Ultra Mini, OneTouch Ultra 2 and OneTouch UltraLink.
This medical device is automation of the exiting process of reporting results to the physician over the phone.
This medical device is not intended to provide real time monitoring. It is not intended for emergency calls or for transmission of any time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.
This medical device does not provide diagnosis of any disease or medical condition and is not a substitute for professional healthcare judgment.
This medical device uses standard communication protocols and encryption to protect patient privacy.
The Ascot HMMS (Home Medical Monitoring System) is a software based device which receives readings in the home or clinical setting from various FDA approved devices (such as home Blood Pressure monitor with pulse or Glucose testing monitor) and transmits readings to the Ascot Central Server (ACS) for review by the Physician. If the Physician modifies medication dosages, the patient medication dosage instructions ordered by the Physician, are transmitted back to the patient and displayed on the HMS. Receipt of each transmission is confirmed within the system.
The Ascot HMMS (Home Medical Monitoring System) reduces risks to health because it speeds up the communication between the Physician and the patient. It improves accuracy because readings are transmitted directly from the home to server for later review by the Physician.
The Ascot Home Medical Monitoring System (HMMS) is a software-based device intended to automate the process of reporting medical readings (blood pressure, pulse, blood glucose) from a patient's home to a physician and transmitting medication dosage changes back to the patient. It acts as a communication link between FDA-approved medical devices used at home and a central server for physician review.
Here's an analysis of the acceptance criteria and study information provided:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not explicitly state specific acceptance criteria with numerical thresholds for the device's performance. Instead, it focuses on the device's functional equivalence to predicate devices and its ability to accurately and securely transmit data and facilitate communication. The "acceptance criteria" are implied by the claims made and the comparison to predicate devices, which suggest the device must perform these functions reliably and securely.
Below is a table summarizing the claimed features and implied performance:
| Acceptance Criteria (Implied) | Reported Device Performance (Ascot HMMS) |
|---|---|
| Data Upload Functionality | Yes, through standard RS232, Bluetooth, or USB Connection. |
| Data Support/Assistance | Through trained healthcare staff, staff training, written instructions & Ascot support. |
| Data Storage | On computer media. |
| Reports & Graphs Generation | Based on readings obtained. |
| Review Readings Interface | Web Interface. |
| Enable Patient & Healthcare Professional Sharing | Yes. |
| Provide Feedback to Patient | Yes, authorized by Physician only. |
| Support for Specific Devices | Blood glucose, non-invasive blood pressure. Specifically tested with: OneTouch Ultra Mini, OneTouch Ultra 2, OneTouch UltraLink (Blood Glucose Monitors); Omron HEM-790IT, HoMedics BPA-260-CB (Automatic Blood Pressure Monitors). |
| Intended for Home Setting Use | Yes. |
| Method of Transmitting Data to Physician | Transmitted across secure computer connection to Ascot server database. Eliminates reporting errors from manual methods. |
| Web Viewer for Physician Access | Yes. |
| No Diagnosis Provided | No. (Explicitly stated) |
| No Provision of New Prescriptions | New prescriptions are not handled or ordered in the HMMS. (Explicitly stated) |
| Security and Privacy | Uses standard communication protocols and encryption to protect patient privacy. (Explicitly stated) |
| Not a Primary Alarm Source / Not for Emergency Use | Not a primary alarm source. Not intended for emergency calls or time-critical data. Not a substitute for direct medical supervision or emergency intervention. (Explicitly stated) |
| Not a Substitute for Professional Healthcare Judgment | Not a substitute for professional healthcare judgment. (Explicitly stated) |
| Reducing Risks and Improving Accuracy (Comparative Claim) | Reduces risks to health because it speeds up the communication between the Physician and the patient. Improves accuracy because readings are transmitted directly from the home to server for later review by the Physician, eliminating reporting errors inherent in the former process (phone reporting). (Claimed benefit over existing manual process, not a direct performance metric). |
| Confirmation of Transmission and Receipt | Receipt of each transmission (readings to server, dosage instructions to patient) is confirmed within the system. |
| Physician Role and Qualifications | For review by the Physician (qualified medical professional who can change medication dosages, e.g., Nurse Practitioners or Physician Assistants). |
| Patient Option for Former Process | If the patient prefers, they may still report readings using the former process. (Functional flexibility) |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" sample size or data provenance in the context of an evaluative study that would typically be described for a diagnostic or AI/ML device. The submission focuses on functional equivalence to predicates and validation of data transmission capabilities. The "devices which have been tested to operate with the Ascot Home Medical Monitoring System" (OneTouch Ultra Mini, OneTouch Ultra 2, OneTouch UltraLink, Omron HEM-790IT, HoMedics BPA-260-CB) implicitly form the "test set" for demonstrating compatibility and successful data exchange, but no specific number of test cases or patients is provided for this. These are tests of system integration and function, not clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and therefore not provided in the document. The device is a data management and communication system, not a diagnostic tool that requires expert-established ground truth for its output. The "ground truth" for this device would be whether the data is transmitted accurately and securely, and if medication instructions are accurately displayed, functionality that is typically verified through system testing and validation rather than expert consensus on medical conditions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods are typically used in studies where a diagnosis or interpretation of medical images/data is being assessed for accuracy against a consensus ground truth. The Ascot HMMS does not provide diagnoses or interpretations.
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
An MRMC comparative effectiveness study was not conducted and is not mentioned. This type of study is relevant for devices that assist human readers in tasks like image interpretation or diagnosis. The Ascot HMMS is a data management and communication system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable in the traditional sense. The device is a software system for data transmission and management, which inherently involves human interaction (patient providing readings, physician reviewing and giving instructions). Its performance is evaluated on its ability to accurately and securely transmit data, rather than on an "algorithm only" performance in a diagnostic context. The core function is providing the data to the human-in-the-loop (the physician) for their decision-making.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe "ground truth" in terms of medical outcomes or diagnoses. For this device, the "ground truth" related to its performance would be the accurate and secure transmission of physiological readings from the patient device to the server, and the accurate display of physician-ordered medication changes to the patient. This would be established through technical validation and system testing, ensuring data integrity, security, and correct communication protocols, rather than medical consensus or pathology.
8. The sample size for the training set
The concept of a "training set" in the context of machine learning algorithms is not applicable to this device as described. The Ascot HMMS is a software system for data management and transmission, not an AI/ML-based diagnostic or predictive algorithm that requires a training set.
9. How the ground truth for the training set was established
As there is no described training set for an AI/ML algorithm, this information is not applicable.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).