(81 days)
Intended Use: The Model 3810A is intended to be used upon prescription of a licensed physician or authorized healthcare provider by patients as a means to automatically collect and transmit medical information, such as weight, blood pressure and non-diagnostic ECG, over normal residential telephone lines, between a patient, typically at home, and a health care professional at the authorized provider.
Indications for Use: The Model 3810A is indicated for patients at home, who are capable and willing self-administrate this device, upon prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day, and the information is transmitted automatically via normal telephone lines to the healthcare provider. The device does not send any real-time alarms. Clinical judgement and experience are required to check and interpret the information delivered.
The Hewlett-Packard (HP) Model 3810A telemedicine device provides a system for daily collection of weight, blood pressure and ECG used in the management of home care patients.
The main flow of information originates in the home where a patient uses a blood pressure unit, a scale and an ECG rhythm recorder on a daily schedule. Each of the units automatically reports their data wirelessly to a home Hub, which in turn relays the data using a standard modem over the telephone to a secure database. Health care professionals (such as physicians, nurses, and case managers) having approval for access use a secure log-on procedure to gain access to their patient's data. The provider follows up on any unexpected or undesired changes in the patient's data trends with a phone call.
The home Hub incorporates a receiver, an embedded processor with memory, a standard modem and an automatic dial up module. It is designed so that its operation does not interfere with normal use of the phone including an answering machine. Its connections are identical to those of an answering machine, consisting of a standard wall power plug and a daisy chain phone connection. The installation and use of the home Hub poses no significant risk to the patient or other people within the patient's home.
The data forwarded through the home Hub arrives though a standard modem contained in the HP system server. This server is separate from the Telemedicine PC in the clinic and is programmed to decode the data from the home units. The system design provides for data security.
This document is a 510(k) Summary for the HP Model 3810A telemedicine device, submitted to the FDA in 1999. It details the device description, intended use, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics or thresholds for the telemedicine system's primary functions (data collection and transmission). Instead, the performance data focuses on compliance with electrical safety and regulatory standards for its physical components.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Electrical Safety Compliance | Received a certificate of compliance with IEC 60601-1:1988 +A1:1991 +A2:1995 |
| FCC Compliance | Received a certificate of compliance with FCC Part 15 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on a specific "test set" in the context of clinical performance data or algorithm validation. The "performance data" section only mentions compliance with electrical safety and FCC standards for the and individual sensor units (scale, blood pressure, rhythm strip recorder). This typically involves laboratory testing of the devices themselves, not patient data.
Therefore, information on:
- Sample size for a test set
- Data provenance (country of origin, retrospective/prospective)
is not available in the provided text.
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)
This information is not available in the provided text. The document does not describe the establishment of a ground truth for a clinical test set, as the performance data focuses on device safety and regulatory compliance rather than clinical accuracy for diagnostic or prognostic purposes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text. As there is no description of a clinical test set requiring ground truth establishment, no adjudication method is mentioned.
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
This information is not available in the provided text. The device is a telemedicine system for data collection and transmission, not an AI-powered diagnostic or interpretive tool. There is no mention of AI assistance or MRMC studies. The document explicitly states: "The device does not send any real-time alarms. Clinical judgement and experience are required to check and interpret the information delivered."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available in the provided text. The device is not presented as an algorithm-only system. Its function is to collect and transmit medical information, with human healthcare professionals responsible for interpretation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not available in the provided text. Since the performance data relates to electrical safety and FCC compliance, there is no mention of clinical ground truth types for patient data.
8. The sample size for the training set
This information is not available in the provided text. There is no mention of a "training set" as the device is not described as an AI/ML product developed with such methodologies.
9. How the ground truth for the training set was established
This information is not available in the provided text, as there is no mention of a training set or ground truth for it.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" described in the provided text is primarily a demonstration of compliance with electrical safety and electromagnetic compatibility (EMC) standards for the physical components of the telemedicine system.
Specifically, the M3813A Scale Unit, the M3815A Blood Pressure Unit, and the M3816A Rhythm Strip Recorder Unit (which form the patient units of the M3810A system) "have been tested for electrical safety and has received a certificate of compliance with IEC 60601-1:1988 +A1:1991 +A2:1995 and FCC Part 15."
This indicates that these individual hardware components have undergone laboratory testing to ensure they meet the relevant safety and electromagnetic interference standards. This type of testing involves subjecting the devices to various electrical and environmental conditions specified by the standards to confirm safe operation and minimal electromagnetic interference. The successful attainment of these certificates serves as the proof that these aspects of the device meet the stated regulatory acceptance criteria.
The document does not detail any clinical studies, performance studies involving patient data accuracy, or validation of an algorithm's diagnostic or interpretive capabilities, as the device's stated function is data collection and transmission for human interpretation.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).