(89 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 may be used for the management of congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post myocardial infarction and other post cardiac events. 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, a 510(k) submission for the HP Model 3810A Telemedicine System, primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices and ensuring electrical safety standards are met. It does not contain information regarding detailed acceptance criteria for clinical performance, nor does it describe a study to prove the device meets such criteria.
Therefore, I cannot populate the requested table and sections regarding clinical performance, sample sizes, ground truth, experts, adjudication, or MRMC studies from the provided text.
The "Performance Data" section (E. Performance Data) only mentions electrical safety testing:
E. Performance Data
The M3810A patient units- the M3813A Scale Unit, the M3815A Blood Pressure Unit, and the M3816A Rhythm Strip Recorder Unit- 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 the primary "acceptance criteria" presented in this document relate to electrical safety and regulatory compliance, not clinical performance of the telemedicine system's ability to accurately manage patient data or improve outcomes.
Here's a breakdown of what can be extracted or inferred based on the document's content, and what cannot:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Safety/Regulatory): Compliance with IEC 60601-1:1988 +A1:1991 +A2:1995 and FCC Part 15.
- Reported Device Performance (Safety/Regulatory): "received a certificate of compliance."
- Clinical Performance Acceptance Criteria: Not specified in the provided text.
- Clinical Performance Reported Performance: Not specified in the provided text.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- For electrical safety: Not specified (generally not applicable for safety compliance testing in the same way it would be for clinical performance).
- For clinical performance: Not specified. No clinical test set is mentioned.
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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 specified, as no clinical performance test set is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified, as no clinical performance test set is described.
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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:
- No MRMC study is mentioned. The device is a "telemedicine system" for data collection and transmission, not an AI-based diagnostic tool for interpretation by human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone performance study for an algorithm is mentioned. The device's function is described as collecting and transmitting data, with "Clinical judgement and experience are required to check and interpret the information delivered." This explicitly states a human-in-the-loop is required for interpretation, implying no standalone diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified, as no clinical performance study is described.
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The sample size for the training set:
- Not applicable/Not specified. The document does not describe an AI/ML algorithm requiring a training set for clinical performance.
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How the ground truth for the training set was established:
- Not applicable/Not specified.
In summary, this 510(k) submission demonstrates the device's safety and regulatory compliance based on testing to electrical standards. It does not provide an analysis of clinical performance or effectiveness studies involving patients or healthcare professionals interpreting data, as these types of studies were likely not required for this particular type of device (a data collection and transmission system, not a diagnostic interpretation tool). The submission focuses on substantial equivalence to predicate devices for its intended use, which is facilitating data transmission.
§ 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).