(319 days)
Family Healthware™ is a self-administered, interactive Web-based tool that assesses familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer) and provides personalized recommendations for lifestyle changes and screening.
Family Healthware™ is a Web-based software tool that can be used to assess a person's familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer). It provides users with a "prevention plan" containing personalized recommendations for lifestyle changes and screening. For each person, the tool collects data about the following:
- Health behaviors (e.g., smoking and exercise),
- Screening tests (e.g., blood cholesterol and mammography),
- Health history among his or her first- and second-degree relatives.
One set of algorithms in the software analyzes users' family history data and assesses their familial risk for each of the six diseases. A second set of algorithms uses the data on familial risk. health behaviors, and screening results to generate personalized prevention messages.
This document is a 510(k) premarket notification for a medical device called "Family Healthware™". It focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a performance study with specific acceptance criteria and detailed device performance metrics.
Therefore, the provided text does not contain the information required to answer your request about acceptance criteria, detailed device performance, study design (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), or training set details.
The document discusses the following:
- Device Name: Family Healthware™
- Regulatory Number: 21 CFR 870.2910 (Radiofrequency Physiological Signal Transmitter and Receiver)
- Regulatory Class: Class II
- Product Code: DRG
- Intended Use: A self-administered, interactive Web-based tool that assesses familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer) and provides personalized recommendations for lifestyle changes and screening.
- Predicate Device: Wellaho Personalized Outpatient Management System (K123671)
- Basis for Substantial Equivalence: Comparison of intended use, indications for use, and technological characteristics (e.g., Internet data collection platform, proprietary software, wireless RF protocol, Wi-Fi, SSL via HTTPS for communication, patient feedback via on-screen display, encrypted patient data on servers).
The primary purpose of a 510(k) submission, as seen here, is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or different technological characteristics that do not raise new questions of safety or effectiveness. This process usually does not involve a clinical performance study with the level of detail you're asking for regarding AI algorithm performance (e.g., sensitivity, specificity, AUC) and its associated validation studies. These types of detailed performance studies are more typical for novel devices or those undergoing PMA (Premarket Approval) pathways, or for AI/ML devices where specific performance claims are made and need to be validated.
In summary, the document does not provide the information to populate the requested table or answer the specific questions about device performance validation studies.
§ 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).