(100 days)
Capsule Surveillance is a clinical decision support device that integrates, analyzes, and displays data from multiple sources including medical devices and healthcare information systems. It uses standardized rules that are based on customers approved clinical protocols, and policies to create clinically relevant alerts in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended to replace clinicians' judgment, but rather to assist clinicians in making timely, informed, higher quality decisions. Capsule Surveillance may be configured for secondary monitoring and alerting intended to be relied upon in deciding to take immediate clinical action. Capsule Surveillance may also be configured for remote display of physiological data and alerts not intended to be relied upon in deciding to take immediate clinical action.
The Capsule Surveillance System is a clinical decision support device that integrates data from multiple sources including medical devices and healthcare information systems. The Capsule Surveillance Systems offers two methods of accessing the clinical application: . A workstation which is a dedicated desktop used exclusively to run the Capsule Surveillance System clinical application in kiosk mode. . The remote display which is any machine that accesses the Capsule Surveillance System via a web browser. Use of the Capsule Surveillance System allows for simultaneous monitoring of different patients in a clinical setting, providing information from integrated data sources that monitor physiological parameters such as, pulse, respiratory rate, SpO2, temperature, and blood pressure.
I am sorry, but the provided text does not contain specific details regarding acceptance criteria for a device, nor does it describe a study that proves a device meets those criteria with the requested information (table of acceptance criteria and reported performance, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, and ground truth establishment for the training set).
The document is a 510(k) premarket notification letter from the FDA, confirming the substantial equivalence of the "Capsule Surveillance System" to a predicate device. It primarily focuses on regulatory approval based on similarities to existing devices, harmonized standards compliance, and non-clinical bench testing.
Specifically:
- There is no table of acceptance criteria or reported device performance metrics in the provided text.
- The document states "No new issues of safety or effectiveness are introduced as a result of using this device" and "The Capsule Surveillance System, like the predicate device, did not require clinical trials." This indicates that a clinical study to prove performance against specific acceptance criteria, as in the context of an AI/ML device relying on diagnostic accuracy metrics, was not performed or required for this device's 510(k) clearance.
- The document mentions "Human factors and usability testing has been completed" and "verification and validation, software validation, usability validation, and risk management activities have taken place," but it does not provide the detailed results, sample sizes, or methodologies for these tests in the format requested.
- It does not discuss the use of experts for ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or details about training sets, as these are typically relevant for AI/ML-based diagnostic devices, which this system, described as a "clinical decision support device" and "physiological monitor," doesn't appear to be in the context of this submission. The device integrates, analyzes, and displays data from other medical devices and healthcare systems to create alerts, based on customer-approved clinical protocols, rather than autonomously diagnosing.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).