(16 days)
The DINAMAP® Pro Series 110N-410N Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate and/or temperature and/or oxygen saturation (pulse oximetry). The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.
The DINAMAP Pro Series 110N-410N Monitor is a prescription device intended for use only by health care professionals. Four configurations of the monitor-all with integrated printer-will offer the following vital signs parameters:
- DINAMAP 110N: Non-Invasive Blood Pressure and Pulse Rate ●
- DINAMAP 210N: Non-Invasive Blood Pressure and Pulse Rate, Temperature ●
- DINAMAP 310N: Non-invasive Blood Pressure and Pulse Rate, Pulse Oximetry ●
- DINAMAP 410N: Non-Invasive Blood Pressure and Pulse Rate, Pulse Oximetry . and Temperature.
This portable device includes an integrated printer and is capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery.
The provided text describes a medical device, the DINAMAP® Pro Series 110N-410N Monitor, and its regulatory submission (510(k)). However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets said criteria.
The document primarily focuses on establishing "substantial equivalence" to a predicate device, which is a regulatory pathway for certain medical devices in the US. While it mentions "Several bench studies were conducted which demonstrate safety and effectiveness," these are listed generally (Electromagnetic Compatibility, Electrical Safety, Mechanical and Environmental) and no performance metrics or acceptance criteria for these studies are provided.
Therefore, I cannot directly answer your request for a table of acceptance criteria and reported device performance, nor can I provide details about sample sizes, ground truth establishment, or clinical study specifics like MRMC analysis or standalone performance.
Here's a breakdown of what cannot be extracted from the provided text based on your request:
- Table of acceptance criteria and reported device performance: Not present. The document states the device has the "same technological characteristics" as the predicate but doesn't list specific performance thresholds or how the new device measured against them.
- Sample size used for the test set and data provenance: Not present. The document only mentions "bench studies" without specifying test sets or data origin.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No information about ground truth establishment is included for the "bench studies."
- Adjudication method for the test set: Not present.
- Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned. The document describes a device for vital sign monitoring, not image analysis or diagnostic support where MRMC studies are typically conducted.
- Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly stated. The device is a monitor, implying continuous measurement. Its performance isn't described in terms of an "algorithm only" without human interaction.
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
In summary, the provided document serves as a regulatory submission emphasizing technological equivalence. It does not contain the detailed study information regarding acceptance criteria and performance metrics that your request seeks. This type of information would typically be found in detailed engineering reports, clinical validation studies, or specific performance standards documents, which are not part of this 510(k) summary.
§ 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).