Search Results

NAVOYCDS is intended to be used with patient data from already cleared patient monitoring devices which measure respiratory rate, systolic blood pressure, and Glasgow Coma Scale (GCS) in adult patients being monitored in a healthcare facility. The device uses an algorithm to calculate a qSOF A score (also known as quickSOFA) which indicates adult patients with suspected infection who are at greater risk for a poor outcome. It uses three criteria, assigning one point for low blood pressure (SBP ≤100 mmHg), high respiratory rate (≥22 breaths per min), or altered mentation (Glasgow coma scale <15).

NAVOYCDS is an adjunct to and is not intended to replace vital signs monitoring.

NAVOYCDS is intended to provide additional information for use during patient monitoring in a healthcare facility. NAVOYCDS is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes.

The device is intended for an adult population.

NAVOYCDS consists of:

• A gateway module for handling clinical data supporting the HL7 format FHIR.

• A qSOFA score module to calculate patients' qSOFA scores and offer their last 72 hours history data.

· A web-based dashboard to render patients' qSOFA scores in a visually distinctive way depending on their value and enable intended users to view patients with suspected infection.

The NAVOYCDS system works in the following sequence:

• · Receive patient data from the HL7 gateway system.
• · Extract 3 vital signs from the patient data and store them in the database.
  · The Glasgow Coma Scale (GCS) of a patient is stored in the database when a user submits it.

· NAVOYCDS calculates the qSOFA score automatically and stores the result in the database.

· NAVOYCDS delivers 3 vital signs. gSOFA score, GCS to users.

· The qSOFA score is presented in a visually distinctive way depending on the value and enables users to view patients with suspected infection.

The provided document is a 510(k) summary for the device NAVOYCDS, a software that calculates qSOFA scores. Based on the content, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document states that NAVOYCDS uses an algorithm to calculate a qSOFA score based on three criteria: low blood pressure (SBP ≤100 mmHg), high respiratory rate (≥22 breaths per minute), or altered mentation (Glasgow Coma Scale <15). However, no specific acceptance criteria (e.g., accuracy, sensitivity, specificity thresholds) are defined in the provided text, nor is there a table comparing acceptance criteria to reported device performance metrics. The document focuses on the method of calculation rather than quantitative performance.

Study Information

It's explicitly stated that Clinical Performance Testing was not needed in this 510(k) to support the substantial equivalence of the subject device to the predicate device. This means there was no standalone clinical study conducted to establish the device's diagnostic or predictive performance against a ground truth.

Therefore, the following details related to clinical studies are not applicable or provided in this document:

1. Sample size used for the test set and the data provenance: Not applicable as no clinical performance study was conducted.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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: Not applicable. The device calculates a score based on fixed criteria, it's not an AI assisting human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device's function is a direct calculation of the qSOFA score based on input vital signs, not a complex algorithm requiring standalone performance validation against clinical outcomes. The document indicates "Non-clinical Performance Testing involved system-level tests, performance tests and safety testing based on hazard analysis," but this refers to software validation and not clinical performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no external ground truth was used for clinical performance validation of the qSOFA calculation itself. The qSOFA score is a defined clinical scoring system.
7. The sample size for the training set: Not applicable. As the device calculates a defined clinical score (qSOFA) based on specified input criteria, it is not a machine learning model that undergoes training on a dataset.
8. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of rule-based calculation.

In summary, the NAVOYCDS device calculates a pre-defined clinical score (qSOFA) based on established criteria. The FDA clearance for this device appears to be based on demonstrating that the software accurately calculates this score according to its definition and meets software development and safety standards, rather than proving the clinical effectiveness or diagnostic accuracy of the qSOFA tool itself (which is already established in clinical practice). Therefore, traditional clinical performance study details (like sensitivity, specificity, expert ground truth, etc.) are not present in this 510(k) summary.

Ask a specific question about this device