Search Results

The intended use of the LoFlo C5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.

The LoFlo C5 CO2 sensor is designed for continuous, non-invasive sidestream monitoring of carbon dioxide. Carbon dioxide is measured on-airway using an infrared absorption (IR) technique. The airway adapters and associated nasal cannulas are already legally marketed as accessories to the predicate device. The LoFlo C5 CO2 sensor is an integrated microprocessor based data acquisition system consisting of CO2 measurement, control circuitry and a high speed serial interface. The LoFlo C5 CO2 sensor uses SRAM for data storage and an EEPROM to store system parameters. The firmware resides in a PROM. The operations performed by the LoFlo C5 CO2 sensor include data acquisition, parameter calculation, zeroing, heater control and corrections to the CO2 signal for N2O, O2 and barometric pressure.

The provided text is a 510(k) summary for a medical device (LoFlo C5 CO2 Sensor) and does not contain detailed information about acceptance criteria or specific study results that prove the device meets acceptance criteria. The document mainly focuses on describing the device, its intended use, technological characteristics, and its substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information about acceptance criteria and study details from this document.

The following information is NOT available in the provided text:

1. A table of acceptance criteria and the reported device performance: The document does not specify any quantitative acceptance criteria or report performance metrics against such criteria.
2. Sample size used for the test set and the data provenance: No information on test set sample sizes or data provenance (country of origin, retrospective/prospective) is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The concept of "ground truth" and expert involvement for a test set is not discussed.
4. Adjudication method for the test set: No information is given regarding adjudication methods.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: MRMC studies and effect sizes are not mentioned.
6. If a standalone study (algorithm only without human-in-the-loop performance) was done: Standalone performance testing is not detailed.
7. The type of ground truth used: The establishment of ground truth is not described.
8. The sample size for the training set: Training set information is not provided.
9. How the ground truth for the training set was established: Ground truth establishment for a training set is not discussed.

Ask a specific question about this device