Search Results

Not Found

The Spegas MicroCap/NPB-75 and the comparison device Gemini+ (K950387) are integrated instruments that measure end tidal CO2 (EtCO2) and saturated arterial oxygen (SpO2). As a derivative of the EtCO2 measurement the devices measure and display the breath rate (BR) and as a derivative of the saturated arterial oxygen measurement the devices measure and display the pulse rate (PR). The capnograph section of both devices function as a carbon dioxide gas analyzer that measures in mmHg, Vol %, or kPa the concentration of CO2 in a gas mixture to aid in determining the patient's ventilatory status. The pulse oximeter module in both devices measures the oxygenated hemoglobin (HbO2) and displays the results as a percent of oxygen and as a plethysmographic waveform. The Spegas MicroCap/NPB-75 pulse oximeter module is essentially identical to the Spegas Gemini+ (K950387) pulse oximeter module. The Gemini+ uses the Nellcor M-203 Spon module and the MicroCap/NPB-75 utilizes the Nellcor MP-204 module. The MP-204 SpO2 module is very similar, essentially equivalent, to the MP-203 module. Spegas integrates the Nellcor MP-204, without alteration, into the MicroCap/NPB-75 and Gemini (MP203).

This looks like a 510(k) premarket notification for a medical device called "Spegas MicroCap/NPB-75." This document primarily focuses on establishing substantial equivalence to a predicate device and describing the device's functions. It does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance validation study would.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone performance information.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The provided text only states that the device measures EtCO2, SpO2, breath rate (BR), and pulse rate (PR) and is substantially equivalent to a previously cleared device (Spegas Gemini+, K950387). The "substantial equivalence" claim is the primary evidence presented in this type of document, meaning it's considered safe and effective because it's essentially the same as a device already on the market.

To answer your request, you would typically need a performance validation report or clinical study summary, which is not present in the provided text.

Ask a specific question about this device