(218 days)
Heated wire circuits to be used with the SCT 3000 are indicated as breathing circuits for patients under going anesthesia or mechanical ventilation.
Various configurations of anesthesia, volume ventilator circuits and heated limbs for use with SCT 3000 Heated Humidifier.
The provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. Instead, the document describes "Heated wire breathing circuits and limbs" and compares them to predicate devices, focusing on attributes like intended use, design, and materials.
The document discusses "Performance Testing" by stating that the device "Meets ASTM breathing systems standard," but it doesn't provide details about:
- Specific acceptance criteria: What are the numerical or qualitative thresholds that define "meeting the ASTM standard" for this device?
- A study proving compliance: There's no description of a study (e.g., methodology, results, sample sizes) that demonstrates the device actually meets the ASTM standard.
Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, or study types like MRMC or standalone. The document's purpose is to outline the device's characteristics and its similarity to existing devices for regulatory submission, not to detail the results of a performance study against specific acceptance criteria.
§ 868.5270 Breathing system heater.
(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).