Search Results

The Evo Heated Humidifier is intended to warm and add moisture to the breathing gases for administration to a patient. It is used for patients requiring Continuous Positive Airway Pressure (CPAP) therapy for the treatment of Obstructive Sleep Apnea. The addition of heated humidification to this therapy relieves the drying and irritating effects on the patient airways, which may arise from the use of a CPAP system. Use only with RemRest 900 series CPAP devices. It is portable and is intended to be used in the home, hospital, and institutional settings.

The RemRest Heated Humidifier is a simple heated humidifier to be used with a CPAP device to provide heated and humidified air to the patient. It operates by a conductive heating surface warming a water reservoir and air passes over the water. The device has the following basic specifications: Size 13.1" L x 8.4" W x 4.7" H, Weight 2.5 lbs. dry, Water capacity 400 ml (1 2/3 cups), Power 100-240 VAC 50/60Hz or 1.0 A max., Heater setting 1-5 (85°F to 149°F / 29.4°C to 65°C), Humidity Range 30 mg H2O/l @ 25 lpm, Pressure drop 0.5 cm H2O @ 40 lpm.

The provided text is a summary of safety and effectiveness for the RemRest heated humidifier and does not describe acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

The TransNeb compressor/nebulizer includes a DC powered air compressor that provides a source of compressed air for home health care use. The compressor is used with a venturi (pneumatic nebulizer) to convert certain inhaled drugs into an acrosol form for inhalation by a patient. The device can be used with adult or pediatric patients.

The TransNeb system consists of a nebulizer and a DC powered piston-type compressor that generates compressed air. Small, lightweight and designed for convenience, the TransNeb device offers the user a choice of running off of AC power via a universal adapter or DC power via an option 12 volt auto adapter or an optional rechargeable battery pack. The device consists of a motor driven piston compressor, a printed circuit board and a switch. The circuit board does not incorporate a microprocessor but serves as a means to prevent double feed of power. The circuit board is not a part of the charging circuit for the battery pack. The nebulizer, which employs a venturi effect to convert the medication into a fine aerosol mist, is used cither snapped directly onto the compressor outlet barb or with an extension tube. Providing a connection between the compressor outlet barb and the nebulizer bottom, the extension tube allows the user to place the compressor on a sturdy surface and to simply hold onto the nebulizer. The nebulizer is designed for single patient and is reusable. The nebulizer with or without its tubing adapter is designed specifically for use only with the TransNeb compressor.

This document describes the TransNeb System, a nebulizer compressor intended for home health care use. It provides general information about the device's function, design, and a comparison to predicate devices, but it does not contain information about a study that tests or proves acceptance criteria for an AI/ML powered device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance as the provided text pertains to a traditional medical device (nebulizer compressor), not an AI/ML-powered device. The document is a 510(k) summary for a Nebulizer Compressor.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

The model 3050 "Sport-Neb" is a small air compressor designed to provide sufficient air pressure and flow to power a hand held nebulizer such as the Salter #8900.

The Model 3050 "sport-Neb" is a small, lightweight, nebulizer compressor. It measures 7 1/2" X 7 1/2" X 4 1/2" The housing is groupe The housing is grey switch, filter housing, AC cord and the air outlet barb. An optional carry bag will be offered to store the patients hand held nebulizer. The handle is built into the housing The operating components are located internally. The compressor, some minor wiring and the exhaust/intake plumbing are located inside.

This document describes a medical device, the Model 3050 "Sport-Neb" compressor, and references a predicate device, the Model 3002 "AEROMAX". However, it does not contain information about acceptance criteria, device performance metrics, or any studies proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information in the format of a table or answer the specific questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document primarily focuses on:

• Device Description: Physical characteristics and internal components of the "Sport-Neb" and its predicate, the "AEROMAX".
• Intended Use: Stating that the "Sport-Neb" has the same intended use as the "AEROMAX."
• Comparison to Predicate: Highlighting that the "Sport-Neb" is "virtually the same as the 'AEROMAX' with the exception of the case which is smaller and more portable."

To answer your questions, additional documentation detailing performance specifications and testing would be required.

Ask a specific question about this device