(255 days)
The PARI Proneb Max is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers with patients for whom doctors have prescribed medication. It is intended for adult and pediatric patients 2 years and older, and may be used in hospital-type facilities, nursing homes, sub-acute institutions and home environments.
The Proneb Max is a tabletop air compressor for use with jet nebulizers, which aerosolize liquid medications for inhalation by patients with respiratory diseases and conditions. The Proneb Max is to be used with adult and pediatric patients ages 2 years and older, and is intended for sale by prescription only. It may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments. It is provided non-sterile.
The Proneb Max compressor creates an airflow that travels to the nebulizer through tubing. The nebulizer is attached to the compressor for its operation. The Proneb Max compressor is constructed of (1) Teflon; (2) ABS; (3) PBT GF30 and, has the following principal internal subcomponents: (1) cylinder/valve system; (2) piston rod/piston sealing: (3) a patient interface (on/off switch): (4) motor 120V/60Hz: (5) power cord/wire harness; and (6) hoses. Energy source for the device is provided by connection to a 120V/60 Hz mains power source.
The provided text describes the Proneb Max nebulizer compressor and its substantial equivalence to predicate devices, primarily the PARI Vios and the reference device Proneb Ultra. However, it does not contain information about a study proving the device meets acceptance criteria in the context of an AI/human reader performance study.
The acceptance criteria and reported performance in this document relate to the engineering and performance characteristics of a medical device (a nebulizer compressor), not the performance of an AI system or human readers. Therefore, I cannot construct a table based on AI/human reader performance, nor can I answer questions about sample sizes, expert ground truth, adjudication methods, or MRMC studies in the context of AI.
The document discusses nonclinical performance testing for the Proneb Max, including:
- Gas Path Testing: Evaluated for harmful gases (Ozone, CO, CO2, VOCs) and particulates (PM 2.5).
- Acceptance Criteria: Met all applicable standards.
- Reported Performance: "All air quality tests concluded that the subject device meets applicable standards."
- Electrical Safety and Electromagnetic Compatibility (EMC): Tested to IEC 60601-1, -2, -6, -11, and IEC 62366.
- Acceptance Criteria: Met applicable requirements of the listed standards.
- Reported Performance: "Testing establishes that, with respect to electrical safety, the Proneb Max meets the applicable requirements..."
- Aerosol Characterization: Compared MMAD, GSD, FPF, and FPD with the reference device Proneb Ultra using PARI jet nebulizer cups.
- Acceptance Criteria: Statistically equivalent to the reference Proneb Ultra.
- Reported Performance:
- MMAD: Statistically equivalent to reference Proneb Ultra.
- GSD: Statistically equivalent to reference Proneb Ultra.
- FPF: Statistically equivalent to reference Proneb Ultra.
- FPD: Statistically equivalent to reference Proneb Ultra.
- Numerical Data Provided (Table 1):
Metric Proneb Max / LC Plus (Atrovent) Proneb Max / LC Plus (Sultanol) Proneb Max / LC Plus (Pulmicort) Proneb Ultra / LC Plus (Atrovent) Proneb Ultra / LC Plus (Sultanol) Proneb Ultra / LC Plus (Pulmicort) Mean values MMAD (µm) 4.1 4.0 6.1 4.1 3.8 6.0 GSD (µm) 2.2 2.2 1.8 2.2 2.2 1.8 Fine Particle Fraction (%) 58 59 35 58 61 36 Fine Particle Dose (µg) 121 712 122 125 710 127
- Simulated Use Test: Assessed if the device remained within specification over its stated useful life.
- Acceptance Criteria: Remained within the specifications stated in the IFU.
- Reported Performance: "The testing concluded that the device remained within the specifications stated in the IFU."
- Mechanical Testing (Packaging Drop Test, Environmental Conditions Test): Evaluated packaging integrity and optimal operating conditions.
- Acceptance Criteria: Packaging satisfactory for transport/storage/sales; relevant environmental conditions established.
- Reported Performance: "The testing concluded that the packaging is satisfactory for the envisioned uses."; "The testing established these environmental conditions."
In summary, the provided document details the regulatory clearance of a nebulizer compressor based on its physical and performance characteristics, demonstrating substantial equivalence to existing devices through non-clinical testing. It does not describe an AI-driven system or a study involving human readers.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).