(455 days)
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) include an AC powered air compressor that provides a source of compressed air for home health care use. The compressor is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatic patients (4 years and older).
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) is a small, piston-type air compressor, sized to provide the proper flow and pressure sufficient to power jet (pneumatic) nebulizers. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device.
When the compressor is used in conjunction with a therapeutic nebulizer set, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter.
The provided document is a 510(k) summary for the JLN-23XX Series Piston Compress Nebulizer. It describes the device, its indications for use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not describe a study involving an AI/Machine Learning device or a study comparing human readers with and without AI assistance.
The "device" in question is a physical nebulizer, not an AI or software algorithm. The "acceptance criteria" and "device performance" discussed refer to the physical and electrical specifications of the nebulizer and its ability to aerosolize drugs, demonstrated through laboratory testing.
Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the device described in this document.
The document focuses on demonstrating substantial equivalence for a physical medical device (nebulizer) based on:
- Identical Indications for Use: Both the proposed and predicate devices are used to convert inhalable drugs into aerosol form for inhalation by adult and pediatric patients (4 years and older).
- Similar Technological Characteristics: The comparison table (Table 1) highlights similar compressor type (piston), electrical requirements, operating conditions (temperature, humidity), and various performance parameters like flow rate, max pressure, and noise level.
- Non-Clinical Bench Testing: The non-clinical tests specifically verify the device's electrical safety (IEC 60601-1, IEC 60601-1-2), EMC protection, noise, pressure, flowrate, and biocompatibility. Crucially, a particle size distribution test was performed to compare the proposed device's aerosol output with that of the predicate device, demonstrating equivalent performance.
- No Clinical Tests Performed: The document explicitly states "Not Applicable" for clinical tests, which is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data.
§ 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).