(91 days)
Like the predicate devices, the North State Plastics Respiratory Mouthpiece is intended for use in providing a direct source of continuous aerosol medication.
The device is injection molded from rigid, clean, chemically inert High Density Polyethylene. The Mouthpiece is equipped with a standard 22mm OD fitting for connection to most aerosol devices.
This 510(k) summary is for a North State Plastics Respiratory Mouthpiece, which is a medical device accessory and not an AI/software as a medical device (SaMD). Therefore, the requested information regarding acceptance criteria, study details, AI performance, ground truth, and sample sizes for training/testing datasets is not applicable to this type of device submission.
Here's why:
- Type of Device: This device is a physical accessory (a mouthpiece) used to deliver aerosol medication. It doesn't involve any algorithms, AI, or software for diagnosis, prognosis, or treatment decisions.
- Regulatory Pathway: The submission is a 510(k), demonstrating "substantial equivalence" to existing predicate devices. For mechanical accessories like this, substantial equivalence is primarily based on:
- Intended Use: The North State Plastics Respiratory Mouthpiece has the same intended use as predicate devices (providing a direct source of continuous aerosol medication).
- Technological Characteristics: It's made of similar materials (High Density Polyethylene), has a standard fitting (22mm OD), and is simplistic in design, just like predicate devices.
- Performance: For simple mechanical accessories, performance is typically confirmed by demonstrating that it functions as intended (e.g., provides a connection for aerosol delivery) and doesn't introduce new safety concerns. This often doesn't require extensive clinical studies or AI performance metrics.
Therefore, I cannot populate the table or answer the specific questions about AI/algorithm performance, ground truth, expert consensus, or sample sizes for diagnostic/prognostic models because those concepts do not apply to this medical device.
The provided text only discusses the device's equivalence to existing devices based on its intended use, design, and materials, which are typical for physical accessories.
§ 868.5620 Breathing mouthpiece.
(a)
Identification. A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.