(233 days)
The Model 9055 Bilevel CPAP is intended for use in treating obstructive sleep apnea in adult patients.
The new DeVilbiss Model 9055 Bilevel CPAP is an AC powered, dual-pressure blower designed to be used in providing CPAP therapy to the spontaneously breathing adult patient population with Obstructive Sleep Apnea. Rapid changes in pressure between EPAP (Expiratory Positive Airway Pressure) and IPAP (Inspiratory Positive Airway Pressure) will be achieved by changing the operating speed of the blower. The bilevel device will have two primary prescription settings: IPAP pressure and EPAP pressure. Electrical power is supplied to the unit using an AC line cord (100 – 240 VAC, 50/60Hz, 400 Hz). The AC input voltage is converted to a DC voltage by an internal switch-mode power supply. The DC voltage is used to power the internal electronics of the product (microcontroller, motor control circuitry, blower, LCD display, etc.). Positive pressure is produced by spinning a reverse-curved impeller with a brushless DC motor. Room air is drawn into the blower through a filter, pressurized in the blower, and then discharged through a 22 mm ID tube.
This 510(k) summary does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) that would typically be found in a study report for a diagnostic device utilizing AI.
This document describes a Bilevel CPAP device (DeVilbiss Model 9055), which is a medical device for treating Obstructive Sleep Apnea. The FDA cleared this device based on substantial equivalence to existing predicate devices, not on a new clinical study assessing its performance against specific acceptance criteria in the way you've outlined for things like diagnostic accuracy.
Therefore, many of your specific questions cannot be answered from this document. I will answer what is available and explain why other information is not present.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)
For this type of device, "acceptance criteria" are related to performance characteristics and safety, demonstrating that the new device performs as well as, or equivalently to, the predicate devices. The "study" for this submission is a comparison to legally marketed predicate devices, not a new clinical trial generating performance metrics like sensitivity/specificity for a diagnostic AI.
| Criteria Category | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as stated in the 510(k)) |
|---|---|---|
| Intended Use | The device must be intended for use in treating Obstructive Sleep Apnea (OSA) in spontaneously breathing adult patients by applying positive air pressure. | "The DeVilbiss Model 9055 Bilevel CPAP is intended for use in treating OSA in spontaneously breathing adult patients by means of application of positive air pressure." "The Model 9055 Bilevel CPAP is intended for use in treating obstructive sleep apnea in adult patients." This matches the predicate devices. |
| Functional Equivalence | The device must provide dual pressures (IPAP and EPAP) for OSA treatment and achieve rapid changes in pressure between EPAP and IPAP, functioning similarly to predicate devices. | "The new dual pressure level CPAP is designed to provide rapid changes in air pressure between EPAP (expiratory positive airway pressure) and IPAP (inspiratory positive airway pressure)." "The DeVilbiss Model 9055 Bilevel CPAP is equivalent in functional characteristics to the existing legally marketed predicate devices. The devices all utilize a microprocessor controlled system to provide a range of dual pressures (IPAP and EPAP) for the treatment of Obstructive Sleep Apnea." This matches the predicate devices. |
| Technological Equivalence | The device must not introduce new technologies compared to predicate devices and utilize similar or identical materials and construction. | "No new technologies have been introduced in the Model 9055 Bilevel CPAP device." "The compressor is constructed of materials, both metal and plastic, that are similar or identical to legally marketed devices." |
| Safety and Standards Compliance | The device must comply with applicable electrical and mechanical safety standards for this type of device. | "The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device." "All of the devices are tested and approved to recognized agency safety standards." (Implies compliance, but specific standards not listed in the provided text). |
Detailed Study Information (Not Present in the Provided Document):
This submission is a 510(k) for a medical device (Bilevel CPAP machine), not an AI/diagnostic software. Therefore, the concepts of "test sets," "ground truth," "expert consensus," "MRMC studies," or "training sets" as they apply to AI/machine learning studies are not applicable here and are not mentioned in the provided text.
- Sample size used for the test set and the data provenance: Not applicable. This is a hardware device; testing would involve engineering, performance, electrical safety, and biocompatibility, not analysis of a "test set" of patient data for diagnostic accuracy.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI for human reader assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device would be its ability to consistently deliver specified pressures and its compliance with safety standards, evaluated through engineering tests and comparison to predicate devices, not clinical pathology or outcomes data in the context of an AI study.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).