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The Respironics BiPAP Plus M Series Bi-level System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.

The Respironics BiPAP Plus M Series Bi-level System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humiditier. The device platform and fundamental technology is based on the Respironics REMstar Pro M Series CPAP System (K052110). The BiPAP Plus M Series Bi-level System includes the flex therapy feature cleared in K043607, which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. Like its predicate, the BiPAP Plus M Series Bilevel System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, an exhalation device, and a patient interface device.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Respironics BiPAP Plus M Series Bi-level System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not include a specific table of acceptance criteria or detailed reported device performance. It broadly states: "Design verification tests were performed on the Respironics BiPAP Plus M Series Bi-level System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."

Therefore, I cannot populate the table with specific metrics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Design verification tests."

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts or the establishment of ground truth for any specific test set. The submission focuses on device design verification rather than clinical outcomes or diagnostic accuracy studies.

4. Adjudication Method

No information is provided about an adjudication method, as there's no mention of expert review or clinical studies requiring such a process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. This submission is for a modified respiratory therapy device, not a diagnostic or AI-assisted system that would typically involve such studies.

6. Standalone Performance Study

The document does not explicitly describe a standalone performance study in terms of algorithm-only performance. The "Design verification tests" are likely related to the device's functional and safety specifications, not its standalone interpretative accuracy.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used. Given the nature of a 510(k) for a modified respiratory device, "ground truth" would likely refer to engineering specifications, performance standards, and safety requirements met through design verification.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This type of information is typically provided for AI/ML-based devices, which this BiPAP system is not described as.

9. How Ground Truth for the Training Set Was Established

Since no training set is mentioned, there is no information on how ground truth for a training set was established.

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