(111 days)
The BiPAP A30 ventilator is intended to provide non-invasive ventilatory support to treat adult and pediatric patients weighing over 10 kg (22lbs) with Obstructive Sleep Apnea (OSA and Respiratory Insufficiency. It is intended to be used in both the home and clinical settings, such as hospitals, sleep laboratories, and sub-acute care institutions.
The Respironics BiPAP A30 Ventilatory Support System is a microprocessor controlled blower based positive pressure ventilatory system with integrated heated humiditier. The device platform being used as the key topic for this submission was previously cleared in K092818. The same ventilation modalities and therapy features, previously cleared in K071509 is also included in the BiPAP A30 Ventilatory Support System, which is the topic of this submission. These modes and therapy features include: CPAP, Spontaneous, Spontaneous/Timed, Pressure Control modes with Bi-Flex or AVAPS therapy features available if enabled by the health care professional.
A Graphical user interface displays device data and device settings.
The BiPAP A30 Ventilatory Support System is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.
Like its predicates, the BiPAP A30 Ventilatory Support 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 tubing, an exhalation device, and a patient interface device.
The provided text describes a 510(k) submission for the Philips Respironics BiPAP A30 Ventilatory Support System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria from an AI/performance perspective.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance with metrics) are not applicable or not available in the provided text, as the submission predates the typical AI/ML device assessment framework and focuses on hardware and software verification testing.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states: "All tests confirmed the product met the predetermined acceptance criteria." and "All tests were verified to meet the required acceptance criteria." It also mentions "Performance testing comprises pressure performance, trigger and cycling, as well as volume assured pressure support ventilation." However, specific quantitative acceptance criteria and corresponding performance metrics are not explicitly listed in a table format in the provided text.
The text emphasizes compliance with various standards, which implicitly define performance criteria.
| Acceptance Criteria (Implied by Compliance) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1 (Medical electrical equipment) | "passing all test protocols" |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | "passing all test protocols" |
| Compliance with EN ISO 8185 (Humidifiers for Medical Use) | "passing all test protocols" |
| Compliance with ISO 10651-6 (Home care ventilatory support devices) | "passing all test protocols" |
| Compliance with FDA Draft Reviewer Guidance for Ventilators (July 1995) | "The new device complies with the applicable requirements" |
| Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) | "The new device complies with the applicable requirements" |
| Design verification tests from risk analysis and product requirements | "All tests were verified to meet the required acceptance criteria." |
| Pressure performance | Confirmed to meet predetermined acceptance criteria |
| Trigger and cycling performance | Confirmed to meet predetermined acceptance criteria |
| Volume assured pressure support ventilation performance | Confirmed to meet predetermined acceptance criteria |
| Substantial Equivalence to predicate devices | "demonstrated that the BiPAP A30 is Substantially Equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the text. The submission focuses on device verification and bench testing, not clinical studies with patient data in the context of AI/ML evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the text. There is no mention of expert involvement in establishing ground truth for a test set, as this is a traditional medical device submission for a ventilatory support system, not an AI/ML diagnostic or prognostic tool.
4. Adjudication Method for the Test Set
This information is not provided in the text. No adjudication method is mentioned, as the focus is on engineering verification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. The submission is for a ventilatory support system and does not involve AI assistance for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a ventilatory support system and has software components, but it is a physical medical device. The "standalone" performance in this context refers to the device functioning according to its design specifications (e.g., delivering correct pressures, reacting to patient triggers). This was addressed through general "Performance Data" and "Design and Verification activities" and "bench testing." Specific standalone performance metrics as would be presented for an AI algorithm are not provided.
7. The Type of Ground Truth Used
For a ventilatory support system, the "ground truth" would be the engineering specifications and established physiological parameters for ventilation. Testing would involve calibrated equipment and simulated physiological conditions to verify the device's output against these known standards. The text implies standard engineering and physiological benchmarks are used as ground truth for testing device functionality (e.g., pressure output, trigger responsiveness).
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this traditional medical device submission. The device is not described as an AI/ML system that undergoes a training phase with a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable. As stated above, this is not an AI/ML device that requires a training set and associated ground truth establishment in the modern sense.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).