(257 days)
The 3B and BMC RESmart® BPAP system is a Bi-level PAP (Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The optional integrated humidifier is indicated for the humidification and warming of air from the flow generator device. These devices are intended for single-patient use by prescription in the home or hospital/intuitional environment on adult patients. It is to be used on patients (>66lbs/30kg) for whom positive airway pressure therapy has been prescribed. The system can deliver bi-level therapy or auto bi-level therapy.
The RESmart BPAP is a microprocessor controlled blower based bilevel positive pressure system that delivers two different positive pressure levels (IPAP/EPAP) from 4 to 25 cmH₂O. The dual pressure levels provide a more natural means of delivering pressure support therapy to the patient resulting in improved patient comfort. Two operation modes are being introduced, including the Auto Bi-Level mode and Spontaneous Bi-Level mode. Bi-Level therapy with automatically adjusting IPAP and EPAP levels is delivered in the Auto Bi-Level mode at the prescribed pressure range. The Spontaneous Bi-Level mode delivers fixed prescribed inspiratory and expiratory pressure. The BPAP device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask).
This document is a 510(k) summary for the RESmart® BPAP 25A device, which is a Bi-level Positive Airway Pressure (BPAP) device. The purpose of this submission is to demonstrate substantial equivalence to predicate devices, not to establish new acceptance criteria through clinical trials. Therefore, much of the requested information about acceptance criteria and study details for proving a device meets them is not present in this type of document.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document states that "Extensive testing was conducted in accordance with ISO 17510-1:2007, Sleep Apnea Breathing Therapy-Part I: Sleep Apnea Breathing Therapy Equipment." and mentions several performance aspects. It also states, "Design verification tests were performed on the RESmart BPAP to ensure product requirements and evaluate risk analysis. All tests were verified to meet the required acceptance criteria." However, the specific quantitative acceptance criteria and their corresponding reported performance values are not explicitly listed in a table format in this summary.
Based on the text, we can infer some general performance aspects that met their acceptance criteria, likely established by the ISO standard and internal design verification:
| Performance Aspect | Acceptance Criteria (Inferred from ISO 17510-1:2007 and general safety/performance standards) | Reported Device Performance |
|---|---|---|
| Max Flow Rate | Meets requirements for patient ventilation (specific value not provided) | Substantially equivalent to predicate device |
| Static Pressure | Within acceptable limits for therapy delivery (specific value not provided) | Substantially equivalent to predicate device |
| Dynamic Pressure | Within acceptable limits for therapy delivery (specific value not provided) | Substantially equivalent to predicate device |
| Sound Pressure | Within acceptable limits for patient comfort (specific value not provided) | Substantially equivalent to predicate device |
| Air Quality | Meets safety and quality standards (specific metrics not provided) | Substantially equivalent to predicate device |
| Electrical Safety | Meets all requirements of IEC 60601-1 | Meets all requirements of IEC 60601-1 |
| EMC | Meets all requirements of IEC 60601-1 | Meets all requirements of IEC 60601-1 |
| Bi-level Functionality | Achieves dual pressure delivery of IPAP and EPAP as intended (specific metrics not provided) | Functionally equivalent to predicate device (Respironics BiPAP Auto) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify a "test set" in the context of human subjects or clinical data for performance evaluation. The testing described appears to be primarily bench testing and engineering verification. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since the document describes bench testing and engineering verification rather than a clinical study with a "ground truth" derived from expert diagnosis, this information is not applicable and therefore not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As no clinical test set requiring expert adjudication is described, this information is not applicable and therefore not provided.
5. 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:
This document describes a medical device (BPAP system) for the treatment of Obstructive Sleep Apnea, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and not mentioned in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone medical device that delivers therapy. The "algorithm" mentioned refers to the software controlling the bi-level functionality. The performance testing outlined (max flow rate, static pressure, dynamic pressure, sound pressure, air quality, electrical safety, EMC) inherently evaluates the device's standalone performance, including its embedded algorithms, against engineering and safety standards. There is no mention of a separate "standalone algorithm only" performance study in the context of a human-in-the-loop comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the engineering and performance testing described, the "ground truth" would be established by the specified engineering standards (e.g., ISO 17510-1:2007, IEC 60601-1) and the performance characteristics of the predicate device. For example, the ground truth for electrical safety is defined by the IEC 60601-1 standard. For functional equivalence, the performance of the predicate device (Respironics BiPAP Auto) serves as the reference.
8. The sample size for the training set:
The term "training set" is typically used in the context of machine learning. While the device contains a microprocessor and software with an algorithm for bi-level functionality, this document does not describe the development or training of a machine learning model. Therefore, a "training set" in that sense is not applicable and not mentioned.
9. How the ground truth for the training set was established:
As there is no mention of a machine learning training set, this information is not applicable. The "ground truth" for the device's design and performance is based on engineering principles, safety standards, and the performance characteristics of the predicate device.
§ 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).