(101 days)
To provide CPAP to spontaneously breathing patients in the hospital, prehospital (EMS) and sub-acute / alternate site facility environments via Face Mask or endo-tracheal tube.
The device provides CPAP support for the care of spontaneously breathing individuals who require oxygen assistance. The device is a restricted medical device for use by qualified medical personnel under the direction of a physician. The device may be used in pre-hospital environments, inter and intra-hospital patient transport, air and ground transport, and all areas of the hospital (NOT for use in the presence of flammable anesthetics or in the MRI). MACS has been specifically designed for ruggedness and ease of use.
The MACS CPAP device uses accessories during normal operation. The primary accessory is a patient tubing circuit and positive airway pressure face mask to attach the device to the patient. The patient circuit and face mask are single-use disposables. The patient circuit is the same circuit included with the previously cleared Pneuton Ventilator K024344 and K043085.
The provided text describes the MACS CPAP System and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the manner described by the request points (e.g., performance metrics, sample sizes, expert adjudication, MRMC studies, or training sets for AI/algorithm performance).
The document details the device's description, intended use, and a comparison with predicate devices in terms of characteristics like environments of use, personnel requirements, operating principle, and safety features. It then summarizes non-clinical testing and validation.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Missing. The document states: "All functions as listed in the specifications have been validated. The device meets all test requirements as identified in the FDA Draft Emergency Resuscitator Guidance (April, 1993)." However, it does not provide a table outlining specific acceptance criteria values (e.g., pressure accuracy within X mmHg, flow rate within Y L/min) or the exact reported performance values achieved by the MACS CPAP system against these criteria. It only makes a general statement of compliance.
2. Sample size used for the test set and the data provenance
Missing. The document states, "Clinical testing was not performed on this device. Safety and efficacy were established through non-clinical testing." This implies that no human patient data (test set) was used in the evaluation for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing. Since clinical testing was not performed and no human data test set was used, there's no mention of experts establishing ground truth for evaluating the device's performance in a clinical context.
4. Adjudication method for the test set
Missing. No clinical test set means no adjudication method was used.
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
Not applicable/Missing. This device is a CPAP system, not an AI or imaging diagnostic device that would involve human "readers" or an MRMC study comparing human performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Missing. This is a hardware medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing/Not applicable in the AI/algorithm context. For regulatory purposes, the "ground truth" for a device like this would typically be established by validated test equipment and simulation environments per engineering and performance standards. The document mentions compliance with ISO standards (ISO 10651-5:2006, ISO 5356-1:2004, CGA V-5:2005) and the FDA Draft Emergency Resuscitator Guidance, implying that performance was measured against these technical benchmarks.
8. The sample size for the training set
Not applicable/Missing. This is not an AI/algorithm device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable/Missing. No training set exists for this type of device.
In summary, the provided document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant non-clinical standards and guidance documents for a mechanical CPAP system. It does not provide the detailed information requested regarding acceptance criteria and performance evaluation methodology that would be typical for an AI/algorithm-based medical device.
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).